Meaningful Improvement in General Health Outcomes with Guselkumab Treatment for Psoriatic Arthritis: Patient-Reported Outcomes Measurement Information System-29 Results from a Phase 3 Study

Ana Maria Orbai, Laura C. Coates, Atul Deodhar, Philip S. Helliwell, Christopher T. Ritchlin, Evan Leibowitz, Alexa P. Kollmeier, Elizabeth C. Hsia, Xie L. Xu, Shihong Sheng, Yusang Jiang, Yan Liu, Chenglong Han

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Abstract

Objective: The Phase 3 DISCOVER-1 study of guselkumab is the first randomized controlled trial to use Patient-Reported Outcomes Measurement Information System (PROMIS) measures to assess the effects of treatment on general health outcomes in patients with psoriatic arthritis (PsA). Methods: Patients (N = 381) with active PsA were randomized 1:1:1 to guselkumab 100 mg every 4 weeks (Q4W); guselkumab 100 mg at Week 0, Week 4, then every 8 weeks (Q8W); or placebo with Week 24 crossover to guselkumab Q4W. The PROMIS-29 Profile contains four items for each of seven domains (anxiety, depression, fatigue, pain interference, physical function, sleep disturbance, and social participation) and one pain-intensity item. Raw domain scores are converted to standardized T-scores, with norms based on a US general population mean of 50 (1 standard deviation (SD) = 10). T-score changes of ≥ 5 are considered clinically meaningful. Least-squares mean PROMIS-29 T-score changes from baseline to Week 24 and Week 52 were summarized for the guselkumab and placebo groups; nominal p-values comparing results between guselkumab and placebo were calculated at Week 24 using a mixed model for repeated measures. The proportions of patients who achieved clinically meaningful improvement in PROMIS-29 T-scores were also summarized at Week 24 and Week 52; nominal p-values comparing results between guselkumab and placebo were calculated at Week 24 using the Cochran-Mantel-Haenszel test. Results: In the DISCOVER-1 patient population, mean PROMIS-29 T-scores at baseline were ~ 1 SD worse for physical function and pain interference and were numerically worse for social participation, fatigue, and sleep disturbance compared with the US general population. At Week 24, mean PROMIS-29 T-scores improved in guselkumab-treated patients, approaching US population norms; T-scores continued to improve through Week 52. Significantly higher proportions of patients in both guselkumab treatment arms (31–52% across domains) had clinically meaningful improvements in pain interference, fatigue, physical function, sleep, and social participation at Week 24 versus placebo (all nominal p ≤ 0.05). Conclusion: In patients with active PsA, guselkumab treatment provided clinically meaningful reductions in fatigue and pain and improvement in physical function and social participation, as measured by the PROMIS-29 Profile. These improvements were maintained through 1 year. ClinicalTrials.gov: Registration number, NCT03162796; Submission date 19 May 2017.

Original languageEnglish (US)
JournalPatient
DOIs
StateAccepted/In press - 2022

ASJC Scopus subject areas

  • Nursing (miscellaneous)

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