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.
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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.
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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.
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By GlobalDataAt 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.
