Treatment with Repository Corticotropin Injection in Patients with Rheumatoid Arthritis, Systemic Lupus Erythematosus, and Dermatomyositis/Polymyositis
Identifieur interne : 000758 ( Pmc/Corpus ); précédent : 000757; suivant : 000759Treatment with Repository Corticotropin Injection in Patients with Rheumatoid Arthritis, Systemic Lupus Erythematosus, and Dermatomyositis/Polymyositis
Auteurs : Nancy Ho-Mahler ; Beni Turner ; Michael Eaddy ; Mark L. Hanke ; Winnie W. NelsonSource :
- Open Access Rheumatology : Research and Reviews [ 1179-156X ] ; 2020.
Abstract
Repository corticotropin injection (RCI) is indicated for a number of autoimmune-mediated diseases including rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), and dermatomyositis (DM)/polymyositis (PM). To better understand the practice patterns and outcomes of RCI in patients with RA, SLE, or DM/PM, we conducted a retrospective medical record analysis.
Participating providers selected deidentified medical records of patients meeting the inclusion criteria (age ≥18 years; physician-reported diagnosis of RA, SLE, or DM/PM; initiation of treatment with RCI between 1/1/2011 and 2/15/2016; ≥3 in-office visits with same site/provider). Collected data spanned 12 months before and after the first prescription date for RCI. Analyses included patient demographics and clinical history, RCI treatment patterns, and physician’s impression of change.
Data from 54 patients with RA, 30 patients with SLE, and 8 patients with DM/PM were analyzed. The most frequently reported reasons for initiating RCI were lack of efficacy with prior treatment, acute exacerbation of disease, and use as add-on to ongoing therapy. The most common initial RCI dosing, 80 U twice weekly, was used for 84% of patients with RA, 75% with SLE, and 86% with DM/PM. The mean duration of treatment was 4.8, 6.5, and 6.8 months for RA, SLE, and DM/PM, respectively. Among the 57 patients with data on physician’s impression of change with RCI, 78.1% of patients with RA, 94.7% with SLE, and 66.7% with DM/PM had a rating of “improved,” and the mean time to best impression of change was 3.4, 4.3, and 3.4 months for RA, SLE, and DM/PM, respectively.
This study reports the real-world patient profile, use patterns, and outcomes of patients who used RCI for the treatment of RA, SLE, and DM/PM. These data can inform appropriate use and clinical expectations when using RCI.
Url:
DOI: 10.2147/OARRR.S231667
PubMed: 32110122
PubMed Central: 7039080
Links to Exploration step
PMC:7039080Le document en format XML
<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Treatment with Repository Corticotropin Injection in Patients with Rheumatoid Arthritis, Systemic Lupus Erythematosus, and Dermatomyositis/Polymyositis</title><author><name sortKey="Ho Mahler, Nancy" sort="Ho Mahler, Nancy" uniqKey="Ho Mahler N" first="Nancy" last="Ho-Mahler">Nancy Ho-Mahler</name><affiliation><nlm:aff id="AFF0001"><institution>Mallinckrodt Pharmaceuticals</institution>,<addr-line>Bedminster</addr-line>,<addr-line>NJ</addr-line>,<country>USA</country></nlm:aff></affiliation></author><author><name sortKey="Turner, Beni" sort="Turner, Beni" uniqKey="Turner B" first="Beni" last="Turner">Beni Turner</name><affiliation><nlm:aff id="AFF0002"><institution>Xcenda</institution>,<addr-line>Palm Harbor</addr-line>,<addr-line>FL</addr-line>,<country>USA</country></nlm:aff></affiliation></author><author><name sortKey="Eaddy, Michael" sort="Eaddy, Michael" uniqKey="Eaddy M" first="Michael" last="Eaddy">Michael Eaddy</name><affiliation><nlm:aff id="AFF0002"><institution>Xcenda</institution>,<addr-line>Palm Harbor</addr-line>,<addr-line>FL</addr-line>,<country>USA</country></nlm:aff></affiliation></author><author><name sortKey="Hanke, Mark L" sort="Hanke, Mark L" uniqKey="Hanke M" first="Mark L" last="Hanke">Mark L. Hanke</name><affiliation><nlm:aff id="AFF0001"><institution>Mallinckrodt Pharmaceuticals</institution>,<addr-line>Bedminster</addr-line>,<addr-line>NJ</addr-line>,<country>USA</country></nlm:aff></affiliation></author><author><name sortKey="Nelson, Winnie W" sort="Nelson, Winnie W" uniqKey="Nelson W" first="Winnie W" last="Nelson">Winnie W. Nelson</name><affiliation><nlm:aff id="AFF0001"><institution>Mallinckrodt Pharmaceuticals</institution>,<addr-line>Bedminster</addr-line>,<addr-line>NJ</addr-line>,<country>USA</country></nlm:aff></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PMC</idno><idno type="pmid">32110122</idno><idno type="pmc">7039080</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7039080</idno><idno type="RBID">PMC:7039080</idno><idno type="doi">10.2147/OARRR.S231667</idno><date when="2020">2020</date><idno type="wicri:Area/Pmc/Corpus">000758</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Corpus" wicri:corpus="PMC">000758</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Treatment with Repository Corticotropin Injection in Patients with Rheumatoid Arthritis, Systemic Lupus Erythematosus, and Dermatomyositis/Polymyositis</title><author><name sortKey="Ho Mahler, Nancy" sort="Ho Mahler, Nancy" uniqKey="Ho Mahler N" first="Nancy" last="Ho-Mahler">Nancy Ho-Mahler</name><affiliation><nlm:aff id="AFF0001"><institution>Mallinckrodt Pharmaceuticals</institution>,<addr-line>Bedminster</addr-line>,<addr-line>NJ</addr-line>,<country>USA</country></nlm:aff></affiliation></author><author><name sortKey="Turner, Beni" sort="Turner, Beni" uniqKey="Turner B" first="Beni" last="Turner">Beni Turner</name><affiliation><nlm:aff id="AFF0002"><institution>Xcenda</institution>,<addr-line>Palm Harbor</addr-line>,<addr-line>FL</addr-line>,<country>USA</country></nlm:aff></affiliation></author><author><name sortKey="Eaddy, Michael" sort="Eaddy, Michael" uniqKey="Eaddy M" first="Michael" last="Eaddy">Michael Eaddy</name><affiliation><nlm:aff id="AFF0002"><institution>Xcenda</institution>,<addr-line>Palm Harbor</addr-line>,<addr-line>FL</addr-line>,<country>USA</country></nlm:aff></affiliation></author><author><name sortKey="Hanke, Mark L" sort="Hanke, Mark L" uniqKey="Hanke M" first="Mark L" last="Hanke">Mark L. Hanke</name><affiliation><nlm:aff id="AFF0001"><institution>Mallinckrodt Pharmaceuticals</institution>,<addr-line>Bedminster</addr-line>,<addr-line>NJ</addr-line>,<country>USA</country></nlm:aff></affiliation></author><author><name sortKey="Nelson, Winnie W" sort="Nelson, Winnie W" uniqKey="Nelson W" first="Winnie W" last="Nelson">Winnie W. Nelson</name><affiliation><nlm:aff id="AFF0001"><institution>Mallinckrodt Pharmaceuticals</institution>,<addr-line>Bedminster</addr-line>,<addr-line>NJ</addr-line>,<country>USA</country></nlm:aff></affiliation></author></analytic><series><title level="j">Open Access Rheumatology : Research and Reviews</title><idno type="eISSN">1179-156X</idno><imprint><date when="2020">2020</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec id="S2001"><title>Purpose</title><p>Repository corticotropin injection (RCI) is indicated for a number of autoimmune-mediated diseases including rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), and dermatomyositis (DM)/polymyositis (PM). To better understand the practice patterns and outcomes of RCI in patients with RA, SLE, or DM/PM, we conducted a retrospective medical record analysis.</p></sec><sec id="S2002"><title>Patients and Methods</title><p>Participating providers selected deidentified medical records of patients meeting the inclusion criteria (age ≥18 years; physician-reported diagnosis of RA, SLE, or DM/PM; initiation of treatment with RCI between 1/1/2011 and 2/15/2016; ≥3 in-office visits with same site/provider). Collected data spanned 12 months before and after the first prescription date for RCI. Analyses included patient demographics and clinical history, RCI treatment patterns, and physician’s impression of change.</p></sec><sec id="S2003"><title>Results</title><p>Data from 54 patients with RA, 30 patients with SLE, and 8 patients with DM/PM were analyzed. The most frequently reported reasons for initiating RCI were lack of efficacy with prior treatment, acute exacerbation of disease, and use as add-on to ongoing therapy. The most common initial RCI dosing, 80 U twice weekly, was used for 84% of patients with RA, 75% with SLE, and 86% with DM/PM. The mean duration of treatment was 4.8, 6.5, and 6.8 months for RA, SLE, and DM/PM, respectively. Among the 57 patients with data on physician’s impression of change with RCI, 78.1% of patients with RA, 94.7% with SLE, and 66.7% with DM/PM had a rating of “improved,” and the mean time to best impression of change was 3.4, 4.3, and 3.4 months for RA, SLE, and DM/PM, respectively.</p></sec><sec id="S2004"><title>Conclusion</title><p>This study reports the real-world patient profile, use patterns, and outcomes of patients who used RCI for the treatment of RA, SLE, and DM/PM. These data can inform appropriate use and clinical expectations when using RCI.</p></sec></div></front><back><div1 type="bibliography"><listBibl><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct></listBibl></div1></back></TEI><pmc article-type="research-article"><pmc-dir>properties open_access</pmc-dir>
<front><journal-meta><journal-id journal-id-type="nlm-ta">Open Access Rheumatol</journal-id><journal-id journal-id-type="iso-abbrev">Open Access Rheumatol</journal-id><journal-id journal-id-type="publisher-id">OARRR</journal-id><journal-id journal-id-type="pmc">rheu</journal-id><journal-title-group><journal-title>Open Access Rheumatology : Research and Reviews</journal-title></journal-title-group><issn pub-type="epub">1179-156X</issn><publisher><publisher-name>Dove</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="pmid">32110122</article-id><article-id pub-id-type="pmc">7039080</article-id><article-id pub-id-type="publisher-id">231667</article-id><article-id pub-id-type="doi">10.2147/OARRR.S231667</article-id><article-categories><subj-group subj-group-type="heading"><subject>Original Research</subject></subj-group></article-categories><title-group><article-title>Treatment with Repository Corticotropin Injection in Patients with Rheumatoid Arthritis, Systemic Lupus Erythematosus, and Dermatomyositis/Polymyositis</article-title><alt-title alt-title-type="running-authors">Ho-Mahler et al</alt-title><alt-title alt-title-type="running-title">Ho-Mahler et al</alt-title></title-group><contrib-group><contrib contrib-type="author"><contrib-id contrib-id-type="orcid" authenticated="false">http://orcid.org/0000-0003-4069-3617</contrib-id><name><surname>Ho-Mahler</surname><given-names>Nancy</given-names></name><xref ref-type="corresp" rid="AN0001"></xref><xref ref-type="aff" rid="AFF0001">1</xref></contrib><contrib contrib-type="author"><name><surname>Turner</surname><given-names>Beni</given-names></name><xref ref-type="aff" rid="AFF0002">2</xref></contrib><contrib contrib-type="author"><contrib-id contrib-id-type="orcid" authenticated="false">http://orcid.org/0000-0002-2896-8721</contrib-id><name><surname>Eaddy</surname><given-names>Michael</given-names></name><xref ref-type="aff" rid="AFF0002">2</xref></contrib><contrib contrib-type="author"><name><surname>Hanke</surname><given-names>Mark L</given-names></name><xref ref-type="aff" rid="AFF0001">1</xref></contrib><contrib contrib-type="author"><contrib-id contrib-id-type="orcid" authenticated="false">http://orcid.org/0000-0003-0013-3199</contrib-id><name><surname>Nelson</surname><given-names>Winnie W</given-names></name><xref ref-type="aff" rid="AFF0001">1</xref></contrib><aff id="AFF0001"><label>1</label><institution>Mallinckrodt Pharmaceuticals</institution>,<addr-line>Bedminster</addr-line>,<addr-line>NJ</addr-line>,<country>USA</country></aff><aff id="AFF0002"><label>2</label><institution>Xcenda</institution>,<addr-line>Palm Harbor</addr-line>,<addr-line>FL</addr-line>,<country>USA</country></aff></contrib-group><author-notes><corresp id="AN0001">Correspondence: Nancy Ho-Mahler <institution>Mallinckrodt Pharmaceuticals</institution>, <addr-line>1425 U.S. Route 206</addr-line>, <addr-line>Bedminster</addr-line>, <addr-line>NJ</addr-line><addr-line>07921</addr-line>, <country>USA</country><phone>Tel +1 747 239 0007</phone><fax>Fax +1 314 654 9440</fax> Email Nancy.Mahler@mnk.com</corresp></author-notes><pub-date pub-type="epub"><day>20</day><month>2</month><year>2020</year></pub-date><pub-date pub-type="collection"><year>2020</year></pub-date><volume>12</volume><fpage>21</fpage><lpage>28</lpage><history><date date-type="received"><day>19</day><month>9</month><year>2019</year></date><date date-type="accepted"><day>14</day><month>1</month><year>2020</year></date></history><permissions><copyright-statement>© 2020 Ho-Mahler et al.</copyright-statement><copyright-year>2020</copyright-year><copyright-holder>Ho-Mahler et al.</copyright-holder><license license-type="open-access" xlink:href="http://creativecommons.org/licenses/by-nc/3.0/"><license-p>This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at <ext-link ext-link-type="uri" xlink:href="https://www.dovepress.com/terms.php">https://www.dovepress.com/terms.php</ext-link> and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License (<ext-link ext-link-type="uri" xlink:href="http://creativecommons.org/licenses/by-nc/3.0/">http://creativecommons.org/licenses/by-nc/3.0/</ext-link>). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms (<ext-link ext-link-type="uri" xlink:href="https://www.dovepress.com/terms.php">https://www.dovepress.com/terms.php</ext-link>).</license-p></license></permissions><abstract><sec id="S2001"><title>Purpose</title><p>Repository corticotropin injection (RCI) is indicated for a number of autoimmune-mediated diseases including rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), and dermatomyositis (DM)/polymyositis (PM). To better understand the practice patterns and outcomes of RCI in patients with RA, SLE, or DM/PM, we conducted a retrospective medical record analysis.</p></sec><sec id="S2002"><title>Patients and Methods</title><p>Participating providers selected deidentified medical records of patients meeting the inclusion criteria (age ≥18 years; physician-reported diagnosis of RA, SLE, or DM/PM; initiation of treatment with RCI between 1/1/2011 and 2/15/2016; ≥3 in-office visits with same site/provider). Collected data spanned 12 months before and after the first prescription date for RCI. Analyses included patient demographics and clinical history, RCI treatment patterns, and physician’s impression of change.</p></sec><sec id="S2003"><title>Results</title><p>Data from 54 patients with RA, 30 patients with SLE, and 8 patients with DM/PM were analyzed. The most frequently reported reasons for initiating RCI were lack of efficacy with prior treatment, acute exacerbation of disease, and use as add-on to ongoing therapy. The most common initial RCI dosing, 80 U twice weekly, was used for 84% of patients with RA, 75% with SLE, and 86% with DM/PM. The mean duration of treatment was 4.8, 6.5, and 6.8 months for RA, SLE, and DM/PM, respectively. Among the 57 patients with data on physician’s impression of change with RCI, 78.1% of patients with RA, 94.7% with SLE, and 66.7% with DM/PM had a rating of “improved,” and the mean time to best impression of change was 3.4, 4.3, and 3.4 months for RA, SLE, and DM/PM, respectively.</p></sec><sec id="S2004"><title>Conclusion</title><p>This study reports the real-world patient profile, use patterns, and outcomes of patients who used RCI for the treatment of RA, SLE, and DM/PM. These data can inform appropriate use and clinical expectations when using RCI.</p></sec></abstract><kwd-group kwd-group-type="author"><title>Keywords</title><kwd>adrenocorticotropic hormone</kwd><kwd>analogue</kwd><kwd>ACTH</kwd><kwd>immunomodulatory</kwd><kwd>real-world patients</kwd></kwd-group><counts><fig-count count="1"></fig-count><table-count count="3"></table-count><ref-count count="26"></ref-count><page-count count="8"></page-count></counts></article-meta></front><body><sec sec-type="intro" id="S0001"><title>Introduction</title><p>The prolonged-release adrenocorticotropic hormone (ACTH) analogue repository corticotropin injection (RCI; Acthar Gel<sup>®</sup>, Mallinckrodt Pharmaceuticals, Bedminster, NJ, USA) acts through multiple mechanisms of action, including anti-inflammatory and immunomodulatory processes.<xref rid="CIT0001" ref-type="bibr">1</xref>–<xref rid="CIT0003" ref-type="bibr">3</xref> RCI is approved by the US Food and Drug administration for 19 indications, including as adjunct therapy for short-term administration in rheumatoid arthritis (RA) and for exacerbation or maintenance therapy in selected cases of systemic lupus erythematosus (SLE) and the inflammatory myopathies dermatomyositis (DM) and polymyositis (PM).<xref rid="CIT0001" ref-type="bibr">1</xref></p><p>With reported incidence rates ranging from 31 to 45 per 100,000 person-years, RA is one of the most common human autoimmune diseases in North America.<xref rid="CIT0004" ref-type="bibr">4</xref> According to a conservative estimate, RA affected 1.28 to 1.36 million adults in the United States in 2014.<xref rid="CIT0005" ref-type="bibr">5</xref> The primary goal for the management of patients with RA is achievement of disease remission through initial treatment with synthetic disease-modifying antirheumatic drugs (DMARDs) with escalation to biological DMARDs.<xref rid="CIT0006" ref-type="bibr">6</xref>,<xref rid="CIT0007" ref-type="bibr">7</xref> Published studies of RCI in patients with refractory RA support its efficacy and safety in this population.<xref rid="CIT0008" ref-type="bibr">8</xref>,<xref rid="CIT0009" ref-type="bibr">9</xref></p><p>Approximately 320,000 people in the United States have definite or suspected SLE.<xref rid="CIT0010" ref-type="bibr">10</xref> Reported incidence rates for SLE in North America range from 1.2 to 8.7 per 100,000 person-years,<xref rid="CIT0004" ref-type="bibr">4</xref> and prevalence rates in studies of US populations range from 5 to 241 per 100,000 people.<xref rid="CIT0011" ref-type="bibr">11</xref> The complex management of patients with SLE entails treatment with hydroxychloroquine to reduce disease flares and improve symptoms as well as administration of low-dose glucocorticoids, immunosuppressive agents, and cytotoxic drugs to address different types of organ system involvement.<xref rid="CIT0012" ref-type="bibr">12</xref> RCI has been used successfully to treat patients with SLE exacerbations not controlled by conventional treatments.<xref rid="CIT0013" ref-type="bibr">13</xref>–<xref rid="CIT0017" ref-type="bibr">17</xref></p><p>In the United States, DM has a prevalence of 1 to 6 per 100,000 persons, and PM ranges from the largest fraction with approximately 10 per 100,000 persons in the United States down to the rarest condition that should only be diagnosed by exclusion.<xref rid="CIT0018" ref-type="bibr">18</xref> Glucocorticoids are used for first-line treatment of patients with DM/PM, followed by (or in conjunction with) immunosuppressive maintenance; in case of intolerance or insufficient response, oral cyclosporine or intravenous immunoglobulin G may be used and, upon relapse or interstitial lung disease, rituximab or cyclophosphamide may be considered.<xref rid="CIT0018" ref-type="bibr">18</xref> Given that DM/PM is a rare disease, it is not surprising that there are a small number of published reports with results on the clinical efficacy and safety of RCI in patients with refractory DM/PM.<xref rid="CIT0019" ref-type="bibr">19</xref>–<xref rid="CIT0021" ref-type="bibr">21</xref></p><p>RCI is not a common medication used for inflammatory conditions. In clinical settings, it is often used after other therapies have failed.<xref rid="CIT0022" ref-type="bibr">22</xref>,<xref rid="CIT0023" ref-type="bibr">23</xref> Due to this unique place in therapy, the literature contains very little information about the profile of patients who would benefit most from RCI therapy or how the therapies are used. Therefore, it is imperative to describe these aspects of real-world data to help ensure appropriate use.</p><p>Additional data are desired to inform clinical decisions regarding the use of RCI to treat patients with RA, SLE, or DM/PM. We performed a retrospective medical record analysis to gain more insights into the practice patterns and outcomes associated with real-world RCI treatment in these patient populations.</p></sec><sec id="S0002"><title>Patients and Methods</title><sec id="S0002-S2001"><title>Study Design</title><p>We contacted potential study sites in the United States to assess their interest and ability to participate in this study of adults with RA, SLE, or DM/PM treated with RCI. After central Institutional Review Board (IRB) approval, we asked providers at each participating site to provide deidentified medical records of all patients meeting the study protocol general inclusion criteria. Trained study abstractors entered prespecified data from each provided patient medical record into an electronic data capture system. Collected data included patient demographics, disease history, treatment history (treatments administered before, at the start of, and during RCI treatment), and dosing information for RCI and concomitant treatments. These abstracted real-world data spanned the 12 months prior (preindex period) and up to 12 months following (follow-up period) the first prescription date for RCI treatment.</p><p>The Chesapeake IRB reviewed and approved this study. The study was conducted in accordance with the principles of the Declaration of Helsinki and was consistent with International Conference on Harmonization Good Clinical Practices and with applicable regulations. Given the retrospective nature of the study, the IRB determined that patient informed consent was not required.</p></sec><sec id="S0002-S2002"><title>Patients</title><p>Patient inclusion criteria were age ≥18 years; a physician-reported diagnosis of RA, SLE, or DM/PM according to American College of Rheumatology (ACR) criteria; initiation of treatment with RCI between January 1, 2011, and February 15, 2016; and ≥3 in-office visits at the same site and with the same healthcare provider, including at least 1 visit before RCI initiation, 1 visit at first RCI prescription, and 1 visit following the first RCI prescription (within at least 12 months and including ≥1 visit during RCI treatment). Patients with RA or DM/PM had to have used RCI as adjunctive therapy. Patients with SLE had to have undergone RCI treatment during an exacerbation or as maintenance therapy.</p><p>Patients were excluded if they had not started active treatment with RCI or if they had a known allergy to RCI or any of its components; if they had treatment contraindications (eg, due to recent surgery, sensitivity to proteins of porcine origin); if they had previously participated or were currently participating in an interventional clinical trial for SLE, RA, or DM/PM; or if they were pregnant. Patients with a diagnosis of stage V or VI membranous or sclerosing lupus nephritis or central nervous system lupus were also excluded from the study.</p></sec><sec id="S0002-S2003"><title>Endpoints</title><p>We defined the index visit as the date of the first prescription for RCI. The follow-up period started the day after this index visit and continued for up to 12 months, including RCI treatment cessation, loss to follow-up, death, or the end of the study period. The study collected data on patient profiles (baseline demographic, clinical, and socioeconomic characteristics), RCI treatment patterns (dose, frequency, duration, and concomitant medications), and physicians’ impression of change as well as adverse events (AEs) and serious adverse events (SAEs) that resulted in dose reduction or treatment discontinuation.</p></sec><sec id="S0002-S2004"><title>Statistics</title><p>Because of the descriptive nature of the study objectives, the sample size was not based on formal statistical hypothesis testing. The sample size was planned to be a maximum of 70 patients with RA, SLE, or DM/PM. All patients who met the eligibility criteria were included in the analysis.</p><p>We presented descriptive statistics as mean and standard deviation (SD) for continuous data and number of patients and percentage for categorical variables. Before analysis, clinical data received from participating sites were validated for accuracy and completeness. Patients were considered to be lost to follow-up if they switched treatment sites during the follow-up period.</p></sec></sec><sec id="S0003"><title>Results</title><sec id="S0003-S2001"><title>Patients</title><p>From 14 participating US clinic sites, we obtained data for 92 patients, including 54 with RA, 30 with SLE, and 8 with DM/PM. <xref rid="T0001" ref-type="table">Table 1</xref> lists the baseline demographic and clinical characteristics of these 3 populations. Overall, patients had a mean age over 49 years, and most were women (78% for RA, 97% for SLE, and 100% for DM/PM). The mean (±SD) follow-up time was 8.5±3.3 months for patients with RA, 9.1±2.6 months for SLE, and 10.3±2.6 months for DM/PM.<table-wrap id="T0001" orientation="portrait" position="float"><label>Table 1</label><caption><p>Baseline Demographic and Clinical Characteristics of Patients with RA, SLE, or DM/PM Who Were Treated with RCI</p></caption><table frame="hsides" rules="groups"><thead><tr><th rowspan="1" colspan="1">Characteristic</th><th rowspan="1" colspan="1">RA (N=54)</th><th rowspan="1" colspan="1">SLE (N=30)</th><th rowspan="1" colspan="1">DM/PM (N=8)</th></tr></thead><tbody><tr><td rowspan="1" colspan="1">Mean age in y (SD)</td><td rowspan="1" colspan="1">54.8 (9.2)</td><td rowspan="1" colspan="1">50.4 (8.6)</td><td rowspan="1" colspan="1">49.3 (11.9)</td></tr><tr><td rowspan="1" colspan="1">Gender, n (%)</td><td rowspan="1" colspan="1"></td><td rowspan="1" colspan="1"></td><td rowspan="1" colspan="1"></td></tr><tr><td rowspan="1" colspan="1"> Female</td><td rowspan="1" colspan="1">42 (78)</td><td rowspan="1" colspan="1">29 (97)</td><td rowspan="1" colspan="1">8 (100)</td></tr><tr><td rowspan="1" colspan="1"> Male</td><td rowspan="1" colspan="1">12 (22)</td><td rowspan="1" colspan="1">1 (3)</td><td rowspan="1" colspan="1">0</td></tr><tr><td rowspan="1" colspan="1">Geographic region, n (%)</td><td rowspan="1" colspan="1"></td><td rowspan="1" colspan="1"></td><td rowspan="1" colspan="1"></td></tr><tr><td rowspan="1" colspan="1"> Northeast</td><td rowspan="1" colspan="1">24 (44)</td><td rowspan="1" colspan="1">10 (33)</td><td rowspan="1" colspan="1">2 (25)</td></tr><tr><td rowspan="1" colspan="1"> Midwest</td><td rowspan="1" colspan="1">5 (9)</td><td rowspan="1" colspan="1">1 (3)</td><td rowspan="1" colspan="1">0</td></tr><tr><td rowspan="1" colspan="1"> Pacific</td><td rowspan="1" colspan="1">0</td><td rowspan="1" colspan="1">0</td><td rowspan="1" colspan="1">0</td></tr><tr><td rowspan="1" colspan="1"> South</td><td rowspan="1" colspan="1">8 (15)</td><td rowspan="1" colspan="1">11 (37)</td><td rowspan="1" colspan="1">4 (50)</td></tr><tr><td rowspan="1" colspan="1"> West</td><td rowspan="1" colspan="1">17 (32)</td><td rowspan="1" colspan="1">8 (27)</td><td rowspan="1" colspan="1">2 (25)</td></tr><tr><td rowspan="1" colspan="1">Follow-up time, mean no. of months (SD)</td><td rowspan="1" colspan="1">8.5 (3.3)</td><td rowspan="1" colspan="1">9.1 (2.6)</td><td rowspan="1" colspan="1">10.3 (2.6)</td></tr><tr><td rowspan="1" colspan="1">Prior therapies, n (%)</td><td rowspan="1" colspan="1"></td><td rowspan="1" colspan="1"></td><td rowspan="1" colspan="1"></td></tr><tr><td rowspan="1" colspan="1"> Antimalarial drugs</td><td rowspan="1" colspan="1">–</td><td rowspan="1" colspan="1">–</td><td rowspan="1" colspan="1">1 (12)</td></tr><tr><td rowspan="1" colspan="1"> Biologic DMARDs</td><td rowspan="1" colspan="1">47 (87)</td><td rowspan="1" colspan="1">–</td><td rowspan="1" colspan="1">–</td></tr><tr><td rowspan="1" colspan="1"> Corticosteroids</td><td rowspan="1" colspan="1">47 (87)</td><td rowspan="1" colspan="1">24 (80)</td><td rowspan="1" colspan="1">6 (75)</td></tr><tr><td rowspan="1" colspan="1"> Immunoglobulins</td><td rowspan="1" colspan="1">–</td><td rowspan="1" colspan="1">–</td><td rowspan="1" colspan="1">1 (12)</td></tr><tr><td rowspan="1" colspan="1"> Immunosuppressive drugs</td><td rowspan="1" colspan="1">–</td><td rowspan="1" colspan="1">17 (57)</td><td rowspan="1" colspan="1">7 (88)</td></tr><tr><td rowspan="1" colspan="1"> Monoclonal antibodies</td><td rowspan="1" colspan="1">–</td><td rowspan="1" colspan="1">14 (47)</td><td rowspan="1" colspan="1">-</td></tr><tr><td rowspan="1" colspan="1"> Nonbiologic DMARDs</td><td rowspan="1" colspan="1">51 (94)</td><td rowspan="1" colspan="1">22 (73)</td><td rowspan="1" colspan="1">–</td></tr></tbody></table><table-wrap-foot><fn><p><bold>Abbreviations:</bold> DMARD, disease-modifying antirheumatic drug; DM/PM, dermatomyositis/polymyositis; RA, rheumatoid arthritis; RCI, repository corticotropin injection; SD, standard deviation; SLE, systemic lupus erythematosus.</p></fn></table-wrap-foot></table-wrap></p><p>Among the 42 of 54 (78%) patients in the RA group with data, 32 (76%) had rheumatoid factor-positive disease. The most common comorbidities among patients with RA included arthralgia (96%), osteoarthritis (39%), hypertension (33%), depression (30%), and anxiety (28%). The most commonly reported symptoms among patients with RA were stiffness/pain in joints (95%), swollen joints (87%), morning stiffness (82%), pain (82%), swollen fingers (78%), fatigue (63%), muscle weakness (44%), and rash (33%).</p><p>Among the 30 patients with SLE, the most common comorbidities were arthralgia (100%), hypertension (40%), depression (33%), Sjogren’s syndrome (33%), and anxiety (27%). The most commonly reported symptoms were pain (93%), stiffness/pain in joints (90%), fatigue (87%), swollen joints (67%), muscle weakness (63%), morning stiffness (50%), shortness of breath (50%), and headaches (47%).</p><p>Among the 8 patients with DM/PM, 5 (62%) had PM and 3 (38%) had DM. The most commonly reported comorbidities among the DM/PM patients were arthralgia (100%), anxiety (50%), depression (50%), and osteoarthritis (38%). The most commonly reported symptoms were muscle weakness (88%), pain (88%), stiffness/pain in joints (88%), edema (63%), weight changes (50%), dizziness (50%), fatigue (50%), and morning stiffness (50%).</p><p>Before receiving RCI, most patients with RA had been treated with nonbiologic DMARDs (94%), corticosteroids (87%), and biologic DMARDs (87%); most patients with SLE had been treated with corticosteroids (80%), nonbiologic DMARDs (73%), and immunosuppressive drugs (57%); and most patients with DM/PM had been treated with immunosuppressive drugs (88%) and corticosteroids (75%).</p></sec><sec id="S0003-S2002"><title>RCI Treatment Patterns</title><p><xref rid="T0002" ref-type="table">Table 2</xref> lists the reasons for initiating treatment with RCI. Across the 3 populations, the most commonly reported reasons for initiating RCI therapy were lack of efficacy with prior treatment (12% to 30% of patients), acute exacerbation/flare of disease (12% to 26%), and as add-on therapy to prior treatment (20% to 25%). In all 3 populations, the most common starting dose and frequency were 80 U twice weekly, which was used in 84% of patients with RA, 75% of patients with SLE, and 86% of patients with DM/PM (<xref rid="T0003" ref-type="table">Table 3</xref>).<table-wrap id="T0002" orientation="portrait" position="float"><label>Table 2</label><caption><p>Reason for Initiating RCI Treatment in Patients with RA, SLE, or DM/PM</p></caption><table frame="hsides" rules="groups"><thead><tr><th rowspan="1" colspan="1">Reason, n (%)</th><th rowspan="1" colspan="1">RA (N=54)</th><th rowspan="1" colspan="1">SLE (N=30)</th><th rowspan="1" colspan="1">DM/PM (N=8)</th></tr></thead><tbody><tr><td rowspan="1" colspan="1">Acute exacerbation/flare</td><td rowspan="1" colspan="1">14 (26)</td><td rowspan="1" colspan="1">5 (17)</td><td rowspan="1" colspan="1">1 (12)</td></tr><tr><td rowspan="1" colspan="1">Add-on therapy to prior treatment</td><td rowspan="1" colspan="1">11 (20)</td><td rowspan="1" colspan="1">6 (20)</td><td rowspan="1" colspan="1">2 (25)</td></tr><tr><td rowspan="1" colspan="1">AEs on prior treatment</td><td rowspan="1" colspan="1">1 (2)</td><td rowspan="1" colspan="1">0</td><td rowspan="1" colspan="1">0</td></tr><tr><td rowspan="1" colspan="1">Bridging to subsequent treatment</td><td rowspan="1" colspan="1">4 (7)</td><td rowspan="1" colspan="1">1 (3)</td><td rowspan="1" colspan="1">0</td></tr><tr><td rowspan="1" colspan="1">Contraindications to other prescribed<break></break> therapy with prior treatment</td><td rowspan="1" colspan="1">2 (4)</td><td rowspan="1" colspan="1">1 (3)</td><td rowspan="1" colspan="1">0</td></tr><tr><td rowspan="1" colspan="1">Cost of prior treatment</td><td rowspan="1" colspan="1">1 (2)</td><td rowspan="1" colspan="1">0</td><td rowspan="1" colspan="1">1 (12)</td></tr><tr><td rowspan="1" colspan="1">Intolerability to prior treatment</td><td rowspan="1" colspan="1">1 (2)</td><td rowspan="1" colspan="1">1 (3)</td><td rowspan="1" colspan="1">3 (38)</td></tr><tr><td rowspan="1" colspan="1">Lack of efficacy/inadequate response/<break></break> disease progression with<break></break> prior treatment</td><td rowspan="1" colspan="1">12 (22)</td><td rowspan="1" colspan="1">9 (30)</td><td rowspan="1" colspan="1">1 (12)</td></tr><tr><td rowspan="1" colspan="1">New diagnosis/first-line therapy</td><td rowspan="1" colspan="1">1 (2)</td><td rowspan="1" colspan="1">0</td><td rowspan="1" colspan="1">0</td></tr><tr><td rowspan="1" colspan="1">Other</td><td rowspan="1" colspan="1">2 (4)</td><td rowspan="1" colspan="1">0</td><td rowspan="1" colspan="1">0</td></tr><tr><td rowspan="1" colspan="1">Missing data</td><td rowspan="1" colspan="1">5 (9)</td><td rowspan="1" colspan="1">7 (23)</td><td rowspan="1" colspan="1">0</td></tr></tbody></table><table-wrap-foot><fn><p><bold>Abbreviations:</bold> AE, adverse event; DM/PM, dermatomyositis/polymyositis; RA, rheumatoid arthritis; RCI, repository corticotropin injection; SLE, systemic lupus erythematosus.</p></fn></table-wrap-foot></table-wrap><table-wrap id="T0003" orientation="portrait" position="float"><label>Table 3</label><caption><p>RCI Treatment Patterns in Patients with RA, SLE, or DM/PM</p></caption><table frame="hsides" rules="groups"><thead><tr><th rowspan="1" colspan="1"></th><th rowspan="1" colspan="1">RA (N=54)</th><th rowspan="1" colspan="1">SLE (N=30)</th><th rowspan="1" colspan="1">DM/PM (N=8)</th></tr></thead><tbody><tr><td colspan="4" rowspan="1">RCI starting dose and frequency, n (%)</td></tr><tr><td rowspan="1" colspan="1"> Patients with data</td><td rowspan="1" colspan="1">43 (80)</td><td rowspan="1" colspan="1">28 (93)</td><td rowspan="1" colspan="1">7 (88)</td></tr><tr><td rowspan="1" colspan="1"> 40 units once per day</td><td rowspan="1" colspan="1">1 (2)</td><td rowspan="1" colspan="1">0</td><td rowspan="1" colspan="1">0</td></tr><tr><td rowspan="1" colspan="1"> 40 units twice per day</td><td rowspan="1" colspan="1">4 (9)</td><td rowspan="1" colspan="1">1 (4)</td><td rowspan="1" colspan="1">1 (14)</td></tr><tr><td rowspan="1" colspan="1"> 80 units once per day</td><td rowspan="1" colspan="1">0</td><td rowspan="1" colspan="1">2 (7)</td><td rowspan="1" colspan="1">0</td></tr><tr><td rowspan="1" colspan="1"> 80 units once per week</td><td rowspan="1" colspan="1">1 (2)</td><td rowspan="1" colspan="1">4 (14)</td><td rowspan="1" colspan="1">0</td></tr><tr><td rowspan="1" colspan="1"> 80 units twice per week</td><td rowspan="1" colspan="1">36 (84)</td><td rowspan="1" colspan="1">21 (75)</td><td rowspan="1" colspan="1">6 (86)</td></tr><tr><td rowspan="1" colspan="1"> 80 units 3 times per week</td><td rowspan="1" colspan="1">1 (2)</td><td rowspan="1" colspan="1">0</td><td rowspan="1" colspan="1">0</td></tr><tr><td colspan="4" rowspan="1">Patients who experienced RCI dose changes during treatment, n (%)</td></tr><tr><td rowspan="1" colspan="1"> Any dose change</td><td rowspan="1" colspan="1">18 (33)</td><td rowspan="1" colspan="1">13 (43)</td><td rowspan="1" colspan="1">2 (25)</td></tr><tr><td rowspan="1" colspan="1"> Any dose increase</td><td rowspan="1" colspan="1">1 (2)</td><td rowspan="1" colspan="1">2 (7)</td><td rowspan="1" colspan="1">1 (12)</td></tr><tr><td rowspan="1" colspan="1"> >1 dose increase</td><td rowspan="1" colspan="1">0</td><td rowspan="1" colspan="1">1 (3)</td><td rowspan="1" colspan="1">0</td></tr><tr><td rowspan="1" colspan="1"> Any dose decrease</td><td rowspan="1" colspan="1">18 (33)</td><td rowspan="1" colspan="1">11 (37)</td><td rowspan="1" colspan="1">1 (12)</td></tr><tr><td rowspan="1" colspan="1"> >1 dose decrease</td><td rowspan="1" colspan="1">5 (9)</td><td rowspan="1" colspan="1">0</td><td rowspan="1" colspan="1">0</td></tr><tr><td rowspan="1" colspan="1">Patients who discontinued RCI, n (%)</td><td rowspan="1" colspan="1">24 (44)</td><td rowspan="1" colspan="1">6 (20)</td><td rowspan="1" colspan="1">5 (62)</td></tr><tr><td colspan="4" rowspan="1">Reasons for RCI discontinuation, n (%)</td></tr><tr><td rowspan="1" colspan="1"> AE related to RCI</td><td rowspan="1" colspan="1">9 (38)</td><td rowspan="1" colspan="1">3 (50)</td><td rowspan="1" colspan="1">2 (40)</td></tr><tr><td rowspan="1" colspan="1"> Disease resolution/remission/<break></break> treatment no longer necessary</td><td rowspan="1" colspan="1">4 (17)</td><td rowspan="1" colspan="1">0</td><td rowspan="1" colspan="1">0</td></tr><tr><td rowspan="1" colspan="1"> Lack of efficacy/inadequate<break></break> response/disease progression</td><td rowspan="1" colspan="1">3 (12)</td><td rowspan="1" colspan="1">0</td><td rowspan="1" colspan="1">2 (40)</td></tr><tr><td rowspan="1" colspan="1"> Patient choice</td><td rowspan="1" colspan="1">1 (4)</td><td rowspan="1" colspan="1">0</td><td rowspan="1" colspan="1">0</td></tr><tr><td rowspan="1" colspan="1"> Physician choice</td><td rowspan="1" colspan="1">4 (17)</td><td rowspan="1" colspan="1">0</td><td rowspan="1" colspan="1">0</td></tr><tr><td rowspan="1" colspan="1"> Missing data</td><td rowspan="1" colspan="1">3 (12)</td><td rowspan="1" colspan="1">3 (50)</td><td rowspan="1" colspan="1">1 (20)</td></tr><tr><td rowspan="1" colspan="1">Duration of RCI treatment, mean no. of months (SD)</td><td rowspan="1" colspan="1">4.8 (3.4)</td><td rowspan="1" colspan="1">6.5 (3.3)</td><td rowspan="1" colspan="1">6.8 (2.2)</td></tr></tbody></table><table-wrap-foot><fn><p><bold>Abbreviations:</bold> AE, adverse event; DM/PM, dermatomyositis/polymyositis; RA, rheumatoid arthritis; RCI, repository corticotropin injection; SD, standard deviation; SLE, systemic lupus erythematosus.</p></fn></table-wrap-foot></table-wrap></p><p>Less than half of the patients had any RCI dose changes during treatment, including 33% of patients with RA, 43% of patients with SLE, and 25% of patients with DM/PM. The most common dose changes were dose decreases, which occurred in 33% of patients with RA, 37% of patients with SLE, and 12% of patients with DM/PM. Among patients with RA, none had >1 dose increase and 9% had >1 dose decrease. Among patients with SLE, 3% had >1 dose increase and none had >1 dose decrease. None of the patients with DM/PM had >1 dose increase or decrease (<xref rid="T0003" ref-type="table">Table 3</xref>).</p><p>The mean ±SD duration of RCI treatment was 4.8±3.4 months for patients with RA, 6.5±3.3 months for patients with SLE, and 6.8±2.2 months for patients with DM/PM (<xref rid="T0003" ref-type="table">Table 3</xref>). RCI treatment was discontinued in 24 (44%) of RA patients, 6 (20%) of SLE patients, and 5 (63%) of DM/PM patients. The most common reasons for discontinuation of RCI treatment for RA were AEs related to RCI (38%), disease resolution/remission/treatment no longer necessary (17%), and physician choice (17%); for SLE, the reasons were treatment-related AEs (50%); and for DM/PM, the reasons were AEs related to RCI (40%) and lack of efficacy/inadequate response/disease progression (40%).</p></sec><sec id="S0003-S2003"><title>Physician Assessment of Efficacy</title><p>Physician’s impression of change data were available for 32 (59%) patients with RA, 19 (63%) with SLE, and 6 (75%) with DM/PM. As shown in <xref rid="F0001" ref-type="fig">Figure 1</xref>, physicians reported a rating of “improved” for 78.1% of patients with RA, 94.7% with SLE, and 66.7% with DM/PM. The mean time to best impression of change was 3.4±2.5 months for RA, 4.3±2.7 for SLE, and 3.4±1.6 for DM/PM.<fig id="F0001" fig-type="figure" orientation="portrait" position="float"><label>Figure 1</label><caption><p>Physician’s impression of change as a percentage of patients with RA, SLE, or DM/PM deemed to have improved, stayed the same, or worsened.</p><p><bold>Note:</bold> The sum of the percentages may not be 100% due to rounding.</p><p><bold>Abbreviations:</bold> DM/PM, dermatomyositis/polymyositis; RA, rheumatoid arthritis; SLE, systemic lupus erythematosus.</p></caption><graphic content-type="print-only" xlink:href="OARRR-12-21-g0001"></graphic></fig></p></sec><sec id="S0003-S2004"><title>Safety</title><p>SAEs were reported in 1 (2%) patient with RA, 4 (13%) with SLE, and 1 (12%) with DM/PM. AEs were reported in 14 (26%) patients with RA, 5 (17%) with SLE, and 2 (25%) with DM/PM. Each AE and SAE occurred in 1 patient in the RA, SLE, and DM/PM groups. The AEs reported in patients with RA included abdominal angina, bruising, diaphoresis, fatigue, gastroenteritis, heartburn, herpes flare, hypoglycemia, hypotension, injection-site reaction, irritability or mood changes, myalgia, upper respiratory infection, vomiting, and weight gain. The 1 patient with RA who had an SAE experienced both pancreatitis and urinary tract infection. AEs reported in patients with SLE included diarrhea, gastrointestinal upset, edema, neuralgia, pneumonia, and weight gain. The SAEs reported in 4 patients with SLE included altered musculoskeletal pain, dehydration, adrenal insufficiency, pneumonia, renal failure, and transient ischemic attack. AEs reported by patients with DM/PM included bruising and red or bloodshot eyes. The 1 patient with DM/PM who had an SAE experienced shortness of breath.</p></sec></sec><sec id="S0004"><title>Discussion</title><p>In this retrospective analysis of RCI treatment in 92 patients with RA, SLE, or DM/PM, we found that the time lag in RCI treatment from prescription to first dose ranged between 1.5 and 2.4 months. The most frequently reported reasons for initiating RCI were lack of efficacy with prior treatment, acute exacerbation or flare of disease, and use as an add-on to ongoing therapy. Among patients with available prescribing information, the most common initial RCI dosing was 80 U twice weekly, which was used for 84% of patients with RA, 75% with SLE, and 86% with DM/PM. Patients with RA had the shortest duration of RCI treatment (4.8 months), while patients with SLE and DM/PM experienced similar duration of RCI treatment (6.5 and 6.8 months, respectively). Among the 57 patients with data on physician impression of change with RCI, 78.1% of patients with RA, 94.7% with SLE, and 66.7% with DM/PM had a rating of “improved.” The mean time for the best impression of change was 3.4±2.5 months for RA, 4.3±2.7 for SLE, and 3.4±1.6 for DM/PM. RCI was generally safe and well tolerated, with AE rates of 26%, 17%, and 25% and SAE rates of 2%, 13%, and 12% in patients with RA, SLE, and DM/PM, respectively.</p><p>Most patients in this retrospective analysis had received multiple therapies before starting treatment with RCI, suggesting that they had refractory disease. Among the patients with RA, 94% had been treated with nonbiologic DMARDs, 87% with corticosteroids, and 87% with biologic DMARDs. Among patients with SLE, 80% had been treated with corticosteroids, 73% with nonbiologic DMARDs, and 57% with immunosuppressive drugs. Among patients with DM/PM, 88% had been treated with immunosuppressive drugs and 75% with corticosteroids. The patients with RA in our study may be similar to the population participating in an ongoing prospective study of RCI in patients with persistently active RA despite treatment with 1 or 2 nonbiologic or biologic DMARDs and corticosteroids (NCT02919761).<xref rid="CIT0024" ref-type="bibr">24</xref> In this 2-part clinical trial, all patients receive RCI 80 U twice weekly for 12 weeks, followed by double-blind randomization to 12 weeks of maintenance therapy with RCI or placebo. According to results presented at the European League Against Rheumatism (EULAR) 2019 annual meeting, the randomized, placebo-controlled, double-blind phase of this 2-part clinical trial demonstrated that significantly more patients with persistently active RA who met response criteria at Week 12 maintained low disease activity (LDA) when treated with RCI (62%) than with placebo (43%) at Week 24. In addition, significantly more patients in the RCI group (86%) than in the placebo group (66%) had sustained LDA at Week 24 as defined by the Clinical Disease Activity Index (CDAI), and the cumulative disease activity flare rate at Week 24 was significantly lower in the RCI continuation group (17%) than in the placebo group (30%). Another key finding of this trial was that the proportion of patients who achieved ACR 20%, 50%, and 70% criteria at Week 24 were 91%, 75%, and 47%, respectively, for the RCI group, and 84%, 70%, and 42%, respectively, for the placebo group. AEs were reported in 33% of the RCI group and 40% of the placebo group. AEs of interest included diabetes mellitus (RCI 1%, placebo 0%), increase in glycosylated hemoglobin (RCI 1%, placebo 3%), hypergyclemia (RCI 4%, placebo 3%), and hypertension (RCI 4%, placebo 0%). These AEs were consistent with those in previous trials of RCI. </p><p>There are few published clinical studies of RCI in patients with RA. A small single-center prospective trial in 8 adults with active RA refractory to ≥3 therapies with different mechanisms of action examined the effects of 12 weeks of RCI (80 U twice weekly) used as add-on therapy.<xref rid="CIT0008" ref-type="bibr">8</xref> The dose used in this trial, 80 U twice weekly, was the most commonly used in our study. The investigators reported achievement of the primary endpoint of improvements in swollen (<italic>P</italic>=0.0047) and tender joint counts (<italic>P</italic>=0.004), assessed using the Ritchie-Camp Articular Index, at the end of the 12-week treatment period and the loss of these gains 4 weeks after termination of RCI treatment. One patient had 2 SAEs, pulmonary embolism and deep vein thrombosis, requiring hospitalization. Similar to the data presented here, none of the other AEs were experienced by >1 patient. A 12-week prospective study of RCI in refractory RA reported that 6 of 9 patients achieved the primary endpoint of a >1.2 point reduction in DAS28 using C-reactive protein (DAS28-CRP) at Week 12 versus baseline.<xref rid="CIT0009" ref-type="bibr">9</xref> After starting on RCI 40 U daily for 7 days, patients with an adequate response switched to 40 U RCI twice weekly and those with an inadequate response took 80 U RCI daily for 7 days, followed by 80 U twice weekly through Week 12. There were no SAEs, and AEs included cushingoid features (2 patients) and mild hyperglycemia, herpes zoster, and pedal edema (1 patient each).</p><p>A handful of other studies have reported results of RCI treatment in patients with SLE. In a retrospective case series, 7 of 9 women with SLE treated with RCI and followed for 3 to 6 months had improvements measured by the ability to taper steroids, decreases in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score, and the extent of unresolved active clinical manifestation.<xref rid="CIT0013" ref-type="bibr">13</xref> These patients had received RCI 80 U biweekly dosing, and none had reported AEs while receiving RCI therapy. A short-term, 10-day trial of daily RCI 80 U in 10 women with SLE (exhibiting symptomatic SLE exacerbations despite conventional treatments) noted no SAEs and statistically significant improvements (<italic>P</italic><0.05) at the 14-day and 28-day follow-up visits in different measures including SLEDAI-2K.<xref rid="CIT0014" ref-type="bibr">14</xref> All 5 participants in the 28-day trial who elected to enter an extension study of biweekly RCI 80 U experienced statistically significant improvements in various measures including SLEDAI-2K (<italic>P</italic>=0.0007), tender joint counts (<italic>P</italic>=0.0020), and swollen joint counts (<italic>P</italic>=0.0041) at 6 months.<xref rid="CIT0015" ref-type="bibr">15</xref> These patients experienced no clinically significant changes in mean systolic and diastolic blood pressure, and no other minor or major AEs were reported. In a Phase 4 pilot study, 38 patients with SLE were randomized 2:1:2:1 to 8 weeks of double-blind, placebo-controlled treatment with RCI (40 or 80 U or volume-matched placebo, once every other day) followed by a 44-week open-label extension phase.<xref rid="CIT0016" ref-type="bibr">16</xref> While this exploratory study found that numerical differences were not statistically significant in the primary endpoint, a composite responder index, secondary endpoints and post hoc analyses linked RCI treatment to sustained improvements in SLE signs and symptoms and a tolerable safety profile.<xref rid="CIT0016" ref-type="bibr">16</xref>,<xref rid="CIT0017" ref-type="bibr">17</xref> These results supported the design of a well-powered, ongoing, randomized, double-blind placebo-controlled study (NCT02953821) to evaluate 24 weeks of treatment with RCI in patients with persistently active SLE despite treatment with moderate-dose corticosteroids.</p><p>In addition to our retrospective analysis, 4 other studies have evaluated RCI treatment in patients with DM/PM. A retrospective case review noted that symptoms improved in women with DM/PM treated for 12 weeks with concomitant RCI 80 U twice weekly (n=4) or once weekly (n=1).<xref rid="CIT0019" ref-type="bibr">19</xref> The investigators reported that none of the patients had significant AEs. An interim analysis of the Acthar in Dermatomyositis and Polymyositis Treatment (ADAPT) registry reported responses to RCI treatment in 14 (58%) of 24 enrolled patients with refractory DM/PM.<xref rid="CIT0020" ref-type="bibr">20</xref> Most of the patients (92%) received RCI 80 U twice weekly, and the mean duration of RCI treatment was 9.7±4.0 months for responders and 3.5±1.4 months for nonresponders. Ten (42%) patients had mild-to-moderate AEs, including worsening of diabetes (12%) and lower extremity edema (8%), which were the only AEs experienced by >1 patient. In a prospective, single-arm clinical trial in patients with refractory active DM/PM, 7 (70%) of 10 patients who completed the minimum 8 weeks of RCI treatment (80 U twice weekly) met the primary definition of improvement.<xref rid="CIT0021" ref-type="bibr">21</xref> Three patients had 5 SAEs, and 8 patients had 22 AEs. Among the SAEs, 2 herpes zoster infections were considered to be related to study drug. In addition, patients who discontinued RCI after 6 months of clinical efficacy experienced a slow increase in disease activity and disability index and a decrease in muscle strength; their first flare occurred 4 months after discontinuation of RCI.<xref rid="CIT0025" ref-type="bibr">25</xref> Interim results from an open-label study of RCI in 9 adults with refractory cutaneous DM reported that at 3 months, 7 patients had improved Cutaneous Dermatomyositis Disease Area and Severity Index activity scores and 8 patients had improved Physician Global Assessment activity scores.<xref rid="CIT0026" ref-type="bibr">26</xref></p><p>The current study is limited by its retrospective design and the small sample size yielded by our recruitment efforts. Another limitation is its reliance on patient medical records, which had missing data, as noted in our analyses, and may have had other unaccounted for errors and omissions (such as care received at other clinics). Reliance on medical records also makes it difficult to assess disease activity, which is not routinely recorded in the medical records or recorded with the appropriate timing to allow evaluation of clinical response to therapy. Future research should consider this limitation and adjust the study design to accommodate. We implemented quality control measures to minimize the occurrence of data entry errors during medical record abstraction. Our study used physician’s impression of change as a descriptive endpoint, a subjective measure that relies on an individual clinician’s own standards of improvement. Physician's impression of change was not available for 38% of the records evaluated. Also, the retrospective noncomparative study design did not allow us to determine if patients were responding to other therapies. Thus, our results are exploratory and should be interpreted with these limitations in mind.</p></sec><sec id="S0005"><title>Conclusion</title><p>The findings from this study describe the real-world patient profile, use patterns, and outcomes of patients who used RCI for the treatment of RA, SLE, and DM/PM. The data can inform appropriate use of RCI as well as the clinical expectations when using this medication. Larger clinical trials are ongoing to add to the body of evidence.</p></sec></body><back><ack><title>Acknowledgments</title><p>The authors thank the physicians who participated in this study. Mallinckrodt Pharmaceuticals, Bedminster, NJ, USA, funded sponsorship of this study and the article processing charges. The authors thank Monica Nicosia, PhD, of Global Outcomes Group for medical writing assistance and Esther Tazartes, MS, of Global Outcomes Group for editorial assistance. This assistance was funded by Mallinckrodt Pharmaceuticals, Bedminster, NJ, USA.</p></ack><sec id="S0006"><title>Author Contributions</title><p>All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship of this manuscript. All authors contributed to data analysis, drafting, and revising the article, take responsibility for the integrity of the work as a whole, and have given approval for the final version to be published. All authors had full access to all the data used in this study and take responsibility for the integrity of the data and accuracy of the data analysis.</p></sec><sec id="S0007" sec-type="COI-statement"><title>Disclosure</title><p>Winnie W. Nelson and Mark L. Hanke were employees of Mallinckrodt Pharmaceuticals, Bedminster, NJ, USA, at the time of this writing. Nancy Ho-Mahler is an employee of Mallinckrodt Pharmaceuticals, Bedminster, NJ, USA. Beni Turner and Michael Eaddy are employees of Xcenda, Palm Harbor, FL, USA, which has received research funding from Mallinckrodt Pharmaceuticals for the conduct of this study. The authors report no other conflicts of interest in this work.</p></sec><ref-list><title>References</title><ref id="CIT0001"><label>1.</label><mixed-citation publication-type="data"><article-title>Acthar<sup>®</sup> Gel (repository corticotropin injection) [prescribing information]</article-title>; <year>2019</year><comment>Available From:</comment><ext-link ext-link-type="uri" xlink:href="https://www.acthar.com/pdf/Acthar-PI.pdf">https://www.acthar.com/pdf/Acthar-PI.pdf</ext-link>. <date-in-citation>Accessed <month>5</month><day>8</day>, 2019</date-in-citation>.</mixed-citation></ref><ref id="CIT0002"><label>2.</label><mixed-citation publication-type="journal"><string-name><surname>Ross</surname><given-names>AP</given-names></string-name>, <string-name><surname>Ben-Zacharia</surname><given-names>A</given-names></string-name>, <string-name><surname>Harris</surname><given-names>C</given-names></string-name>, <string-name><surname>Smrtka</surname><given-names>J</given-names></string-name>. <article-title>Multiple sclerosis, relapses, and the mechanism of action of adrenocorticotropic hormone</article-title>. <source><italic toggle="yes">Front Neurol</italic></source>. <year>2013</year>;<volume>4</volume>:<fpage>21</fpage>. doi:<pub-id pub-id-type="doi">10.3389/fneur.2013.00021</pub-id><pub-id pub-id-type="pmid">23482896</pub-id></mixed-citation></ref><ref id="CIT0003"><label>3.</label><mixed-citation publication-type="journal"><string-name><surname>Montero-Melendez</surname><given-names>T</given-names></string-name>. <article-title>ACTH: the forgotten therapy</article-title>. <source><italic toggle="yes">Semin Immunol</italic></source>. <year>2015</year>;<volume>27</volume>:<fpage>216</fpage>–<lpage>226</lpage>. doi:<pub-id pub-id-type="doi">10.1016/j.smim.2015.02.003</pub-id><pub-id pub-id-type="pmid">25726511</pub-id></mixed-citation></ref><ref id="CIT0004"><label>4.</label><mixed-citation publication-type="journal"><string-name><surname>Wang</surname><given-names>L</given-names></string-name>, <string-name><surname>Wang</surname><given-names>FS</given-names></string-name>, <string-name><surname>Gershwin</surname><given-names>ME</given-names></string-name>. <article-title>Human autoimmune diseases: a comprehensive update</article-title>. <source><italic toggle="yes">J Intern Med</italic></source>. <year>2015</year>;<volume>278</volume>:<fpage>369</fpage>–<lpage>395</lpage>. doi:<pub-id pub-id-type="doi">10.1111/joim.12395</pub-id><pub-id pub-id-type="pmid">26212387</pub-id></mixed-citation></ref><ref id="CIT0005"><label>5.</label><mixed-citation publication-type="journal"><string-name><surname>Hunter</surname><given-names>TM</given-names></string-name>, <string-name><surname>Boytsov</surname><given-names>NN</given-names></string-name>, <string-name><surname>Zhang</surname><given-names>X</given-names></string-name>, <string-name><surname>Schroeder</surname><given-names>K</given-names></string-name>, <string-name><surname>Michaud</surname><given-names>K</given-names></string-name>, <string-name><surname>Araujo</surname><given-names>AB</given-names></string-name>. <article-title>Prevalence of rheumatoid arthritis in the United States adult population in healthcare claims databases, 2004–2014</article-title>. <source><italic toggle="yes">Rheumatol Int</italic></source>. <year>2017</year>;<volume>37</volume>:<fpage>1551</fpage>–<lpage>1557</lpage>. doi:<pub-id pub-id-type="doi">10.1007/s00296-017-3726-1</pub-id><pub-id pub-id-type="pmid">28455559</pub-id></mixed-citation></ref><ref id="CIT0006"><label>6.</label><mixed-citation publication-type="journal"><string-name><surname>Smolen</surname><given-names>JS</given-names></string-name>, <string-name><surname>Aletaha</surname><given-names>D</given-names></string-name>, <string-name><surname>Barton</surname><given-names>A</given-names></string-name>, et al. <article-title>Rheumatoid arthritis</article-title>. <source><italic toggle="yes">Nat Rev Dis Primers</italic></source>. <year>2018</year>;<volume>4</volume>:<fpage>18001</fpage>. doi:<pub-id pub-id-type="doi">10.1038/nrdp.2018.1</pub-id><pub-id pub-id-type="pmid">29417936</pub-id></mixed-citation></ref><ref id="CIT0007"><label>7.</label><mixed-citation publication-type="journal"><string-name><surname>Smolen</surname><given-names>JS</given-names></string-name>, <string-name><surname>Landewe</surname><given-names>R</given-names></string-name>, <string-name><surname>Bijlsma</surname><given-names>J</given-names></string-name>, et al. <article-title>EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2016 update</article-title>. <source><italic toggle="yes">Ann Rheum Dis</italic></source>. <year>2017</year>;<volume>76</volume>:<fpage>960</fpage>–<lpage>977</lpage>. doi:<pub-id pub-id-type="doi">10.1136/annrheumdis-2016-210715</pub-id><pub-id pub-id-type="pmid">28264816</pub-id></mixed-citation></ref><ref id="CIT0008"><label>8.</label><mixed-citation publication-type="journal"><string-name><surname>Gillis</surname><given-names>T</given-names></string-name>, <string-name><surname>Crane</surname><given-names>M</given-names></string-name>, <string-name><surname>Hinkle</surname><given-names>C</given-names></string-name>, <string-name><surname>Wei</surname><given-names>N</given-names></string-name>. <article-title>Repository corticotropin injection as adjunctive therapy in patients with rheumatoid arthritis who have failed previous therapies with at least three different modes of action</article-title>. <source><italic toggle="yes">Open Access Rheumatol</italic></source>. <year>2017</year>;<volume>9</volume>:<fpage>131</fpage>–<lpage>138</lpage>. doi:<pub-id pub-id-type="doi">10.2147/OARRR</pub-id><pub-id pub-id-type="pmid">28790870</pub-id></mixed-citation></ref><ref id="CIT0009"><label>9.</label><mixed-citation publication-type="journal"><string-name><surname>Fischer</surname><given-names>PA</given-names></string-name>, <string-name><surname>Rapoport</surname><given-names>RJ</given-names></string-name>. <article-title>Repository corticotropin injection in patients with rheumatoid arthritis resistant to biologic therapies</article-title>. <source><italic toggle="yes">Open Access Rheumatol</italic></source>. <year>2018</year>;<volume>10</volume>:<fpage>13</fpage>–<lpage>19</lpage>. doi:<pub-id pub-id-type="doi">10.2147/OARRR</pub-id><pub-id pub-id-type="pmid">29445306</pub-id></mixed-citation></ref><ref id="CIT0010"><label>10.</label><mixed-citation publication-type="journal"><string-name><surname>Helmick</surname><given-names>CG</given-names></string-name>, <string-name><surname>Felson</surname><given-names>DT</given-names></string-name>, <string-name><surname>Lawrence</surname><given-names>RC</given-names></string-name>, et al. <article-title>Estimates of the prevalence of arthritis and other rheumatic conditions in the United States</article-title>. <source><italic toggle="yes">Part I. Arthritis Rheum</italic></source>. <year>2008</year>;<volume>58</volume>:<fpage>15</fpage>–<lpage>25</lpage>.<pub-id pub-id-type="pmid">18163481</pub-id></mixed-citation></ref><ref id="CIT0011"><label>11.</label><mixed-citation publication-type="journal"><string-name><surname>Rees</surname><given-names>F</given-names></string-name>, <string-name><surname>Doherty</surname><given-names>M</given-names></string-name>, <string-name><surname>Grainge</surname><given-names>MJ</given-names></string-name>, <string-name><surname>Lanyon</surname><given-names>P</given-names></string-name>, <string-name><surname>Zhang</surname><given-names>W</given-names></string-name>. <article-title>The worldwide incidence and prevalence of systemic lupus erythematosus: a systematic review of epidemiological studies</article-title>. <source><italic toggle="yes">Rheumatology (Oxford)</italic></source>. <year>2017</year>;<volume>56</volume>:<fpage>1945</fpage>–<lpage>1961</lpage>. doi:<pub-id pub-id-type="doi">10.1093/rheumatology/kex260</pub-id><pub-id pub-id-type="pmid">28968809</pub-id></mixed-citation></ref><ref id="CIT0012"><label>12.</label><mixed-citation publication-type="journal"><string-name><surname>Lam</surname><given-names>NC</given-names></string-name>, <string-name><surname>Ghetu</surname><given-names>MV</given-names></string-name>, <string-name><surname>Bieniek</surname><given-names>ML</given-names></string-name>. <article-title>Systemic lupus erythematosus: primary care approach to diagnosis and management</article-title>. <source><italic toggle="yes">Am Fam Physician</italic></source>. <year>2016</year>;<volume>94</volume>:<fpage>284</fpage>–<lpage>294</lpage>.<pub-id pub-id-type="pmid">27548593</pub-id></mixed-citation></ref><ref id="CIT0013"><label>13.</label><mixed-citation publication-type="journal"><string-name><surname>Li</surname><given-names>X</given-names></string-name>, <string-name><surname>Golubovsky</surname><given-names>J</given-names></string-name>, <string-name><surname>Hui-Yuen</surname><given-names>J</given-names></string-name>, et al. <article-title>Adrenocorticotropic hormone gel in the treatment of systemic lupus erythematosus: a retrospective study of patients</article-title>. <source><italic toggle="yes">F1000Res</italic></source>. <year>2015</year>;<volume>4</volume>:<fpage>1103</fpage>. doi:<pub-id pub-id-type="doi">10.12688/f1000research</pub-id><pub-id pub-id-type="pmid">27158444</pub-id></mixed-citation></ref><ref id="CIT0014"><label>14.</label><mixed-citation publication-type="journal"><string-name><surname>Fiechtner</surname><given-names>JJ</given-names></string-name>, <string-name><surname>Montroy</surname><given-names>T</given-names></string-name>. <article-title>Treatment of moderately to severely active systemic lupus erythematosus with adrenocorticotropic hormone: a single-site, open-label trial</article-title>. <source><italic toggle="yes">Lupus</italic></source>. <year>2014</year>;<volume>23</volume>:<fpage>905</fpage>–<lpage>912</lpage>. doi:<pub-id pub-id-type="doi">10.1177/0961203314532562</pub-id><pub-id pub-id-type="pmid">24795067</pub-id></mixed-citation></ref><ref id="CIT0015"><label>15.</label><mixed-citation publication-type="journal"><string-name><surname>Fiechtner</surname><given-names>JJ</given-names></string-name>, <string-name><surname>Montroy</surname><given-names>T</given-names></string-name>. <article-title>Six months’ treatment of moderately to severely active systemic lupus erythematosus with repository corticotropin injection: an extension of a single-site, open-label trial</article-title>. <source><italic toggle="yes">J Immunol Clin Res</italic></source>. <year>2016</year>;<volume>3</volume>:<fpage>1025</fpage>.</mixed-citation></ref><ref id="CIT0016"><label>16.</label><mixed-citation publication-type="journal"><string-name><surname>Furie</surname><given-names>R</given-names></string-name>, <string-name><surname>Mitrane</surname><given-names>M</given-names></string-name>, <string-name><surname>Zhao</surname><given-names>E</given-names></string-name>, <string-name><surname>Das</surname><given-names>M</given-names></string-name>, <string-name><surname>Li</surname><given-names>D</given-names></string-name>, <string-name><surname>Becker</surname><given-names>PM</given-names></string-name>. <article-title>Efficacy and tolerability of repository corticotropin injection in patients with persistently active SLE: results of a phase 4, randomised, controlled pilot study</article-title>. <source><italic toggle="yes">Lupus Sci Med</italic></source>. <year>2016</year>;<volume>3</volume>:<fpage>e000180</fpage>. doi:<pub-id pub-id-type="doi">10.1136/lupus-2016-000180</pub-id><pub-id pub-id-type="pmid">27933199</pub-id></mixed-citation></ref><ref id="CIT0017"><label>17.</label><mixed-citation publication-type="journal"><string-name><surname>Furie</surname><given-names>RA</given-names></string-name>, <string-name><surname>Mitrane</surname><given-names>M</given-names></string-name>, <string-name><surname>Zhao</surname><given-names>E</given-names></string-name>, <string-name><surname>Becker</surname><given-names>PM</given-names></string-name>. <article-title>Repository corticotropin injection in patients with persistently active SLE requiring corticosteroids: post hoc analysis of results from a two-part, 52-week pilot study</article-title>. <source><italic toggle="yes">Lupus Sci Med</italic></source>. <year>2017</year>;<volume>4</volume>:<fpage>e000240</fpage>. doi:<pub-id pub-id-type="doi">10.1136/lupus-2017-000240</pub-id><pub-id pub-id-type="pmid">29344387</pub-id></mixed-citation></ref><ref id="CIT0018"><label>18.</label><mixed-citation publication-type="journal"><string-name><surname>Schmidt</surname><given-names>J</given-names></string-name>. <article-title>Current classification and management of inflammatory myopathies</article-title>. <source><italic toggle="yes">J Neuromuscul Dis</italic></source>. <year>2018</year>;<volume>5</volume>:<fpage>109</fpage>–<lpage>129</lpage>. doi:<pub-id pub-id-type="doi">10.3233/JND-180308</pub-id><pub-id pub-id-type="pmid">29865091</pub-id></mixed-citation></ref><ref id="CIT0019"><label>19.</label><mixed-citation publication-type="journal"><string-name><surname>Levine</surname><given-names>T</given-names></string-name>. <article-title>Treating refractory dermatomyositis or polymyositis with adrenocorticotropic hormone gel: a retrospective case series</article-title>. <source><italic toggle="yes">Drug Des Devel Ther</italic></source>. <year>2012</year>;<volume>6</volume>:<fpage>133</fpage>–<lpage>139</lpage>. doi:<pub-id pub-id-type="doi">10.2147/DDDT</pub-id></mixed-citation></ref><ref id="CIT0020"><label>20.</label><mixed-citation publication-type="journal"><string-name><surname>Levine</surname><given-names>T</given-names></string-name>, <string-name><surname>Malone</surname><given-names>J</given-names></string-name>, <string-name><surname>Efthimiou</surname><given-names>P</given-names></string-name>, et al. <article-title>H.P. Acthar<sup>®</sup> Gel in dermatomyositis and polymyositis treatment registry: an interim analysis</article-title>. <source><italic toggle="yes">J Neurol Disord</italic></source>. <year>2016</year>;<volume>4</volume>:<fpage>292</fpage>. doi:<pub-id pub-id-type="doi">10.4172/2329-6895.1000292</pub-id></mixed-citation></ref><ref id="CIT0021"><label>21.</label><mixed-citation publication-type="journal"><string-name><surname>Aggarwal</surname><given-names>R</given-names></string-name>, <string-name><surname>Marder</surname><given-names>G</given-names></string-name>, <string-name><surname>Koontz</surname><given-names>DC</given-names></string-name>, <string-name><surname>Nandkumar</surname><given-names>P</given-names></string-name>, <string-name><surname>Qi</surname><given-names>Z</given-names></string-name>, <string-name><surname>Oddis</surname><given-names>CV</given-names></string-name>. <article-title>Efficacy and safety of adrenocorticotropic hormone gel in refractory dermatomyositis and polymyositis</article-title>. <source><italic toggle="yes">Ann Rheum Dis</italic></source>. <year>2018</year>;<volume>77</volume>:<fpage>720</fpage>–<lpage>727</lpage>. doi:<pub-id pub-id-type="doi">10.1136/annrheumdis-2017-212047</pub-id><pub-id pub-id-type="pmid">29237618</pub-id></mixed-citation></ref><ref id="CIT0022"><label>22.</label><mixed-citation publication-type="journal"><string-name><surname>Chopra</surname><given-names>I</given-names></string-name>, <string-name><surname>Qin</surname><given-names>Y</given-names></string-name>, <string-name><surname>Kranyak</surname><given-names>J</given-names></string-name>, et al. <article-title>Repository corticotropin injection in patients with advanced symptomatic sarcoidosis: retrospective analysis of medical records</article-title>. <source><italic toggle="yes">Ther Adv Respir Dis</italic></source>. <year>2019</year>;<volume>13</volume>:<fpage>1753466619888127</fpage>. doi:<pub-id pub-id-type="doi">10.1177/1753466619888127</pub-id><pub-id pub-id-type="pmid">31722624</pub-id></mixed-citation></ref><ref id="CIT0023"><label>23.</label><mixed-citation publication-type="journal"><string-name><surname>Nelson</surname><given-names>WW</given-names></string-name>, <string-name><surname>Lima</surname><given-names>AF</given-names></string-name>, <string-name><surname>Kranyak</surname><given-names>J</given-names></string-name>, et al. <article-title>Retrospective medical record review to describe use of repository corticotropin injection among patients with uveitis in the United States</article-title>. <source><italic toggle="yes">J Ocul Pharmacol Ther</italic></source>. <year>2019</year>;<volume>35</volume>(<issue>3</issue>):<fpage>182</fpage>–<lpage>188</lpage>. doi:<pub-id pub-id-type="doi">10.1089/jop.2018.0090</pub-id><pub-id pub-id-type="pmid">30676837</pub-id></mixed-citation></ref><ref id="CIT0024"><label>24.</label><mixed-citation publication-type="journal"><string-name><surname>Fleischmann</surname><given-names>R</given-names></string-name>, <string-name><surname>Furst</surname><given-names>DE</given-names></string-name>, <string-name><surname>Connolly-Strong</surname><given-names>E</given-names></string-name>, <string-name><surname>Liu</surname><given-names>J</given-names></string-name>, <string-name><surname>Zhu</surname><given-names>J</given-names></string-name>, <string-name><surname>Brasington</surname><given-names>R</given-names></string-name>. <article-title>A multicentre study assessing the efficacy and safety of repository corticotropin injection in patients with persistently active rheumatoid arthritis: Poster presented at: The European League Against Rheumatism (EULAR) Annual Congress</article-title>; June 12–15, <year>2019</year>; Madrid, Spain. </mixed-citation></ref><ref id="CIT0025"><label>25.</label><mixed-citation publication-type="journal"><string-name><surname>Saygin</surname><given-names>D</given-names></string-name>, <string-name><surname>Marder</surname><given-names>G</given-names></string-name>, <string-name><surname>Oddis</surname><given-names>CV</given-names></string-name>, et al. <article-title>Long term follow-up results of myositis patients treated with H. P. Acthar Gel [abstract]</article-title>. <source><italic toggle="yes">Arthritis Rheum</italic></source>. <year>2018</year>;<volume>70</volume>.</mixed-citation></ref><ref id="CIT0026"><label>26.</label><mixed-citation publication-type="journal"><string-name><surname>Fernandez</surname><given-names>A</given-names></string-name>. <article-title>Interim results of an open-label study assessing efficacy and safety of adrenocorticotropic hormone gel for treatment of refractory cutaneous manifestations of dermatomyositis [abstract]</article-title>. <source><italic toggle="yes">Arthritis Rheum</italic></source>. <year>2018</year>;<volume>70</volume>.</mixed-citation></ref></ref-list></back></pmc></record>Pour manipuler ce document sous Unix (Dilib)
EXPLOR_STEP=$WICRI_ROOT/Sante/explor/ChloroquineV1/Data/Pmc/Corpus
HfdSelect -h $EXPLOR_STEP/biblio.hfd -nk 000758 | SxmlIndent | more
Ou
HfdSelect -h $EXPLOR_AREA/Data/Pmc/Corpus/biblio.hfd -nk 000758 | SxmlIndent | more
Pour mettre un lien sur cette page dans le réseau Wicri
{{Explor lien
|wiki= Sante
|area= ChloroquineV1
|flux= Pmc
|étape= Corpus
|type= RBID
|clé= PMC:7039080
|texte= Treatment with Repository Corticotropin Injection in Patients with Rheumatoid Arthritis, Systemic Lupus Erythematosus, and Dermatomyositis/Polymyositis
}}
Pour générer des pages wiki
HfdIndexSelect -h $EXPLOR_AREA/Data/Pmc/Corpus/RBID.i -Sk "pubmed:32110122" \
| HfdSelect -Kh $EXPLOR_AREA/Data/Pmc/Corpus/biblio.hfd \
| NlmPubMed2Wicri -a ChloroquineV1
| This area was generated with Dilib version V0.6.33. |  |