Mumbai and Princeton: Drug major, Sun Pharmaceutical Industries Limited, has recently 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.
Patients 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. These data were presented for the first time at the 29th European Academy of Dermatology and Venereology (EADV) Virtual Congress.
"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," said Richard Langley, M.D., FRCPC, professor of medicine and director of research, Department of Medicine, Dalhousie University. "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."
In an analysis of the pooled reSURFACE 1 and reSURFACE 2 extension studies, patients received ILUMYA 100 mg or 200 mg through five years of continuous treatment. ILUMYA 100 mg is approved in the U.S., Japan and Australia, and 200 mg is additionally approved under the brand name ILUMETRI 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.
The standard goal of treatment, a PASI 75 response, was achieved by 88.7% of patients at Week 244. The long-term analyses also showed absolute PASI <1/<3/<5 scores at Week 28 (50.8%, 85.1% and 96.4%, respectively) were sustained through Week 244 (47.7%, 78.8% and 88.7%, 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.
ILUMYA 100 mg was well-tolerated during the Phase 3 trials. The three adverse reactions that occurred more frequently than placebo and ≥1% in clinical trials were upper respiratory infections (14% vs. 12%), injection site reactions (3% vs. 2%) and diarrhea (2% vs. 1%). Furthermore, the analysis demonstrated similar exposure-adjusted incidence rates of malignancies throughout five years of study. A majority of malignancies were singular events with similar incidence rates as seen in the general US population.
"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," said Abhay Gandhi, CEO, Sun Pharma, North America. "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 is approved for adults with moderate-to-severe plaque psoriasis and is being evaluated for other possible uses.
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