Sun Pharmaceutical has reported positive data from pooled analyses of two Phase III trials of Ilumya (tildrakizumab-asmn) in patients with moderate-to-severe plaque psoriasis.
The data showed that patients who received Ilumya for five years maintained consistent and extensive skin clearance with no new safety issues reported.
Ilumya is a humanised lgG1/k monoclonal antibody approved for treating adults with moderate-to-severe plaque psoriasis.
The randomised, placebo-controlled, multicenter, three-part reSURFACE 1 and reSURFACE 2 studies evaluated the efficacy and safety of Ilumya 100mg and 200mg in moderate-to-severe plaque psoriasis compared to placebo and comparative drug to assess safety and tolerability.
In these extension studies, patients received Ilumya 100mg or 200mg through five years of continuous treatment.
About 65.9% of patients treated with Ilumya 100mg had clear or almost clear skin, while 32.8% achieved completely clear skin at week 244.
At week 224, 88.7% of patients achieved a PASI 75 response, which is considered as the standard goal of treatment.
The long-term analyses showed absolute PASI lesser than 1/3/5 scores at week 28 were sustained until week 244.
Sun Pharma North America CEO Abhay Gandhi said: “These impressive results show that Ilumya keeps working year-on-year, maintaining a high level of skin clearance and a durable safety profile regardless of baseline level of skin disease, age or background illnesses.
“Patients living with moderate-to-severe plaque psoriasis need therapies they can use over long periods of time without loss of efficacy, and we are pleased these data show that Ilumya is a sustainable choice for patients over the long term.”
Ilumya 100mg was well-tolerated during the trials, with the only adverse reactions noted being upper respiratory infections, injection site reactions, and diarrhoea.