Positive results were announced from a phase 3 study evaluating the long-term efficacy and safety of guselkumab, a selective interleukin (IL)-23 inhibitor, in patients with active psoriatic arthritis.
The multicenter, randomized, double-blind, placebo-controlled DISCOVER-2 trial (ClinicalTrials.gov Identifier: NCT03158285) included 739 biologic-naïve adults with active psoriatic arthritis. Patients were randomly assigned to receive guselkumab 100mg every 4 weeks, guselkumab 100mg at weeks 0 and 4 then once every 8 weeks, or placebo every 4 weeks with crossover at week 24 to guselkumab.
Results through 2 years showed that 91% of patients receiving guselkumab every 4 weeks and 87% of patients receiving guselkumab every 8 weeks maintained an American College of Rheumatology (ACR)20 response. At week 100, ACR50 response was maintained in 83% of patients treated every 4 weeks and 79% of patients treated every 8 weeks, while ACR70 response was maintained in 72% of patients treated every 4 weeks and 80% of patients treated every 8 weeks.
Among those who received guselkumab from week 0, 62% and 55% of patients in the 4 week and 8 week treatment arms, respectively, achieved an Investigator’s Global Assessment score (IGA) of 0 (clear) at week 100; 76% and 72% had an IGA score of 0 or 1 (almost clear).
At week 100, low rates of radiographic progression were observed across all 3 guselkumab dosing regimens. Enthesitis and dactylitis resolution rates also showed amelioration of arthritis signs and symptoms. Durable improvements in physical function and maintenance of low disease activity were also observed.
Guselkumab is marketed under the brand name Tremfya and is currently indicated for the treatment of adults with active psoriatic arthritis, and adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
“These comprehensive, two-year data yield important insights into how patients with psoriatic arthritis can achieve and sustain improvements across symptoms with the ultimate goal being full remission,” said study investigator Philip Mease, MD, Director of Rheumatology Research at the Swedish Medical Center/Providence St. Joseph Health and Clinical Professor at the University of Washington School of Medicine. “It’s helpful for both health care providers and patients to understand the long-term profile of therapies like Tremfya in order to make informed decisions about treatment for a life-long disease like psoriatic arthritis.”
New comprehensive phase 3 data show first-in-class Tremfya® (guselkumab) provided durable improvements in measures of psoriatic arthritis (PsA) disease activity through two years. News release. Janssen Pharmaceutical Companies of Johnson & Johnson. Accessed November 1, 2021. https://www.prnewswire.com/news-releases/new-comprehensive-phase-3-data-show-first-in-class-tremfya-guselkumab-provided-durable-improvements-in-measures-of-psoriatic-arthritis-psa-disease-activity-through-two-years-301412833.html.