In adults with active psoriatic arthritis, continued treatment with guselkumab was associated with skin clearance and joint symptom improvement through 2 years, according to long-term data from the phase 3 DISCOVER-2 study.
In DISCOVER-2 (ClinicalTrials.gov: NCT03158285), patients with active psoriatic arthritis (N=739) were randomly assigned to guselkumab 100mg every 4 or every 8 weeks for 2 years, or to placebo with crossover to guselkumab every 4 weeks at week 24 through 2 years. The study aimed to evaluate multiple clinical outcomes including joint and skin symptoms and radiographic progression in patients with psoriatic arthritis.
Results at week 100 showed that 76% of patients receiving guselkumab every 4 weeks and 74% of patients receiving treatment every 8 weeks achieved at least 20 percent improvement in the American College of Rheumatology (ACR20) response criteria. Findings also revealed that 56% and 55% of patients treated with guselkumab every 4 weeks and 8 weeks, respectively, achieved at least 50 percent improvement in ACR score. Moreover, low rates of radiographic progression of joint damage were observed in patients receiving guselkumab from week 52-100.
Among patients who had clinically meaningful skin involvement at baseline, 59% and 53% of patients treated with guselkumab every 4 weeks and 8 weeks, respectively, achieved complete skin clearance (Psoriasis Area Severity Index [PASI] 100). Additionally, 62% and 55% of patients receiving guselkumab every 4 and 8 weeks, respectively, achieved complete skin clearance as measured by the Investigator Global Assessment (IGA) score of 0.
The safety of guselkumab in patients with active psoriatic arthritis through 2 years was found to be comparable to safety at 6 months and 1 year and was consistent with the safety profile seen in patients with moderate to severe plaque psoriasis. No new safety signals were observed through week 112.
Full data from the DISCOVER-2 trial will be presented during the Innovations in Dermatology: Virtual Spring Conference, March 16 to 20, 2021.
Guselkumab, an interleukin-23 antagonist, is marketed under the trade name Tremfya® and is approved for the treatment of psoriatic arthritis and moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.
New phase 3 data show first-in-class Tremfya® (guselkumab) achieved complete skin clearance and favorable joint efficacy in adult patients with active psoriatic arthritis (PsA) through two years. [press release]. Spring House, PA: Janssen; March 16, 2021.