1412: Improvements in Patient-Reported Outcomes Through 6 Months of Guselkumab Treatment in Patients with Active Psoriatic Arthritis: Real-World Data from the CorEvitas Psoriatic Arthritis/Spondyloarthritis (PsA/SpA) Registry

Philip J. Mease¹, Alexis R Ogdie², John Tesser³, Natalie shiff⁴, Iris Lin⁵, Soumya Chakravarty⁶, Mike Kelleman⁷, Rhiannon Dodge⁷, Robert McLean⁷, Aaron Broadwell⁸, Arthur Kavanaugh⁹ and Joseph F. Merola¹⁰, ¹Swedish Medical Center/Providence St. Joseph Health and University of Washington School of Medicine, Seattle, WA, ²University of Pennsylvania, Philadelphia, PA, ³Arizona Arthritis & Rheumatology Associates, Phoenix, AZ, ⁴Immunology, Janssen Scientific Affairs, LLC / Adjunct, Community Health and Epidemiology, University of Saskatchewan, Horsham, PA, ⁵Janssen, Horsham, PA, ⁶Immunology, Janssen Scientific Affairs, LLC / Division of Rheumatology, Drexel University College of Medicine, Villanova, PA, ⁷CorEvitas, LLC, Waltham, MA, ⁸Department of Rheumatology, Rheumatology and Osteoporosis Specialists, Shreveport, LA, ⁹Division of Rheumatology, Allergy, and Immunology, University of California San Diego, La Jolla, CA, ¹⁰Brigham and Women's Hospital and Harvard Medical School, Boston, MA

Background/Purpose: Guselkumab (GUS) has demonstrated significant efficacy across disease domains in controlled clinical trials of patients (pts) with active PsA.^1,2 Recent CorEvitas PsA/SpA Registry analyses confirmed real-world GUS effectiveness, showing that pts with persistent on-label GUS use at 6 months had significant mean improvements from baseline (BL) in peripheral joint and skin symptoms and pt-reported pain.³ Here we report secondary findings from the CorEvitas PsA/SpA Registry further assessing changes in pt-reported outcomes (PROs) among pts with persistent GUS use from BL through the 6-month visit (On-Label GUS Persisters).

Methods: This analysis includes registry pts who initiated on-label GUS after FDA approval for active PsA (7/13/2020; 100 mg SC at Weeks 0 & 4 then Q8W) and were On-Label Persisters. Demographics, PsA disease activity, PROs, and medication history at GUS initiation (BL visit) were summarized descriptively. Among On-Label GUS Persisters not meeting response criteria at BL, response rates at 6 months were determined for established outcomes related to improvements or achievement of low levels of disease activity in pt-reported pain (0-100 mm visual analog scale [VAS]), pt global assessment of arthritis + psoriasis (PtGA; 0-100 mm VAS), and HAQ-DI (0-3). Unadjusted, nominal p-values were calculated using a single-proportion, one-sided test to determine if response at the 6-month visit differed from 0% at BL. Mean (95% CI) change from BL to 6 months was determined for fatigue (0-100 mm VAS); nominal p-value calculated using a paired t-test at α=0.05.

Results: Among 114 on-label GUS initiators with a 6-month follow-up visit, 90 (79%) had persistent on-label GUS use. On average, pts had longstanding, treatment-resistant, active PsA (Table 1). BL pt-reported pain, HAQ-DI, and fatigue scores were 57.0, 0.9, and 56.5, respectively. Substantial proportions of On-Label GUS Persisters experienced clinically meaningful improvements in pain (38% with ≥30% reduction and 40% with ≥15-mm reduction), overall joint and skin disease (47% with ≥15-mm reduction in PtGA), and physical function (30% with HAQ-DI improvement ≥0.35; all nominal p< 0.001; Figure 1). Further, up to one quarter of pts achieved the more stringent thresholds of response, generally representing a major response or minimal disease activity, including 22% with ≥50% reduction in pain, 18% with pain score ≤15 mm, 26% with PtGA score ≤20 mm, and 10% with HAQ-DI ≤0.5 (all nominal p< 0.001; Figure 2). Mean change (95% CI) in fatigue from BL at 6 months was -8.8 (-14.9, -2.7; nominal p=0.005).

Conclusion: In this real-world population of pts with treatment-resistant active PsA and persistent on-label GUS use, consistent with prior results for physician-reported endpoints of joint and skin disease, pts reported meaningful improvements in pain, physical function, and fatigue. These represent difficult-to-treat domains that are important contributors to pts' health-related quality of life.

References:

¹Deodhar. Lancet 2020;395:1115-25
²Mease. Lancet 2020;395:1126-36
³Mease. 6-M Persistence and Multi-Domain Effectiveness of GUS in Adults with PsA: RW Data from the CorEvitas Registry [abstr]. Maui Derm; June 21-24, 2023; Colorado Springs, CO








P. Mease: AbbVie, 2, 5, 6, Acelyrin, 2, Aclaris, 2, Amgen, 2, 5, 6, Boehringer Ingelheim, 2, Bristol Myers Squibb, 2, 5, Eli Lilly, 2, 5, 6, Galapagos, 2, Gilead, 2, GlaxoSmithKline, 2, Inmagene, 2, Janssen, 2, 5, 6, MoonLake Pharma, 2, Novartis, 2, 5, 6, Pfizer, 2, 5, 6, Sun Pharma, 2, 5, UCB Pharma, 2, 5, 6, Ventyx, 2, Xinthera, 2; A. Ogdie: AbbVie/Abbott, 2, 5, Amgen, 2, 5, Bristol-Myers Squibb(BMS), 2, Celgene, 2, CorEvitas, 2, Eli Lilly, 2, Gilead, 2, GSK, 2, Janssen, 2, 5, Novartis, 2, 5, Pfizer, 2, 5, Takeda, 2, UCB, 2; J. Tesser: AbbVie, 2, 5, 6, Alpine, 5, Amgen, 2, 5, 6, Anthrosi Therapeutics, 5, AstraZeneca, 2, 6, Aurinia, 2, 6, Bendcare, 5, Biogen, 5, Boehringer Ingelheim, 2, 5, Bristol-Myers Squibb (BMS), 2, 5, 6, Celgene, 5, Corevitas, 5, CSL Behring, 5, DRL, 5, Eli Lilly, 2, 5, 6, Emerald, 5, Exagen, 5, Genentech, 5, 6, Gilead, 5, GlaxoSmithKlein (GSK), 2, 6, Global Health Living Foundation, 5, Horizon, 5, Janssen, 2, 5, 6, Kolon TissueGene, 5, Mitsubishi, 5, Nēsos, 5, Novartis, 2, Organogenesis, 5, Pfizer, 2, 5, 6, Sanofi-Genzyme, 2, 6, Sanumen/Biosplice, 2, 5, Selecta, 5, Setpoint, 5, Sun Pharma, 5, Takeda, 5, UCB, 2; N. shiff: AbbVie, 11, Gilead, 11, Iovance, 11, Janssen Scientific Affairs, LLC, 3, Johnson & Johnson, 11, Novo-Nordisc, 11, Pfizer, 11; I. Lin: Janssen, 3, Johnson & Johnson, 11; S. Chakravarty: Janssen Scientific Affairs, 3, Johnson & Johnson, 11; M. Kelleman: CorEvitas, LLC, 3; R. Dodge: CorEvitas, LLC, 3; R. McLean: CorEvitas, LLC, 3, 11; A. Broadwell: AbbVie/Abbott, 2, 6, Amgen, 2, 6, Aurinia, 2, Celgene, 2, Eli Lilly, 2, 6, Horizon, 6, Janssen, 2, 6, Mallinckrodt, 6, Novartis, 2, 6, Pfizer, 2, 6, Radius, 6, Sandoz, 2, Sanofi/Regeneron, 6, UCB, 6; A. Kavanaugh: Amgen, 2, BMS, 2, Eli Lilly, 2, Novartis, 2, Pfizer, 2, UCB, 2; J. Merola: AbbVie, 12, Consultant and/or investigator, Amgen, 2, Biogen, 12, Consultant and/or investigator, Bristol Myers Squibb, 2, Dermavant, 12, Consultant and/or investigator, Eli Lilly, 12, Consultant and/or investigator, Janssen, 12, Consultant and/or investigator, LEO Pharma, 12, Consultant and/or investigator, Novartis, 12, Consultant and/or investigator, Pfizer, 12, Consultant and/or investigator, Regeneron, 12, Consultant and/or investigator, Sanofi, 12, Consultant and/or investigator, Sun Pharmaceuticals, 12, Consultant and/or investigator, UCB Pharma, 12, Consultant and/or investigator.