Mease, Philip
Kavanaugh, Arthur
Gladman, Dafna
FitzGerald, Oliver
Soriano, Enrique R.
Nash, Peter
Feng, Dai
Lertratanakul, Apinya
Douglas, Kevin
Lippe, Ralph
Gossec, Laure
Clinical trials referenced in this document:
Documents that mention this clinical trial
Efficacy and Safety of Upadacitinib in Patients with Psoriatic Arthritis: 2-Year Results from the Phase 3 SELECT-PsA 1 Study
https://doi.org/10.1007/s40744-022-00499-w
Upadacitinib for psoriatic arthritis refractory to biologics: SELECT-PsA 2
https://doi.org/10.1136/annrheumdis-2020-218870
POS1047 IMPACT OF UPADACITINIB ON REDUCING PAIN IN PATIENTS WITH ACTIVE PSORIATIC ARTHRITIS: RESULTS FROM TWO PHASE 3 TRIALS IN PATIENTS WITH INADEQUATE RESPONSE TO NON-BIOLOGIC OR BIOLOGIC DMARDs
https://doi.org/10.1136/annrheumdis-2021-eular.1633
AB1090 EFFICACY OF UPADACITINIB IN PATIENTS WITH PSORIATIC ARTHRITIS STRATIFIED BY INVOLVEMENT OF WEIGHT-BEARING JOINT REGIONS: A POST HOC SUBGROUP ANALYSIS OF THE PHASE 3, RANDOMIZED, SELECT-PSA 1 AND SELECT-PSA 2 TRIALS
https://doi.org/10.1136/annrheumdis-2023-eular.3944
POS0657 LONG-TERM SAFETY OF UPADACITINIB IN PSORIATIC ARTHRITIS, ANKYLOSING SPONDYLITIS, AND NON-RADIOGRAPHIC AXIAL SPONDYLOARTHRITIS UP TO 5 YEARS
https://doi.org/10.1136/annrheumdis-2023-eular.2699
MACE and VTE across upadacitinib clinical trial programmes in rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis
https://doi.org/10.1136/rmdopen-2023-003392
Safety profile of upadacitinib over 15 000 patient-years across rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and atopic dermatitis
https://doi.org/10.1136/rmdopen-2022-002735
POS0081 LONG-TERM EFFICACY AND SAFETY OF UPADACITINIB IN PATIENTS WITH PSORIATIC ARTHRITIS: 2-YEAR RESULTS FROM THE PHASE 3 SELECT-PsA 1 STUDY
https://doi.org/10.1136/annrheumdis-2022-eular.799
Upadacitinib in patients with psoriatic arthritis and an inadequate response to non-biological therapy: 56-week data from the phase 3 SELECT-PsA 1 study
https://doi.org/10.1136/rmdopen-2021-001838
Disease Control with Upadacitinib in Patients with Psoriatic Arthritis: A Post Hoc Analysis of the Randomized, Placebo-Controlled SELECT-PsA 1 and 2 Phase 3 Trials
https://doi.org/10.1007/s40744-022-00449-6
Safety Profile of Upadacitinib up to 3 Years in Psoriatic Arthritis: An Integrated Analysis of Two Pivotal Phase 3 Trials
https://doi.org/10.1007/s40744-021-00410-z
Malignancy in the Upadacitinib Clinical Trials for Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, and Non-radiographic Axial Spondyloarthritis
https://doi.org/10.1007/s40744-023-00621-6
OP0061 DEVELOPMENT OF EXTRA-MUSCULOSKELETAL MANIFESTATIONS IN UPADACITINIB-TREATED PATIENTS WITH PSORIATIC ARTHRITIS, ANKYLOSING SPONDYLITIS, OR NON-RADIOGRAPHIC AXIAL SPONDYLOARTHRITIS
https://doi.org/10.1136/annrheumdis-2023-eular.2394
Improvement in Patient-Reported Outcomes in Patients with Psoriatic Arthritis Treated with Upadacitinib Versus Placebo or Adalimumab: Results from SELECT-PsA 1
https://doi.org/10.1007/s40744-021-00379-9
Effect of upadacitinib on reducing pain in patients with active psoriatic arthritis or ankylosing spondylitis: post hoc analysis of three randomised clinical trials
https://doi.org/10.1136/rmdopen-2021-002049
POS0894 SAFETY OF UPADACITINIB ACROSS RHEUMATOID ARTHRITIS, PSORIATIC ARTHRITIS, AND AXIAL SPONDYLOARTHRITIS ENCOMPASSING 15,000 PATIENT-YEARS OF CLINICAL TRIAL DATA
https://doi.org/10.1136/annrheumdis-2024-eular.809
OP0233 EFFICACY AND SAFETY OF UPADACITINIB IN PATIENTS WITH PSORIATIC ARTHRITIS AND AXIAL INVOLVEMENT
https://doi.org/10.1136/annrheumdis-2021-eular.439
Documents that mention this clinical trial
Upadacitinib for psoriatic arthritis refractory to biologics: SELECT-PsA 2 (Results)
https://doi.org/10.1136/annrheumdis-2020-218870
POS1047 IMPACT OF UPADACITINIB ON REDUCING PAIN IN PATIENTS WITH ACTIVE PSORIATIC ARTHRITIS: RESULTS FROM TWO PHASE 3 TRIALS IN PATIENTS WITH INADEQUATE RESPONSE TO NON-BIOLOGIC OR BIOLOGIC DMARDs
https://doi.org/10.1136/annrheumdis-2021-eular.1633
AB1090 EFFICACY OF UPADACITINIB IN PATIENTS WITH PSORIATIC ARTHRITIS STRATIFIED BY INVOLVEMENT OF WEIGHT-BEARING JOINT REGIONS: A POST HOC SUBGROUP ANALYSIS OF THE PHASE 3, RANDOMIZED, SELECT-PSA 1 AND SELECT-PSA 2 TRIALS
https://doi.org/10.1136/annrheumdis-2023-eular.3944
POS0657 LONG-TERM SAFETY OF UPADACITINIB IN PSORIATIC ARTHRITIS, ANKYLOSING SPONDYLITIS, AND NON-RADIOGRAPHIC AXIAL SPONDYLOARTHRITIS UP TO 5 YEARS
https://doi.org/10.1136/annrheumdis-2023-eular.2699
MACE and VTE across upadacitinib clinical trial programmes in rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis
https://doi.org/10.1136/rmdopen-2023-003392
Safety profile of upadacitinib over 15 000 patient-years across rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and atopic dermatitis
https://doi.org/10.1136/rmdopen-2022-002735
Disease Control with Upadacitinib in Patients with Psoriatic Arthritis: A Post Hoc Analysis of the Randomized, Placebo-Controlled SELECT-PsA 1 and 2 Phase 3 Trials
https://doi.org/10.1007/s40744-022-00449-6
Safety Profile of Upadacitinib up to 3 Years in Psoriatic Arthritis: An Integrated Analysis of Two Pivotal Phase 3 Trials
https://doi.org/10.1007/s40744-021-00410-z
POS1041 LONG-TERM EFFICACY AND SAFETY OF UPADACITINIB IN PATIENTS WITH PSORIATIC ARTHRITIS REFRACTORY TO BIOLOGIC THERAPIES: 2-YEAR RESULTS FROM THE PHASE 3 SELECT-PsA 2 STUDY
https://doi.org/10.1136/annrheumdis-2022-eular.1897
Malignancy in the Upadacitinib Clinical Trials for Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, and Non-radiographic Axial Spondyloarthritis
https://doi.org/10.1007/s40744-023-00621-6
OP0061 DEVELOPMENT OF EXTRA-MUSCULOSKELETAL MANIFESTATIONS IN UPADACITINIB-TREATED PATIENTS WITH PSORIATIC ARTHRITIS, ANKYLOSING SPONDYLITIS, OR NON-RADIOGRAPHIC AXIAL SPONDYLOARTHRITIS
https://doi.org/10.1136/annrheumdis-2023-eular.2394
Effect of upadacitinib on reducing pain in patients with active psoriatic arthritis or ankylosing spondylitis: post hoc analysis of three randomised clinical trials
https://doi.org/10.1136/rmdopen-2021-002049
POS0894 SAFETY OF UPADACITINIB ACROSS RHEUMATOID ARTHRITIS, PSORIATIC ARTHRITIS, AND AXIAL SPONDYLOARTHRITIS ENCOMPASSING 15,000 PATIENT-YEARS OF CLINICAL TRIAL DATA
https://doi.org/10.1136/annrheumdis-2024-eular.809
OP0233 EFFICACY AND SAFETY OF UPADACITINIB IN PATIENTS WITH PSORIATIC ARTHRITIS AND AXIAL INVOLVEMENT
https://doi.org/10.1136/annrheumdis-2021-eular.439
Funding for this research was provided by:
AbbVie
Article History
Received: 9 February 2022
Accepted: 7 April 2022
First Online: 23 May 2022
Declarations
:
: AbbVie Inc (North Chicago, IL, USA) funded this study and the journal’s Rapid Service Fee, and participated in the study design, research, analysis, data collection, interpretation of data, reviewing, and approval of the publication.
: Medical writing support was provided by Russell Craddock, PhD, and Laura Chalmers, PhD, of 2 the Nth, and was funded by AbbVie Inc.
: All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this article, take responsibility for the integrity of the work as a whole, and have given their approval for this version to be published.
: Dr. Mease was involved in study conception and design, data collection, analysis and interpretation, drafting the article, and revising it for critically important intellectual content, and approving the final version of the manuscript. Dr. Kavanaugh was involved in study conception and design, data collection, analysis and interpretation, drafting the article, and revising it for critically important intellectual content, and approving the final version of the manuscript. Dr. Gladman was involved in study conception and design, data collection, analysis and interpretation, drafting the article, and revising it for critically important intellectual content, and approving the final version of the manuscript. Prof. FitzGerald was involved in study conception and design, data collection, analysis and interpretation, drafting the article, and revising it for critically important intellectual content, and approving the final version of the manuscript. Dr. Soriano was involved in study conception and design, data collection, analysis and interpretation, drafting the article, and revising it for critically important intellectual content, and approving the final version of the manuscript. Prof. Nash was involved in study conception and design, data collection, analysis and interpretation, drafting the article, and revising it for critically important intellectual content, and approving the final version of the manuscript. Dr. Feng was involved in study conception and design, data analysis and interpretation, statistical analysis, drafting the article, and revising it for critically important intellectual content, and approving the final version of the manuscript. Dr. Lertratanakul was involved in study conception and design, data analysis and interpretation, drafting the article, and revising it for critically important intellectual content, and approving the final version of the manuscript. Dr. Douglas was involved in study conception and design, data analysis and interpretation, drafting the article, and revising it for critically important intellectual content, and approving the final version of the manuscript. Dr. Lippe was involved in study conception and design, data analysis and interpretation, drafting the article, and revising it for critically important intellectual content, and approving the final version of the manuscript. Prof. Gossec was involved in study conception and design, data collection, analysis and interpretation, drafting the article, and revising it for critically important intellectual content, and approving the final version of the manuscript.
: Philip Mease has received research grants, consulting fees, and/or speaker’s fees from AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Galapagos, Gilead, GlaxoSmithKline, Eli Lilly, Janssen, Merck, Novartis, Pfizer, Sun Pharma, and UCB. Arthur Kavanaugh has received grant/research support and/or provided expert advice to AbbVie, Amgen, AstraZeneca, Bristol Myers Squibb, Celgene, Centocor-Janssen, Pfizer, Roche, and UCB. Dafna Gladman has received grant/research support from AbbVie, Amgen, Bristol Myers Squibb, Celgene Corporation, Eli Lilly, Galapagos, Gilead, Janssen, Novartis, Pfizer, and UCB. Oliver FitzGerald has received research grants, consulting fees, and/or speaker’s fees from AbbVie, Amgen, Bristol Myers Squibb, Celgene, Eli Lilly, Janssen, Novartis, Pfizer, and UCB. Enrique R. Soriano has received research grants, consulting fees, and/or speaker’s fees from AbbVie, Amgen, Bristol Myers Squibb, Celgene, Eli Lilly, Janssen, Novartis, Pfizer, Roche, Sanofi-Aventis, and UCB. Peter Nash has received funding for clinical trials, research grants, and honoraria for lectures and advice from AbbVie, Amgen, Bristol Myers Squibb, Celgene, Eli Lilly, Janssen, Novartis, Pfizer, Roche, Sanofi-Aventis, and UCB. Dai Feng, Kevin Douglas, and Ralph Lippe are employees of AbbVie Inc and may hold AbbVie stock or options. Apinya Lertratanakul is a former employee of AbbVie Inc. Laure Gossec has received research grants from Amgen, Eli Lilly, Galapagos, Pfizer, Sandoz, and Sanofi-Aventis; and consulting fees from AbbVie, Amgen, Bristol Myers Squibb, Eli Lilly, Galapagos, Gilead, Janssen, Novartis, Pfizer, Samsung Bioepis, Sanofi-Aventis, and UCB.
: Both trials were conducted according to the International Conference on Harmonization guidelines and the principles of the Declaration of Helsinki of 1964 and its later amendments. All patients provided written informed consent. The trial protocols were approved by the relevant independent ethics committees and institutional review boards of all participating institutions (previously published) and were sponsored by AbbVie, which provided upadacitinib, adalimumab, and placebo. All authors have provided their approval for this version to be published.
: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual, and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications. These clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing agreement. Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered. For more information on the process, or to submit a request, visit the following link: ExternalRef removed.