A. Blauvelt1, H. Sofen2, K. Papp3, M. Gooderham3, Y. Zhao4, J. Parno4, A. Mendelsohn4, S. Lowry4, S. Rozzo4, K. Reich5
Background: Tildrakizumab is a monoclonal antibody selectively directed against IL-23p19, with demonstrated efficacy in patients with moderate-to-severe plaque psoriasis from two phase-3, double-blinded, randomized controlled trials.
Methods: This post-hoc pooled analysis included patients on tildrakizumab 100 mg during the first 28 weeks from its two phase-3 clinical trials. Sub-cohorts were created based on prior exposure to biologic therapy for psoriasis. Within each sub-cohort, 5 mutually exclusive groups were created based on week-28 PASI response: PASI 100, 90-99, 75-89, 50-74, and <50. Percent of PASI improvements from baseline were examined. Results: The analysis included 475 bio-naïve and 100 bio-experienced patients. Among bio-naïve patients, 24.4%, 29.9%, 24.2%, 14.5%, and 6.9% achieved PASI 100, 90-99, 75-89, 50-74, and <50 at week 28, respectively. Among bio-experienced patients, the percentages were 17.0%, 33.0%, 22.0%, 13.0%, and 15.0%. Overall, PASI improvements were the highest for PASI 100 and the lowest for PASI <50 patients at all visits over the first 28 weeks. Patients achieving week-28 PASI 90-100 had ≥ 44% PASI improvement at week 4. Among patients achieving week-28 PASI ≥ 50 and continuing on tildrakizumab 100 mg till 52 weeks, PASI improvements were maintained or enhanced from week 28 to week 52. Conclusions: Tildrakizumab efficacy was similar regardless of patients’ previous biologic exposure, with its efficacy achieved at week 28 maintained or enhanced till week 52. Tildrakizumab patients with PASI 90-100 at week 28 showed rapid PASI improvements by week 4, indicating that super responders to tildrakizumab might be identified early during the therapy.