Clinical Implications and Predictive Values of Early PASI Responses to Tildrakizumab in Patients with Moderate-to-severe Plaque Psoriasis

Objective To evaluate whether early Psoriasis Area Severity Index (PASI) improvements can predict week 28 tildrakizumab responders and nonresponders. Methods Psoriasis patients pooled from two tildrakizumab phase 3 trials randomized to receive tildrakizumab 100 mg at weeks 0, 4, 16, and 28 were included. Patients were grouped by week 28 PASI responses (<50, 50-74, 75-89, and 90-100). PASI improvements from baseline at weeks 4 and 16 were analyzed for each response group. Results Of 575 patients included, 8.3%, 14.3%, 23.8%, and 53.6%, respectively, achieved PASI <50, 50-74, 75-89, and 90-100 at week 28. Of patients with PASI <50 at week 16, 85% did not achieve PASI >= 75 at week 28 (nonresponders). Rapid response, defined as PASI >= 50 at week 4 (after a single tildrakizumab dose), was observed in 41% of patients. Of these patients, 87% were week 28 responders (PASI >= 75); 67% were 'super responders' (PASI 90-100). Among week 28 responders and super responders, 45% and 50% achieved PASI >= 50 at week 4, respectively. Conclusions Tildrakizumab week 28 nonresponders can be identified by week 16 PASI response. PASI improvements as early as week 4 can predict patients' week 28 PASI improvement status.