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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 a 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, roč. 8, č. 2, s. 903-919. ISSN 2198-6576. Dostupné z: https://dx.doi.org/10.1007/s40744-021-00305-z.

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TY  - JOUR
ID  - 1827543
AU  - Mease, P.J. - Lertratanakul, A. - Papp, K.A. - van den Bosch, F.E. - Tsuji, S. - Dokoupilová, Eva - Keiserman, M.W. - Bu, X.W. - Chen, L. - McCaskill, R.M. - Zueger, P. - McDearmon-Blondell, E.L. - Pangan, A.L. - Tillett, W.
PY  - 2021
TI  - Upadacitinib in Patients with Psoriatic Arthritis and Inadequate Response to Biologics: 56-Week Data from the Randomized Controlled Phase 3 SELECT-PsA 2 Study
JF  - RHEUMATOLOGY AND THERAPY
VL  - 8
IS  - 2
SP  - 903-919
EP  - 903-919
PB  - SPRINGER
SN  - 21986576
KW  - Upadacitinib
KW  - Psoriatic arthritis
KW  - Janus kinase inhibitors
UR  - https://link.springer.com/article/10.1007%2Fs40744-021-00305-z
N2  - 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.
ER  -

Základní údaje
Originální název	Upadacitinib in Patients with Psoriatic Arthritis and Inadequate Response to Biologics: 56-Week Data from the Randomized Controlled Phase 3 SELECT-PsA 2 Study
Autoři	MEASE, P.J. (garant), A. LERTRATANAKUL, K.A. PAPP, F.E. VAN DEN BOSCH, S. TSUJI, Eva DOKOUPILOVÁ (203 Česká republika, domácí), M.W. KEISERMAN, X.W. BU, L. CHEN, R.M. MCCASKILL, P. ZUEGER, E.L. MCDEARMON-BLONDELL, A.L. PANGAN a W. TILLETT.
Vydání	RHEUMATOLOGY AND THERAPY, NEW YORK, SPRINGER, 2021, 2198-6576.

Další údaje
Originální jazyk	angličtina
Typ výsledku	Článek v odborném periodiku
Obor	30104 Pharmacology and pharmacy
Stát vydavatele	Spojené státy
Utajení	není předmětem státního či obchodního tajemství
WWW	URL
Impakt faktor	Impact factor: 4.081
Kód RIV	RIV/00216224:14160/21:00123963
Organizační jednotka	Farmaceutická fakulta
Doi	http://dx.doi.org/10.1007/s40744-021-00305-z
UT WoS	000645292500001
Klíčová slova anglicky	Upadacitinib; Psoriatic arthritis; Janus kinase inhibitors
Štítky	rivok, ÚFT
Příznaky	Mezinárodní význam, Recenzováno
Změnil	Změnila: JUDr. Sabina Krejčiříková, učo 383857. Změněno: 26. 1. 2022 14:49.

Anotace
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.

Anotace

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.