Pharma major Sun Pharmaceutical Industries Limited has announced that one of its wholly owned subsidiaries presented positive, five-year Phase 3 data for ILUMYA (tildrakizumab-asmn) from the combined reSURFACE 1 and reSURFACE 2 extension studies.
It said people with moderate-to-severe plaque psoriasis who continued to receive ILUMYA through five years of continuous treatment maintained consistent and extensive skin clearance with no new safety issues reported.
The results were presented for the first time at the 29th European Academy of Dermatology and Venereology (EADV) Virtual Congress.
Richard Langley, M.D., FRCPC, professor of medicine and director of research, Department of Medicine, Dalhousie University, said, “These results are important as we now have five-year data reinforcing our understanding that ILUMYA may provide patients with sustained skin clearance and a well understood safety profile that was comparable to placebo.”
He added that ILUMYA is a valued option for patients in the treatment of moderate-to-severe plaque psoriasis, and these findings are reassuring for physicians and their patients living with this chronic disease.
Patients received ILUMYA 100 mg or 200 mg in an analysis of the pooled reSURFACE 1 and reSURFACE 2 extension studies through five years of continuous treatment.
ILUMYA 100 mg is approved in Japan, the United States and Australia, and 200 mg is additionally approved under the brand name ILUMETRITM in Europe. In patients who were treated with ILUMYA 100 mg, clear or almost clear skin (PASI 90) was achieved by 65.9% of patients and 32.8% of patients achieved completely clear skin (PASI 100) at Week 244.
Sun Pharma said the standard goal of treatment, a PASI 75 response, was achieved by 88.7 per cent of patients at Week 244.1 The long-term analyses also showed absolute PASI <1/<3/<5 scores at Week 28 (50.8 per cent, 85.1 per cent and 96.4 per cent, respectively) were sustained through Week 244 (47.7 per cent, 78.8 per cent and 88.7 per cent, respectively).
Absolute PASI scores can provide an indication of the extent of residual disease after treatment. Achievement of an absolute PASI score of <3 has been proposed as comparable to a PASI 90 response, which is equivalent to clear or almost clear skin.
Approved for adults with moderate-to-severe plaque psoriasis, ILUMYA is being evaluated for other possible uses.
(With inputs from The OnLook News Research Bureau)
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