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Authors
Takeuchi, Tsutomu
Tanaka, Yoshiya https://orcid.org/0000-0002-0807-7139
Yamanaka, Hisashi https://orcid.org/0000-0001-8453-6731
Yamaoka, Kunihiro
Sugiyama, Naonobu https://orcid.org/0000-0002-5008-0665
Iikuni, Noriko
Toyoizumi, Shigeyuki https://orcid.org/0000-0002-7011-5263
Kwok, Kenneth
Tsai, Wen-Chan
Mysler, Eduardo
Moots, Robert J.
Smolen, Josef S.
Fleischmann, Roy https://orcid.org/0000-0002-6630-1477
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Clinical Trials BETA
Clinical trials referenced in this document:
nct02187055 at ClinicalTrials.govDocuments that mention this clinical trial
THU0193 EFFICACY OF TOFACITINIB MONOTHERAPY, TOFACITINIB WITH METHOTREXATE AND ADALIMUMAB WITH METHOTREXATE IN PATIENTS WITH EARLY (≤2 YEARS) VS ESTABLISHED (>2 YEARS) RHEUMATOID ARTHRITIS: A POST HOC ANALYSIS OF DATA FROM ORAL STRATEGY
https://doi.org/10.1136/annrheumdis-2019-eular.587
AB0449 PAIN REDUCTION IN PATIENTS WITH RHEUMATOID ARTHRITIS RECEIVING TOFACITINIB MONOTHERAPY WITH OR WITHOUT PAIN MEDICATION: A POST HOC ANALYSIS OF POOLED DATA FROM PHASE 2, PHASE 3 AND PHASE 3B/4 STUDIES
https://doi.org/10.1136/annrheumdis-2019-eular.416
Efficacy and Safety of Tofacitinib and Adalimumab in Rheumatoid Arthritis by Body Mass Index-Normalized Methotrexate Dose: A Post Hoc Analysis
https://doi.org/10.1007/s40744-025-00823-0
Long-term safety of tofacitinib up to 9.5 years: a comprehensive integrated analysis of the rheumatoid arthritis clinical development programme
https://doi.org/10.1136/rmdopen-2020-001395
Frequency and Duration of Early Non-serious Adverse Events in Patients with Rheumatoid Arthritis and Psoriatic Arthritis Treated with Tofacitinib
https://doi.org/10.1007/s40744-021-00405-w
Tofacitinib Efficacy in Patients with Rheumatoid Arthritis and Probable Depression/Anxiety: Post Hoc Analysis of Phase 3 and 3b/4 Randomized Controlled Trials
https://doi.org/10.1007/s40744-023-00612-7
LB0003 Tofacitinib with and without methotrexate versus adalimumab with methotrexate for the treatment of rheumatoid arthritis: results from oral strategy, a phase 3b/4 randomised trial
https://doi.org/10.1136/annrheumdis-2017-eular.7113
The effect of tofacitinib on residual pain in patients with rheumatoid arthritis and psoriatic arthritis (Results)
https://doi.org/10.1136/rmdopen-2022-002478
Patient-reported outcomes for tofacitinib with and without methotrexate, or adalimumab with methotrexate, in rheumatoid arthritis: a phase IIIB/IV trial
https://doi.org/10.1136/rmdopen-2019-001040
SAT0220 Evaluation of live zoster vaccine in a subset of patients with rheumatoid arthritis treated with tofacitinib with or without methotrexate, and adalimumab with methotrexate: results from a phase 3b/4 randomised trial
https://doi.org/10.1136/annrheumdis-2018-eular.1469
FRI0144 JOINT-SPECIFIC RESPONSES TO TOFACITINIB AND ADALIMUMAB IN RHEUMATOID ARTHRITIS: A POST HOC ANALYSIS OF DATA FROM ORAL STANDARD AND ORAL STRATEGY
https://doi.org/10.1136/annrheumdis-2019-eular.1196
SAT0252 Clinical and functional response to tofacitinib and adalimumab in patients with rheumatoid arthritis: probability plot analysis of results from the oral strategy trial
https://doi.org/10.1136/annrheumdis-2018-eular.3735
Efficacy of tofacitinib monotherapy in methotrexate-naive patients with early or established rheumatoid arthritis
https://doi.org/10.1136/rmdopen-2016-000262
OP0052 THE EFFECT OF TOFACITINIB ON RESIDUAL PAIN IN PATIENTS WITH RHEUMATOID ARTHRITIS AND PSORIATIC ARTHRITIS WITH COMPLETE CONTROL OF INFLAMMATION
https://doi.org/10.1136/annrheumdis-2022-eular.58
Impact of cardiovascular risk enrichment on incidence of major adverse cardiovascular events in the tofacitinib rheumatoid arthritis clinical programme
https://doi.org/10.1136/ard-2022-223406
SAT0139 AGE-BASED (<65 VS ≥65 YEARS) INCIDENCE OF INFECTIONS AND SERIOUS INFECTIONS IN TOFACITINIB-, ADALIMUMAB- AND PLACEBO-TREATED PATIENTS WITH RHEUMATOID ARTHRITIS: A POST HOC ANALYSIS OF PHASE 2, PHASE 3 AND PHASE 3B/4 TOFACITINIB STUDIES
https://doi.org/10.1136/annrheumdis-2020-eular.1432
AB0417 EFFICACY AND SAFETY OF TOFACITINIB IN PATIENTS WITH RHEUMATOID ARTHRITIS ACCORDING TO DURATION OF PRIOR CSDMARD TREATMENT AND NUMBER OF PRIOR CSDMARDS: A POST HOC ANALYSIS OF PHASE 3 AND PHASE 3B/4 TRIALS
https://doi.org/10.1136/annrheumdis-2019-eular.417
SAT0256 Tofacitinib with and without methotrexate versus adalimumab with methotrexate for the treatment of rheumatoid arthritis: patient-reported outcomes from a phase 3b/4 randomised trial
https://doi.org/10.1136/annrheumdis-2018-eular.1312
AB0454 FREQUENCY AND DURATION OF EARLY NON-SERIOUS ADVERSE EVENTS IN RHEUMATOID ARTHRITIS PATIENTS TREATED WITH TOFACITINIB 5 MG TWICE DAILY AS MONOTHERAPY AND COMBINATION THERAPY
https://doi.org/10.1136/annrheumdis-2019-eular.418
Age-based (<65 vs ≥65 years) incidence of infections and serious infections with tofacitinib versus biological DMARDs in rheumatoid arthritis clinical trials and the US Corrona RA registry
https://doi.org/10.1136/annrheumdis-2020-218992
SAT0247 Impact of glucocorticoids on efficacy and safety of tofacitinib with and without methotrexate and adalimumab with methotrexate for rheumatoid arthritis: results from a phase 3b/4 randomised trial
https://doi.org/10.1136/annrheumdis-2018-eular.1533
Identification of two tofacitinib subpopulations with different relative risk versus TNF inhibitors: an analysis of the open label, randomised controlled study ORAL Surveillance
https://doi.org/10.1136/ard-2022-223715
Influenza Adverse Events in Patients with Rheumatoid Arthritis, Ulcerative Colitis, or Psoriatic Arthritis in the Tofacitinib Clinical Development Programs
https://doi.org/10.1007/s40744-022-00507-z
AB0247 ANALYSIS OF THE IMPACT OF TOFACITINIB TREATMENT ON WEIGHT IN PATIENTS WITH RHEUMATOID ARTHRITIS
https://doi.org/10.1136/annrheumdis-2021-eular.360
Malignancy risk with tofacitinib versus TNF inhibitors in rheumatoid arthritis: results from the open-label, randomised controlled ORAL Surveillance trial
https://doi.org/10.1136/ard-2022-222543
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Funding
Funding for this research was provided by:
Pfizer
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Article History
Received: 6 September 2025
Accepted: 19 December 2025
First Online: 22 January 2026
Declarations
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: Tsutomu Takeuchi has received research grants and consultancy fees from AbbVie, Asahi Kasei, Astellas, AstraZeneca, AYUMI, Bristol Myers Squibb, Chugai, Daiichi Sankyo, Eisai, Eli Lilly Japan, Janssen, Mitsubishi Tanabe, Nippon Kayaku, Novartis, Pfizer Japan Inc, Taiho, Taisho Toyama, Takeda, and Teijin. Yoshiya Tanaka has received research grants from Chugai, Eisai, Mitsubishi Tanabe, and Taisho, and speaker fees and/or honoraria from AbbVie, AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Chugai, Eisai, Eli Lilly, Gilead, GlaxoSmithKline, Pfizer Inc, Taiho, and Taisho. Hisashi Yamanaka has received speaker or consultancy fees from AbbVie, Chugai, Teijin Pharma, and YLBio. Kunihiro Yamaoka has received speaker and consultancy fees from Actelion, Astellas, Chugai, Eisai, Eli Lilly, GlaxoSmithKline, Janssen, Mitsubishi Tanabe, Nippon Shinyaku, Pfizer Inc, and Takeda. Naonobu Sugiyama was an employee and shareholder of Pfizer Japan Inc at the time of the study/analysis and is a current employee of Bristol Myers Squibb K.K. Noriko Iikuni was an employee of Pfizer Inc at the time of the study/analysis, and is a current employee of Xencor Inc. Shigeyuki Toyoizumi is an employee of Pfizer R&D Japan. Kenneth Kwok is an employee and shareholder of Pfizer Inc. Wen-Chan Tsai has received speaker and consultancy fees from Abbott, AstraZeneca, Bristol Myers Squibb, Chugai, Janssen, Mitsubishi Tanabe, Pfizer Inc, and Roche. Eduardo Mysler has received research grants and consultancy fees from AbbVie, Amgen, AstraZeneca, Bristol Myers Squibb, Eli Lilly, GlaxoSmithKline, Janssen, Pfizer Inc, Roche, and Sanofi. Robert J. Moots has received research grants and speaker and consultancy fees from AbbVie, Bristol Myers Squibb, Chugai, Eli Lilly, Novartis, Pfizer Inc, Roche, Sandoz, and UCB. Josef S. Smolen has received research grants from AbbVie, Eli Lilly, Janssen, MSD, Pfizer Inc, and Roche, and consultancy fees from AbbVie, Amgen, AstraZeneca, Astro, Celgene, Celltrion, Eli Lilly, GlaxoSmithKline, ILTOO, Janssen, Medimmune, MSD, Novartis-Sandoz, Pfizer Inc, Roche, Samsung, Sanofi, and UCB. Roy Fleischmann has received consultancy fees from AbbVie, Almirall, Artiva Biotherapeutics, Atomwise, Biohaven Pharmaceuticals, Bristol Myers Squibb, Cyoxone, Deep Cure, Dren Bio, ECOR, Galvani, Gates Bio, Gilead, GlaxoSmithKline, Halia, Immunovant, ImmuneMed, InventisBio, Istesso, Janssen, Janux, Eli Lilly, Monte Rosa, MSD, Novartis, Overland, Pfizer Inc, Synact, TPG, UCB, VYNE Therapeutics, and Xencor. Roy Fleischmann is the Editor-in-Chief of Rheumatology and Therapy . Roy Fleischmann was not involved in the selection of peer reviewers for the manuscript nor any of the subsequent editorial decisions.
: All procedures were conducted in accordance with the Declaration of Helsinki and International Council for Harmonisation Guidelines for Good Clinical Practice, and were approved by the Institutional Review Board/Ethics Committee at each study center. All patients provided written informed consent.
