Strober, Bruce http://orcid.org/0000-0002-8394-2057
Coates, Laura C. http://orcid.org/0000-0002-4756-663X
Lebwohl, Mark G.
Deodhar, Atul http://orcid.org/0000-0002-4195-8616
Leibowitz, Evan http://orcid.org/0000-0002-0041-6984
Rowland, Katelyn
Kollmeier, Alexa P. http://orcid.org/0000-0002-2059-7866
Miller, Megan http://orcid.org/0000-0002-8676-6706
Wang, Yanli
Li, Shu
Chakravarty, Soumya D. http://orcid.org/0000-0001-7957-838X
Chan, Daphne
Shawi, May http://orcid.org/0000-0001-6005-3938
Yang, Ya-Wen
Thaҫi, Diamant http://orcid.org/0000-0002-2706-7171
Rahman, Proton http://orcid.org/0000-0002-4521-2029
Clinical trials referenced in this document:
Documents that mention this clinical trial
Guselkumab induces robust reduction in acute phase proteins and type 17 effector cytokines in active psoriatic arthritis: results from phase 3 trials
https://doi.org/10.1136/rmdopen-2021-001679
Sustained and improved guselkumab response in patients with active psoriatic arthritis regardless of baseline demographic and disease characteristics: pooled results through week 52 of two phase III, randomised, placebo-controlled studies
https://doi.org/10.1136/rmdopen-2022-002195
Incidence of infections in patients with psoriatic arthritis and axial spondyloarthritis treated with biological or targeted disease-modifying agents: a systematic review and meta-analysis of randomised controlled trials, open-label studies and observational studies
https://doi.org/10.1136/rmdopen-2023-003064
Work Productivity and General Health Through 2 Years of Guselkumab Treatment in a Phase 3 Randomized Trial of Patients With Active Psoriatic Arthritis
https://doi.org/10.1007/s40744-024-00642-9
Long-Term Safety of Guselkumab in Patients with Psoriatic Disease: An Integrated Analysis of Eleven Phase II/III Clinical Studies in Psoriasis and Psoriatic Arthritis
https://doi.org/10.1007/s40264-023-01361-w
The Effect of Guselkumab on General Health State in Biologic-Naïve Patients with Active Psoriatic Arthritis Through Week 52 of the Phase 3, Randomized, Placebo-Controlled DISCOVER-2 Trial
https://doi.org/10.1007/s12325-022-02269-0
Efficacy of Guselkumab on Axial-Related Symptoms Through up to 2 Years in Adults with Active Psoriatic Arthritis in the Phase 3, Randomized, Placebo-Controlled DISCOVER-2 Study
https://doi.org/10.1007/s40744-023-00592-8
Collagen Turnover Biomarkers Associate with Active Psoriatic Arthritis and Decrease with Guselkumab Treatment in a Phase 3 Clinical Trial (DISCOVER-2)
https://doi.org/10.1007/s40744-022-00444-x
Identification of PsA phenotypes with machine learning analytics using data from two phase III clinical trials of guselkumab in a bio-naïve population of patients with PsA
https://doi.org/10.1136/rmdopen-2022-002934
Low rates of radiographic progression associated with clinical efficacy following up to 2 years of treatment with guselkumab: results from a phase 3, randomised, double-blind, placebo-controlled study of biologic-naïve patients with active psoriatic arthritis
https://doi.org/10.1136/rmdopen-2022-002789
Guselkumab provides durable improvement across psoriatic arthritis disease domains: post hoc analysis of a phase 3, randomised, double-blind, placebo-controlled study
https://doi.org/10.1136/rmdopen-2023-003977
Funding for this research was provided by:
Janssen Research and Development
Janssen Pharmaceuticals
Article History
Accepted: 4 October 2023
First Online: 31 October 2023
Declarations
:
: These studies were funded by Janssen Research & Development, LLC, and Janssen Pharmaceutical, Tokyo, Japan.
: Bruce Strober has served as a consultant (honoraria) and/or speaker and/or investigator for AbbVie, Almirall, Amgen, Arcutis, Arena, Aristea, Asana, Boehringer Ingelheim, Bristol Myers Squibb, Cara, Connect Biopharma, CorEvitas Psoriasis Registry, Dermavant, Dermira, Eli Lilly, EPI Health, Evelo Biosciences, Immunic Therapeutics, Incyte, Janssen, LEO Pharma, Maruho, Meiji Seika Pharma, Mindera Health, Novartis, Ono, Pfizer, Regeneron, Sanofi-Genzyme, Sun Pharma, UCB Pharma, Union Therapeutics, Ventyxbio, and vTv Therapeutics; and served as Co-Scientific Director (consulting fee) of CorEvitas (formerly Corrona) Psoriasis Registry and Editor-in-Chief (honorarium) of the Journal of Psoriasis and Psoriatic Arthritis. Laura C. Coates has received grants/research support from AbbVie, Amgen, Celgene, Eli Lilly, Janssen, Novartis, Pfizer and UCB; worked as a paid consultant for AbbVie, Amgen, Bristol Myers Squibb, Celgene, Eli Lilly, Gilead, Galapagos, Janssen, MoonLake, Novartis, Pfizer, and UCB; and has been paid as a speaker for AbbVie, Amgen, Biogen, Celgene, Eli Lilly, Galapagos, Gilead, GlaxoSmithKline, Janssen, Medac, Novartis, Pfizer, and UCB. Dr. Coates is supported by the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (BRC). The views expressed are those of the author(s) and are not necessarily those of the NHS, the NIHR, or the Department of Health. Mark G. Lebwohl is an employee of Mount Sinai and receives research funds from AbbVie, Amgen, Arcutis, Avotres, Boehringer Ingelheim, Cara Therapeutics, Dermavant Sciences, Eli Lilly, Incyte, Inozyme, Janssen Research & Development, LLC, Ortho Dermatologics, Pfizer, Sanofi-Regeneron, and UCB, Inc., and is a consultant for Almirall, AltruBio Inc., AnaptysBio, Apogee, Arcutis, Inc., AstraZeneca, Atomwise, Avotres Therapeutics, Brickell Biotech, Boehringer Ingelheim, Bristol Myers Squibb, Castle Biosciences, Celltrion, CorEvitas, Dermavant Sciences, EPI, Evommune, Inc., Facilitation of International Dermatology Education, Forte Biosciences, Foundation for Research and Education in Dermatology, Galderma, Genentech, Incyte, LEO Pharma, Meiji Seika Pharma, Mindera, Pfizer, Sanofi-Regeneron, Seanergy, Strata, Takeda, Trevi, and Verrica. Atul Deodhar has received consulting fees for participation in advisory boards from AbbVie, Amgen, Aurinia, Bristol Myers Squibb, Celgene, Eli Lilly, GlaxoSmithKline, Janssen, MoonLake, Novartis, Pfizer, and UCB; research grant funding from AbbVie, Eli Lilly, GlaxoSmithKline, Novartis, Pfizer, and UCB; and speaker fees from AbbVie, Eli Lilly, Janssen, Novartis, Pfizer, and UCB. Evan Leibowitz, Katelyn Rowland, Soumya D. Chakravarty, and Daphne Chan are employees of Janssen Scientific Affairs, LLC (a subsidiary of Johnson & Johnson); employees may own Johnson & Johnson stock/stock options. Alexa P. Kollmeier, Megan Miller, Yanli Wang, Shu Li, and May Shawi are employees of Janssen Research & Development, LLC (a subsidiary of Johnson & Johnson); employees may own Johnson & Johnson stock/stock options. Ya-Wen Yang is an employee of Janssen Pharmaceutical Companies of Johnson & Johnson; employees may own Johnson & Johnson stock/stock options. Diamant Thaҫi has received honoraria for participation on advisory boards, as a speaker, and for consultancy from AbbVie, Almirall, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, Galapagos, Galderma, Janssen, Kyowa Hakko Kirin, La Roche-Posay, LEO Pharma, Merck Sharp & Dohme, Morphosys, New Bridge, Novartis, Pfizer, Regeneron Pharmaceuticals, Sandoz-Hexal, Sanofi, Sun Pharma, and UCB, and has received research grants from LEO Pharma and Novartis. Proton Rahman discloses consulting fees from AbbVie, Amgen, Bristol Myers Squibb, Celgene, Eli Lilly, Janssen, Merck, Novartis, Pfizer, and UCB; travel support from Janssen; and grant/research support from Janssen and Novartis.
: All studies were conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with Good Clinical Practice. For all studies, the protocol was approved by an Institutional Review Board (IRB) or independent Ethics Committee at each site. Sterling IRB was a central US IRB for several studies (VOYAGE 1, 4809C; VOYAGE 2, 4810C; NAVIGATE, 4808C; ORION, 5600C; ECLIPSE, 5789C; DISCOVER-1, 5959C; DISCOVER-2, 5910C). A full listing of IRBs and Ethics Committees for all studies is provided in Online Resource Table 3. Additional details are available upon request.
: All participants provided written informed consent to participate.
: All participants provided consent acknowledging that the results of the studies may be published in a medical book or journal, or presented at meetings for educational purposes.
: The data sharing policy of Janssen Pharmaceutical Companies of Johnson & Johnson is available at ExternalRef removed. As noted on this site, requests for access to the study data can be submitted through the Yale Open Data Access Project site at ExternalRef removed.
: Not applicable.
: All authors were involved in drafting the article or revising it critically for important intellectual content, and approved the final version to be published. All authors contributed to study conception and design. BS, LCC, MGL, AD, DT, and PR contributed to the acquisition of data, and all authors contributed to the analysis and interpretation of data.