The Food and Drug Administration (FDA) has approved Tremfya® (guselkumab; Janssen) for the treatment of adult patients with active psoriatic arthritis (PsA).
The approval was based on data from 2 multicenter, double-blind, placebo-controlled phase 3 trials (DISCOVER-1 and DISCOVER-2) that evaluated the efficacy and safety of guselkumab, an interleukin-23 (IL-23) antagonist, in adults with active PsA. DISCOVER-1 included 381 patients with active PsA who had an inadequate response to standard therapies, including anti-tumor necrosis factor (TNF) alpha biologics; DISCOVER-2 included 739 biologic-naïve patients who had an inadequate response to standard therapies. Patients were randomized to receive either guselkumab 100mg subcutaneously every 4 weeks, or guselkumab 100mg at week 0, 4, then every 8 weeks, or placebo.
Results from DISCOVER-1 and DISCOVER-2 showed that both studies met the primary end point with 52% and 64% of patients treated with guselkumab every 8 weeks achieving an American College of Rheumatology (ACR) 20 response at week 24 compared with 22% and 33% of placebo-treated patients (P <.001 and P <.0001), respectively.
Additionally, in DISCOVER-1 and DISCOVER-2, the guselkumab (every 8 weeks) treatment arm met key secondary end points at week 24 vs placebo including:
- ACR50 response of 30% and 31% vs 9% and 14% (both P <.0001), respectively;
- Investigator’s Global Assessment (IGA) psoriasis response of clear (0) or almost clear (1): 57% and 70% vs 15% and 19% (both P <.0001), respectively;
- Higher response rates with guselkumab for ACR70, Psoriasis Area and Severity Index (PASI) 75, PASI 90, and PASI 100;
- Statistically significant and clinically meaningful improvements in Health Assessment Questionnaire Disability Index (HAQ-DI) and the 36-Item Short-Form Health Survey (SF-36) Physical Component Summary score (PCS).
The safety profile of guselkumab was found to be consistent with that seen in previous trials. The incidence of serious adverse events with guselkumab were similar to those observed with placebo.
“Psoriatic arthritis is a complex multifaceted disease and, for many patients, additional biologic options are very much needed,” said Philip J. Measei, MD, DISCOVER-2 lead study investigator, Director of Rheumatology Research at the Swedish Medical Center/Providence St. Joseph Health and Clinical Professor at the University of Washington School of Medicine in Seattle, WA. “The two phase 3 pivotal trials evaluating the safety and efficacy of Tremfya, an IL-23 inhibitor, for the treatment of adults with active psoriatic arthritis provided insight into how it can improve joint symptoms.”
Tremfya is already indicated for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
For more information visit janssen.com.