MEASE, P.J., A. LERTRATANAKUL, K.A. PAPP, F.E. VAN DEN BOSCH, S. TSUJI, Eva DOKOUPILOVÁ, M.W. KEISERMAN, X.W. BU, L. CHEN, R.M. MCCASKILL, P. ZUEGER, E.L. MCDEARMON-BLONDELL, A.L. PANGAN and W. TILLETT. Upadacitinib in Patients with Psoriatic Arthritis and Inadequate Response to Biologics: 56-Week Data from the Randomized Controlled Phase 3 SELECT-PsA 2 Study. RHEUMATOLOGY AND THERAPY. NEW YORK: SPRINGER, 2021, vol. 8, No 2, p. 903-919. ISSN 2198-6576. Available from: https://dx.doi.org/10.1007/s40744-021-00305-z.
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Basic information
Original name Upadacitinib in Patients with Psoriatic Arthritis and Inadequate Response to Biologics: 56-Week Data from the Randomized Controlled Phase 3 SELECT-PsA 2 Study
Authors MEASE, P.J. (guarantor), A. LERTRATANAKUL, K.A. PAPP, F.E. VAN DEN BOSCH, S. TSUJI, Eva DOKOUPILOVÁ (203 Czech Republic, belonging to the institution), M.W. KEISERMAN, X.W. BU, L. CHEN, R.M. MCCASKILL, P. ZUEGER, E.L. MCDEARMON-BLONDELL, A.L. PANGAN and W. TILLETT.
Edition RHEUMATOLOGY AND THERAPY, NEW YORK, SPRINGER, 2021, 2198-6576.
Other information
Original language English
Type of outcome Article in a journal
Field of Study 30104 Pharmacology and pharmacy
Country of publisher United States of America
Confidentiality degree is not subject to a state or trade secret
WWW URL
Impact factor Impact factor: 4.081
RIV identification code RIV/00216224:14160/21:00123963
Organization unit Faculty of Pharmacy
Doi http://dx.doi.org/10.1007/s40744-021-00305-z
UT WoS 000645292500001
Keywords in English Upadacitinib; Psoriatic arthritis; Janus kinase inhibitors
Tags rivok, ÚFT
Tags International impact, Reviewed
Changed by Changed by: JUDr. Sabina Krejčiříková, učo 383857. Changed: 26/1/2022 14:49.
Abstract
Introduction Upadacitinib is a Janus kinase inhibitor under investigation in patients with psoriatic arthritis (PsA). This study assessed the 56-week efficacy and safety of upadacitinib in patients with PsA and an inadequate response or intolerance to biologic therapy. Methods In the phase 3 SELECT-PsA 2 study, patients were randomized to 56 weeks of blinded treatment with oral upadacitinib 15 or 30 mg once daily, or placebo switched to upadacitinib 15 or 30 mg once daily at week 24. Efficacy endpoints included the proportion of patients achieving 20/50/70% improvement in American College of Rheumatology criteria (ACR20/50/70), 75/90/100% improvement in Psoriasis Area and Severity Index (PASI75/90/100), and minimal disease activity. Safety was assessed throughout the study. Results Of 641 patients who received >= 1 dose of study drug, 479 (74.7%) completed 56 weeks of treatment. Improvements in the proportion of patients achieving ACR20/50/70, PASI75/90/100, and minimal disease activity were maintained with both doses of upadacitinib through 56 weeks. Week 56 results for patients who switched from placebo to upadacitinib at week 24 were similar to those for patients originally randomized to the upadacitinib groups. The exposure-adjusted event rate for serious infections was 2.6 and 6.1 events/100 patient-years in the upadacitinib 15 and 30 mg groups, respectively. Herpes zoster occurred more frequently with upadacitinib 30 versus 15 mg; most cases were non-serious. Conclusion In patients with PsA who had an inadequate response or intolerance to biologic therapy, the efficacy of upadacitinib was maintained over 56 weeks with no new significant safety signals observed.
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