Burmester, Gerd R.
Curtis, Jeffrey R.
Yun, Huifeng
FitzGerald, Oliver
Winthrop, Kevin L.
Azevedo, Valderilio F.
Rigby, William F. C.
Kanik, Keith S.
Wang, Cunshan
Biswas, Pinaki
Jones, Thomas
Palmetto, Niki
Hendrikx, Thijs
Menon, Sujatha
Rojo, Ricardo
Clinical trials referenced in this document:
Documents that mention this clinical trial
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
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
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
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
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
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
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
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
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
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
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
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
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
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
POS1045 MASS SPECTROMETRY-BASED PROTEOMICS FOR THE IDENTIFICATION OF CANDIDATE SERUM PROTEIN BIOMARKERS THAT MAY PREDICT TREATMENT RESPONSE IN PATIENTS WITH PSORIATIC ARTHRITIS
https://doi.org/10.1136/annrheumdis-2022-eular.2091
FRI0335 THE EFFECT OF TOFACITINIB ON RESIDUAL PAIN IN PATIENTS WITH PSORIATIC ARTHRITIS
https://doi.org/10.1136/annrheumdis-2020-eular.949
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
SAT0330 Changes in lymphocytes and lymphocyte subsets in tofacitinib-treated patients with psoriatic arthritis
https://doi.org/10.1136/annrheumdis-2018-eular.3490
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
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
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
POS1020 EFFICACY OF TOFACITINIB ON DACTYLITIS IN INDIVIDUAL DIGITS IN PATIENTS WITH ACTIVE PSORIATIC ARTHRITIS
https://doi.org/10.1136/annrheumdis-2021-eular.73
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
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
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
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
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
SAT0439 Integrated safety summary of tofacitinib in psoriatic arthritis clinical studies
https://doi.org/10.1136/annrheumdis-2017-eular.1573
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
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
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
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
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
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
The effect of tofacitinib on residual pain in patients with rheumatoid arthritis and psoriatic arthritis (Results)
https://doi.org/10.1136/rmdopen-2022-002478
Documents that mention this clinical trial
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
POS1020 EFFICACY OF TOFACITINIB ON DACTYLITIS IN INDIVIDUAL DIGITS IN PATIENTS WITH ACTIVE PSORIATIC ARTHRITIS
https://doi.org/10.1136/annrheumdis-2021-eular.73
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
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
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
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
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
SAT0439 Integrated safety summary of tofacitinib in psoriatic arthritis clinical studies
https://doi.org/10.1136/annrheumdis-2017-eular.1573
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
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
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
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
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
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
The effect of tofacitinib on residual pain in patients with rheumatoid arthritis and psoriatic arthritis (Results)
https://doi.org/10.1136/rmdopen-2022-002478
Documents that mention this clinical trial
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
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
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
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
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
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
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
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
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
SAT0439 Integrated safety summary of tofacitinib in psoriatic arthritis clinical studies
https://doi.org/10.1136/annrheumdis-2017-eular.1573
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
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
Funding for this research was provided by:
Pfizer Inc
Article History
First Online: 31 January 2020
Compliance with Ethical Standards
:
: This study was funded by Pfizer Inc. Medical writing support, under the guidance of the authors, was provided by Carole Evans, PhD, and Richard Knight, PhD, CMC Connect, McCann Health Medical Communications Ltd, and was funded by Pfizer Inc, New York, NY, USA, in accordance with good publication practice (GPP3) guidelines (<i>Ann Intern Med</i> 2015;163:461–4).
: Gerd R. Burmester has received consulting fees from AbbVie, Gilead, Lilly, and Pfizer Inc and lecture fees from AbbVie, Lilly, and Pfizer Inc. Jeffrey R. Curtis has received research grants and consulting fees from AbbVie, Amgen, Bristol-Myers Squibb, Corrona, Eli Lilly, Janssen, Myriad, Pfizer Inc, Regeneron, Roche, and UCB. Huifeng Yun has received grant/research support from Pfizer Inc. Oliver FitzGerald has received research grants and honoraria from AbbVie, Celgene, Janssen, Lilly, Novartis, Pfizer Inc, and UCB. Kevin L. Winthrop has received consulting fees from AbbVie, Galapagos, Gilead, GSK, Lilly, Pfizer Inc, Roche, and UCB. Valderilio F. Azevedo has received grant/research support and consulting fees from AbbVie, Lilly, Novartis, and Pfizer Inc and lecture fees from AbbVie, Boehringer Ingelheim, Celltrion, Janssen, Lilly, Novartis, and Pfizer Inc. William F.C. Rigby has received consulting fees for work unrelated to this manuscript. Keith S. Kanik, Cunshan Wang, Pinaki Biswas, Thomas Jones, Thijs Hendrikx, and Ricardo Rojo are shareholders and employees of Pfizer Inc. Sujatha Menon is an employee of Pfizer Inc. Niki Palmetto was an employee of Pfizer Inc at the time of the analysis.
: All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional review board or independent ethics committee at each investigational site and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. Patient data from the US Truven MarketScan database were de-identified and complied with the patient confidentiality requirements of the Health Insurance Portability and Accountability Act. Therefore, institutional review board approval was not required.
: Informed consent was obtained from all individual participants included in the study.