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

Author:

Mease Philip J.1ORCID,Ogdie Alexis2,Tesser John3,Shiff Natalie J.4,Zhao Ruizhi Sophia5,Chakravarty Soumya D.6ORCID,Kelleman Michael7,Dodge Rhiannon7,McLean Robert R.7,Broadwell Aaron8,Kavanaugh Arthur9,Merola Joseph F.1011

Affiliation:

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

Abstract

ObjectiveEvaluate 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.MethodsThis 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).ResultsOf 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).ConclusionPain 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.

Funder

Janssen Scientific Affairs

Publisher

Wiley

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