TY - JOUR
T1 - Guselkumab, an inhibitor of the IL-23p19 subunit, provides sustained improvement in signs and symptoms of active psoriatic arthritis
T2 - 1 year results of a phase III randomised study of patients who were biologic-naïve or TNFα inhibitor-experienced
AU - Ritchlin, Christopher T.
AU - Helliwell, Philip S.
AU - Boehncke, Wolf Henning
AU - Soriano, Enrique R.
AU - Hsia, Elizabeth C.
AU - Kollmeier, Alexa P.
AU - Chakravarty, Soumya D.
AU - Zazzetti, Federico
AU - Subramanian, Ramanand A.
AU - Xu, Xie L.
AU - Zuraw, Qing C.
AU - Sheng, Shihong
AU - Jiang, Yusang
AU - Agarwal, Prasheen
AU - Zhou, Bei
AU - Zhuang, Yanli
AU - Shawi, May
AU - Karyekar, Chetan S.
AU - Deodhar, Atul
N1 - Funding Information:
funded by Janssen) for substantive manuscript review, Michelle Pupek BS (Janssen employee) for programming support and Michelle L Perate MS (Janssen employee) for assistance with manuscript preparation and submission. Part of this work was previously presented at the EULAR 2020 E-Congress: McInnes IB, Rahman P, Gottlieb AB, et al. Efficacy and safety of guselkumab, a monoclonal antibody specific to the p19-subunit of interleukin-23, through week 52 of a phase 3, randomized, double-blind, placebo-controlled study conducted in biologic-naïve patients with active psoriatic arthritis. Ann Rheum Dis 2020;79 (Suppl 1):1148.
Funding Information:
Competing interests CTR has received research funding from AbbVie, Amgen and UCB; and serves as a consultant for AbbVie, Amgen, Janssen, Eli Lilly, Novartis, Pfizer and UCB. PSH has received grants and research support paid to Leeds Teaching Hospitals Charitable Foundation from AbbVie, Janssen and Novartis; and honoraria or consultation fees paid to Leeds Teaching Hospitals Charitable Foundation from AbbVie, Amgen, Pfizer, and UCB and to himself from Celgene and Galapagos. W-HB has received honoraria as a speaker or advisor from AbbVie, Almirall, Celgene, Eli Lilly, Janssen, Leo, Novartis and UCB; and he has received a research grant from Pfizer to investigate the role of JAK inhibition in psoriasis. ERS has received honoraria as speaker or advisor from AbbVie, Amgen, BMS, Celgene, Janssen, Eli Lilly, Novartis, Pfizer, Roche, Sanofi, and UCB, and received research grants from Glaxo, Novartis, Pfizer and Roche. ECH, APK, SDC, FZ, RAS, XLX, QCZ, SS, PA, BZ, YZ, MS and CSK are employed by Janssen (a subsidiary of Johnson & Johnson) and own Johnson & Johnson stock and/or stock options. YJ is a consultant funded by Janssen Research & Development. AD has received grants and research support paid to his university from AbbVie, Eli Lilly, GlaxoSmithKline, Novartis, Pfizer and UCB; and honoraria or consultation fees from AbbVie, Amgen, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly, GlaxoSmithKline, Janssen, Novartis, Pfizer and UCB.
Publisher Copyright:
© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
Copyright:
Copyright 2021 Elsevier B.V., All rights reserved.
PY - 2021/2/10
Y1 - 2021/2/10
N2 - Objective Evaluation of the efficacy and safety of guselkumab, a human monoclonal antibody targeting the interleukin-23p19 subunit, in patients with psoriatic arthritis (PsA) through 1 year. Methods Adults who met ClASsification criteria for Psoriatic ARthritis, with active disease (≥3 swollen and ≥3 tender joints; C reactive protein ≥0.3 mg/dL) despite standard treatment (31% previously received ≤2 tumour necrosis factor inhibitors (TNFi)), were randomised (1:1:1) to guselkumab 100 mg every 4 weeks (Q4W); guselkumab 100 mg at Week0, Week4, then Q8W; or placebo with cross-over to guselkumab 100 mg Q4W at Week24 (PBO→Q4W) through Week48. Clinical efficacy through Week52 (employing non-responder imputation) and adverse events (AEs) through Week60 were evaluated. Results Of 381 treated patients, 90% completed the study. Numerical increases in the proportions of patients achieving ≥20% improvement in ACR criteria (ACR20) were observed post-Week24, reaching 73% (94/128) and 60% (76/127) for Q4W-randomised and Q8W-randomised patients, respectively, by Week52. Proportions of patients achieving ACR50/ACR70/skin responses and minimal/very low disease activity were maintained, as were improvements in physical function and health-related quality of life, through Week52 in guselkumab-randomised patients. Response to guselkumab was maintained in both TNFi-naïve and TNFi-experienced patients. Serious AEs and serious infections occurred in similar proportions of guselkumab Q4W-randomised (3% and 0%) and Q8W-randomised (6% and 2%) patients through Week60, with no new safety concerns versus observations through Week24. No guselkumab-treated patient and two patients receiving placebo died; no study participant developed opportunistic infection or inflammatory bowel disease. Conclusion Guselkumab provided sustained improvement across multiple clinical manifestations of PsA, maintaining a favourable benefit-risk profile, through 1 year regardless of prior TNFi exposure.
AB - Objective Evaluation of the efficacy and safety of guselkumab, a human monoclonal antibody targeting the interleukin-23p19 subunit, in patients with psoriatic arthritis (PsA) through 1 year. Methods Adults who met ClASsification criteria for Psoriatic ARthritis, with active disease (≥3 swollen and ≥3 tender joints; C reactive protein ≥0.3 mg/dL) despite standard treatment (31% previously received ≤2 tumour necrosis factor inhibitors (TNFi)), were randomised (1:1:1) to guselkumab 100 mg every 4 weeks (Q4W); guselkumab 100 mg at Week0, Week4, then Q8W; or placebo with cross-over to guselkumab 100 mg Q4W at Week24 (PBO→Q4W) through Week48. Clinical efficacy through Week52 (employing non-responder imputation) and adverse events (AEs) through Week60 were evaluated. Results Of 381 treated patients, 90% completed the study. Numerical increases in the proportions of patients achieving ≥20% improvement in ACR criteria (ACR20) were observed post-Week24, reaching 73% (94/128) and 60% (76/127) for Q4W-randomised and Q8W-randomised patients, respectively, by Week52. Proportions of patients achieving ACR50/ACR70/skin responses and minimal/very low disease activity were maintained, as were improvements in physical function and health-related quality of life, through Week52 in guselkumab-randomised patients. Response to guselkumab was maintained in both TNFi-naïve and TNFi-experienced patients. Serious AEs and serious infections occurred in similar proportions of guselkumab Q4W-randomised (3% and 0%) and Q8W-randomised (6% and 2%) patients through Week60, with no new safety concerns versus observations through Week24. No guselkumab-treated patient and two patients receiving placebo died; no study participant developed opportunistic infection or inflammatory bowel disease. Conclusion Guselkumab provided sustained improvement across multiple clinical manifestations of PsA, maintaining a favourable benefit-risk profile, through 1 year regardless of prior TNFi exposure.
KW - arthritis
KW - biological therapy
KW - cytokines
KW - psoriatic
KW - tumor necrosis factor inhibitors
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U2 - 10.1136/rmdopen-2020-001457
DO - 10.1136/rmdopen-2020-001457
M3 - Article
C2 - 33568556
AN - SCOPUS:85101011582
VL - 7
JO - RMD Open
JF - RMD Open
SN - 2056-5933
IS - 1
M1 - 001457
ER -