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DISCOVER-2 is a phase 3, randomized, double-blind, multicenter study assessing the safety and efficacy of subcutaneous guselkumab treatment in biologic-naïve patients with active PsA.
Patients with active psoriatic arthritis (PsA) who had an early response to guselkumab reported more meaningful, long-term improvement in health-related quality of life (HR-QoL) at week 100 when compared with those who did not achieve early response or were receiving 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 through week 100.
“Patients with active psoriatic arthritis may struggle with engaging in everyday tasks as a result of health-related quality of life symptoms often associated with the disease,” Philip Mease, MD, rheumatologist and Director of Rheumatology Research at the Swedish Medical Center/Providence-St Joseph Health, explained. “In these analyses, we see that achieving early clinical strides in distinct symptom domains may demonstrate future gains in health-related quality of life and fatigue improvement, which underscores the important role this therapy plays in the management of the multiple and complex symptoms of active psoriatic arthritis.”
DISCOVER-2 is a phase 3, randomized, double-blind, multicenter study assessing 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 incorporated a placebo-controlled group from baseline to week 24, and a blinded active treatment period from week 24 to week 100. The safety follow-up period continued through week 112.
Post-hoc analysis of the phase 3 DISCOVER-2 study reported that early clinical improvements of patients with active PsA receiving guselkumab were linked to meaningful improvements in overall and physical HR-QoL from week 52 through week 100, including joint and skin disease, dactylitis, and enthesitis, when compared with placebo. Patients who were not early responders also displayed benefits in long-term HRQoL when compared with the placebo cohort.
Early improvement was defined as ≥ 20% improvement in swollen joint count (SJC), tender joint count (TJC), Health Assessment Questionnaire-Disability Index (HAQ-DI), patient pain visual analogue scale (VAS), and patient Skin VAS. Other indicators were reductions in the Leeds enthesitis index (LEI) or dactylitis severity score (DSS) and clinically important improvement in the clinical Disease Activity in PsA (cDAPSA) composite score.
Another post-hoc analysis revealed that clinically meaningful improvement in fatigue was seen as early as week 8, increased between week 24 and week 52, and continued to improve through 2 years in the guselkumab-treated groups when compared with placebo. Fatigue was measured by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F). Patients with FACIT-F improvement of ≥2 points by the 8-week mark were more likely to improve ≥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 all the more urgent and challenging,” Terence Rooney, MD, Vice President, Rheumatology and Maternal-Fetal Immunology Disease Area Leader at Janssen Research & Development, LLC, concluded. “These analyses 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 wellbeing.”