A study presented at the ACR/ARP Annual Meeting detailed 24-week outcomes among patients with active psoriatic arthritis (PsA) treated with tildrakizumab compared with placebo. In this double-blind, placebo-controlled, multiple-dose, phase IIb study, active PsA patients were randomized to receive placebo (n=79) or one of the following tildrakizumab doses: 200 mg once every four weeks (n=78), 200 mg once every 12 weeks (n=79), 100 mg once every 12 weeks (n=77), or 20 mg once every 12 weeks (n=78). Some patients received stable concomitant methotrexate or leflunomide. Eligibility criteria included age ≥18 years, PsA diagnosis with symptoms for six months, and at least three tender and swollen joints. The main outcome measure was the proportion of patients achieving a 20% reduction from baseline in ACR response criteria after 24 weeks (ACR24); additional outcomes included 24-week ACR50/70 responses, Psoriasis Area and Severity Index (PASI) 75, PASI 90, and changes in swollen and tender joint count. Patients were also monitored for treatment-related adverse events (AEs).
A total of 500 patients were considered for the trial, 391 of whom met inclusion criteria. After 24 weeks, a significantly greater proportion of patients receiving tildrakizumab achieved ACR20/50/70 and PASI 75/90 compared with placebo. Differences were observed as early as eight weeks into the trial, according to the authors.
During the study period, the most common AEs included nasopharyngitis (pooled tildrakizumab groups, 5.4% [n=17/312] vs. placebo, 6.3% [n=5/79]) and diarrhea (1.3% [n=4/312] vs. 0.0%, respectively). No cases of candidiasis, inflammatory bowel disease, major adverse cardiac events, malignancy, or death were reported. None of the treatment-related AEs caused patients to exit the study early. The rate of serious treatment-related AEs was similar between the pooled tildrakizumab (2.2%; n=7/312) and placebo groups (2.5%; n=2/79). The researchers did not report a significantly increased response in skin or joint response scores between patients receiving tildrakizumab 200 mg every 12 weeks versus every four weeks.