Improvements in Patient-Reported Outcomes Through Six Months of Guselkumab Treatment in Patients With Active Psoriatic Arthritis: Real-World Data From the CorEvitas Psoriatic Arthritis/Spondyloarthritis Registry

Philip J Mease; Alexis Ogdie; John Tesser; Natalie J Shiff; Ruizhi Sophia Zhao; Soumya D Chakravarty; Michael Kelleman; Rhiannon Dodge; Robert R McLean; Aaron Broadwell; Arthur Kavanaugh; Joseph F Merola

doi:10.1002/acr2.11657

Improvements in Patient-Reported Outcomes Through Six Months of Guselkumab Treatment in Patients With Active Psoriatic Arthritis: Real-World Data From the CorEvitas Psoriatic Arthritis/Spondyloarthritis Registry

ACR Open Rheumatol. 2024 May;6(5):304-311. doi: 10.1002/acr2.11657. Epub 2024 Feb 28.

Authors

Affiliations

¹ Rheumatology Research, Providence Swedish Medical Center and University of Washington School of Medicine, Seattle, Washington.
² University of Pennsylvania, Philadelphia, Pennsylvania.
³ Arizona Arthritis & Rheumatology Associates, P.C., Phoenix, Arizona.
⁴ Janssen Scientific Affairs, LLC, Horsham, Pennsylvania, and University of Saskatchewan, Saskatoon, Saskatchewan, Canada.
⁵ Janssen Scientific Affairs, LLC, Horsham, Pennsylvania.
⁶ Janssen Scientific Affairs, LLC, Horsham, and Drexel University, Philadelphia, Pennsylvania.
⁷ CorEvitas, LLC, Waltham, Massachusetts.
⁸ Rheumatology and Osteoporosis Specialists, Shreveport, Louisiana.
⁹ University of California San Diego, La Jolla, California.
¹⁰ Department of Dermatology and Department of Medicine, Division of Rheumatology, UT Southwestern Medical Center, Dallas, Texas.
¹¹ Brigham and Women's Hospital, Division of Rheumatology and Immunology, Harvard Medical School, Boston, Massachusetts.

PMID: 38417434
DOI: 10.1002/acr2.11657

Abstract

Objective: Evaluate patient-reported outcomes after 6 months of on-label guselkumab use in patients with rheumatologist-diagnosed active psoriatic arthritis (PsA) enrolled in the CorEvitas PsA/Spondyloarthritis Registry.

Methods: This analysis includes registry participants who initiated and persisted with on-label guselkumab (after US Food and Drug Administration approval for PsA; 100 mg at weeks 0, 4, and every 8 weeks) at their 6-month follow-up visit (On-Label Persisters). Among patients not meeting response criteria at baseline, responses at 6 months were determined for patient-reported outcomes, including patient-reported pain (0-100 mm visual analog scale), patient global assessment of arthritis + psoriasis (PtGA; 0-100 visual analog scale), and Health Assessment Questionnaire-Disability Index (HAQ-DI; 0-3). Unadjusted, nominal P values were calculated via single-proportion, one-sided test (H₀ = 0%; α = 0.05).

Results: Of 90 On-Label Persisters, most had treatment-resistant PsA (92.2% and 73.3% previously received ≥1 and ≥2 biologic/targeted synthetic disease-modifying antirheumatic drugs, respectively), with mean (SD) baseline patient-reported pain, PtGA, and HAQ-DI scores of 57.0 (24.6), 50.3 (24.4), and 0.9 (0.6), respectively. Among those with patient-reported pain and PtGA scores of at least 15 at baseline, 40.2% (33/82) and 46.8% (36/77), respectively, achieved at least 15-mm reductions at 6 months; among those with HAQ-DI scores of at least 0.35 and more than 0.5 at baseline, respectively, 30.4% (21/69) achieved improvements of at least 0.35 and 10.3% (6/58) achieved scores of 0.5 or lower at 6 months (all nominal P < 0.001).

Conclusion: Pain and physical function are important contributors to health-related quality of life. In this real-world population of patients with treatment-resistant PsA and 6 months of persistent guselkumab treatment, clinically meaningful improvements in pain and physical function were achieved by approximately 40% and 30% of patients, respectively.

Abstract

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