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Authors
Orbai, Ana-Maria
Mease, Philip J.
Helliwell, Philip S.
FitzGerald, Oliver
Fleishaker, Dona L.
Mundayat, Rajiv
Young, Pamela
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Clinical Trials BETA
Clinical trials referenced in this document:
nct01877668 at ClinicalTrials.govnct01882439 at ClinicalTrials.govDocuments that mention this clinical trial
Identification of two tofacitinib subpopulations with different relative risk versus TNF inhibitors: an analysis of the open label, randomised controlled study ORAL Surveillance
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POS1025 TOFACITINIB TREATMENT IN PATIENTS WITH PSORIATIC ARTHRITIS AND PROBABLE DEPRESSION AND/OR ANXIETY: A POST HOC ANALYSIS OF TWO PHASE 3 CLINICAL TRIALS
https://doi.org/10.1136/annrheumdis-2021-eular.176
Median time to pain improvement and the impact of baseline pain severity on pain response in patients with psoriatic arthritis treated with tofacitinib
https://doi.org/10.1136/rmdopen-2021-001609
OP0225 TOFACITINIB AS MONOTHERAPY FOLLOWING METHOTREXATE WITHDRAWAL IN PATIENTS WITH PSORIATIC ARTHRITIS PREVIOUSLY TREATED WITH OPEN-LABEL TOFACITINIB + METHOTREXATE: A RANDOMISED, PLACEBO-CONTROLLED SUBSTUDY OF OPAL BALANCE
https://doi.org/10.1136/annrheumdis-2020-eular.529
AB0902 Efficacy of tofacitinib by background methotrexate dose in patients with psoriatic arthritis: a post-hoc analysis of pooled data from 2 phase 3 trials
https://doi.org/10.1136/annrheumdis-2018-eular.1278
FRI0509 Safety and efficacy of tofacitinib, an oral janus kinase inhibitor, up to 24 months in patients with active psoriatic arthritis: interim data from opal balance, an open-label, long-term extension study
https://doi.org/10.1136/annrheumdis-2017-eular.1414
THU0323 Tofacitinib improves composite endpoint measures of disease in patients with psoriatic arthritis
https://doi.org/10.1136/annrheumdis-2018-eular.1275
Incidence of infections in patients with psoriatic arthritis and axial spondyloarthritis treated with biological or targeted disease-modifying agents: a systematic review and meta-analysis of randomised controlled trials, open-label studies and observational studies
https://doi.org/10.1136/rmdopen-2023-003064
Impact of baseline body mass index on the efficacy and safety of tofacitinib in patients with psoriatic arthritis
https://doi.org/10.1136/rmdopen-2020-001486
AB0831 COMPARISON OF DIFFERENT REMISSION INDICES IN PATIENTS WITH PSORIATIC ARTHRITIS: A POST HOC ANALYSIS OF DATA FROM PHASE 3 TOFACITINIB STUDIES
https://doi.org/10.1136/annrheumdis-2020-eular.948
AB0774 TIME TO RESPONSE FOR CLINICAL AND PATIENT-REPORTED OUTCOMES IN PATIENTS WITH PSORIATIC ARTHRITIS TREATED WITH TOFACITINIB, ADALIMUMAB OR PLACEBO
https://doi.org/10.1136/annrheumdis-2020-eular.994
Multicentre, randomised, open-label, parallel-group study evaluating the efficacy and safety of ixekizumab versus adalimumab in patients with psoriatic arthritis naïve to biological disease-modifying antirheumatic drug: final results by week 52
https://doi.org/10.1136/annrheumdis-2020-217372
AB0838 IDENTIFYING MEDIATORS OF PAIN REDUCTION IN PATIENTS WITH PSORIATIC ARTHRITIS TREATED WITH TOFACITINIB: ROLE OF INFLAMMATION ASSOCIATED WITH PERIPHERAL ARTHRITIS, ENTHESITIS AND SKIN DISEASE
https://doi.org/10.1136/annrheumdis-2020-eular.1052
SAT0293 Safety and efficacy of tofacitinib, an oral janus kinase inhibitor, up to 36 months in patients with active psoriatic arthritis: data from the third interim analysis of opal balance, an open-label, long-term extension study
https://doi.org/10.1136/annrheumdis-2018-eular.3115
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
Efficacy and safety of tofacitinib in Chinese patients with active psoriatic arthritis: a phase 3, randomised, double-blind, placebo-controlled study
https://doi.org/10.1136/rmdopen-2022-002559
POS1045 MASS SPECTROMETRY-BASED PROTEOMICS FOR THE IDENTIFICATION OF CANDIDATE SERUM PROTEIN BIOMARKERS THAT MAY PREDICT TREATMENT RESPONSE IN PATIENTS WITH PSORIATIC ARTHRITIS
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AB0837 ITCH AS THE MAJOR MEDIATOR OF THE EFFECT OF TOFACITINIB ON HEALTH-RELATED QUALITY OF LIFE IN PsA: A MEDIATION ANALYSIS
https://doi.org/10.1136/annrheumdis-2020-eular.1808
SAT0330 Changes in lymphocytes and lymphocyte subsets in tofacitinib-treated patients with psoriatic arthritis
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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
FRI0335 THE EFFECT OF TOFACITINIB ON RESIDUAL PAIN IN PATIENTS WITH PSORIATIC ARTHRITIS
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FRI0462 UNDERSTANDING MEDIATORS OF PAIN REDUCTION IN PSORIATIC ARTHRITIS PATIENTS TREATED WITH TOFACITINIB: ROLE OF INFLAMMATION
https://doi.org/10.1136/annrheumdis-2019-eular.1921
POS1544 LONG-TERM SAFETY AND EFFICACY OF TOFACITINIB IN PATIENTS WITH PSORIATIC ARTHRITIS BY PRIOR BIOLOGIC DISEASE-MODIFYING ANTIRHEUMATIC DRUG EXPOSURE
https://doi.org/10.1136/annrheumdis-2023-eular.3308
Identifying and Quantifying the Role of Inflammation in Pain Reduction for Patients With Psoriatic Arthritis Treated With Tofacitinib: A Mediation Analysis
https://doi.org/10.1007/s40744-022-00482-5
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
https://doi.org/10.1007/s40264-020-00904-9
Effect of tofacitinib on dactylitis and patient-reported outcomes in patients with active psoriatic arthritis: post-hoc analysis of phase III studies
https://doi.org/10.1186/s41927-022-00298-4
POS1020 EFFICACY OF TOFACITINIB ON DACTYLITIS IN INDIVIDUAL DIGITS IN PATIENTS WITH ACTIVE PSORIATIC ARTHRITIS
https://doi.org/10.1136/annrheumdis-2021-eular.73
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
AB0768 BASELINE PAIN SEVERITY AS A PREDICTOR OF PAIN IMPROVEMENT FOLLOWING TREATMENT WITH TOFACITINIB IN PSORIATIC ARTHRITIS
https://doi.org/10.1136/annrheumdis-2019-eular.1364
SAT0439 Integrated safety summary of tofacitinib in psoriatic arthritis clinical studies
https://doi.org/10.1136/annrheumdis-2017-eular.1573
FRI0496 Comparing tofacitinib safety profile in patients with psoriatic arthritis in clinical studies with real-world data
https://doi.org/10.1136/annrheumdis-2017-eular.2448
SAT0317 Tofacitinib in patients with psoriatic arthritis and metabolic syndrome: a post-hoc analysis of phase 3 studies
https://doi.org/10.1136/annrheumdis-2018-eular.3242
SAT0469 Integrated efficacy analysis of tofacitinib, an oral janus kinase inhibitor, in patients with active psoriatic arthritis
https://doi.org/10.1136/annrheumdis-2017-eular.2444
FRI0452 TOFACITINIB IN PATIENTS WITH PSORIATIC ARTHRITIS: ANALYSIS OF DERMATOLOGIC ENDPOINTS FROM 2 PHASE 3 STUDIES
https://doi.org/10.1136/annrheumdis-2019-eular.798
THU0299 An integrated analysis of changes in lipid levels and incidence of cardiovascular events following tofacitinib treatment in patients with psoriatic arthritis across phase 3 and long-term extension studies
https://doi.org/10.1136/annrheumdis-2018-eular.1459
Tofacitinib or adalimumab versus placebo: patient-reported outcomes from OPAL Broaden—a phase III study of active psoriatic arthritis in patients with an inadequate response to conventional synthetic disease-modifying antirheumatic drugs
https://doi.org/10.1136/rmdopen-2018-000806
Effect of tofacitinib on patient-reported outcomes in patients with active psoriatic arthritis and an inadequate response to tumour necrosis factor inhibitors in the phase III, randomised controlled trial: OPAL Beyond
https://doi.org/10.1136/rmdopen-2018-000808
SAT0221 Effect of tofacitinib on reducing pain in patients with rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis
https://doi.org/10.1136/annrheumdis-2018-eular.3247
AB0827 IMPACT OF BASELINE BODY MASS INDEX ON THE EFFICACY AND SAFETY OF TOFACITINIB IN PATIENTS WITH PSORIATIC ARTHRITIS
https://doi.org/10.1136/annrheumdis-2020-eular.993
AB0794 Effect of tofacitinib on patient-reported outcomes in patients with active psoriatic arthritis: results from two phase 3 studies
https://doi.org/10.1136/annrheumdis-2017-eular.2445
AB0921 Impact of baseline demographics, disease activity and concomitant medication on american college of rheumatology 20 response rate and health assessment questionnaire-disability index score with tofacitinib in active psoriatic arthritis: a pooled subgroup analysis of 2 phase 3 studies
https://doi.org/10.1136/annrheumdis-2018-eular.3210
The effect of tofacitinib on residual pain in patients with rheumatoid arthritis and psoriatic arthritis (Results)
https://doi.org/10.1136/rmdopen-2022-002478
Efficacy of tofacitinib in reducing pain in patients with rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis
https://doi.org/10.1136/rmdopen-2019-001042
Sex differences in the efficacy, safety and persistence of patients with psoriatic arthritis treated with tofacitinib: a post-hoc analysis of phase 3 trials and long-term extension
https://doi.org/10.1136/rmdopen-2022-002718
Documents that mention this clinical trial
Median time to pain improvement and the impact of baseline pain severity on pain response in patients with psoriatic arthritis treated with tofacitinib
https://doi.org/10.1136/rmdopen-2021-001609
THU0323 Tofacitinib improves composite endpoint measures of disease in patients with psoriatic arthritis
https://doi.org/10.1136/annrheumdis-2018-eular.1275
Incidence of infections in patients with psoriatic arthritis and axial spondyloarthritis treated with biological or targeted disease-modifying agents: a systematic review and meta-analysis of randomised controlled trials, open-label studies and observational studies
https://doi.org/10.1136/rmdopen-2023-003064
POS1025 TOFACITINIB TREATMENT IN PATIENTS WITH PSORIATIC ARTHRITIS AND PROBABLE DEPRESSION AND/OR ANXIETY: A POST HOC ANALYSIS OF TWO PHASE 3 CLINICAL TRIALS
https://doi.org/10.1136/annrheumdis-2021-eular.176
FRI0509 Safety and efficacy of tofacitinib, an oral janus kinase inhibitor, up to 24 months in patients with active psoriatic arthritis: interim data from opal balance, an open-label, long-term extension study
https://doi.org/10.1136/annrheumdis-2017-eular.1414
OP0225 TOFACITINIB AS MONOTHERAPY FOLLOWING METHOTREXATE WITHDRAWAL IN PATIENTS WITH PSORIATIC ARTHRITIS PREVIOUSLY TREATED WITH OPEN-LABEL TOFACITINIB + METHOTREXATE: A RANDOMISED, PLACEBO-CONTROLLED SUBSTUDY OF OPAL BALANCE
https://doi.org/10.1136/annrheumdis-2020-eular.529
AB0902 Efficacy of tofacitinib by background methotrexate dose in patients with psoriatic arthritis: a post-hoc analysis of pooled data from 2 phase 3 trials
https://doi.org/10.1136/annrheumdis-2018-eular.1278
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
Impact of baseline body mass index on the efficacy and safety of tofacitinib in patients with psoriatic arthritis
https://doi.org/10.1136/rmdopen-2020-001486
AB0831 COMPARISON OF DIFFERENT REMISSION INDICES IN PATIENTS WITH PSORIATIC ARTHRITIS: A POST HOC ANALYSIS OF DATA FROM PHASE 3 TOFACITINIB STUDIES
https://doi.org/10.1136/annrheumdis-2020-eular.948
AB0774 TIME TO RESPONSE FOR CLINICAL AND PATIENT-REPORTED OUTCOMES IN PATIENTS WITH PSORIATIC ARTHRITIS TREATED WITH TOFACITINIB, ADALIMUMAB OR PLACEBO
https://doi.org/10.1136/annrheumdis-2020-eular.994
AB0838 IDENTIFYING MEDIATORS OF PAIN REDUCTION IN PATIENTS WITH PSORIATIC ARTHRITIS TREATED WITH TOFACITINIB: ROLE OF INFLAMMATION ASSOCIATED WITH PERIPHERAL ARTHRITIS, ENTHESITIS AND SKIN DISEASE
https://doi.org/10.1136/annrheumdis-2020-eular.1052
SAT0293 Safety and efficacy of tofacitinib, an oral janus kinase inhibitor, up to 36 months in patients with active psoriatic arthritis: data from the third interim analysis of opal balance, an open-label, long-term extension study
https://doi.org/10.1136/annrheumdis-2018-eular.3115
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
Efficacy and safety of tofacitinib in Chinese patients with active psoriatic arthritis: a phase 3, randomised, double-blind, placebo-controlled study
https://doi.org/10.1136/rmdopen-2022-002559
Identifying and Quantifying the Role of Inflammation in Pain Reduction for Patients With Psoriatic Arthritis Treated With Tofacitinib: A Mediation Analysis
https://doi.org/10.1007/s40744-022-00482-5
AB0837 ITCH AS THE MAJOR MEDIATOR OF THE EFFECT OF TOFACITINIB ON HEALTH-RELATED QUALITY OF LIFE IN PsA: A MEDIATION ANALYSIS
https://doi.org/10.1136/annrheumdis-2020-eular.1808
FRI0462 UNDERSTANDING MEDIATORS OF PAIN REDUCTION IN PSORIATIC ARTHRITIS PATIENTS TREATED WITH TOFACITINIB: ROLE OF INFLAMMATION
https://doi.org/10.1136/annrheumdis-2019-eular.1921
SAT0330 Changes in lymphocytes and lymphocyte subsets in tofacitinib-treated patients with psoriatic arthritis
https://doi.org/10.1136/annrheumdis-2018-eular.3490
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
https://doi.org/10.1007/s40264-020-00904-9
Effect of tofacitinib on dactylitis and patient-reported outcomes in patients with active psoriatic arthritis: post-hoc analysis of phase III studies
https://doi.org/10.1186/s41927-022-00298-4
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
POS1020 EFFICACY OF TOFACITINIB ON DACTYLITIS IN INDIVIDUAL DIGITS IN PATIENTS WITH ACTIVE PSORIATIC ARTHRITIS
https://doi.org/10.1136/annrheumdis-2021-eular.73
SAT0439 Integrated safety summary of tofacitinib in psoriatic arthritis clinical studies
https://doi.org/10.1136/annrheumdis-2017-eular.1573
AB0768 BASELINE PAIN SEVERITY AS A PREDICTOR OF PAIN IMPROVEMENT FOLLOWING TREATMENT WITH TOFACITINIB IN PSORIATIC ARTHRITIS
https://doi.org/10.1136/annrheumdis-2019-eular.1364
THU0299 An integrated analysis of changes in lipid levels and incidence of cardiovascular events following tofacitinib treatment in patients with psoriatic arthritis across phase 3 and long-term extension studies
https://doi.org/10.1136/annrheumdis-2018-eular.1459
FRI0496 Comparing tofacitinib safety profile in patients with psoriatic arthritis in clinical studies with real-world data
https://doi.org/10.1136/annrheumdis-2017-eular.2448
SAT0317 Tofacitinib in patients with psoriatic arthritis and metabolic syndrome: a post-hoc analysis of phase 3 studies
https://doi.org/10.1136/annrheumdis-2018-eular.3242
FRI0452 TOFACITINIB IN PATIENTS WITH PSORIATIC ARTHRITIS: ANALYSIS OF DERMATOLOGIC ENDPOINTS FROM 2 PHASE 3 STUDIES
https://doi.org/10.1136/annrheumdis-2019-eular.798
SAT0469 Integrated efficacy analysis of tofacitinib, an oral janus kinase inhibitor, in patients with active psoriatic arthritis
https://doi.org/10.1136/annrheumdis-2017-eular.2444
Tofacitinib or adalimumab versus placebo: patient-reported outcomes from OPAL Broaden—a phase III study of active psoriatic arthritis in patients with an inadequate response to conventional synthetic disease-modifying antirheumatic drugs
https://doi.org/10.1136/rmdopen-2018-000806
Effect of tofacitinib on patient-reported outcomes in patients with active psoriatic arthritis and an inadequate response to tumour necrosis factor inhibitors in the phase III, randomised controlled trial: OPAL Beyond
https://doi.org/10.1136/rmdopen-2018-000808
The effect of tofacitinib on residual pain in patients with rheumatoid arthritis and psoriatic arthritis (Results)
https://doi.org/10.1136/rmdopen-2022-002478
SAT0221 Effect of tofacitinib on reducing pain in patients with rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis
https://doi.org/10.1136/annrheumdis-2018-eular.3247
AB0794 Effect of tofacitinib on patient-reported outcomes in patients with active psoriatic arthritis: results from two phase 3 studies
https://doi.org/10.1136/annrheumdis-2017-eular.2445
AB0827 IMPACT OF BASELINE BODY MASS INDEX ON THE EFFICACY AND SAFETY OF TOFACITINIB IN PATIENTS WITH PSORIATIC ARTHRITIS
https://doi.org/10.1136/annrheumdis-2020-eular.993
AB0921 Impact of baseline demographics, disease activity and concomitant medication on american college of rheumatology 20 response rate and health assessment questionnaire-disability index score with tofacitinib in active psoriatic arthritis: a pooled subgroup analysis of 2 phase 3 studies
https://doi.org/10.1136/annrheumdis-2018-eular.3210
Efficacy of tofacitinib in reducing pain in patients with rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis
https://doi.org/10.1136/rmdopen-2019-001042
Sex differences in the efficacy, safety and persistence of patients with psoriatic arthritis treated with tofacitinib: a post-hoc analysis of phase 3 trials and long-term extension
https://doi.org/10.1136/rmdopen-2022-002718
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Funding
Funding for this research was provided by:
Pfizer Inc
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Article History
Received: 25 January 2022
Accepted: 30 July 2022
First Online: 1 September 2022
Declarations
:
: Both studies were conducted in accordance with the International Council for Harmonisation Good Clinical Practice Guidelines and the principles of the Declaration of Helsinki. The study protocols were approved by the Institutional Review Board or Independent Ethics Committee at each center, and all patients provided written informed consent.
: Not applicable.
: A-M Orbai has received grant/research support from AbbVie, Amgen, Celgene, Eli Lilly, Gilead Sciences, Horizon, Janssen, and Novartis; and is a consultant for Bristol-Myers Squibb, Eli Lilly, Janssen, Novartis, Pfizer Inc, and UCB. PJ Mease has received grant/research support from AbbVie, Amgen, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Eli Lilly, Galapagos, Gilead Sciences, Janssen, Novartis, Pfizer Inc, Sun, and UCB; is a consultant for AbbVie, Amgen, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Eli Lilly, Galapagos, Gilead Sciences, Janssen, Novartis, Pfizer Inc, Sun, and UCB; and has been on speakers’ bureaus for AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Eli Lilly, Genentech, Janssen, Novartis, Pfizer Inc, and UCB. PS Helliwell has received consulting fees from Eli Lilly; and has received fees for educational services from AbbVie, Janssen, Novartis, and Pfizer Inc. O FitzGerald has received grant/research support from AbbVie, Bristol-Myers Squibb, Eli Lilly, Novartis, Pfizer Inc, and UCB; has received consulting fees from Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, and Pfizer Inc; and has been on speakers’ bureaus for AbbVie, Janssen, and Pfizer Inc. DL Fleishaker, R Mundayat, and P Young are employees and shareholders of Pfizer Inc.
