Studies Examine Promising New Option for Plaque Psoriasis
Tildrakizumab safely and effectively treated moderate-to-severe plaque psoriasis, according to the results of 2 phase 3 clinical trials.
The researchers conducted two 3-part parallel group, double-blind, randomized controlled studies (reSURFACE 1 and reSURFACE 2) that recruited participants 18 years of age or older with moderate-to-severe chronic plaque psoriasis. The proportion of patients achieving Physician's Global Assessment (PGA) response and Psoriasis Area and Severity Index (PASI) score of 75 at week 12 were assessed as the primary endpoints. In addition, the researchers assessed the safety of all treatments in patients
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A total of 772 patients were included in reSURFACE 1, 308 of whom were randomly assigned to receive a subcutaneous dose of tildrakizumab at 200 mg, 309 of whom were assigned to receive a subcutaneous dose of tildrakizumab at 100 mg, and 155 were assigned to the placebo group.
A total of 1090 patients were included in reSURFACE 2, 314 of whom were randomly assigned to receive subcutaneous dose of tildrakizumab at 200 mg, 307 were assigned to receive subcutaneous dose of tildrakizumab at 100 mg, and 313 received 50 mg of etanercept.
In reSURFACE 1, 192 patients (62%) who received 200 mg of tildrakizumab and 197 patients (64%) who received 100 mg of tildrakizumab achieved PASI score of 75 at week 12 compared with only 9 patients (6%) in the placebo group. PGA response was achieved by 182 patients (59%) in the 200 mg group and 179 patients (58%) in the 100 mg group compared with 11 patients (7%) in the placebo group.
In reSURFACE 2, 206 patients (66%) in the 200 mg group and 188 patients (61%) in the 100 mg group achieved PASI scores of 75 at week 12 compared with 151 patients (48%) in the etanercept group and only 9 patients (6%) in the placebo group.
Overall, both trials showed similar serious adverse events and the occurrence was low for all groups. Only 1 patient in the 100 mg group who had alcoholic cardiomyopathy and steatohepatitis died, but the researchers were unable to determine the cause of death.
“In two phase 3 trials, tildrakizumab 200 mg and 100 mg were efficacious compared with placebo and etanercept and were well tolerated in the treatment of patients with moderate-to-severe chronic plaque psoriasis, the researchers concluded.
Reich K, Papp KA, Blauvelt A, et al. Tildrakizumab versus placebo or etanercept for chronic plaque psoriasis (reSURFACE 1 and reSURFACE 2): results from two randomised controlled, phase 3 trials [published online June 5, 2017]. Lancet. http://dx.doi.org/10.1016/S0140-6736(17)31279-5.