Serveur d'exploration Tocilizumab

Attention, ce site est en cours de développement !
Attention, site généré par des moyens informatiques à partir de corpus bruts.
Les informations ne sont donc pas validées.

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 : 000589

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

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 :

RBID : PMC:7105422

Abstract

Introduction

Tofacitinib is an oral Janus kinase inhibitor for the treatment of psoriatic arthritis (PsA).

Objective

Our objective was to compare the incidence rates (IRs) of adverse events in tofacitinib clinical trials and real-world observational data for alternative treatments.

Methods

The tofacitinib “dose-comparison cohort” included months 0–12 of two phase III studies (tofacitinib 5 [n = 238] and 10 [n = 236] mg twice daily [BID]); the “all-tofacitinib comparison cohort” (n = 783) included two phase III and one ongoing long-term extension study (data cutoff May 2016). An “observational comparison cohort” (n = 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.

Results

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.

Conclusion

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.

Trial Registration

ClinicalTrials.gov: NCT01877668; NCT01882439; NCT01976364.

Electronic supplementary material

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:


Links toward previous steps (curation, corpus...)


Links to Exploration step

PMC:7105422

Le document en format XML

<record>
<TEI>
<teiHeader>
<fileDesc>
<titleStmt>
<title xml:lang="en">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>
<author>
<name sortKey="Burmester, Gerd R" sort="Burmester, Gerd R" uniqKey="Burmester G" first="Gerd R." last="Burmester">Gerd R. Burmester</name>
<affiliation wicri:level="3">
<nlm:aff id="Aff1">
<institution-wrap>
<institution-id institution-id-type="GRID">grid.6363.0</institution-id>
<institution-id institution-id-type="ISNI">0000 0001 2218 4662</institution-id>
<institution>Charité – University Medicine Berlin,</institution>
</institution-wrap>
Charitéplatz 1, 11017 Berlin, Germany</nlm:aff>
<country xml:lang="fr">Allemagne</country>
<wicri:regionArea>Charitéplatz 1, 11017 Berlin</wicri:regionArea>
<placeName>
<region type="land" nuts="3">Berlin</region>
<settlement type="city">Berlin</settlement>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Curtis, Jeffrey R" sort="Curtis, Jeffrey R" uniqKey="Curtis J" first="Jeffrey R." last="Curtis">Jeffrey R. Curtis</name>
<affiliation wicri:level="2">
<nlm:aff id="Aff2">
<institution-wrap>
<institution-id institution-id-type="GRID">grid.265892.2</institution-id>
<institution-id institution-id-type="ISNI">0000000106344187</institution-id>
<institution>University of Alabama at Birmingham,</institution>
</institution-wrap>
Birmingham, AL 35294 USA</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<placeName>
<region type="state">Alabama</region>
</placeName>
<wicri:cityArea>Birmingham</wicri:cityArea>
</affiliation>
</author>
<author>
<name sortKey="Yun, Huifeng" sort="Yun, Huifeng" uniqKey="Yun H" first="Huifeng" last="Yun">Huifeng Yun</name>
<affiliation wicri:level="2">
<nlm:aff id="Aff2">
<institution-wrap>
<institution-id institution-id-type="GRID">grid.265892.2</institution-id>
<institution-id institution-id-type="ISNI">0000000106344187</institution-id>
<institution>University of Alabama at Birmingham,</institution>
</institution-wrap>
Birmingham, AL 35294 USA</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<placeName>
<region type="state">Alabama</region>
</placeName>
<wicri:cityArea>Birmingham</wicri:cityArea>
</affiliation>
</author>
<author>
<name sortKey="Fitzgerald, Oliver" sort="Fitzgerald, Oliver" uniqKey="Fitzgerald O" first="Oliver" last="Fitzgerald">Oliver Fitzgerald</name>
<affiliation wicri:level="1">
<nlm:aff id="Aff3">
<institution-wrap>
<institution-id institution-id-type="GRID">grid.412751.4</institution-id>
<institution-id institution-id-type="ISNI">0000 0001 0315 8143</institution-id>
<institution>Department of Rheumatology,</institution>
<institution>St Vincent’s University Hospital,</institution>
</institution-wrap>
Elm Park, Dublin 4, Ireland</nlm:aff>
<country xml:lang="fr">Irlande (pays)</country>
<wicri:regionArea>Elm Park, Dublin 4</wicri:regionArea>
<wicri:noRegion>Dublin 4</wicri:noRegion>
</affiliation>
</author>
<author>
<name sortKey="Winthrop, Kevin L" sort="Winthrop, Kevin L" uniqKey="Winthrop K" first="Kevin L." last="Winthrop">Kevin L. Winthrop</name>
<affiliation wicri:level="2">
<nlm:aff id="Aff4">
<institution-wrap>
<institution-id institution-id-type="GRID">grid.5288.7</institution-id>
<institution-id institution-id-type="ISNI">0000 0000 9758 5690</institution-id>
<institution>Oregon Health and Science University,</institution>
</institution-wrap>
3181 SW Sam Jackson Park Road L457, Portland, OR 97239-3098 USA</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<placeName>
<region type="state">Oregon</region>
</placeName>
<wicri:cityArea>3181 SW Sam Jackson Park Road L457, Portland</wicri:cityArea>
</affiliation>
</author>
<author>
<name sortKey="Azevedo, Valderilio F" sort="Azevedo, Valderilio F" uniqKey="Azevedo V" first="Valderilio F." last="Azevedo">Valderilio F. Azevedo</name>
<affiliation>
<nlm:aff id="Aff5">
<institution-wrap>
<institution-id institution-id-type="GRID">grid.20736.30</institution-id>
<institution-id institution-id-type="ISNI">0000 0001 1941 472X</institution-id>
<institution>Universidade Federal do Paraná,</institution>
</institution-wrap>
Rua XV de Novembro, Rua Alvaro Alvin 224 casa 18, Curitiba, Paraná 80440080 Brazil</nlm:aff>
<wicri:noCountry code="subfield">Paraná 80440080 Brazil</wicri:noCountry>
</affiliation>
</author>
<author>
<name sortKey="Rigby, William F C" sort="Rigby, William F C" uniqKey="Rigby W" first="William F. C." last="Rigby">William F. C. Rigby</name>
<affiliation wicri:level="2">
<nlm:aff id="Aff6">
<institution-wrap>
<institution-id institution-id-type="GRID">grid.254880.3</institution-id>
<institution-id institution-id-type="ISNI">0000 0001 2179 2404</institution-id>
<institution>Geisel School of Medicine at Dartmouth,</institution>
</institution-wrap>
One Medical Center Drive, Lebanon, NH 03756 USA</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<placeName>
<region type="state">New Hampshire</region>
</placeName>
<wicri:cityArea>One Medical Center Drive, Lebanon</wicri:cityArea>
</affiliation>
</author>
<author>
<name sortKey="Kanik, Keith S" sort="Kanik, Keith S" uniqKey="Kanik K" first="Keith S." last="Kanik">Keith S. Kanik</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>
</affiliation>
</author>
<author>
<name sortKey="Wang, Cunshan" sort="Wang, Cunshan" uniqKey="Wang C" first="Cunshan" last="Wang">Cunshan Wang</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>
</affiliation>
</author>
<author>
<name sortKey="Biswas, Pinaki" sort="Biswas, Pinaki" uniqKey="Biswas P" first="Pinaki" last="Biswas">Pinaki Biswas</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="Jones, Thomas" sort="Jones, Thomas" uniqKey="Jones T" first="Thomas" last="Jones">Thomas Jones</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="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>
</affiliation>
</author>
<author>
<name sortKey="Rojo, Ricardo" sort="Rojo, Ricardo" uniqKey="Rojo R" first="Ricardo" last="Rojo">Ricardo Rojo</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>
</affiliation>
</author>
</titleStmt>
<publicationStmt>
<idno type="wicri:source">PMC</idno>
<idno type="pmid">32006348</idno>
<idno type="pmc">7105422</idno>
<idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7105422</idno>
<idno type="RBID">PMC:7105422</idno>
<idno type="doi">10.1007/s40264-020-00904-9</idno>
<date when="2020">2020</date>
<idno type="wicri:Area/Pmc/Corpus">000277</idno>
<idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Corpus" wicri:corpus="PMC">000277</idno>
<idno type="wicri:Area/Pmc/Curation">000277</idno>
<idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Curation">000277</idno>
<idno type="wicri:Area/Pmc/Checkpoint">000420</idno>
<idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Checkpoint">000420</idno>
<idno type="wicri:Area/Ncbi/Merge">002851</idno>
<idno type="wicri:Area/Ncbi/Curation">002851</idno>
<idno type="wicri:Area/Ncbi/Checkpoint">002851</idno>
<idno type="wicri:doubleKey">0114-5916:2020:Burmester G:an:integrated:analysis</idno>
<idno type="wicri:Area/Main/Merge">000588</idno>
<idno type="wicri:Area/Main/Curation">000588</idno>
<idno type="wicri:Area/Main/Exploration">000588</idno>
<idno type="wicri:Area/2020/Extraction">000588</idno>
</publicationStmt>
<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>
<author>
<name sortKey="Burmester, Gerd R" sort="Burmester, Gerd R" uniqKey="Burmester G" first="Gerd R." last="Burmester">Gerd R. Burmester</name>
<affiliation wicri:level="3">
<nlm:aff id="Aff1">
<institution-wrap>
<institution-id institution-id-type="GRID">grid.6363.0</institution-id>
<institution-id institution-id-type="ISNI">0000 0001 2218 4662</institution-id>
<institution>Charité – University Medicine Berlin,</institution>
</institution-wrap>
Charitéplatz 1, 11017 Berlin, Germany</nlm:aff>
<country xml:lang="fr">Allemagne</country>
<wicri:regionArea>Charitéplatz 1, 11017 Berlin</wicri:regionArea>
<placeName>
<region type="land" nuts="3">Berlin</region>
<settlement type="city">Berlin</settlement>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Curtis, Jeffrey R" sort="Curtis, Jeffrey R" uniqKey="Curtis J" first="Jeffrey R." last="Curtis">Jeffrey R. Curtis</name>
<affiliation wicri:level="2">
<nlm:aff id="Aff2">
<institution-wrap>
<institution-id institution-id-type="GRID">grid.265892.2</institution-id>
<institution-id institution-id-type="ISNI">0000000106344187</institution-id>
<institution>University of Alabama at Birmingham,</institution>
</institution-wrap>
Birmingham, AL 35294 USA</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<placeName>
<region type="state">Alabama</region>
</placeName>
<wicri:cityArea>Birmingham</wicri:cityArea>
</affiliation>
</author>
<author>
<name sortKey="Yun, Huifeng" sort="Yun, Huifeng" uniqKey="Yun H" first="Huifeng" last="Yun">Huifeng Yun</name>
<affiliation wicri:level="2">
<nlm:aff id="Aff2">
<institution-wrap>
<institution-id institution-id-type="GRID">grid.265892.2</institution-id>
<institution-id institution-id-type="ISNI">0000000106344187</institution-id>
<institution>University of Alabama at Birmingham,</institution>
</institution-wrap>
Birmingham, AL 35294 USA</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<placeName>
<region type="state">Alabama</region>
</placeName>
<wicri:cityArea>Birmingham</wicri:cityArea>
</affiliation>
</author>
<author>
<name sortKey="Fitzgerald, Oliver" sort="Fitzgerald, Oliver" uniqKey="Fitzgerald O" first="Oliver" last="Fitzgerald">Oliver Fitzgerald</name>
<affiliation wicri:level="1">
<nlm:aff id="Aff3">
<institution-wrap>
<institution-id institution-id-type="GRID">grid.412751.4</institution-id>
<institution-id institution-id-type="ISNI">0000 0001 0315 8143</institution-id>
<institution>Department of Rheumatology,</institution>
<institution>St Vincent’s University Hospital,</institution>
</institution-wrap>
Elm Park, Dublin 4, Ireland</nlm:aff>
<country xml:lang="fr">Irlande (pays)</country>
<wicri:regionArea>Elm Park, Dublin 4</wicri:regionArea>
<wicri:noRegion>Dublin 4</wicri:noRegion>
</affiliation>
</author>
<author>
<name sortKey="Winthrop, Kevin L" sort="Winthrop, Kevin L" uniqKey="Winthrop K" first="Kevin L." last="Winthrop">Kevin L. Winthrop</name>
<affiliation wicri:level="2">
<nlm:aff id="Aff4">
<institution-wrap>
<institution-id institution-id-type="GRID">grid.5288.7</institution-id>
<institution-id institution-id-type="ISNI">0000 0000 9758 5690</institution-id>
<institution>Oregon Health and Science University,</institution>
</institution-wrap>
3181 SW Sam Jackson Park Road L457, Portland, OR 97239-3098 USA</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<placeName>
<region type="state">Oregon</region>
</placeName>
<wicri:cityArea>3181 SW Sam Jackson Park Road L457, Portland</wicri:cityArea>
</affiliation>
</author>
<author>
<name sortKey="Azevedo, Valderilio F" sort="Azevedo, Valderilio F" uniqKey="Azevedo V" first="Valderilio F." last="Azevedo">Valderilio F. Azevedo</name>
<affiliation>
<nlm:aff id="Aff5">
<institution-wrap>
<institution-id institution-id-type="GRID">grid.20736.30</institution-id>
<institution-id institution-id-type="ISNI">0000 0001 1941 472X</institution-id>
<institution>Universidade Federal do Paraná,</institution>
</institution-wrap>
Rua XV de Novembro, Rua Alvaro Alvin 224 casa 18, Curitiba, Paraná 80440080 Brazil</nlm:aff>
<wicri:noCountry code="subfield">Paraná 80440080 Brazil</wicri:noCountry>
</affiliation>
</author>
<author>
<name sortKey="Rigby, William F C" sort="Rigby, William F C" uniqKey="Rigby W" first="William F. C." last="Rigby">William F. C. Rigby</name>
<affiliation wicri:level="2">
<nlm:aff id="Aff6">
<institution-wrap>
<institution-id institution-id-type="GRID">grid.254880.3</institution-id>
<institution-id institution-id-type="ISNI">0000 0001 2179 2404</institution-id>
<institution>Geisel School of Medicine at Dartmouth,</institution>
</institution-wrap>
One Medical Center Drive, Lebanon, NH 03756 USA</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<placeName>
<region type="state">New Hampshire</region>
</placeName>
<wicri:cityArea>One Medical Center Drive, Lebanon</wicri:cityArea>
</affiliation>
</author>
<author>
<name sortKey="Kanik, Keith S" sort="Kanik, Keith S" uniqKey="Kanik K" first="Keith S." last="Kanik">Keith S. Kanik</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>
</affiliation>
</author>
<author>
<name sortKey="Wang, Cunshan" sort="Wang, Cunshan" uniqKey="Wang C" first="Cunshan" last="Wang">Cunshan Wang</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>
</affiliation>
</author>
<author>
<name sortKey="Biswas, Pinaki" sort="Biswas, Pinaki" uniqKey="Biswas P" first="Pinaki" last="Biswas">Pinaki Biswas</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="Jones, Thomas" sort="Jones, Thomas" uniqKey="Jones T" first="Thomas" last="Jones">Thomas Jones</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="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>
</affiliation>
</author>
<author>
<name sortKey="Rojo, Ricardo" sort="Rojo, Ricardo" uniqKey="Rojo R" first="Ricardo" last="Rojo">Ricardo Rojo</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>
</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>
<back>
<div1 type="bibliography">
<listBibl>
<biblStruct>
<analytic>
<author>
<name sortKey="Coates, Lc" uniqKey="Coates L">LC Coates</name>
</author>
<author>
<name sortKey="Kavanaugh, A" uniqKey="Kavanaugh A">A Kavanaugh</name>
</author>
<author>
<name sortKey="Mease, Pj" uniqKey="Mease P">PJ Mease</name>
</author>
<author>
<name sortKey="Soriano, Er" uniqKey="Soriano E">ER Soriano</name>
</author>
<author>
<name sortKey="Acosta Felquer, Ml" uniqKey="Acosta Felquer M">ML Acosta-Felquer</name>
</author>
<author>
<name sortKey="Armstrong, Aw" uniqKey="Armstrong A">AW Armstrong</name>
</author>
</analytic>
</biblStruct>
<biblStruct>
<analytic>
<author>
<name sortKey="Gossec, L" uniqKey="Gossec L">L Gossec</name>
</author>
<author>
<name sortKey="Smolen, Js" uniqKey="Smolen J">JS Smolen</name>
</author>
<author>
<name sortKey="Ramiro, S" uniqKey="Ramiro S">S Ramiro</name>
</author>
<author>
<name sortKey="De Wit, M" uniqKey="De Wit M">M de Wit</name>
</author>
<author>
<name sortKey="Cutolo, M" uniqKey="Cutolo M">M Cutolo</name>
</author>
<author>
<name sortKey="Dougados, M" uniqKey="Dougados M">M Dougados</name>
</author>
</analytic>
</biblStruct>
<biblStruct>
<analytic>
<author>
<name sortKey="Gottlieb, A" uniqKey="Gottlieb A">A Gottlieb</name>
</author>
<author>
<name sortKey="Korman, Nj" uniqKey="Korman N">NJ Korman</name>
</author>
<author>
<name sortKey="Gordon, Kb" uniqKey="Gordon K">KB Gordon</name>
</author>
<author>
<name sortKey="Feldman, Sr" uniqKey="Feldman S">SR Feldman</name>
</author>
<author>
<name sortKey="Lebwohl, M" uniqKey="Lebwohl M">M Lebwohl</name>
</author>
<author>
<name sortKey="Koo, Jy" uniqKey="Koo J">JY Koo</name>
</author>
</analytic>
</biblStruct>
<biblStruct>
<analytic>
<author>
<name sortKey="Mease, Pj" uniqKey="Mease P">PJ Mease</name>
</author>
<author>
<name sortKey="Armstrong, Aw" uniqKey="Armstrong A">AW Armstrong</name>
</author>
</analytic>
</biblStruct>
<biblStruct>
<analytic>
<author>
<name sortKey="Nadarajan, P" uniqKey="Nadarajan P">P Nadarajan</name>
</author>
<author>
<name sortKey="Fabre, A" uniqKey="Fabre A">A Fabre</name>
</author>
<author>
<name sortKey="Kelly, E" uniqKey="Kelly E">E Kelly</name>
</author>
</analytic>
</biblStruct>
<biblStruct>
<analytic>
<author>
<name sortKey="Ceponis, A" uniqKey="Ceponis A">A Ceponis</name>
</author>
<author>
<name sortKey="Kavanaugh, A" uniqKey="Kavanaugh A">A Kavanaugh</name>
</author>
</analytic>
</biblStruct>
<biblStruct>
<analytic>
<author>
<name sortKey="Sevilla Mantilla, C" uniqKey="Sevilla Mantilla C">C Sevilla-Mantilla</name>
</author>
<author>
<name sortKey="Ortega, L" uniqKey="Ortega L">L Ortega</name>
</author>
<author>
<name sortKey="Agundez, Ja" uniqKey="Agundez J">JA Agúndez</name>
</author>
<author>
<name sortKey="Fernandez Gutierrez, B" uniqKey="Fernandez Gutierrez B">B Fernández-Gutiérrez</name>
</author>
<author>
<name sortKey="Ladero, Jm" uniqKey="Ladero J">JM Ladero</name>
</author>
<author>
<name sortKey="Diaz Rubio, M" uniqKey="Diaz Rubio M">M Díaz-Rubio</name>
</author>
</analytic>
</biblStruct>
<biblStruct>
<analytic>
<author>
<name sortKey="Krathen, Ms" uniqKey="Krathen M">MS Krathen</name>
</author>
<author>
<name sortKey="Gottlieb, Ab" uniqKey="Gottlieb A">AB Gottlieb</name>
</author>
<author>
<name sortKey="Mease, Pj" uniqKey="Mease P">PJ Mease</name>
</author>
</analytic>
</biblStruct>
<biblStruct>
<analytic>
<author>
<name sortKey="Minozzi, S" uniqKey="Minozzi S">S Minozzi</name>
</author>
<author>
<name sortKey="Bonovas, S" uniqKey="Bonovas S">S Bonovas</name>
</author>
<author>
<name sortKey="Lytras, T" uniqKey="Lytras T">T Lytras</name>
</author>
<author>
<name sortKey="Pecoraro, V" uniqKey="Pecoraro V">V Pecoraro</name>
</author>
<author>
<name sortKey="Gonzalez Lorenzo, M" uniqKey="Gonzalez Lorenzo M">M González-Lorenzo</name>
</author>
<author>
<name sortKey="Bastiampillai, Aj" uniqKey="Bastiampillai A">AJ Bastiampillai</name>
</author>
</analytic>
</biblStruct>
<biblStruct>
<analytic>
<author>
<name sortKey="Mease, P" uniqKey="Mease P">P Mease</name>
</author>
<author>
<name sortKey="Hall, S" uniqKey="Hall S">S Hall</name>
</author>
<author>
<name sortKey="Fitzgerald, O" uniqKey="Fitzgerald O">O FitzGerald</name>
</author>
<author>
<name sortKey="Van Der Heijde, D" uniqKey="Van Der Heijde D">D van der Heijde</name>
</author>
<author>
<name sortKey="Merola, Jf" uniqKey="Merola J">JF Merola</name>
</author>
<author>
<name sortKey="Avila Zapata, F" uniqKey="Avila Zapata F">F Avila-Zapata</name>
</author>
</analytic>
</biblStruct>
<biblStruct>
<analytic>
<author>
<name sortKey="Gladman, D" uniqKey="Gladman D">D Gladman</name>
</author>
<author>
<name sortKey="Rigby, W" uniqKey="Rigby W">W Rigby</name>
</author>
<author>
<name sortKey="Azevedo, Vf" uniqKey="Azevedo V">VF Azevedo</name>
</author>
<author>
<name sortKey="Behrens, F" uniqKey="Behrens F">F Behrens</name>
</author>
<author>
<name sortKey="Blanco, R" uniqKey="Blanco R">R Blanco</name>
</author>
<author>
<name sortKey="Kaszuba, A" uniqKey="Kaszuba A">A Kaszuba</name>
</author>
</analytic>
</biblStruct>
<biblStruct>
<analytic>
<author>
<name sortKey="Nash, P" uniqKey="Nash P">P Nash</name>
</author>
<author>
<name sortKey="Coates, Lc" uniqKey="Coates L">LC Coates</name>
</author>
<author>
<name sortKey="Kivitz, Aj" uniqKey="Kivitz A">AJ Kivitz</name>
</author>
<author>
<name sortKey="Mease, Pj" uniqKey="Mease P">PJ Mease</name>
</author>
<author>
<name sortKey="Gladman, Dd" uniqKey="Gladman D">DD Gladman</name>
</author>
<author>
<name sortKey="Covarrubias Cobos, Ja" uniqKey="Covarrubias Cobos J">JA Covarrubias-Cobos</name>
</author>
</analytic>
</biblStruct>
<biblStruct>
<analytic>
<author>
<name sortKey="Winthrop, Kl" uniqKey="Winthrop K">KL Winthrop</name>
</author>
<author>
<name sortKey="Novosad, Sa" uniqKey="Novosad S">SA Novosad</name>
</author>
<author>
<name sortKey="Baddley, Jw" uniqKey="Baddley J">JW Baddley</name>
</author>
<author>
<name sortKey="Calabrese, L" uniqKey="Calabrese L">L Calabrese</name>
</author>
<author>
<name sortKey="Chiller, T" uniqKey="Chiller T">T Chiller</name>
</author>
<author>
<name sortKey="Polgreen, P" uniqKey="Polgreen P">P Polgreen</name>
</author>
</analytic>
</biblStruct>
<biblStruct>
<analytic>
<author>
<name sortKey="Daly, L" uniqKey="Daly L">L Daly</name>
</author>
</analytic>
</biblStruct>
<biblStruct>
<analytic>
<author>
<name sortKey="Baddley, Jw" uniqKey="Baddley J">JW Baddley</name>
</author>
<author>
<name sortKey="Winthrop, Kl" uniqKey="Winthrop K">KL Winthrop</name>
</author>
<author>
<name sortKey="Chen, L" uniqKey="Chen L">L Chen</name>
</author>
<author>
<name sortKey="Liu, L" uniqKey="Liu L">L Liu</name>
</author>
<author>
<name sortKey="Grijalva, Cg" uniqKey="Grijalva C">CG Grijalva</name>
</author>
<author>
<name sortKey="Delzell, E" uniqKey="Delzell E">E Delzell</name>
</author>
</analytic>
</biblStruct>
<biblStruct>
<analytic>
<author>
<name sortKey="Bharat, A" uniqKey="Bharat A">A Bharat</name>
</author>
<author>
<name sortKey="Xie, F" uniqKey="Xie F">F Xie</name>
</author>
<author>
<name sortKey="Baddley, Jw" uniqKey="Baddley J">JW Baddley</name>
</author>
<author>
<name sortKey="Beukelman, T" uniqKey="Beukelman T">T Beukelman</name>
</author>
<author>
<name sortKey="Chen, L" uniqKey="Chen L">L Chen</name>
</author>
<author>
<name sortKey="Calabrese, L" uniqKey="Calabrese L">L Calabrese</name>
</author>
</analytic>
</biblStruct>
<biblStruct>
<analytic>
<author>
<name sortKey="Curtis, Jr" uniqKey="Curtis J">JR Curtis</name>
</author>
<author>
<name sortKey="Chen, Sy" uniqKey="Chen S">SY Chen</name>
</author>
<author>
<name sortKey="Werther, W" uniqKey="Werther W">W Werther</name>
</author>
<author>
<name sortKey="John, A" uniqKey="John A">A John</name>
</author>
<author>
<name sortKey="Johnson, Da" uniqKey="Johnson D">DA Johnson</name>
</author>
</analytic>
</biblStruct>
<biblStruct>
<analytic>
<author>
<name sortKey="Curtis, Jr" uniqKey="Curtis J">JR Curtis</name>
</author>
<author>
<name sortKey="Lanas, A" uniqKey="Lanas A">A Lanas</name>
</author>
<author>
<name sortKey="John, A" uniqKey="John A">A John</name>
</author>
<author>
<name sortKey="Johnson, Da" uniqKey="Johnson D">DA Johnson</name>
</author>
<author>
<name sortKey="Schulman, Kl" uniqKey="Schulman K">KL Schulman</name>
</author>
</analytic>
</biblStruct>
<biblStruct>
<analytic>
<author>
<name sortKey="Curtis, Jr" uniqKey="Curtis J">JR Curtis</name>
</author>
<author>
<name sortKey="Sarsour, K" uniqKey="Sarsour K">K Sarsour</name>
</author>
<author>
<name sortKey="Napalkov, P" uniqKey="Napalkov P">P Napalkov</name>
</author>
<author>
<name sortKey="Costa, La" uniqKey="Costa L">LA Costa</name>
</author>
<author>
<name sortKey="Schulman, Kl" uniqKey="Schulman K">KL Schulman</name>
</author>
</analytic>
</biblStruct>
<biblStruct>
<analytic>
<author>
<name sortKey="Haynes, K" uniqKey="Haynes K">K Haynes</name>
</author>
<author>
<name sortKey="Beukelman, T" uniqKey="Beukelman T">T Beukelman</name>
</author>
<author>
<name sortKey="Curtis, Jr" uniqKey="Curtis J">JR Curtis</name>
</author>
<author>
<name sortKey="Newcomb, C" uniqKey="Newcomb C">C Newcomb</name>
</author>
<author>
<name sortKey="Herrinton, Lj" uniqKey="Herrinton L">LJ Herrinton</name>
</author>
<author>
<name sortKey="Graham, Dj" uniqKey="Graham D">DJ Graham</name>
</author>
</analytic>
</biblStruct>
<biblStruct>
<analytic>
<author>
<name sortKey="Kiyota, Y" uniqKey="Kiyota Y">Y Kiyota</name>
</author>
<author>
<name sortKey="Schneeweiss, S" uniqKey="Schneeweiss S">S Schneeweiss</name>
</author>
<author>
<name sortKey="Glynn, Rj" uniqKey="Glynn R">RJ Glynn</name>
</author>
<author>
<name sortKey="Cannuscio, Cc" uniqKey="Cannuscio C">CC Cannuscio</name>
</author>
<author>
<name sortKey="Avorn, J" uniqKey="Avorn J">J Avorn</name>
</author>
<author>
<name sortKey="Solomon, Dh" uniqKey="Solomon D">DH Solomon</name>
</author>
</analytic>
</biblStruct>
<biblStruct>
<analytic>
<author>
<name sortKey="Kumamaru, H" uniqKey="Kumamaru H">H Kumamaru</name>
</author>
<author>
<name sortKey="Judd, Se" uniqKey="Judd S">SE Judd</name>
</author>
<author>
<name sortKey="Curtis, Jr" uniqKey="Curtis J">JR Curtis</name>
</author>
<author>
<name sortKey="Ramachandran, R" uniqKey="Ramachandran R">R Ramachandran</name>
</author>
<author>
<name sortKey="Hardy, Nc" uniqKey="Hardy N">NC Hardy</name>
</author>
<author>
<name sortKey="Rhodes, Jd" uniqKey="Rhodes J">JD Rhodes</name>
</author>
</analytic>
</biblStruct>
<biblStruct>
<analytic>
<author>
<name sortKey="Patkar, Nm" uniqKey="Patkar N">NM Patkar</name>
</author>
<author>
<name sortKey="Curtis, Jr" uniqKey="Curtis J">JR Curtis</name>
</author>
<author>
<name sortKey="Teng, Gg" uniqKey="Teng G">GG Teng</name>
</author>
<author>
<name sortKey="Allison, Jj" uniqKey="Allison J">JJ Allison</name>
</author>
<author>
<name sortKey="Saag, M" uniqKey="Saag M">M Saag</name>
</author>
<author>
<name sortKey="Martin, C" uniqKey="Martin C">C Martin</name>
</author>
</analytic>
</biblStruct>
<biblStruct>
<analytic>
<author>
<name sortKey="Scott, Fi" uniqKey="Scott F">FI Scott</name>
</author>
<author>
<name sortKey="Mamtani, R" uniqKey="Mamtani R">R Mamtani</name>
</author>
<author>
<name sortKey="Brensinger, Cm" uniqKey="Brensinger C">CM Brensinger</name>
</author>
<author>
<name sortKey="Haynes, K" uniqKey="Haynes K">K Haynes</name>
</author>
<author>
<name sortKey="Chiesa Fuxench, Zc" uniqKey="Chiesa Fuxench Z">ZC Chiesa-Fuxench</name>
</author>
<author>
<name sortKey="Zhang, J" uniqKey="Zhang J">J Zhang</name>
</author>
</analytic>
</biblStruct>
<biblStruct>
<analytic>
<author>
<name sortKey="Setoguchi, S" uniqKey="Setoguchi S">S Setoguchi</name>
</author>
<author>
<name sortKey="Solomon, Dh" uniqKey="Solomon D">DH Solomon</name>
</author>
<author>
<name sortKey="Glynn, Rj" uniqKey="Glynn R">RJ Glynn</name>
</author>
<author>
<name sortKey="Cook, Ef" uniqKey="Cook E">EF Cook</name>
</author>
<author>
<name sortKey="Levin, R" uniqKey="Levin R">R Levin</name>
</author>
<author>
<name sortKey="Schneeweiss, S" uniqKey="Schneeweiss S">S Schneeweiss</name>
</author>
</analytic>
</biblStruct>
<biblStruct>
<analytic>
<author>
<name sortKey="Winthrop, Kl" uniqKey="Winthrop K">KL Winthrop</name>
</author>
<author>
<name sortKey="Baxter, R" uniqKey="Baxter R">R Baxter</name>
</author>
<author>
<name sortKey="Liu, L" uniqKey="Liu L">L Liu</name>
</author>
<author>
<name sortKey="Mcfarland, B" uniqKey="Mcfarland B">B McFarland</name>
</author>
<author>
<name sortKey="Austin, D" uniqKey="Austin D">D Austin</name>
</author>
<author>
<name sortKey="Varley, C" uniqKey="Varley C">C Varley</name>
</author>
</analytic>
</biblStruct>
<biblStruct>
<analytic>
<author>
<name sortKey="Winthrop, Kl" uniqKey="Winthrop K">KL Winthrop</name>
</author>
<author>
<name sortKey="Neal, J" uniqKey="Neal J">J Neal</name>
</author>
<author>
<name sortKey="Hrycaj, P" uniqKey="Hrycaj P">P Hrycaj</name>
</author>
<author>
<name sortKey="Soma, K" uniqKey="Soma K">K Soma</name>
</author>
<author>
<name sortKey="Wilkinson, B" uniqKey="Wilkinson B">B Wilkinson</name>
</author>
<author>
<name sortKey="Hodge, J" uniqKey="Hodge J">J Hodge</name>
</author>
</analytic>
</biblStruct>
<biblStruct>
<analytic>
<author>
<name sortKey="Xie, F" uniqKey="Xie F">F Xie</name>
</author>
<author>
<name sortKey="Yun, H" uniqKey="Yun H">H Yun</name>
</author>
<author>
<name sortKey="Bernatsky, S" uniqKey="Bernatsky S">S Bernatsky</name>
</author>
<author>
<name sortKey="Curtis, Jr" uniqKey="Curtis J">JR Curtis</name>
</author>
</analytic>
</biblStruct>
<biblStruct>
<analytic>
<author>
<name sortKey="Yawn, Bp" uniqKey="Yawn B">BP Yawn</name>
</author>
<author>
<name sortKey="Wollan, P" uniqKey="Wollan P">P Wollan</name>
</author>
<author>
<name sortKey="St, Sauver J" uniqKey="St S">Sauver J St</name>
</author>
</analytic>
</biblStruct>
<biblStruct>
<analytic>
<author>
<name sortKey="Yun, H" uniqKey="Yun H">H Yun</name>
</author>
<author>
<name sortKey="Xie, F" uniqKey="Xie F">F Xie</name>
</author>
<author>
<name sortKey="Delzell, E" uniqKey="Delzell E">E Delzell</name>
</author>
<author>
<name sortKey="Chen, L" uniqKey="Chen L">L Chen</name>
</author>
<author>
<name sortKey="Levitan, Eb" uniqKey="Levitan E">EB Levitan</name>
</author>
<author>
<name sortKey="Lewis, Jd" uniqKey="Lewis J">JD Lewis</name>
</author>
</analytic>
</biblStruct>
<biblStruct>
<analytic>
<author>
<name sortKey="Cohen, Sb" uniqKey="Cohen S">SB Cohen</name>
</author>
<author>
<name sortKey="Tanaka, Y" uniqKey="Tanaka Y">Y Tanaka</name>
</author>
<author>
<name sortKey="Mariette, X" uniqKey="Mariette X">X Mariette</name>
</author>
<author>
<name sortKey="Curtis, Jr" uniqKey="Curtis J">JR Curtis</name>
</author>
<author>
<name sortKey="Lee, Eb" uniqKey="Lee E">EB Lee</name>
</author>
<author>
<name sortKey="Nash, P" uniqKey="Nash P">P Nash</name>
</author>
</analytic>
</biblStruct>
<biblStruct>
<analytic>
<author>
<name sortKey="Papp, Ka" uniqKey="Papp K">KA Papp</name>
</author>
<author>
<name sortKey="Krueger, Jg" uniqKey="Krueger J">JG Krueger</name>
</author>
<author>
<name sortKey="Feldman, Sr" uniqKey="Feldman S">SR Feldman</name>
</author>
<author>
<name sortKey="Langley, Rg" uniqKey="Langley R">RG Langley</name>
</author>
<author>
<name sortKey="Thaci, D" uniqKey="Thaci D">D Thaci</name>
</author>
<author>
<name sortKey="Torii, H" uniqKey="Torii H">H Torii</name>
</author>
</analytic>
</biblStruct>
<biblStruct>
<analytic>
<author>
<name sortKey="Sandborn, Wj" uniqKey="Sandborn W">WJ Sandborn</name>
</author>
<author>
<name sortKey="Ghosh, S" uniqKey="Ghosh S">S Ghosh</name>
</author>
<author>
<name sortKey="Panes, J" uniqKey="Panes J">J Panés</name>
</author>
<author>
<name sortKey="Vranic, I" uniqKey="Vranic I">I Vranic</name>
</author>
<author>
<name sortKey="Su, C" uniqKey="Su C">C Su</name>
</author>
<author>
<name sortKey="Rousell, S" uniqKey="Rousell S">S Rousell</name>
</author>
</analytic>
</biblStruct>
<biblStruct>
<analytic>
<author>
<name sortKey="Ramiro, S" uniqKey="Ramiro S">S Ramiro</name>
</author>
<author>
<name sortKey="Sepriano, A" uniqKey="Sepriano A">A Sepriano</name>
</author>
<author>
<name sortKey="Chatzidionysiou, K" uniqKey="Chatzidionysiou K">K Chatzidionysiou</name>
</author>
<author>
<name sortKey="Nam, Jl" uniqKey="Nam J">JL Nam</name>
</author>
<author>
<name sortKey="Smolen, Js" uniqKey="Smolen J">JS Smolen</name>
</author>
<author>
<name sortKey="Van Der Heijde, D" uniqKey="Van Der Heijde D">D van der Heijde</name>
</author>
</analytic>
</biblStruct>
<biblStruct>
<analytic>
<author>
<name sortKey="Desai, Rj" uniqKey="Desai R">RJ Desai</name>
</author>
<author>
<name sortKey="Thaler, Kj" uniqKey="Thaler K">KJ Thaler</name>
</author>
<author>
<name sortKey="Mahlknecht, P" uniqKey="Mahlknecht P">P Mahlknecht</name>
</author>
<author>
<name sortKey="Gartlehner, G" uniqKey="Gartlehner G">G Gartlehner</name>
</author>
<author>
<name sortKey="Mcdonagh, Ms" uniqKey="Mcdonagh M">MS McDonagh</name>
</author>
<author>
<name sortKey="Mesgarpour, B" uniqKey="Mesgarpour B">B Mesgarpour</name>
</author>
</analytic>
</biblStruct>
<biblStruct>
<analytic>
<author>
<name sortKey="Winthrop, Kl" uniqKey="Winthrop K">KL Winthrop</name>
</author>
<author>
<name sortKey="Yamanaka, H" uniqKey="Yamanaka H">H Yamanaka</name>
</author>
<author>
<name sortKey="Valdez, H" uniqKey="Valdez H">H Valdez</name>
</author>
<author>
<name sortKey="Mortensen, E" uniqKey="Mortensen E">E Mortensen</name>
</author>
<author>
<name sortKey="Chew, R" uniqKey="Chew R">R Chew</name>
</author>
<author>
<name sortKey="Krishnaswami, S" uniqKey="Krishnaswami S">S Krishnaswami</name>
</author>
</analytic>
</biblStruct>
<biblStruct>
<analytic>
<author>
<name sortKey="Winthrop, Kl" uniqKey="Winthrop K">KL Winthrop</name>
</author>
<author>
<name sortKey="Lebwohl, M" uniqKey="Lebwohl M">M Lebwohl</name>
</author>
<author>
<name sortKey="Cohen, Ad" uniqKey="Cohen A">AD Cohen</name>
</author>
<author>
<name sortKey="Weinberg, Jm" uniqKey="Weinberg J">JM Weinberg</name>
</author>
<author>
<name sortKey="Tyring, Sk" uniqKey="Tyring S">SK Tyring</name>
</author>
<author>
<name sortKey="Rottinghaus, St" uniqKey="Rottinghaus S">ST Rottinghaus</name>
</author>
</analytic>
</biblStruct>
<biblStruct>
<analytic>
<author>
<name sortKey="Winthrop, Kl" uniqKey="Winthrop K">KL Winthrop</name>
</author>
<author>
<name sortKey="Curtis, Jr" uniqKey="Curtis J">JR Curtis</name>
</author>
<author>
<name sortKey="Lindsey, S" uniqKey="Lindsey S">S Lindsey</name>
</author>
<author>
<name sortKey="Tanaka, Y" uniqKey="Tanaka Y">Y Tanaka</name>
</author>
<author>
<name sortKey="Yamaoka, K" uniqKey="Yamaoka K">K Yamaoka</name>
</author>
<author>
<name sortKey="Valdez, H" uniqKey="Valdez H">H Valdez</name>
</author>
</analytic>
</biblStruct>
<biblStruct>
<analytic>
<author>
<name sortKey="Winthrop, Kl" uniqKey="Winthrop K">KL Winthrop</name>
</author>
<author>
<name sortKey="Park, Sh" uniqKey="Park S">SH Park</name>
</author>
<author>
<name sortKey="Gul, A" uniqKey="Gul A">A Gul</name>
</author>
<author>
<name sortKey="Cardiel, Mh" uniqKey="Cardiel M">MH Cardiel</name>
</author>
<author>
<name sortKey="Gomez Reino, Jj" uniqKey="Gomez Reino J">JJ Gomez-Reino</name>
</author>
<author>
<name sortKey="Tanaka, Y" uniqKey="Tanaka Y">Y Tanaka</name>
</author>
</analytic>
</biblStruct>
<biblStruct>
<analytic>
<author>
<name sortKey="Leiter, U" uniqKey="Leiter U">U Leiter</name>
</author>
<author>
<name sortKey="Garbe, C" uniqKey="Garbe C">C Garbe</name>
</author>
</analytic>
</biblStruct>
<biblStruct>
<analytic>
<author>
<name sortKey="Burmester, Gr" uniqKey="Burmester G">GR Burmester</name>
</author>
<author>
<name sortKey="Panaccione, R" uniqKey="Panaccione R">R Panaccione</name>
</author>
<author>
<name sortKey="Gordon, Kb" uniqKey="Gordon K">KB Gordon</name>
</author>
<author>
<name sortKey="Mcilraith, Mj" uniqKey="Mcilraith M">MJ McIlraith</name>
</author>
<author>
<name sortKey="Lacerda, Ap" uniqKey="Lacerda A">AP Lacerda</name>
</author>
</analytic>
</biblStruct>
<biblStruct>
<analytic>
<author>
<name sortKey="Weinblatt, Me" uniqKey="Weinblatt M">ME Weinblatt</name>
</author>
<author>
<name sortKey="Moreland, Lw" uniqKey="Moreland L">LW Moreland</name>
</author>
<author>
<name sortKey="Westhovens, R" uniqKey="Westhovens R">R Westhovens</name>
</author>
<author>
<name sortKey="Cohen, Rb" uniqKey="Cohen R">RB Cohen</name>
</author>
<author>
<name sortKey="Kelly, Sm" uniqKey="Kelly S">SM Kelly</name>
</author>
<author>
<name sortKey="Khan, N" uniqKey="Khan N">N Khan</name>
</author>
</analytic>
</biblStruct>
<biblStruct>
<analytic>
<author>
<name sortKey="Bykerk, Vp" uniqKey="Bykerk V">VP Bykerk</name>
</author>
<author>
<name sortKey="Cush, J" uniqKey="Cush J">J Cush</name>
</author>
<author>
<name sortKey="Winthrop, K" uniqKey="Winthrop K">K Winthrop</name>
</author>
<author>
<name sortKey="Calabrese, L" uniqKey="Calabrese L">L Calabrese</name>
</author>
<author>
<name sortKey="Lortholary, O" uniqKey="Lortholary O">O Lortholary</name>
</author>
<author>
<name sortKey="De Longueville, M" uniqKey="De Longueville M">M de Longueville</name>
</author>
</analytic>
</biblStruct>
<biblStruct>
<analytic>
<author>
<name sortKey="Gladman, Dd" uniqKey="Gladman D">DD Gladman</name>
</author>
<author>
<name sortKey="Ang, M" uniqKey="Ang M">M Ang</name>
</author>
<author>
<name sortKey="Su, L" uniqKey="Su L">L Su</name>
</author>
<author>
<name sortKey="Tom, Bd" uniqKey="Tom B">BD Tom</name>
</author>
<author>
<name sortKey="Schentag, Ct" uniqKey="Schentag C">CT Schentag</name>
</author>
<author>
<name sortKey="Farewell, Vt" uniqKey="Farewell V">VT Farewell</name>
</author>
</analytic>
</biblStruct>
<biblStruct>
<analytic>
<author>
<name sortKey="Ogdie, A" uniqKey="Ogdie A">A Ogdie</name>
</author>
<author>
<name sortKey="Yu, Y" uniqKey="Yu Y">Y Yu</name>
</author>
<author>
<name sortKey="Haynes, K" uniqKey="Haynes K">K Haynes</name>
</author>
<author>
<name sortKey="Love, Tj" uniqKey="Love T">TJ Love</name>
</author>
<author>
<name sortKey="Maliha, S" uniqKey="Maliha S">S Maliha</name>
</author>
<author>
<name sortKey="Jiang, Y" uniqKey="Jiang Y">Y Jiang</name>
</author>
</analytic>
</biblStruct>
<biblStruct>
<analytic>
<author>
<name sortKey="Polachek, A" uniqKey="Polachek A">A Polachek</name>
</author>
<author>
<name sortKey="Touma, Z" uniqKey="Touma Z">Z Touma</name>
</author>
<author>
<name sortKey="Anderson, M" uniqKey="Anderson M">M Anderson</name>
</author>
<author>
<name sortKey="Eder, L" uniqKey="Eder L">L Eder</name>
</author>
</analytic>
</biblStruct>
<biblStruct>
<analytic>
<author>
<name sortKey="Charles Schoeman, C" uniqKey="Charles Schoeman C">C Charles-Schoeman</name>
</author>
<author>
<name sortKey="Wicker, P" uniqKey="Wicker P">P Wicker</name>
</author>
<author>
<name sortKey="Gonzalez Gay, Ma" uniqKey="Gonzalez Gay M">MA Gonzalez-Gay</name>
</author>
<author>
<name sortKey="Boy, M" uniqKey="Boy M">M Boy</name>
</author>
<author>
<name sortKey="Zuckerman, A" uniqKey="Zuckerman A">A Zuckerman</name>
</author>
<author>
<name sortKey="Soma, K" uniqKey="Soma K">K Soma</name>
</author>
</analytic>
</biblStruct>
<biblStruct>
<analytic>
<author>
<name sortKey="Wu, Jj" uniqKey="Wu J">JJ Wu</name>
</author>
<author>
<name sortKey="Strober, Be" uniqKey="Strober B">BE Strober</name>
</author>
<author>
<name sortKey="Hansen, Pr" uniqKey="Hansen P">PR Hansen</name>
</author>
<author>
<name sortKey="Ahlehoff, O" uniqKey="Ahlehoff O">O Ahlehoff</name>
</author>
<author>
<name sortKey="Egeberg, A" uniqKey="Egeberg A">A Egeberg</name>
</author>
<author>
<name sortKey="Qureshi, A" uniqKey="Qureshi A">A Qureshi</name>
</author>
</analytic>
</biblStruct>
<biblStruct>
<analytic>
<author>
<name sortKey="Taylor, Pc" uniqKey="Taylor P">PC Taylor</name>
</author>
<author>
<name sortKey="Weinblatt, Me" uniqKey="Weinblatt M">ME Weinblatt</name>
</author>
<author>
<name sortKey="Burmester, Gr" uniqKey="Burmester G">GR Burmester</name>
</author>
<author>
<name sortKey="Rooney, Tp" uniqKey="Rooney T">TP Rooney</name>
</author>
<author>
<name sortKey="Witt, S" uniqKey="Witt S">S Witt</name>
</author>
<author>
<name sortKey="Walls, Cd" uniqKey="Walls C">CD Walls</name>
</author>
</analytic>
</biblStruct>
<biblStruct>
<analytic>
<author>
<name sortKey="Genovese, Mc" uniqKey="Genovese M">MC Genovese</name>
</author>
<author>
<name sortKey="Fleischmann, R" uniqKey="Fleischmann R">R Fleischmann</name>
</author>
<author>
<name sortKey="Combe, B" uniqKey="Combe B">B Combe</name>
</author>
<author>
<name sortKey="Hall, S" uniqKey="Hall S">S Hall</name>
</author>
<author>
<name sortKey="Rubbert Roth, A" uniqKey="Rubbert Roth A">A Rubbert-Roth</name>
</author>
<author>
<name sortKey="Zhang, Y" uniqKey="Zhang Y">Y Zhang</name>
</author>
</analytic>
</biblStruct>
<biblStruct></biblStruct>
<biblStruct></biblStruct>
<biblStruct>
<analytic>
<author>
<name sortKey="Matsui, D" uniqKey="Matsui D">D Matsui</name>
</author>
</analytic>
</biblStruct>
</listBibl>
</div1>
</back>
</TEI>
<affiliations>
<list>
<country>
<li>Allemagne</li>
<li>Irlande (pays)</li>
<li>États-Unis</li>
</country>
<region>
<li>Alabama</li>
<li>Berlin</li>
<li>Connecticut</li>
<li>New Hampshire</li>
<li>Oregon</li>
<li>Pennsylvanie</li>
<li>État de New York</li>
</region>
<settlement>
<li>Berlin</li>
</settlement>
</list>
<tree>
<noCountry>
<name sortKey="Azevedo, Valderilio F" sort="Azevedo, Valderilio F" uniqKey="Azevedo V" first="Valderilio F." last="Azevedo">Valderilio F. Azevedo</name>
</noCountry>
<country name="Allemagne">
<region name="Berlin">
<name sortKey="Burmester, Gerd R" sort="Burmester, Gerd R" uniqKey="Burmester G" first="Gerd R." last="Burmester">Gerd R. Burmester</name>
</region>
</country>
<country name="États-Unis">
<region name="Alabama">
<name sortKey="Curtis, Jeffrey R" sort="Curtis, Jeffrey R" uniqKey="Curtis J" first="Jeffrey R." last="Curtis">Jeffrey R. Curtis</name>
</region>
<name sortKey="Biswas, Pinaki" sort="Biswas, Pinaki" uniqKey="Biswas P" first="Pinaki" last="Biswas">Pinaki Biswas</name>
<name sortKey="Hendrikx, Thijs" sort="Hendrikx, Thijs" uniqKey="Hendrikx T" first="Thijs" last="Hendrikx">Thijs Hendrikx</name>
<name sortKey="Jones, Thomas" sort="Jones, Thomas" uniqKey="Jones T" first="Thomas" last="Jones">Thomas Jones</name>
<name sortKey="Kanik, Keith S" sort="Kanik, Keith S" uniqKey="Kanik K" first="Keith S." last="Kanik">Keith S. Kanik</name>
<name sortKey="Menon, Sujatha" sort="Menon, Sujatha" uniqKey="Menon S" first="Sujatha" last="Menon">Sujatha Menon</name>
<name sortKey="Palmetto, Niki" sort="Palmetto, Niki" uniqKey="Palmetto N" first="Niki" last="Palmetto">Niki Palmetto</name>
<name sortKey="Rigby, William F C" sort="Rigby, William F C" uniqKey="Rigby W" first="William F. C." last="Rigby">William F. C. Rigby</name>
<name sortKey="Rojo, Ricardo" sort="Rojo, Ricardo" uniqKey="Rojo R" first="Ricardo" last="Rojo">Ricardo Rojo</name>
<name sortKey="Wang, Cunshan" sort="Wang, Cunshan" uniqKey="Wang C" first="Cunshan" last="Wang">Cunshan Wang</name>
<name sortKey="Winthrop, Kevin L" sort="Winthrop, Kevin L" uniqKey="Winthrop K" first="Kevin L." last="Winthrop">Kevin L. Winthrop</name>
<name sortKey="Yun, Huifeng" sort="Yun, Huifeng" uniqKey="Yun H" first="Huifeng" last="Yun">Huifeng Yun</name>
</country>
<country name="Irlande (pays)">
<noRegion>
<name sortKey="Fitzgerald, Oliver" sort="Fitzgerald, Oliver" uniqKey="Fitzgerald O" first="Oliver" last="Fitzgerald">Oliver Fitzgerald</name>
</noRegion>
</country>
</tree>
</affiliations>
</record>

Pour manipuler ce document sous Unix (Dilib)

EXPLOR_STEP=$WICRI_ROOT/Sante/explor/TocilizumabV1/Data/2020/Analysis
HfdSelect -h $EXPLOR_STEP/biblio.hfd -nk 000588 | SxmlIndent | more

Ou

HfdSelect -h $EXPLOR_AREA/Data/2020/Analysis/biblio.hfd -nk 000588 | SxmlIndent | more

Pour mettre un lien sur cette page dans le réseau Wicri

{{Explor lien
   |wiki=    Sante
   |area=    TocilizumabV1
   |flux=    2020
   |étape=   Analysis
   |type=    RBID
   |clé=     PMC:7105422
   |texte=   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
}}

Pour générer des pages wiki

HfdIndexSelect -h $EXPLOR_AREA/Data/2020/Analysis/RBID.i   -Sk "pubmed:32006348" \
       | HfdSelect -Kh $EXPLOR_AREA/Data/2020/Analysis/biblio.hfd   \
       | NlmPubMed2Wicri -a TocilizumabV1 

Wicri

This area was generated with Dilib version V0.6.34.
Data generation: Fri May 22 09:34:00 2020. Site generation: Sun Mar 28 09:01:19 2021