Interim results of an ongoing randomized, double-blind, multidose, placebo-controlled, phase IIb study on the efficacy of tildrakizumab on psoriasis treatment in patients with psoriatic arthritis (PsA) were presented during the ACR/ARP Annual Meeting. Specifically, the researchers discussed the effect of tildrakizumab on Psoriasis Area and Severity Index (PASI) 75/90/100 response rates.
The study included patients aged ≥18 years with active disease, defined per the Classification of Psoriatic Arthritis criteria, who were classified based on prior anti-tumor necrosis factor (TNF) use and body weight at baseline (≤90 kg vs ≥90 kg). Patients were randomized 1:1:1:1:1 to receive either varying doses of tildrakizumab (200 mg once every four weeks, 200 mg every 12 weeks, 100 mg every 12 weeks, or 20 mg every 12 weeks to week 24) or placebo (every four weeks to week 24). The primary outcome measures were PASI75/90/100. Safety outcomes were also assessed.
A total of 500 patients were considered for participation, of whom 391 met the study’s inclusion criteria: 78 received tildrakizumab 200 mg every four weeks, 79 received tildrakizumab 200 every 12 weeks, 77 received tildrakizumab 100 mg every 12 weeks, 78 received tildrakizumab 20 mg every 12 weeks, and 79 received placebo. A total of 234 patients had measurable psoriasis, defined as ≥3% of the body surface area affected at baseline (n=53, n=44, n=54, n=41, and n=42, respectively). Mean age (SD) was 48.8 (12.6) years, and most (96.7%) were white. The average body mass index was 29.7 kg/m2; less than one-quarter of patients (23.3%) were anti-TNF–naïve.
Twenty-four-week results were analyzed by pooling the tildrakizumab data and measuring it against the placebo data. The combined PASI 75 response in the tildrakizumab group was 61.5% versus 16.7% in the placebo group; PASI 90 responses were 43.2% versus 7.1%, respectively; and PASI 100 responses were 26.0% versus 4.8%, respectively. The most commonly observed treatment-related adverse events were nasopharyngitis (pooled tildrakizumab 5.4% vs placebo 6.3%) and upper respiratory tract infection (3.5% vs 1.3%, respectively); no deaths occurred.
The researchers called for future studies to compare tildrakizumab 100 mg versus 200 mg doses. They concluded, “These data provide evidence that tildrakizumab significantly improves psoriasis in patients with PsA and is well tolerated in a mixed population of anti–TNF-naïve and -experienced patients.”