Outcomes from a new randomized trial, presented at the American College of Rheumatology/Empowering Rheumatology Professionals Annual Meeting, compared the efficacy of tildrakizumab on 66 swollen joint counts (SJC) and 68 tender joint counts (TJC) and pain in patients with active PsA versus placebo after 24 weeks.
Active PsA patients who were classified by their history of anti-TNF use and baseline body weight (≤90 kg and ≥90 kg) were randomly assigned to receive either placebo (n=79) or one of the following doses of tildrakizumab: 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). Patients were evaluated at baseline and every four weeks for 24 weeks. Pain was self-reported with a visual analog scale. Researchers assessed 500 patients for eligibility and included a total of 391; mean (SD) patient age of the total cohort was 48.8 (12.6) years, mean body mass index was 29.7 (6.2) kg/m2, and mean disease duration was 6.8 (7.1) years.
The 24-week least squares mean (standard error [SE]) reduction from baseline in SJC in the tildrakizumab groups was 8.3 (0.5) in the four-week 200 mg group, 7.7 (0.5) in the 12-week 200 mg group, 8.2 (0.5) in the 12-week 100 mg group, and 7.6 (0.5) in the 12-week 20 mg group, compared to 6.5 (0.5) in the placebo group; reductions reached statistical significance in the 12-week 100 mg and four-week 200 mg groups compared to placebo (P=0.0189 and 0.0111, respectively). LS mean (SE) reduction in TJC for the respective tildrakizumab treatment arms was 11.9 (1.0), 12.6 (1.0), 13.0 (1.0), and 12.0 (1.0), compared to 9.4 (1.0) in the placebo group; reductions reached statistical significance in the tildrakizumab 12-week 100 mg and 200 mg groups compared to placebo (P=0.0140 and 0.0234, respectively). Regarding pain, LS mean (SE) reduction in the respective tildrakizumab groups was 35.2 (2.7), 31.7 (2.6), 32.2 (2.6), and 28.9 (2.7), compared to 21.5 (2.6) in the placebo cohort; statistical significance was achieved in the tildrakizumab 12-week 100 mg and 200 mg and four-week 200 mg groups compared to placebo (P=0.0039, 0.0056, and 0.0003, respectively). There were no reported cases of malignancies, major adverse cardiac events, or deaths.