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Abstract Number: 1806

Designing a Phase 3b, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Investigate the Effect of Guselkumab (TREMFYA®/sup>) Dosing Interval in Psoriatic Arthritis Patients with Inadequate Response to Tumor Necrosis Factor Inhibition

Alexis Ogdie-Beatty1, Joseph Merola2, Philip Mease3, Christopher Ritchlin4, Jose Scher5, Daphne Chan6, Soumya Chakravarty7, Wayne Langholff8, Olivia Choi9, Yevgeniy Krol9, Katelyn Rowland9 and Alice Gottlieb10, 1University of Pennsylvania, Philadelphia, PA, 2Harvard Medical School, Brigham and Women’s Hospital, Boston, MA, 3Swedish Medical Center/Providence St. Joseph Health and University of Washington, Seattle, WA, 4Division of Allergy, Immunology, and Rheumatology, School of Medicine and Dentistry, University of Rochester Medical Center, Rochester, NY, 5New York University School of Medicine, New York, NY, 6Janssen Scientific Affairs, LLC, Spring House, PA, 7Janssen Scientific Affairs, LLC and Drexel University College of Medicine, Horsham, PA, 8Janssen Research & Development, LLC, Spring House, PA, 9Janssen Scientific Affairs, LLC, Horsham, PA, 10Icahn School of Medicine at Mount Sinai, New York, NY

Meeting: ACR Convergence 2021

Keywords: Anti-TNF Drugs, Biologicals, clinical trial, Psoriatic arthritis, Spondylarthropathies

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Session Information

Date: Tuesday, November 9, 2021

Session Title: Spondyloarthritis Including PsA – Treatment Poster III: Psoriatic Arthritis II (1801–1835)

Session Type: Poster Session D

Session Time: 8:30AM-10:30AM

Background/Purpose: Tumor necrosis factor inhibitors (TNFi) are frequently chosen as the first biologic therapy for patients (pts) with PsA, though a sizeable proportion of pts have an inadequate response (IR), and some may also have intolerance. Guselkumab (GUS), a human mAb that targets the IL-23 p19 subunit, provides an alternative mechanism of action by which to treat PsA. In the Phase 3 (Ph3) DISCOVER-1 study of GUS in active PsA, GUS Q4W and Q8W clinical response rates were generally consistent between TNFi-naïve (263 pts) and TNFi-experienced (118 pts) cohorts. In the TNFi-experienced cohort and the limited number of DISCOVER-1 pts with IR to their prior TNFi (N=44), ACR 50% improvement (ACR50) and ACR70 response rates at W24 were numerically higher in GUS Q4W- than Q8W-treated pts.1 Seeking to further investigate whether GUS Q4W could provide incremental benefit to some TNFi-IR PsA pts, we analyzed the existing DISCOVER-1 dataset to facilitate the design of a new clinical trial.

Methods: Study feasibility assessments included comparison of key efficacy endpoints by treatment group at W24 among TNFi-experienced pts receiving GUS Q8W and Q4W in DISCOVER-1. Results from the DISCOVER-1 study also informed sample size power calculations for a primary endpoint of ACR20 response at W24 in a future trial in a TNFi-IR PsA pt population.

Results: Comparison of several efficacy endpoints (ACR70 response, minimal disease activity [MDA], Investigator’s Global Assessment [IGA] of psoriasis 0/1 response) across treatment group in the TNFi-experienced DISCOVER-1 cohort supports a potential dose response, with more frequent GUS administration eliciting numerically higher response rates (Table 1). A similar trend was observed for ACR20/50/70 responses in the smaller TNFi-IR population1, though these findings should be interpreted with caution due to limited sample size. ACR20 response rates at W24 of DISCOVER-1 were employed to estimate sample size requirements for a new study. Assuming comparable rates of GUS treatment effect seen in DISCOVER-1, a sample size of 150 randomized pts per group for PBO, GUS Q8W, and GUS Q4W would provide >90% power to detect a significant difference between each GUS group and PBO for ACR20 response at W24 (Table 2). Based on these findings, a new Ph3b, multicenter, randomized, double-blind, PBO-controlled study, SOLSTICE, was designed to further evaluate the efficacy and safety of GUS in approximately 450 pts with active PsA who had IR to one prior TNFi, and to investigate the effect of GUS dosing interval in this important cohort of pts with PsA (Fig).

Conclusion: PsA pts with TNFi-IR are typically difficult to treat. Overall data from the pivotal DISCOVER-1 trial of GUS in pts with active PsA showed consistent clinical response between doses and between TNFi-naïve and TNFi-experienced pts. Analyses based on limited numbers of TNFi-experienced pts from DISCOVER-1 demonstrated potential incremental benefit for achievement of higher response criteria with more frequent dosing in some TNFi-IR pts. SOLSTICE, a Ph3b, randomized, placebo-controlled trial, will test this hypothesis.

References
1. Deodhar A. Lancet. 2020;395:1115-1125

Table 1. Clinical efficacy at W24 among DISCOVER_1 TNFi-experienced pts.

Table 2. Power calculations for SOLSTICE primary endpoint (ACR20 response rate at W24).

Figure. SOLSTICE study design.


Disclosures: A. Ogdie-Beatty, AbbVie, 2, Amgen, 2, 5, BMS, 2, Celgene, 2, CorEvitas (formerly Corrona), 2, Janssen, 2, Eli Lilly, 2, Novartis, 2, Pfizer, 2, UCB, 2, National Institutes of Health/National Institute of Arthritis and Musculoskeletal and Skin Diseases, 5, Rheumatology Research Foundation, 5, National Psoriasis Foundation, 5, Pfizer (to University of Pennsylvania), 5, AbbVie (to University of Pennsylvania), 5, Novartis (to University of Pennsylvania), 5, Gilead, 2; J. Merola, AbbVie, 2, Arena, 2, Biogen, 2, Dermavant Sciences, 2, Eli Lilly, 2, Janssen, 2, Novartis, 2, Pfizer Inc, 2, Sun Pharma, 2, UCB Pharma, 2, Avotres Inc, 2, Celgene, 2, EMD Serono, 2, Regeneron, 2, Sanofi, 2, Leo Pharma, 2, Merck, 2, Bristol-Myers Squibb, 2; P. Mease, AbbVie, 2, 5, 6, Amgen, 2, 5, 6, Bristol-Myers Squibb, 2, 5, Eli Lilly, 2, 5, 6, Galapagos, 2, 5, Celgene, 2, Boehringer Ingelheim, 2, Genentech, 2, 5, 6, Janssen, 2, 5, 6, Gilead Sciences, 2, 5, 6, Novartis, 2, 5, 6, Pfizer, 2, 5, 6, Sun Pharma, 2, 5, UCB Pharma, 2, 6, GSK, 2; C. Ritchlin, UCB, 2, 5, AbbVie, 2, 5, Amgen, 2, 5, Eli Lilly, 2, Pfizer, 2, Novartis, 2, Gilead, 2, Janssen, 2; J. Scher, Janssen, 2, 5, Novartis, 2, 5, Pfizer, 2, 5, AbbVie, 2, Sanofi, 2, Kaleido, 2, UCB, 2; D. Chan, Janssen Scientific Affairs, LLC (a subsidiary of Johnson & Johnson), 3, 11; S. Chakravarty, Janssen Scientific Affairs, LLC (a subsidiary of Johnson & Johnson), 3, 11; W. Langholff, Janssen Research & Development (a subsidiary of Johnson & Johnson), 3, 11; O. Choi, Janssen Scientific Affairs, LLC (a subsidiary of Johnson & Johnson), 3, 11; Y. Krol, Janssen Scientific Affairs, LLC (a subsidiary of Johnson & Johnson), 3, 11; K. Rowland, Janssen Scientific Affairs, LLC (a subsidiary of Johnson & Johnson), 3, 11; A. Gottlieb, Boehringer Ingelheim, 1, 2, 5, Incyte, 1, 2, 5, Janssen, 1, 2, 5, Novartis, 1, 2, 5, UCB, 1, 2, 5, Xbiotech, 1, 2, 5, Bristol Myers Squibb, 1, 2, LEO Pharma, 1, 2, AnaptysBio, 1, 2, Avotres, 1, 2, Eli Lilly, 1, 2, Pfizer, 1, 2, Beiersdorf, 1, 2, Sun Pharmaceuticals, 1, 2, 5, Dermavant, 1, 2, GlaxoSmithKline, 1, 2.

To cite this abstract in AMA style:

Ogdie-Beatty A, Merola J, Mease P, Ritchlin C, Scher J, Chan D, Chakravarty S, Langholff W, Choi O, Krol Y, Rowland K, Gottlieb A. Designing a Phase 3b, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Investigate the Effect of Guselkumab (TREMFYA®/sup>) Dosing Interval in Psoriatic Arthritis Patients with Inadequate Response to Tumor Necrosis Factor Inhibition [abstract]. Arthritis Rheumatol. 2021; 73 (suppl 10). https://acrabstracts.org/abstract/designing-a-phase-3b-multicenter-randomized-double-blind-placebo-controlled-study-to-investigate-the-effect-of-guselkumab-tremfya-sup-dosing-interval-in-psoriatic-arthritis-patients-with/. Accessed May 16, 2022.
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