Boni Elewski1, Alan Menter2, Jeffrey Crowley3, Stephen Tyring4, Yang Zhao5, Simon Lowry5, Stephen Rozzo5, Alan M Mendelsohn5, Jeffrey Parno5, Kenneth Gordon6. 1. a Department of Dermatology, University of Alabama at Birmingham , Birmingham , AL , USA. 2. b Division of Dermatology, Baylor Scott & White , Dallas , TX , USA. 3. c Bakersfield Dermatology , Bakersfield , CA , USA. 4. d Department of Dermatology, University of Texas Health Science Center , Houston , TX , USA. 5. e Sun Pharmaceuticals , Princeton , NJ , USA. 6. f Medical College of Wisconsin , Milwaukee , WI , USA.
Abstract
Background: Tildrakizumab is a high-affinity, humanized, IgG1 κ, anti-interleukin-23 monoclonal antibody approved for moderate-to-severe plaque psoriasis. Objectives: This analysis examined whether tildrakizumab's week-28 efficacy can be sustained or improved to week 52. Methods:Psoriasis patients on the same-dose tildrakizumab (100 or 200 mg) in the first 52 weeks achieving week-28 PASI ≥50 were pooled from two phase-3 randomized controlled trials, and grouped into four mutually exclusive week-28 PASI response groups. Patients' week-52 PASI responses were compared to their week-28 PASI responses. Results: Of 352 patients receiving100-mg tildrakizumab, 10.5%, 25.3%, 38.4%, and 25.9% achieved PASI 50-74, 75-89, 90-99, and 100 at week 28, respectively. Among patients achieving PASI ≥90, ≥75, or ≥50 at week 28, 89.4%, 91.1%, or 97.4% maintained their week-28 PASI responses at week 52, respectively. Among patients achieving PASI 50-74, 75-89, or 90-99 at week 28, 64.8%, 33.7%, or 25.2% improved their week-28 PASI responses at week 52, respectively. Limitations: This post hoc analysis may be less robust than an a priori analysis. Conclusions: Most tildrakizumab-treated patients with week-28 PASI ≥75 maintained their week-28 PASI improvement at week 52. More than half of week-28 partial responders (PASI 50-74) improved their PASI responses to PASI ≥75 at week 52. Clinicaltrials.gov identifiers: NCT01722331, NCT01729754.
RCT Entities:
Background: Tildrakizumab is a high-affinity, humanized, IgG1 κ, anti-interleukin-23 monoclonal antibody approved for moderate-to-severe plaque psoriasis. Objectives: This analysis examined whether tildrakizumab's week-28 efficacy can be sustained or improved to week 52. Methods:Psoriasispatients on the same-dose tildrakizumab (100 or 200 mg) in the first 52 weeks achieving week-28 PASI ≥50 were pooled from two phase-3 randomized controlled trials, and grouped into four mutually exclusive week-28 PASI response groups. Patients' week-52 PASI responses were compared to their week-28 PASI responses. Results: Of 352 patients receiving 100-mg tildrakizumab, 10.5%, 25.3%, 38.4%, and 25.9% achieved PASI 50-74, 75-89, 90-99, and 100 at week 28, respectively. Among patients achieving PASI ≥90, ≥75, or ≥50 at week 28, 89.4%, 91.1%, or 97.4% maintained their week-28 PASI responses at week 52, respectively. Among patients achieving PASI 50-74, 75-89, or 90-99 at week 28, 64.8%, 33.7%, or 25.2% improved their week-28 PASI responses at week 52, respectively. Limitations: This post hoc analysis may be less robust than an a priori analysis. Conclusions: Most tildrakizumab-treated patients with week-28 PASI ≥75 maintained their week-28 PASI improvement at week 52. More than half of week-28 partial responders (PASI 50-74) improved their PASI responses to PASI ≥75 at week 52. Clinicaltrials.gov identifiers: NCT01722331, NCT01729754.