Secukinumab demonstrates long-term safety, efficacy for treatment of psoriasis

Secukinumab provided high levels of skin clearance and improved quality of life over 5 years in patients with moderate to severe psoriasis, according to findings presented at the American Academy of Dermatology Annual Meeting.

Robert Bissonnette, MD, of Innovaderm Research in Montreal, and colleagues analyzed the long-term sustainability and safety of secukinumab among patients in the extension phase of the SCULPTURE study. Participants in the core SCULPTURE study who responded to treatment according to the Psoriasis Area and Severity Index 75 at week 12 continued treatment with 300 mg secukinumab subcutaneously every 4 weeks through the end of 1 year (n = 168). The extension phase, which continued through year 3, involved the same double-blind treatment protocol; the trial was then unblinded through year 5 (n = 126).

At the end of year 1, 168 patients were enrolled in the extension study. Mean PASI, body surface area involvement and Dermatology Quality of Life Index scores at baseline were 23.5, 33.1% and 13.1, respectively, which indicated “a high disease severity” at the start of the study, according to the researchers.

At 5 years, 126 patients had finished treatment with secukinumab; 42 patients discontinued treatment. Treatment with secukinumab led to, on average, a 90% improvement in psoriasis by the end of year 5; mean improvement in mean absolute PASI scores was 91.1% from baseline to year 1 and 90.1% from baseline to year 5. Response rates for PASI 75, 90 and 100 were consistent from year 1 (88.9%, 68.5% and 43.8%, respectively) to year 5 (88.5%, 66.4% and 41%). Improvements in absolute PASI 1/2/3 responses were maintained from year 1 (58.6%, 67.9% and 74.1%) to year 5 (53.3%, 66.4% and 75.4%), as were improvements in absolute body surface area 1/2/3 (60.5%, 73.5% and 77.2% at year 1 vs. 62.3%, 71.3% and 78.7% at year 5).

Two-thirds of patients reported that skin disease had no impact on their lives through 5 years of treatment. Dermatology Quality of Life Index 0/1 scores were 72.7% at year 1 and 65.5% at year 5.

Secukinumab demonstrated consistently favorable safety through 5 years, according to researchers. No increase in adverse events from year to year was noted. There were no new safety signals observed and the safety profile was unchanged from the one established during a large phase 3 trial. - by Marley Ghizzone

Reference:

Bissonnette R, et al. Abstract 6813. Presented at: AAD Annual Meeting; Feb. 16-20, 2018; San Diego.

Disclosures: Bissonnette reports serving as an investigator, advisory board member, speaker and/or consultant for, and/or receiving honoria or grants from, Abbvie, Amgen, Boehringer Ingelheim, BMS, Celgene, Eli Lilly, Galderma, GSK-Stiefel, Immune Tolerance, Incyte, Janssen, Kineta, Leo Pharma, Merck, Novartis, Pfizer and Zenoport. The study was funded by Novartis. Please see the study for all other authors’ relevant financial disclosures.