Five-Year Data for Ilumya Show Long-term Efficacy, Safety

Long-term data from Phase 3 extension trials for Sun Pharma’s Ilumya (tildrakizumab) in psoriasis show the treatment provided sustained disease control over five years among subjects who were week 28 tildrakizumab responders and etanercept partial responders/nonresponders. Ilumya provided a durable safety profile regardless of baseline level of skin disease, age, or background illness, including in those with metabolic syndrome. 

Findings, which represent the longest complete dataset of an IL-23 inhibitor reported to date, appear in the British Journal of Dermatology. The ReSURFACE 1 and ReSURFACE 2 extension studies reflect a total Ilumya exposure of more than 5,400 patient-years.

“We are proud to share 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,” says Abhay Gandhi, CEO, Sun Pharma, North America, in a statement. “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.”

Findings from the five year analysis show that median improvement from baseline PASI score was 95.5%, and 65.5% of patients achieved PGA 0/1 at Week 244. Patients achieved a median absolute PASI score of 1.1 on the 72-point PASI disease activity scale at Week 244. A median absolute PASI score of 1.1 indicates that patients treated with ILUMYA had low residual disease following treatment.  

The safety profile of ILUMYA was further investigated in analyses of incidence rates for severe infections, malignancies, major adverse cardiovascular events, and in patients over 65 years of age. No new safety signals were reported in any of these sub-groups.