Journal article
Efficacy and safety of guselkumab in patients with active psoriatic arthritis who had inadequate efficacy and/or intolerance to one prior tumor necrosis factor inhibitor: study protocol for SOLSTICE, a phase 3B, multicenter, randomized, double-blind, placebo-controlled study
BMC rheumatology, v 8(1), 20
21 May 2024
PMID: 38773563
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Abstract
Background Tumor necrosis factor inhibitors (TNFi) are frequently chosen as the first biologic for patients with psoriatic arthritis (PsA). Given that many patients with PsA are TNFi inadequate responders (TNF-IR; either inadequate efficacy or intolerance), treatments utilizing alternative mechanisms of action are needed. In phase 3 studies, the fully human interleukin (IL)-23p19 subunit-inhibitor, guselkumab, was efficacious in patients with active PsA, including TNFi-IR. Efficacy was generally consistent between TNFi-naive and TNFi-experienced cohorts; however, in the latter, higher response rates have been observed with the Q4W dosing regimen relative to the Q8W dosing regimen for some endpoints, suggesting the need to evaluate whether more frequent dosing may provide an incremental clinical benefit for TNFi-IR patients.
Methods The phase 3b SOLSTICE study will assess guselkumab efficacy and safety in TNFi-IR PsA patients. Eligibility criteria include a PsA diagnosis for >= 6 months; active disease (>= 3 swollen, >= 3 tender joints, C-reactive protein >= 0.3 mg/dL); and inadequate efficacy with, and/or intolerance to, one prior TNFi. Participants will be randomized 1:1:1 to guselkumab Q4W or Q8W or placebo -> guselkumab Q4W (at Week 24). The primary endpoint is the proportion of patients achieving >= 20% improvement in the American College of Rheumatology criteria (ACR20) at Week 24. Major secondary endpoints include ACR50, ACR70; an Investigator's Global Assessment (IGA) of psoriasis score of 0/1 plus >= 2-grade reduction and >= 90% improvement in Psoriasis Area and Severity Index (both among patients with >= 3% body surface area affected by psoriasis and baseline IGA >= 2); minimal/very low disease activity; and changes from baseline in Health Assessment Questionnaire-Disability Index, the 36-item Short-Form Health Survey Physical Component Summary, and Functional Assessment of Chronic Illness Therapy-Fatigue scores. The target sample size (N = 450) is estimated to provide > 90% power in detecting differences between each guselkumab group and the placebo group for the primary endpoint assuming a 2-sided alpha = 0.05. Cochran-Mantel-Haenszel testing and analyses of covariance will be used to compare efficacy for binary and continuous endpoints, respectively.
Discussion Findings from the phase 3b SOLSTICE study, the design of which was informed by results from previously conducted phase 3 studies, is expected to provide important efficacy and safety information on guselkumab therapy in TNFi-IR patients with PsA.
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Details
- Title
- Efficacy and safety of guselkumab in patients with active psoriatic arthritis who had inadequate efficacy and/or intolerance to one prior tumor necrosis factor inhibitor: study protocol for SOLSTICE, a phase 3B, multicenter, randomized, double-blind, placebo-controlled study
- Creators
- Alexis Ogdie - University of PennsylvaniaJoseph F. Merola - Brigham and Women's HospitalPhilip J. Mease - University of WashingtonChristopher T. Ritchlin - University of Rochester Medical CenterJose U. Scher - New York UniversityKimberly Parnell Lafferty - Johnson & JohnsonDaphne Chan - Johnson & JohnsonSoumya D. Chakravarty - Drexel UniversityWayne Langholff - JanssenYanli Wang - JanssenOlivia Choi - JanssenYevgeniy Krol - Johnson & JohnsonAlice B. Gottlieb - Icahn School of Medicine at Mount Sinai
- Publication Details
- BMC rheumatology, v 8(1), 20
- Publisher
- Springer Nature
- Number of pages
- 12
- Grant note
- 175: 1298-1304 / Janssen Research and Development Janssen Scientific Affairs, LLC
- Resource Type
- Journal article
- Language
- English
- Academic Unit
- Rheumatology; General Internal Medicine
- Web of Science ID
- WOS:001228903900001
- Scopus ID
- 2-s2.0-85200608433
- Other Identifier
- 991021930450904721
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- Collaboration types
- Industry collaboration
- Domestic collaboration
- Web of Science research areas
- Rheumatology