The use of biological disease-modifying antirheumatic drugs for inflammatory arthritis in Korea: results of a Korean Expert Consensus
Identifieur interne : 000B86 ( Pmc/Curation ); précédent : 000B85; suivant : 000B87The use of biological disease-modifying antirheumatic drugs for inflammatory arthritis in Korea: results of a Korean Expert Consensus
Auteurs : Eun-Jung Park [Corée du Sud] ; Hyungjin Kim [Corée du Sud] ; Seung Min Jung [Corée du Sud] ; Yoon-Kyoung Sung [Corée du Sud] ; Han Joo Baek [Corée du Sud] ; Jisoo Lee [Corée du Sud]Source :
- The Korean Journal of Internal Medicine [ 1226-3303 ] ; 2020.
Abstract
Biological disease-modifying antirheumatic drugs (bDMARDs) are highly effective agents for the treatment of inf lammatory arthritis; however, they also possess a potential risk for serious infection. Recently, with the rapid expansion of the bDMARDs market in Korea, reports of serious adverse events related to the agents have also increased, necessitating guidance for the use of bDMARDs. Current work entitled, “Expert consensus for the use of bDMARDs drugs for inflammatory arthritis in Korea,” is the first to describe the appropriate use of bDMARDs in the management of inflammatory arthritis in Korea, with an aim to provide guidance for the local medical community to improve the quality of clinical care. Twelve consensus statements regarding the use of bDMARDs for the management of rheumatoid arthritis and ankylosing spondylitis were generated. In this review, we provide detailed guidance on bDMARDs use based on expert consensus, including who should prescribe, the role of education, indications for use, and monitoring strategies for safety.
Url:
DOI: 10.3904/kjim.2019.411
PubMed: 31935319
PubMed Central: 6960050
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strict</wicri:regionArea></affiliation></author><author><name sortKey="Baek, Han Joo" sort="Baek, Han Joo" uniqKey="Baek H" first="Han Joo" last="Baek">Han Joo Baek</name><affiliation wicri:level="1"><nlm:aff id="af5-kjim-2019-411">Division of Rheumatology, Department of Internal Medicine, Gachon University Gil Medical Center, Incheon,<country>Korea</country></nlm:aff><country xml:lang="fr">Corée du Sud</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Lee, Jisoo" sort="Lee, Jisoo" uniqKey="Lee J" first="Jisoo" last="Lee">Jisoo Lee</name><affiliation wicri:level="1"><nlm:aff id="af6-kjim-2019-411">Division of Rheumatology, Department of Internal Medicine, Ewha Womans University School of Medicine, Seoul,<country>Korea</country></nlm:aff><country xml:lang="fr">Corée du Sud</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author></titleStmt><publicationStmt><idno 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Rheumatology, Department of Medicine, National Medical Center, Seoul,<country>Korea</country></nlm:aff><country xml:lang="fr">Corée du Sud</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Kim, Hyungjin" sort="Kim, Hyungjin" uniqKey="Kim H" first="Hyungjin" last="Kim">Hyungjin Kim</name><affiliation wicri:level="1"><nlm:aff id="af2-kjim-2019-411">Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul,<country>Korea</country></nlm:aff><country xml:lang="fr">Corée du Sud</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Jung, Seung Min" sort="Jung, Seung Min" uniqKey="Jung S" first="Seung Min" last="Jung">Seung Min Jung</name><affiliation wicri:level="1"><nlm:aff id="af3-kjim-2019-411">Division of Rheumatology, Department of Medicine, Yonsei University College of Medicine, Seoul,<country>Korea</country></nlm:aff><country xml:lang="fr">Corée du Sud</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Sung, Yoon Kyoung" sort="Sung, Yoon Kyoung" uniqKey="Sung Y" first="Yoon-Kyoung" last="Sung">Yoon-Kyoung Sung</name><affiliation wicri:level="1"><nlm:aff id="af4-kjim-2019-411">Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, Seoul,<country>Korea</country></nlm:aff><country xml:lang="fr">Corée du Sud</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Baek, Han Joo" sort="Baek, Han Joo" uniqKey="Baek H" first="Han Joo" last="Baek">Han Joo Baek</name><affiliation wicri:level="1"><nlm:aff id="af5-kjim-2019-411">Division of Rheumatology, Department of Internal Medicine, Gachon University Gil Medical Center, Incheon,<country>Korea</country></nlm:aff><country xml:lang="fr">Corée du Sud</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Lee, Jisoo" sort="Lee, Jisoo" uniqKey="Lee J" first="Jisoo" last="Lee">Jisoo Lee</name><affiliation wicri:level="1"><nlm:aff id="af6-kjim-2019-411">Division of Rheumatology, Department of Internal Medicine, Ewha Womans University School of Medicine, Seoul,<country>Korea</country></nlm:aff><country xml:lang="fr">Corée du Sud</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author></analytic><series><title level="j">The Korean Journal of Internal Medicine</title><idno type="ISSN">1226-3303</idno><idno type="eISSN">2005-6648</idno><imprint><date when="2020">2020</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><p>Biological disease-modifying antirheumatic drugs (bDMARDs) are highly effective agents for the treatment of inf lammatory arthritis; however, they also possess a potential risk for serious infection. Recently, with the rapid expansion of the bDMARDs market in Korea, reports of serious adverse events related to the agents have also increased, necessitating guidance for the use of bDMARDs. Current work entitled, “Expert consensus for the use of bDMARDs drugs for inflammatory arthritis in Korea,” is the first to describe the appropriate use of bDMARDs in the management of inflammatory arthritis in Korea, with an aim to provide guidance for the local medical community to improve the quality of clinical care. Twelve consensus statements regarding the use of bDMARDs for the management of rheumatoid arthritis and ankylosing spondylitis were generated. 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<front><journal-meta><journal-id journal-id-type="nlm-ta">Korean J Intern Med</journal-id><journal-id journal-id-type="iso-abbrev">Korean J. Intern. Med</journal-id><journal-id journal-id-type="publisher-id">KJIM</journal-id><journal-title-group><journal-title>The Korean Journal of Internal Medicine</journal-title></journal-title-group><issn pub-type="ppub">1226-3303</issn><issn pub-type="epub">2005-6648</issn><publisher><publisher-name>The Korean Association of Internal Medicine</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="pmid">31935319</article-id><article-id pub-id-type="pmc">6960050</article-id><article-id pub-id-type="doi">10.3904/kjim.2019.411</article-id><article-id pub-id-type="publisher-id">kjim-2019-411</article-id><article-categories><subj-group subj-group-type="heading"><subject>Guideline</subject></subj-group></article-categories><title-group><article-title>The use of biological disease-modifying antirheumatic drugs for inflammatory arthritis in Korea: results of a Korean Expert Consensus</article-title></title-group><contrib-group><contrib contrib-type="author"><name><surname>Park</surname><given-names>Eun-Jung</given-names></name><xref ref-type="aff" rid="af1-kjim-2019-411"><sup>1</sup></xref></contrib><contrib contrib-type="author"><name><surname>Kim</surname><given-names>Hyungjin</given-names></name><xref ref-type="aff" rid="af2-kjim-2019-411"><sup>2</sup></xref></contrib><contrib contrib-type="author"><name><surname>Jung</surname><given-names>Seung Min</given-names></name><xref ref-type="aff" rid="af3-kjim-2019-411"><sup>3</sup></xref></contrib><contrib contrib-type="author"><name><surname>Sung</surname><given-names>Yoon-Kyoung</given-names></name><xref ref-type="aff" rid="af4-kjim-2019-411"><sup>4</sup></xref></contrib><contrib contrib-type="author"><name><surname>Baek</surname><given-names>Han Joo</given-names></name><xref ref-type="aff" rid="af5-kjim-2019-411"><sup>5</sup></xref></contrib><contrib contrib-type="author"><contrib-id contrib-id-type="orcid" authenticated="false">http://orcid.org/0000-0001-6279-7025</contrib-id><name><surname>Lee</surname><given-names>Jisoo</given-names></name><xref ref-type="corresp" rid="c1-kjim-2019-411"></xref><xref ref-type="aff" rid="af6-kjim-2019-411"><sup>6</sup></xref></contrib><aff id="af1-kjim-2019-411"><label>1</label>Division of Rheumatology, Department of Medicine, National Medical Center, Seoul,<country>Korea</country></aff><aff id="af2-kjim-2019-411"><label>2</label>Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul,<country>Korea</country></aff><aff id="af3-kjim-2019-411"><label>3</label>Division of Rheumatology, Department of Medicine, Yonsei University College of Medicine, Seoul,<country>Korea</country></aff><aff id="af4-kjim-2019-411"><label>4</label>Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, Seoul,<country>Korea</country></aff><aff id="af5-kjim-2019-411"><label>5</label>Division of Rheumatology, Department of Internal Medicine, Gachon University Gil Medical Center, Incheon,<country>Korea</country></aff><aff id="af6-kjim-2019-411"><label>6</label>Division of Rheumatology, Department of Internal Medicine, Ewha Womans University School of Medicine, Seoul,<country>Korea</country></aff></contrib-group><author-notes><corresp id="c1-kjim-2019-411">Correspondence to Jisoo Lee, M.D. Division of Rheumatology, Department of Internal Medicine, Ewha Womans University School of Medicine, 1071 Anyangcheon-ro, Yangcheon-gu, Seoul 07985, Korea Tel: +82-2-2650-6164 Fax: +82-2-2650-2590 E-mail: <email>leejisoo@ewha.ac.kr</email></corresp><fn id="fn1-kjim-2019-411"><p>These guidelines are copublished by the <italic>Korean Journal of Internal Medicine</italic> and <italic>Journal of Rheumatic Diseases</italic> for facilitated distribution.</p></fn></author-notes><pub-date pub-type="ppub"><month>1</month><year>2020</year></pub-date><pub-date pub-type="epub"><day>2</day><month>1</month><year>2020</year></pub-date><volume>35</volume><issue>1</issue><fpage>41</fpage><lpage>59</lpage><history><date date-type="received"><day>2</day><month>12</month><year>2019</year></date><date date-type="accepted"><day>23</day><month>12</month><year>2019</year></date></history><permissions><copyright-statement>Copyright © 2020 The Korean Association of Internal Medicine</copyright-statement><copyright-year>2020</copyright-year><license><license-p>This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (<ext-link ext-link-type="uri" xlink:href="http://creativecommons.org/licenses/by-nc/4.0/">http://creativecommons.org/licenses/by-nc/4.0/</ext-link>) which permits unrestricted noncommercial use, distribution, and reproduction in any medium, provided the original work is properly cited.</license-p></license></permissions><abstract><p>Biological disease-modifying antirheumatic drugs (bDMARDs) are highly effective agents for the treatment of inf lammatory arthritis; however, they also possess a potential risk for serious infection. Recently, with the rapid expansion of the bDMARDs market in Korea, reports of serious adverse events related to the agents have also increased, necessitating guidance for the use of bDMARDs. Current work entitled, “Expert consensus for the use of bDMARDs drugs for inflammatory arthritis in Korea,” is the first to describe the appropriate use of bDMARDs in the management of inflammatory arthritis in Korea, with an aim to provide guidance for the local medical community to improve the quality of clinical care. Twelve consensus statements regarding the use of bDMARDs for the management of rheumatoid arthritis and ankylosing spondylitis were generated. In this review, we provide detailed guidance on bDMARDs use based on expert consensus, including who should prescribe, the role of education, indications for use, and monitoring strategies for safety. </p></abstract><kwd-group><kwd>Expert consensus</kwd><kwd>Biological disease-modifying antirheumatic drugs</kwd><kwd>Inflammatory arthritis</kwd><kwd>Arthritis, rheumatoid</kwd><kwd>Spondylitis, ankylosing</kwd></kwd-group></article-meta></front><floats-group><table-wrap id="t1-kjim-2019-411" orientation="portrait" position="float"><label>Table 1.</label><caption><p>Significance of the quality of evidence according to the GRADE system [<xref rid="b19-kjim-2019-411" ref-type="bibr">19</xref>,<xref rid="b20-kjim-2019-411" ref-type="bibr">20</xref>]</p></caption><table frame="hsides" rules="groups"><thead><tr><th align="left" valign="middle" rowspan="1" colspan="1">Quality level</th><th align="center" valign="middle" rowspan="1" colspan="1">Definition</th></tr></thead><tbody><tr><td valign="top" align="left" rowspan="1" colspan="1">High</td><td valign="top" align="left" rowspan="1" colspan="1">We are very confident that the true effect lies close to that of the estimate of the effect.</td></tr><tr><td valign="top" align="left" rowspan="1" colspan="1">Moderate</td><td valign="top" align="left" rowspan="1" colspan="1">We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different.</td></tr><tr><td valign="top" align="left" rowspan="1" colspan="1">Low</td><td valign="top" align="left" rowspan="1" colspan="1">Our confidence in the effect estimate is limited. The true effect may be substantially different from the estimate of the effect.</td></tr><tr><td valign="top" align="left" rowspan="1" colspan="1">Very low</td><td valign="top" align="left" rowspan="1" colspan="1">We have very little confidence in the effect estimate. The true effect is likely to be substantially differ- ent from the estimate of effect.</td></tr></tbody></table><table-wrap-foot><fn><p>GRADE, Grades of Recommendation, Assessment, Development, and Evaluation.</p></fn></table-wrap-foot></table-wrap><table-wrap id="t2-kjim-2019-411" orientation="portrait" position="float"><label>Table 2.</label><caption><p>Expert opinion for the management of inflammatory arthritis in adults with biological disease-modifying antirheumatic drugs<sup><xref rid="tfn1-kjim-2019-411" ref-type="table-fn">a</xref></sup> in South Korea</p></caption><table frame="hsides" rules="groups"><thead><tr><th align="left" valign="middle" colspan="2" rowspan="1">Recommendation</th><th align="center" valign="middle" rowspan="1" colspan="1">Appropriateness<sup><xref rid="tfn2-kjim-2019-411" ref-type="table-fn">b</xref></sup>/median Likert Scale score</th><th align="center" valign="middle" rowspan="1" colspan="1">Level of agreement<sup><xref rid="tfn3-kjim-2019-411" ref-type="table-fn">c</xref></sup> (%, agreement)</th></tr></thead><tbody><tr><td valign="top" align="left" rowspan="1" colspan="1">1.</td><td valign="top" align="left" rowspan="1" colspan="1">bDAMRDs should be prescribed by an expert experienced in the diagnosing and managing rheumatic diseases, who can monitor disease activity using standardized assessment tools, and perform safety monitoring (LOE: low; SOR: strongly recommended).</td><td valign="top" align="center" rowspan="1" colspan="1">A/9</td><td valign="top" align="left" rowspan="1" colspan="1">High agreement (100)</td></tr><tr><td valign="top" align="left" rowspan="1" colspan="1">2.</td><td valign="top" align="left" rowspan="1" colspan="1">Patients should be provided with education about their treatment with bDMARDs (LOE: moderate; SOR: strongly recommended).</td><td valign="top" align="center" rowspan="1" colspan="1">A/9</td><td valign="top" align="left" rowspan="1" colspan="1">High agreement (100)</td></tr><tr><td valign="top" align="left" rowspan="1" colspan="1">3.</td><td valign="top" align="left" rowspan="1" colspan="1">In RA, if the treatment target is not achieved with the first csDMARDs strategy, when poor prognostic factors<sup><xref rid="tfn4-kjim-2019-411" ref-type="table-fn">d</xref></sup> are present, addition of a bDMARD should be considered (LOE: moderate; SOR: strongly recommended).</td><td valign="top" align="center" rowspan="1" colspan="1">A/9</td><td valign="top" align="left" rowspan="1" colspan="1">High agreement (100)</td></tr><tr><td valign="top" align="left" rowspan="1" colspan="1">4.</td><td valign="top" align="left" rowspan="1" colspan="1">In AS, bDMARDs should be considered in patients with persistently high disease activity despite conventional treatments including NSAIDs; current practice is to start with TNF inhibitor therapy (LOE: high for TNF inhibitor/moderate for IL- 17 inhibitor; SOR: strongly recommended).</td><td valign="top" align="center" rowspan="1" colspan="1">A/9</td><td valign="top" align="left" rowspan="1" colspan="1">High agreement (100)</td></tr><tr><td valign="top" align="left" rowspan="1" colspan="1">5.</td><td valign="top" align="left" rowspan="1" colspan="1">In RA, bDMARDs should be combined with a csDMARDs such as MTX (LOE: high; SOR: strongly recommended).</td><td valign="top" align="center" rowspan="1" colspan="1">A/9</td><td valign="top" align="left" rowspan="1" colspan="1">High agreement (100)</td></tr><tr><td valign="top" align="left" rowspan="1" colspan="1">6.</td><td valign="top" align="left" rowspan="1" colspan="1">In AS, bDMARD monotherapy without csDMARDs is recommended patients with purely axial disease (LOE: high; SOR: strongly recommended).</td><td valign="top" align="center" rowspan="1" colspan="1">A/9</td><td valign="top" align="left" rowspan="1" colspan="1">High agreement (93.8)</td></tr><tr><td valign="top" align="left" rowspan="1" colspan="1">7.</td><td valign="top" align="left" rowspan="1" colspan="1">In RA, if a bDMARD has failed, switching to another bDMARD should be considered (LOE: high; SOR: strongly recommended).</td><td valign="top" align="center" rowspan="1" colspan="1">A/9</td><td valign="top" align="left" rowspan="1" colspan="1">High agreement (100)</td></tr><tr><td valign="top" align="left" rowspan="1" colspan="1">8.</td><td valign="top" align="left" rowspan="1" colspan="1">In AS, if the treatment with the first TNF inhibitor has failed, switching to another TNF ihibitors or IL-17 inhibitor should be considered (LOE: low for TNF inhibitor/moderate for IL-17 inhibitor; SOR: weakly recommended for TNF inhibitors, strongly recommended for IL-17 inhibitor).</td><td valign="top" align="center" rowspan="1" colspan="1">A/9</td><td valign="top" align="left" rowspan="1" colspan="1">High agreement (100)</td></tr><tr><td valign="top" align="left" rowspan="1" colspan="1">9.</td><td valign="top" align="left" rowspan="1" colspan="1">Prior to initiating bDMARDs, disease activity, joint damage, functional capacity, extra-articular manifestations, comorbidities, vaccination history, and pregnancy status should be assessed in all patients with inflammatory arthritis (LOE: low; SOR: strongly recommended).</td><td valign="top" align="center" rowspan="1" colspan="1">A/9</td><td valign="top" align="left" rowspan="1" colspan="1">High agreement (100)</td></tr><tr><td valign="top" align="left" rowspan="1" colspan="1">10.</td><td valign="top" align="left" rowspan="1" colspan="1">All patients should be screened for active or latent tuberculosis before starting bDMARDs, and if tuberculosis is detected, patients should receive adequate anti-tuberculosis treatment, appropriately (LOE: low; SOR: strongly recommended).</td><td valign="top" align="center" rowspan="1" colspan="1">A/9</td><td valign="top" align="left" rowspan="1" colspan="1">High agreement (100)</td></tr><tr><td valign="top" align="left" rowspan="1" colspan="1">11.</td><td valign="top" align="left" rowspan="1" colspan="1">All patients should be screened for hepatitis B virus infection before starting bDMARDs, and if hepatitis B virus infection is identified, proper antiviral therapy should be considered (LOE: high for screening/low for antiviral therapy; SOR: strongly recommended).</td><td valign="top" align="center" rowspan="1" colspan="1">A/9</td><td valign="top" align="left" rowspan="1" colspan="1">High agreement (100)</td></tr><tr><td valign="top" align="left" rowspan="1" colspan="1">12.</td><td valign="top" align="left" rowspan="1" colspan="1">All patients receiving bDMARDs should be monitored for disease activity, joint damage, functional capacity, extra-articular manifestations, comorbidities, and drug side effects and toxicity (LOE: low; SOR: strongly recommended).</td><td valign="top" align="center" rowspan="1" colspan="1">A/9</td><td valign="top" align="left" rowspan="1" colspan="1">High agreement (100)</td></tr></tbody></table><table-wrap-foot><fn><p>bDMARD, biologic disease modifying antirheumatic drug; LOE, level of evidence; SOR, strength of recommendation; A, appropriateness; RA, rheumatoid arthritis; csDMARD, conventional synthetic disease modifying antirheumatic drug; AS, ankylosing spondylitis; NSAID, nonsteroidal anti-inflammatory drug; TNF, tumor necrosis factor; IL-17, interleukin-17; MTX, methotrexate.</p></fn><fn id="tfn1-kjim-2019-411"><label>a</label><p>TNF inhibitors (adalimumab, etanercept, golimumab, or infliximab), abatacept, rituximab, tocilizumab, or the respective European Medicines Agency (EMA)-approved/Food and Drug Administration (FDA)-approved biosimilars for the patients with RA; TNF inhibitors (adalimumab, etanercept, golimumab, infliximab, or the respective EMA-approved/FDA-approved biosimilars) or IL-17 inhibitors for the patients with AS.</p></fn><fn id="tfn2-kjim-2019-411"><label>b</label><p>Appropriateness was evaluated according to RAND/University of California Los Angeles (ULCA) appropriateness method; appropriate (A) was defined as median score ranged 7–9 without disagreement.</p></fn><fn id="tfn3-kjim-2019-411"><label>c</label><p>Level of agreement was evaluated according to 9-point Likert scale; high agreement was defined as agreement scored between 7 and 9.</p></fn><fn id="tfn4-kjim-2019-411"><label>d</label><p>Positivity of rheumatoid factor or anti-citrullinated protein antibodies, joint damage, high disease activity, failure of ≥ 2 csDMARDs.</p></fn></table-wrap-foot></table-wrap></floats-group></pmc></record>Pour manipuler ce document sous Unix (Dilib)
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