VIENNA – When the occasional patient on secukinumab for moderate to severe psoriasis fails to achieve a PASI 75 response initially, don’t despair: Continuing treatment with the biologic usually gets them over that bar, Christopher E. Griffiths, MD, reported at the annual congress of the European Academy of Dermatology and Venereology.
A new secondary pooled analysis of four phase III, 52-week, pivotal clinical trials of secukinumab (Cosentyx) indicates that more than three-quarters of initial suboptimal responders will go on to achieve a PASI 75 response. Moreover, more than one-third will have a PASI 90 response by week 16, which is sustained through week 52. And almost one in five slow responders will have a PASI 100 response – clear skin – at week 52, according to Dr. Griffiths, professor of dermatology at the University of Manchester, England.
Dr. Christopher E. Griffiths
He presented a secondary analysis of four phase III studies: ERASURE (Efficacy of Response and Safety of Two Fixed Secukinumab Regimens in Psoriasis), FEATURE (First Study of Secukinumab in Pre-filled Syringes in Subjects With Chronic Plaque-type Psoriasis: Response at 12 Weeks), FIXTURE (Full Year Investigative Examination of Secukinumab vs. Etanercept Using Two Dosing Regimens to Determine Efficacy in Psoriasis), and JUNCTURE (Judging the Efficacy of Secukinumab in Patients With Psoriasis Using AutoiNjector: a Clinical Trial Evaluating Treatment Results). The analysis was conducted to provide additional perspective on the product labeling statement that treatment discontinuation should be considered in patients who haven’t responded to secukinumab by week 16.
The four studies featured a total of 2,405 patients with moderate to severe psoriasis on secukinumab at the approved dosing schedule.
The key findings: At week 12 – the primary endpoint in the four trials – only 5.2% of patients on secukinumab had not achieved a PASI 75 response. Yet just 4 weeks later, at week 16, 56% of this group had managed to get there. Seventy-seven percent of early non- or partial responders achieved a PASI 75 response at some point during weeks 13-52, and 55% had a PASI 75 response at 52 weeks.
Thirty-five percent of early poor responders achieved PASI 90 at 16 weeks and 37% at 52 weeks. Twelve percent of patients who didn’t get to PASI 75 at 12 weeks had a PASI 100 response by 16 weeks, and nearly 18% did by week 52.
This analysis was supported by secukinumab manufacturer Novartis. Dr. Griffiths reported receiving research funds from and serving as a consultant to Novartis and numerous other pharmaceutical companies.