An Integrated Analysis of the Safety of Tofacitinib in Psoriatic Arthritis across Phase III and Long-Term Extension Studies with Comparison to Real-World Observational Data
Identifieur interne : 000588 ( 2020/Analysis ); précédent : 000587; suivant : 000589An Integrated Analysis of the Safety of Tofacitinib in Psoriatic Arthritis across Phase III and Long-Term Extension Studies with Comparison to Real-World Observational Data
Auteurs : Gerd R. Burmester [Allemagne] ; Jeffrey R. Curtis [États-Unis] ; Huifeng Yun [États-Unis] ; Oliver Fitzgerald [Irlande (pays)] ; Kevin L. Winthrop [États-Unis] ; Valderilio F. Azevedo ; William F. C. Rigby [États-Unis] ; Keith S. Kanik [États-Unis] ; Cunshan Wang [États-Unis] ; Pinaki Biswas [États-Unis] ; Thomas Jones [États-Unis] ; Niki Palmetto [États-Unis] ; Thijs Hendrikx [États-Unis] ; Sujatha Menon [États-Unis] ; Ricardo Rojo [États-Unis]Source :
- Drug Safety [ 0114-5916 ] ; 2020.
Abstract
Tofacitinib is an oral Janus kinase inhibitor for the treatment of psoriatic arthritis (PsA).
Our objective was to compare the incidence rates (IRs) of adverse events in tofacitinib clinical trials and real-world observational data for alternative treatments.
The tofacitinib “dose-comparison cohort” included months 0–12 of two phase III studies (tofacitinib 5 [
IRs (patients with events/100 patient-years) for SIEs were similar between the tofacitinib dose-comparison cohort (5 mg BID: 1.3; 10 mg BID: 2.0) and the observational comparison cohort (1.1–7.9; treatment dependent). The tofacitinib dose-comparison cohort had a higher rate of HZ (5 mg BID: 2.0; 10 mg BID: 2.7) than did the observational comparison cohort (0.8–2.0). IRs for NMSC were generally lower in the all-tofacitinib comparison cohort (0.5) than in the observational comparison cohort (0.4–6.0). IRs for MACE, malignancies excluding NMSC, and NMSC were similar between cohorts.
In patients with PsA, tofacitinib had a safety profile similar to that of other systemic therapies in real-world settings, except for the risk of HZ, a known risk of tofacitinib.
ClinicalTrials.gov: NCT01877668; NCT01882439; NCT01976364.
The online version of this article (10.1007/s40264-020-00904-9) contains supplementary material, which is available to authorized users.
Url:
DOI: 10.1007/s40264-020-00904-9
PubMed: 32006348
PubMed Central: 7105422
Affiliations:
- Allemagne, Irlande (pays), États-Unis
- Alabama, Berlin, Connecticut, New Hampshire, Oregon, Pennsylvanie, État de New York
- Berlin
Links toward previous steps (curation, corpus...)
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Links to Exploration step
PMC:7105422Le document en format XML
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<sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">An Integrated Analysis of the Safety of Tofacitinib in Psoriatic Arthritis across Phase III and Long-Term Extension Studies with Comparison to Real-World Observational Data</title>
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</author>
<author><name sortKey="Palmetto, Niki" sort="Palmetto, Niki" uniqKey="Palmetto N" first="Niki" last="Palmetto">Niki Palmetto</name>
<affiliation wicri:level="2"><nlm:aff id="Aff8"><institution-wrap><institution-id institution-id-type="GRID">grid.410513.2</institution-id>
<institution-id institution-id-type="ISNI">0000 0000 8800 7493</institution-id>
<institution>Pfizer Inc,</institution>
</institution-wrap>
New York, NY USA</nlm:aff>
<country>États-Unis</country>
<placeName><region type="state">État de New York</region>
</placeName>
<wicri:cityArea>New York</wicri:cityArea>
</affiliation>
</author>
<author><name sortKey="Hendrikx, Thijs" sort="Hendrikx, Thijs" uniqKey="Hendrikx T" first="Thijs" last="Hendrikx">Thijs Hendrikx</name>
<affiliation wicri:level="2"><nlm:aff id="Aff9"><institution-wrap><institution-id institution-id-type="GRID">grid.410513.2</institution-id>
<institution-id institution-id-type="ISNI">0000 0000 8800 7493</institution-id>
<institution>Pfizer Inc,</institution>
</institution-wrap>
Collegeville, PA USA</nlm:aff>
<country>États-Unis</country>
<placeName><region type="state">Pennsylvanie</region>
</placeName>
<wicri:cityArea>Collegeville</wicri:cityArea>
</affiliation>
</author>
<author><name sortKey="Menon, Sujatha" sort="Menon, Sujatha" uniqKey="Menon S" first="Sujatha" last="Menon">Sujatha Menon</name>
<affiliation wicri:level="2"><nlm:aff id="Aff7"><institution-wrap><institution-id institution-id-type="GRID">grid.410513.2</institution-id>
<institution-id institution-id-type="ISNI">0000 0000 8800 7493</institution-id>
<institution>Pfizer Inc,</institution>
</institution-wrap>
445 Eastern Point Rd (MS 8260-2578), Groton, CT 06340 USA</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<placeName><region type="state">Connecticut</region>
</placeName>
<wicri:cityArea>445 Eastern Point Rd (MS 8260-2578), Groton</wicri:cityArea>
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</author>
<author><name sortKey="Rojo, Ricardo" sort="Rojo, Ricardo" uniqKey="Rojo R" first="Ricardo" last="Rojo">Ricardo Rojo</name>
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<institution-id institution-id-type="ISNI">0000 0000 8800 7493</institution-id>
<institution>Pfizer Inc,</institution>
</institution-wrap>
445 Eastern Point Rd (MS 8260-2578), Groton, CT 06340 USA</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<placeName><region type="state">Connecticut</region>
</placeName>
<wicri:cityArea>445 Eastern Point Rd (MS 8260-2578), Groton</wicri:cityArea>
</affiliation>
</author>
</analytic>
<series><title level="j">Drug Safety</title>
<idno type="ISSN">0114-5916</idno>
<idno type="eISSN">1179-1942</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><title>Introduction</title>
<p id="Par1">Tofacitinib is an oral Janus kinase inhibitor for the treatment of psoriatic arthritis (PsA).</p>
</sec>
<sec><title>Objective</title>
<p id="Par2">Our objective was to compare the incidence rates (IRs) of adverse events in tofacitinib clinical trials and real-world observational data for alternative treatments.</p>
</sec>
<sec><title>Methods</title>
<p id="Par3">The tofacitinib “dose-comparison cohort” included months 0–12 of two phase III studies (tofacitinib 5 [<italic>n </italic>
= 238] and 10 [<italic>n </italic>
= 236] mg twice daily [BID]); the “all-tofacitinib comparison cohort” (<italic>n </italic>
= 783) included two phase III and one ongoing long-term extension study (data cutoff May 2016). An “observational comparison cohort” (<italic>n </italic>
= 5799) comprised patients initiating a conventional synthetic disease-modifying antirheumatic drug (DMARD), biologic DMARD, or apremilast in the US Truven MarketScan database from 2010 to 2015. IRs for serious infections (SIEs; requiring hospitalization), herpes zoster (HZ), malignancies (excluding non-melanoma skin cancer [NMSC]), NMSC, and major adverse cardiovascular events (MACE) across cohorts were qualitatively compared.</p>
</sec>
<sec><title>Results</title>
<p id="Par4">IRs (patients with events/100 patient-years) for SIEs were similar between the tofacitinib dose-comparison cohort (5 mg BID: 1.3; 10 mg BID: 2.0) and the observational comparison cohort (1.1–7.9; treatment dependent). The tofacitinib dose-comparison cohort had a higher rate of HZ (5 mg BID: 2.0; 10 mg BID: 2.7) than did the observational comparison cohort (0.8–2.0). IRs for NMSC were generally lower in the all-tofacitinib comparison cohort (0.5) than in the observational comparison cohort (0.4–6.0). IRs for MACE, malignancies excluding NMSC, and NMSC were similar between cohorts.</p>
</sec>
<sec><title>Conclusion</title>
<p id="Par5">In patients with PsA, tofacitinib had a safety profile similar to that of other systemic therapies in real-world settings, except for the risk of HZ, a known risk of tofacitinib.</p>
</sec>
<sec><title>Trial Registration</title>
<p id="Par6">ClinicalTrials.gov: NCT01877668; NCT01882439; NCT01976364.</p>
</sec>
<sec><title>Electronic supplementary material</title>
<p>The online version of this article (10.1007/s40264-020-00904-9) contains supplementary material, which is available to authorized users.</p>
</sec>
</div>
</front>
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