Upadacitinib in Patients with Psoriatic Arthritis and Inadequate Response to Biologics: 56-Week Data from the Randomized Controlled Phase 3 SELECT-PsA 2 Study

Philip J Mease; Apinya Lertratanakul; Kim A Papp; Filip E van den Bosch; Shigeyoshi Tsuji; Eva Dokoupilova; Mauro W Keiserman; Xianwei Bu; Liang Chen; Reva M McCaskill; Patrick Zueger; Erin L McDearmon-Blondell; Aileen L Pangan; William Tillett

doi:10.1007/s40744-021-00305-z

Upadacitinib in Patients with Psoriatic Arthritis and Inadequate Response to Biologics: 56-Week Data from the Randomized Controlled Phase 3 SELECT-PsA 2 Study

Philip J Mease, Apinya Lertratanakul, Kim A Papp, Filip E van den Bosch, Shigeyoshi Tsuji, Eva Dokoupilova, Mauro W Keiserman, Xianwei Bu, Liang Chen, Reva M McCaskill, Patrick Zueger, Erin L McDearmon-Blondell, Aileen L Pangan, William Tillett

Research output: Contribution to journal › Article › peer-review

57 Citations (SciVal)

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.

TRIAL REGISTRATION: NCT03104374.

Original language	English
Pages (from-to)	903-919
Number of pages	17
Journal	Rheumatology and therapy
Volume	8
Issue number	2
Early online date	28 Apr 2021
DOIs	https://doi.org/10.1007/s40744-021-00305-z
Publication status	Published - 30 Jun 2021

Bibliographical note

Funding Information:
Medical writing assistance was provided by John Ewbank, PhD, Frances Smith, PhD, and Russell Craddock, PhD, of 2 the Nth (Cheshire, UK), and was funded by AbbVie.

Funding Information:
Philip Mease has received research grants, consulting fees, and/or speaker’s fees from AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squib, Celgene, Galapagos, Genentech, Gilead, GlaxoSmithKline, Janssen, Lilly, Novartis, Pfizer, Sun Pharma, and UCB. Kim Papp has served as a scientific adviser and/or clinical study investigator for AbbVie, Akros, Allergan, Almirall, Amgen, Arcutis, Avillion, Bausch Health, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Dermavant, Dermira, Eli Lilly and Company, Galderma, Genentech/Roche, GlaxoSmithKline, Janssen, Kyowa Kirin, LEO, Meiji, Merck Sharp & Dohme, Novartis, Pfizer, Regeneron, Sanofi Genzyme, Sienna Pharmaceuticals, Sun Pharma, Takeda, UCB, and Valeant; and as a paid speaker for AbbVie, Akros, Allergan, Almirall, Amgen, Bausch Health, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Dermavant, Dermira, Eli Lilly and Company, Galderma, Genentech/Roche, Janssen, Kyowa Kirin, LEO, Meiji, Merck Sharp & Dohme, Novartis, Pfizer, Regeneron, Sanofi Genzyme, Sienna Pharmaceuticals, Sun Pharma, Takeda, UCB, and Valeant. Filip van den Bosch has received speaker and/or consulting fees from AbbVie, Bristol Myers Squibb, Celgene, Eli Lilly, Galapagos, Janssen, Merck, Novartis, Pfizer, Sanofi, and UCB. Shigeyoshi Tsuji has received research grants and speaker and/or consulting fees from AbbVie, Eli Lilly, Janssen, Novartis, and UCB. Eva Dokoupilova has received research grants from AbbVie, Affibody AB, Eli Lilly, Galapagos, Gilead, GlaxoSmithKline, Hexal AG, Merck, Novartis, Pfizer, R-Pharm, Sanofi-Aventis, and UCB Biopharma SPRL. Apinya Lertratanakul, Xianwei Bu, Liang Chen, Reva M. McCaskill, Patrick Zueger, Erin L. McDearmon-Blondell, and Aileen L. Pangan are employees of AbbVie and may own stock or options. Mauro Keiserman has received research/speaker/advisory board grants/fees from AbbVie, Celgene, Lilly, Bristol, Roche, Novartis, Pfizer, Janssen, and UCB. William Tillett has received grant/research support from AbbVie, Celgene, Janssen, and Eli Lilly, has acted as a consultant for AbbVie, Amgen, Celgene, Eli Lilly, MSD, Novartis, Pfizer, and UCB, and has received speaker bureau fees from AbbVie, Amgen, Celgene, Eli Lilly, Janssen, Novartis, UCB, and Pfizer.

Publisher Copyright:
© 2021, The Author(s).

Keywords

Janus kinase inhibitors
Psoriatic arthritis
Upadacitinib

ASJC Scopus subject areas

Rheumatology
Immunology and Allergy

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10.1007/s40744-021-00305-zLicence: CC BY

Cite this

Mease, P. J., Lertratanakul, A., Papp, K. A., van den Bosch, F. E., Tsuji, S., Dokoupilova, E., Keiserman, M. W., Bu, X., Chen, L., McCaskill, R. M., Zueger, P., McDearmon-Blondell, E. L., Pangan, A. L., & Tillett, W. (2021). 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, 8(2), 903-919. https://doi.org/10.1007/s40744-021-00305-z

Mease, PJ, Lertratanakul, A, Papp, KA, van den Bosch, FE, Tsuji, S, Dokoupilova, E, Keiserman, MW, Bu, X, Chen, L, McCaskill, RM, Zueger, P, McDearmon-Blondell, EL, Pangan, AL & Tillett, W 2021, '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, vol. 8, no. 2, pp. 903-919. https://doi.org/10.1007/s40744-021-00305-z

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title = "Upadacitinib in Patients with Psoriatic Arthritis and Inadequate Response to Biologics: 56-Week Data from the Randomized Controlled Phase 3 SELECT-PsA 2 Study",

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.TRIAL REGISTRATION: NCT03104374.",

keywords = "Janus kinase inhibitors, Psoriatic arthritis, Upadacitinib",

author = "Mease, {Philip J} and Apinya Lertratanakul and Papp, {Kim A} and {van den Bosch}, {Filip E} and Shigeyoshi Tsuji and Eva Dokoupilova and Keiserman, {Mauro W} and Xianwei Bu and Liang Chen and McCaskill, {Reva M} and Patrick Zueger and McDearmon-Blondell, {Erin L} and Pangan, {Aileen L} and William Tillett",

note = "Funding Information: Medical writing assistance was provided by John Ewbank, PhD, Frances Smith, PhD, and Russell Craddock, PhD, of 2 the Nth (Cheshire, UK), and was funded by AbbVie. Funding Information: Philip Mease has received research grants, consulting fees, and/or speaker{\textquoteright}s fees from AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squib, Celgene, Galapagos, Genentech, Gilead, GlaxoSmithKline, Janssen, Lilly, Novartis, Pfizer, Sun Pharma, and UCB. Kim Papp has served as a scientific adviser and/or clinical study investigator for AbbVie, Akros, Allergan, Almirall, Amgen, Arcutis, Avillion, Bausch Health, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Dermavant, Dermira, Eli Lilly and Company, Galderma, Genentech/Roche, GlaxoSmithKline, Janssen, Kyowa Kirin, LEO, Meiji, Merck Sharp & Dohme, Novartis, Pfizer, Regeneron, Sanofi Genzyme, Sienna Pharmaceuticals, Sun Pharma, Takeda, UCB, and Valeant; and as a paid speaker for AbbVie, Akros, Allergan, Almirall, Amgen, Bausch Health, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Dermavant, Dermira, Eli Lilly and Company, Galderma, Genentech/Roche, Janssen, Kyowa Kirin, LEO, Meiji, Merck Sharp & Dohme, Novartis, Pfizer, Regeneron, Sanofi Genzyme, Sienna Pharmaceuticals, Sun Pharma, Takeda, UCB, and Valeant. Filip van den Bosch has received speaker and/or consulting fees from AbbVie, Bristol Myers Squibb, Celgene, Eli Lilly, Galapagos, Janssen, Merck, Novartis, Pfizer, Sanofi, and UCB. Shigeyoshi Tsuji has received research grants and speaker and/or consulting fees from AbbVie, Eli Lilly, Janssen, Novartis, and UCB. Eva Dokoupilova has received research grants from AbbVie, Affibody AB, Eli Lilly, Galapagos, Gilead, GlaxoSmithKline, Hexal AG, Merck, Novartis, Pfizer, R-Pharm, Sanofi-Aventis, and UCB Biopharma SPRL. Apinya Lertratanakul, Xianwei Bu, Liang Chen, Reva M. McCaskill, Patrick Zueger, Erin L. McDearmon-Blondell, and Aileen L. Pangan are employees of AbbVie and may own stock or options. Mauro Keiserman has received research/speaker/advisory board grants/fees from AbbVie, Celgene, Lilly, Bristol, Roche, Novartis, Pfizer, Janssen, and UCB. William Tillett has received grant/research support from AbbVie, Celgene, Janssen, and Eli Lilly, has acted as a consultant for AbbVie, Amgen, Celgene, Eli Lilly, MSD, Novartis, Pfizer, and UCB, and has received speaker bureau fees from AbbVie, Amgen, Celgene, Eli Lilly, Janssen, Novartis, UCB, and Pfizer. Publisher Copyright: {\textcopyright} 2021, The Author(s).",

year = "2021",

month = jun,

day = "30",

doi = "10.1007/s40744-021-00305-z",

language = "English",

volume = "8",

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journal = "Rheumatology and therapy",

issn = "2198-6576",

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TY - JOUR

T1 - Upadacitinib in Patients with Psoriatic Arthritis and Inadequate Response to Biologics

T2 - 56-Week Data from the Randomized Controlled Phase 3 SELECT-PsA 2 Study

AU - Mease, Philip J

AU - Lertratanakul, Apinya

AU - Papp, Kim A

AU - van den Bosch, Filip E

AU - Tsuji, Shigeyoshi

AU - Dokoupilova, Eva

AU - Keiserman, Mauro W

AU - Bu, Xianwei

AU - Chen, Liang

AU - McCaskill, Reva M

AU - Zueger, Patrick

AU - McDearmon-Blondell, Erin L

AU - Pangan, Aileen L

AU - Tillett, William

N1 - Funding Information: Medical writing assistance was provided by John Ewbank, PhD, Frances Smith, PhD, and Russell Craddock, PhD, of 2 the Nth (Cheshire, UK), and was funded by AbbVie. Funding Information: Philip Mease has received research grants, consulting fees, and/or speaker’s fees from AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squib, Celgene, Galapagos, Genentech, Gilead, GlaxoSmithKline, Janssen, Lilly, Novartis, Pfizer, Sun Pharma, and UCB. Kim Papp has served as a scientific adviser and/or clinical study investigator for AbbVie, Akros, Allergan, Almirall, Amgen, Arcutis, Avillion, Bausch Health, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Dermavant, Dermira, Eli Lilly and Company, Galderma, Genentech/Roche, GlaxoSmithKline, Janssen, Kyowa Kirin, LEO, Meiji, Merck Sharp & Dohme, Novartis, Pfizer, Regeneron, Sanofi Genzyme, Sienna Pharmaceuticals, Sun Pharma, Takeda, UCB, and Valeant; and as a paid speaker for AbbVie, Akros, Allergan, Almirall, Amgen, Bausch Health, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Dermavant, Dermira, Eli Lilly and Company, Galderma, Genentech/Roche, Janssen, Kyowa Kirin, LEO, Meiji, Merck Sharp & Dohme, Novartis, Pfizer, Regeneron, Sanofi Genzyme, Sienna Pharmaceuticals, Sun Pharma, Takeda, UCB, and Valeant. Filip van den Bosch has received speaker and/or consulting fees from AbbVie, Bristol Myers Squibb, Celgene, Eli Lilly, Galapagos, Janssen, Merck, Novartis, Pfizer, Sanofi, and UCB. Shigeyoshi Tsuji has received research grants and speaker and/or consulting fees from AbbVie, Eli Lilly, Janssen, Novartis, and UCB. Eva Dokoupilova has received research grants from AbbVie, Affibody AB, Eli Lilly, Galapagos, Gilead, GlaxoSmithKline, Hexal AG, Merck, Novartis, Pfizer, R-Pharm, Sanofi-Aventis, and UCB Biopharma SPRL. Apinya Lertratanakul, Xianwei Bu, Liang Chen, Reva M. McCaskill, Patrick Zueger, Erin L. McDearmon-Blondell, and Aileen L. Pangan are employees of AbbVie and may own stock or options. Mauro Keiserman has received research/speaker/advisory board grants/fees from AbbVie, Celgene, Lilly, Bristol, Roche, Novartis, Pfizer, Janssen, and UCB. William Tillett has received grant/research support from AbbVie, Celgene, Janssen, and Eli Lilly, has acted as a consultant for AbbVie, Amgen, Celgene, Eli Lilly, MSD, Novartis, Pfizer, and UCB, and has received speaker bureau fees from AbbVie, Amgen, Celgene, Eli Lilly, Janssen, Novartis, UCB, and Pfizer. Publisher Copyright: © 2021, The Author(s).

PY - 2021/6/30

Y1 - 2021/6/30

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.TRIAL REGISTRATION: NCT03104374.

AB - 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.TRIAL REGISTRATION: NCT03104374.

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Upadacitinib in Patients with Psoriatic Arthritis and Inadequate Response to Biologics: 56-Week Data from the Randomized Controlled Phase 3 SELECT-PsA 2 Study

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