PMID- 33568556 OWN - NLM STAT- MEDLINE DCOM- 20210831 LR - 20210831 IS - 2056-5933 (Electronic) IS - 2056-5933 (Linking) VI - 7 IP - 1 DP - 2021 Feb TI - Guselkumab, an inhibitor of the IL-23p19 subunit, provides sustained improvement in signs and symptoms of active psoriatic arthritis: 1 year results of a phase III randomised study of patients who were biologic-naive or TNFalpha inhibitor-experienced. LID - 10.1136/rmdopen-2020-001457 [doi] LID - e001457 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 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-naive 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. CI - (c) 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. FAU - Ritchlin, Christopher T AU - Ritchlin CT AUID- ORCID: 0000-0002-2602-1219 AD - Rheumatology, University of Rochester Medical Center, Rochester, New York, USA Christopher_Ritchlin@URMC.Rochester.edu. FAU - Helliwell, Philip S AU - Helliwell PS AUID- ORCID: 0000-0002-4155-9105 AD - Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, West Yorkshire, UK. FAU - Boehncke, Wolf-Henning AU - Boehncke WH AD - Dermatology, University of Geneva Hospitals, Geneva, Switzerland. FAU - Soriano, Enrique R AU - Soriano ER AUID- ORCID: 0000-0003-3143-1084 AD - Rheumatology Unit, Hospital Italiano de Buenos Aires, Buenos Aires, Federal District, Argentina. FAU - Hsia, Elizabeth C AU - Hsia EC AD - Immunology, Janssen Research & Development LLC, Spring House, Pennsylvania, USA. AD - Rheumatology, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, USA. FAU - Kollmeier, Alexa P AU - Kollmeier AP AD - Immunology, Janssen Research & Development LLC, San Diego, California, USA. FAU - Chakravarty, Soumya D AU - Chakravarty SD AUID- ORCID: 0000-0001-7957-838X AD - Rheumatology, Drexel University College of Medicine, Philadelphia, Pennsylvania, USA. AD - Immunology Medical Affairs, Janssen Scientific Affairs LLC, Horsham, Pennsylvania, USA. FAU - Zazzetti, Federico AU - Zazzetti F AD - Immunology Medical Affairs, Janssen Latin America LLC, Buenos Aires, Argentina. FAU - Subramanian, Ramanand A AU - Subramanian RA AD - Immunology, Janssen Research & Development LLC, Spring House, Pennsylvania, USA. FAU - Xu, Xie L AU - Xu XL AD - Immunology, Janssen Research & Development LLC, San Diego, California, USA. FAU - Zuraw, Qing C AU - Zuraw QC AD - Immunology, Janssen Research & Development LLC, Spring House, Pennsylvania, USA. FAU - Sheng, Shihong AU - Sheng S AD - Biostatistics, Janssen Research & Development LLC, Spring House, Pennsylvania, USA. FAU - Jiang, Yusang AU - Jiang Y AD - Biostatistics, Cytel Inc on behalf of Janssen Research & Development LLC, Spring House, Pennsylvania, USA. FAU - Agarwal, Prasheen AU - Agarwal P AD - Biostatistics, Janssen Research & Development LLC, Spring House, Pennsylvania, USA. FAU - Zhou, Bei AU - Zhou B AD - Biostatistics, Janssen Research & Development LLC, Spring House, Pennsylvania, USA. FAU - Zhuang, Yanli AU - Zhuang Y AD - Biologics Clinical Pharmacology, Janssen Research & Development LLC, Spring House, Pennsylvania, USA. FAU - Shawi, May AU - Shawi M AD - Immunology Medical Affairs, Janssen Global Services LLC, Horsham, PA, USA. FAU - Karyekar, Chetan S AU - Karyekar CS AD - Immunology, Janssen Research & Development LLC, Spring House, Pennsylvania, USA. FAU - Deodhar, Atul AU - Deodhar A AD - Division of Arthritis and Rheumatic Diseases, Oregon Health & Science University, Portland, Oregon, USA. LA - eng PT - Clinical Trial, Phase III PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't PL - England TA - RMD Open JT - RMD open JID - 101662038 RN - 0 (Antibodies, Monoclonal, Humanized) RN - 0 (Antirheumatic Agents) RN - 0 (Biological Products) RN - 0 (Interleukin-23 Subunit p19) RN - 089658A12D (guselkumab) SB - IM MH - Adult MH - Antibodies, Monoclonal, Humanized MH - *Antirheumatic Agents/adverse effects MH - *Arthritis, Psoriatic/drug therapy MH - *Biological Products/therapeutic use MH - Humans MH - Interleukin-23 Subunit p19 MH - Quality of Life PMC - PMC7880108 OTO - NOTNLM OT - arthritis OT - biological therapy OT - cytokines OT - psoriatic OT - tumor necrosis factor inhibitors COIS- 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. EDAT- 2021/02/12 06:00 MHDA- 2021/09/01 06:00 PMCR- 2021/02/10 CRDT- 2021/02/11 05:45 PHST- 2020/09/29 00:00 [received] PHST- 2020/11/24 00:00 [revised] PHST- 2020/12/03 00:00 [accepted] PHST- 2021/02/11 05:45 [entrez] PHST- 2021/02/12 06:00 [pubmed] PHST- 2021/09/01 06:00 [medline] PHST- 2021/02/10 00:00 [pmc-release] AID - rmdopen-2020-001457 [pii] AID - 10.1136/rmdopen-2020-001457 [doi] PST - ppublish SO - RMD Open. 2021 Feb;7(1):e001457. doi: 10.1136/rmdopen-2020-001457.