Patients with active psoriatic arthritis (PsA) who had an early response to guselkumab reported a more significant, long-term improvement in health-related quality of life (HR-QoL) at week 100 compared with those who did not achieve an early response response or were receiving a placebo, according to data presented at the American College of Rheumatology Convergence 2022. The drug is the first fully human selective interleukin-23 (IL-23) inhibitor approved in the United States for PsA and moderate-to-severe plaque psoriasis (PsO ). Improvements in fatigue were seen as early as week 8, and approximately one-third of patients were able to maintain normative levels by week 100.
“Patients with active psoriatic arthritis may have difficulty engaging in daily tasks as a result of health-related quality of life symptoms often associated with the disease,” Philip Meese, MD, rheumatologist and director of rheumatology research at Swedish Medical Center/ Providence- St. Joseph Health Explained. “In these analyses, we see that achieving early clinical strides in various symptom domains can demonstrate future gains in health-related quality of life and improvement in fatigue, highlighting the important role this therapy plays in managing multiple and complex symptoms.” of active psoriatic arthritis.”
DISCOVER-2 is a phase 3, randomized, double-blind, multicenter trial evaluating the safety and efficacy of subcutaneous guselkumab treatment in biologic-naïve patients with active PsA. The study analyzed 739 participants treated with the drug for approximately 2 years. This included a screening phase, a blinded treatment phase that included a placebo-controlled arm from baseline to week 24, and a blinded active treatment period from week 24 to week 100. The safety follow-up period continued until week 112.
A post-hoc analysis of the phase 3 DISCOVER-2 trial reported that early clinical improvements in patients with active PsA receiving guselkumab were associated with significant improvements in general and physical HR-QoL from week 52 to week 100, including joint and skin disease , dactylitis and enthesitis, compared to placebo. Early non-responders also showed benefits in long-term HRQoL compared with the placebo group.
Early improvement was defined as ≥ 20% improvement in swollen joint count (SJC), tender joint count (TJC), Health Assessment Questionnaire-Disability Index (HAQ-DI), Patient Visual Analogue Pain Scale (VAS ) and the patient’s skin VAS. Other indicators were reductions in the Leeds Enthesitis Index (LEI) or Dactylitis Severity Score (DSS) and a clinically meaningful improvement in the composite score of clinical disease activity in PsA (cDAPSA).
Another post-hoc analysis revealed that a clinically significant improvement in fatigue was observed as early as week 8, increased between weeks 24 and 52, and continued to improve after 2 years in the guselkumab-treated groups compared with placebo. Fatigue was measured by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F). Patients with a FACIT-F improvement of ≥2 points by the 8-week mark were more likely to improve by ≥4 points at week 100.
“The burden of active psoriatic arthritis on a patient’s quality of life makes the task of effectively managing the debilitating symptoms of this disease even more urgent and challenging,” Terence Rooney, MD, vice president, rheumatology and chief of maternal immunology and the fetus at Janssen Research & Development, LLC, concluded. “These analyzes from DISCOVER-2 provide patients and physicians with critical insights as they consider the most appropriate treatment option to manage physical symptoms and help improve overall well-being.”