AT THE EADV CONGRESS

VIENNA (FRONTLINE MEDICAL NEWS) – Four-year follow-up of patients on secukinumab for psoriasis shows sustained very high efficacy, with almost 100% of patients who had a Psoriasis Area and Severity Index (PASI) 90 or 100 response at 1 year maintaining it through 4 years, Robert Bissonnette, MD, reported at the annual congress of the European Academy of Dermatology and Venereology.

“I must warn you that my presentation will be very boring as compared to what I’ve seen earlier at this meeting, the very cutting edge phase II and phase III data being presented. My presentation doesn’t contain any surprises. However, as a clinician who is using interleukin-17A inhibition in my practice to treat psoriasis patients, that’s probably what I want,” said Dr. Bissonnette , president of Innovaderm Research in Montreal.

“This is the longest-term safety and efficacy data available to date for patients treated with an IL-17 antagonist using an approved dose,” he noted.

The data come from the extension phase of an earlier phase III study aimed at examining two doses of secukinumab – 150 versus 300 mg – and a fixed dosing schedule versus as-needed dosing when patients lost their PASI 75 response. Regulators ultimately approved secukinumab (Cosentyx) for moderate to severe plaque psoriasis at 300 mg on a fixed schedule at week 0, 1, 2, 3, and 4, and monthly thereafter.

Dr. Bissonnette presented 4-year results in the 165 participants who took the approved regimen from the start of the study. These were patients at the serious end of the disease severity spectrum. Their mean baseline PASI score was 23.5, with 33% of their body surface area being affected. Their mean Dermatology Life Quality Index (DLQI) score was 13.1. The mean body mass index was 28.7 kg/m2. A total of 71% of subjects had previously been on systemic therapy. One-third of participants had been on other biologics.

At 1 year, 88.9% of subjects had a PASI 75 response; at 4 years, the PASI 75 rate was 88.5%. Similarly, the PASI 90 rate was 68.5% at 1 year and 66.4% after 4 years. The PASI 100 rate was 43.8% at 1 year and 43.5% at year 4.

After 1 year on secukinumab, patients showed a mean 91.1% improvement, compared with their baseline PASI score. At 4 years, the figure was 90.8%.

Bearing in mind that the average baseline DLQI score at baseline was 13.1, it’s noteworthy that after 1 year on secukinumab, 72.7% of patients had a DLQI of 0 or 1, indicating psoriasis had no impact on their life. At year 4, the rate was 70.8%, Dr. Bissonnette continued.

As an audience member observed, however, the study population decreased from 165 patients to 131 over the course of 4 years. And since this was an “as observed” analysis, outcomes were counted only in those patients still in the study. It’s accepted as a legitimate statistical method, but it casts outcomes in a particularly favorable light.

“The main reason for dropouts was for personal reasons,” Dr. Bissonnette explained in response. “Number two was lack of or loss of efficacy. Loss of efficacy over time occurred at an absolute rate of 4%-8% per year.”

Overall, adverse event rates declined over the course of 4 years of follow-up.

“This is reassuring, but I don’t think it’s evidence that adverse events actually decrease over time because of longer use of secukinumab. I think it’s probably due to something we usually see in long-term clinical trials: a phenomenon of underreporting. When patients are treated with a new agent they tend to be very, very conscientious about what’s going on with their well-being. They will report a slight sore throat, a slight congestion. But once they’ve been on treatment for a longer time they’re less likely to report those very minor adverse events,” according to the dermatologist.

The Food and Drug Administration requires clinical trialists to keep careful track of selected adverse events in studies of biologic agents. In 4 years on secukinumab, there were no cases of tuberculosis, neutropenia, major adverse cardiovascular events, or Crohn’s disease. There were two cases of ulcerative colitis in year 2; however, one involved an exacerbation of preexisting disease. Also, two patients developed cancer other than nonmelanoma skin cancer in year 2. The incidence of vulvovaginal candidiasis was 1.8% during years 1 and 2, 0.6% in year 3, and zero in year 4.

Thus, the safety profile was favorable, with no pattern of increasing adverse events with longer medication use, Dr. Bissonnette concluded.

The study was sponsored by Novartis. Dr. Bissonnette reported serving as an investigator for and consultant to Novartis and 16 other pharmaceutical companies.

bjancin@frontlinemedcom.com

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