A study that will be presented at the American College of Rheumatology/Empowering Rheumatology Professionals Annual Meeting evaluated safety outcomes in patients with active psoriatic arthritis (PsA) taking tildrakizumab.
The study included patients aged ≥18 years who received a PsA diagnosis and had at least three tender and swollen joints. Patients were randomized 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). The researchers monitored patients for treatment-related adverse events, which were defined as events that took place on or after the first dose of tildrakizumab but before week 24, or on or before the last dose in patients who terminated treatment early.
Of 500 screened patients, 391 met eligibility criteria; 24-week treatment completion was met by 78.2% (n = 60) of four-week 200 mg tildrakizumab, 81.0% (n = 64) of 12-week 200 mg tildrakizumab, 77.9% (n = 60) of 100 mg tildrakizumab, 91.0% (n = 71) of 20 mg tildrakizumab, and 93.7% (n = 74) of placebo patients. Discontinuation was attributed to adverse events in 1.3% (n = 1), 2.5% (n = 2), 1.3% (n = 1), 2.6% (n = 2), and 0% of patients, respectively, and lack of efficacy in 11.5% (n = 9), 15.2% (n = 12), 16.9% (n = 13), 0%, and 0% of patients, respectively. Data were pooled for all four tildrakizumab subgroups to measure treatment-emergent adverse event (TEAE) rates.
In the pooled analysis, by week 24, 50% (n = 156) of tildrakizumab patients and 43% (n = 34) of placebo patients had sustained any TEAE. Serious TEAEs were recorded in 2.2% (n = 7) and 2.5% (n = 2) of the treatment and placebo groups, respectively, and treatment-related TEAEs in 11.2% (n = 35) and 12.7% (n = 10), respectively. Across groups, the most prevalent TEAEs were nasopharyngitis (tildrakizumab group, 5.4% [n = 17] vs. placebo group, 6.3% [n = 5]), headache (4.8% [n = 15] vs. 2.5% [n = 2], respectively), and hypertension (3.5% [n = 11] vs. 5.1% [n = 4]); hypertension was also the most common series TEAE in tildrakizumab patients (0.6% [n = 2]). One serious infection was reported, in the tildrakizumab group. There were no reported cases of candidiasis, inflammatory bowel disease, major adverse cardiac events, significantly increased liver enzymes, or malignancies at the 24-week mark.