Tildrakizumab Sustains Disease Control Over 5 Years in Phase 3 Studies

Sun Pharmaceuticals Industries Inc. announced the publication of results from its 5-year phase 3 extension studies (ReSURFACE 1 and ReSURFACE 2) investigating the safety and efficacy of tildrakizumab-asmn (ILUMYA, Sun Pharmaceuticals) in patients with moderate-to-severe plaque psoriasis in the British Journal of Dermatology, according to a company press release.¹

Tildrakizumab-asmn is a humanized lgG1/k monoclonal antibody that works to blind selectively to the p19 subunit of interleukin (IL)-23 while inhibiting the interaction with the receptor, further inhibiting the release of proinflammatory cytokines and chemokines.

The studies were both phase 3, randomized, multicenter, placebo-controlled, 3-part trials that evaluated the efficacy and safety of tildrakizumab-asmn 100 mg and 200 mg in patients with moderate-to-severe plaque psoriasis versus placebo and comparative drug, as well as assessed safety and tolerability.

Patients were randomized 2:2:1 to receive either tildrakizumab-asmn 100 mg, 200mg, or placebo at Weeks 0 and 4, and then every 12 weeks thereafter, with ReSURFACE 2 including an etanercept arm.

Results of the studies demonstrated high levels of skin clearance and no new safety signals through 5 years of continuous treatment in patients treated with tildrakizumab-asmn. The company reports that to date, this is the first and longest complete dataset published of an IL-23 inhibitor in a peer-reviewed medical journal.

In a pooled analysis of reSURFACE 1 and reSURFACE 2, patients who responded at Week 28 had well maintained efficacy through Week 244. Additionally, patients who received tildrakizumab-asmn 100 mg achieved a 95.5% median improvement from baseline Psoriasis Area and Severity Index (PASI) score, and 65.5% of patients achieved Physician's Global Assessment (PGA) 0/1 at Week 244.

Results also showed patients reached a median absolute PASI score of 1.1 on the PASI disease activity scale at Week 244, meaning there was low residual disease following treatment in tildrakizumab-asmn patients

Tildrakizumab-asmn 100 mg demonstrated good tolerability in the trials, with 3 adverse events (AEs) occurring more often than placebo and ≥1% in clinical trials, including respiratory infections (14% vs 12%), injection site reactions (3% vs 2%), and diarrhea (2% vs 1%).

Additionally, no new safety signs were detected during the studies and the incidence rates of severe infections, major adverse cardiovascular events, malignancies and AEs in plaque psoriasis patients over 65 years were comparable through 5 years of treatment.

"We are proud to publish five-year data reinforcing our understanding that a high level of sustained skin clearance and a durable safety profile is achievable with ILUMYA, regardless of baseline level of skin disease, age or background illnesses," said Abhay Gandhi, CEO, Sun Pharma, North America. "These impressive results underscore our commitment to patients living with moderate-to-severe plaque psoriasis by providing further assurance of the long-term efficacy and safety of ILUMYA."

Reference:

1. Pharma S. Sun pharma announces british journal of dermatology publication on ilumya (Tildrakizumab-asmn), the first il-23 inhibitor to complete five years of continuous treatment in moderate-to-severe plaque psoriasis. Press release. Cision PR Newswire. Accessed March 11, 2021. https://www.prnewswire.com/news-releases/sun-pharma-announces-british-journal-of-dermatology-publication-on-ilumya-tildrakizumab-asmn-the-first-il-23-inhibitor-to-complete-five-years-of-continuous-treatment-in-moderate-to-severe-plaque-psoriasis-301245613.html