Patients with moderate-to-severe plaque psoriasis who continued to receive Ilumya (tildrakizumab-asmn) through five years of continuous treatment maintained consistent and extensive skin clearance with no new safety signals, according to Phase 3 data from the combined reSURFACE 1 and reSURFACE 2 extension studies.
The findings were presented at the 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," says Richard Langley, MD, FRCPC, professor of medicine and director of research, Department of Medicine, Dalhousie University, in a news release. "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 Ilumeteri in Europe. In patients who were treated with Ilumya 100 mg, clear or almost clear skin (PASI 90) was achieved by 65.9 percent of patients and 32.8 percent 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 percent 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," says 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."