Tildrakizumab Demonstrates Efficacy in Treating Patients with Psoriatic Arthritis
Study results demonstrate superior efficacy and comparable safety for tildrakizumab versus a placebo in patients with psoriatic arthritis.
Tildrakizumab demonstrated superior efficacy and comparable safety versus placebo in patients with psoriatic arthritis (PsA), according to the results of a phase 2b study.
The study data were presented at the Annual European Congress of Rheumatology in Madrid, Spain.
Tildrakizumab, a humanized monoclonal antibody targeting interleukin (IL)-23p19, is currently approved for the treatment of moderate-to-severe plaque psoriasis. However, current guidelines recommend consideration of biological disease-modifying anti-rheumatic drugs (DMARDs) targeting IL-12/23 or IL-17 pathways in patients with PsA who have had an inadequate response to conventional therapies and for whom tumor necrosis factor inhibitors are not appropriate.
The 24-week study included 391 adults with PsA who had 3 or more tender and 3 or more swollen joints. Patients received either tildrakizumab 200 mg every 4 weeks, 200 mg, 100 mg, or 20 mg every 12 weeks or a placebo every 4 weeks. Stable concomitant methotrexate or leflunomide use was permitted but not mandated.
According to the data, by week 24, a significantly higher proportion of patients treated with tildrakizumab at any dose achieved a 90% reduction in Psoriasis Area and Severity Index (PASI 90) and a 50% reduction in American College of Rheumatology response criteria (ACR 50) versus placebo. Additionally, the study showed that response rates improved as the dose increased, although shortening the dosing interval of 200 mg from 12 to 4 weeks did not demonstrate a measurable increase in skin or joint response scores.
In patients who received 200 mg tildrakizumab every 12 weeks, 79.6% and 50% achieved PASI 75 and PASI 90, respectively, versus 16.7% and 7.1% in the placebo group.
The findings demonstrated a clear separation between tildrakizumab and the placebo as early as 8 weeks for ACR20 and 12 weeks for ACR50, according to the study.
Serious adverse events (AEs) were observed in 2.2% of patients treated with tildrakizumab and 2.5% of placebo-treated patients. The most commonly reported AEs included nasopharyngitis and diarrhea, with no reports of candidiasis, inflammatory bowel disease, major adverse cardiac events, or malignancy.
Mease PJ, Chohan S, Garcia FJ, et al. Randomized, double-blind, placebo-controlled, multiple-dose, phase 2b study to demonstrate the safety and efficacy of tildrakizumab, a high-affinity anti-interleukin-23p19 monoclonal antibody, in patients with active psoriatic arthritis. EULAR 2019; Madrid, Spain. Abstract LB00002.