Sustained and continuously improved efficacy of tildrakizumab in patients with moderate-to-severe plaque psoriasis

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 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.

Keywords:

• Tildrakizumab
• psoriasis
• sustained efficacy
• PASI

Acknowledgements

Institutional review board approvals were obtained for both trials.

Disclosure statement

The authors were either clinical trial investigators or researchers sponsored or employed by Merck & Co. Inc. and Sun Pharmaceutical Industries, Inc. Drs. Boni Elewski, Alan Menter, Jeffrey Crowley, Stephen Tyring and Kenneth Gordon were clinical investigators with financial support from Merck & Co., Inc.; and Sun Pharmaceutical Industries, Inc. Drs. Yang Zhao, Simon Lowry, Stephen Rozzo, Alan Mendelsohn and Mr. Jeffrey Parno are employees of Sun Pharmaceutical Industries, Inc.

Additional information

Funding

This work is supported by Merck & Co., Inc. and Sun Pharmaceutical Industries, Inc.