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Patients were continually treated with the 300 mg for five years.
The improved skin clearance and favorable safety profile achieved with the interleukin-17A (IL-17A) inhibitor secukinumab is maintained through at least five years of treatment, new data suggest.
The findings, presented here at the 26th European Academy of Dermatology and Venereology (EADV) Congress in Geneva, are based on the patients originally enrolled in the phase III SCULPTURE (Severe Chronic Plaque-type Psoriasis Assessing Different Doses and Dose Regimens) study.
In particular, the population in this extension study included patients who had a Psoriasis Area and Severity Index (PASI) 75 response at week 12, continued receiving subcutaneous secukinumab 300 mg every four weeks until one year of treatment (n = 168); continued on the same double-blinded treatment regimen to year three; and subsequently continued un-blinded to year five of treatment (n = 126).
For the patients who reached year one, the rates of PASI 75 and PASI 90 were 89% and 69%, respectively; by year five, those rates were maintained at 89% and 66%, respectively. Completely clear skin (PASI 100) was seen in 44% of patients at year one, which was maintained to 41% at year five.
Secukinumab’s safety profile remained favorable and consistent at five years, according to investigators, with no cumulative adverse events or unexpected safety concerns. Similar to what was previously reported in phase III data, the most common adverse events included nasopharyngitis, upper respiratory tract infection, and headache.
These results confirm that secukinumab is a safe and effective treatment option, according to Jeffrey J. Crowley, M.D., a private practice dermatologist in Bakersfield, Calif.
“Efficacy appears to really be maintained quite well,” said Dr. Crowley, who attended EADV but was not involved in the SCULPTURE study. “It's not a large number of patients, but it is patients that were continually treated with the 300 mg dose for the entire five-year period.“
“These patients are really kind of ‘locked in’ terms of their response,” Dr. Crowley continued. “They respond well up front, they maintain response, and there is not a lot of drop-off.”
Dr. Crowley, who has been principal investigator on more than 30 clinical trials and has served on clinical faculty at Stanford and UCLA also remarked on the high retention rate from year one to year five of the extension study: “I think that's usually a testament to patients doing well,” he said, “and high levels of efficacy, which were certainly achieved and maintained here.”
Discontinuation in the extension study was most commonly attributed to subject or guardian decision (13 patients, 7.7%), adverse event (10 patients, 6.6%), and lack of efficacy (7 patients, 4.2%).
The one caveat, according to Dr. Crowley, was a few cases of ulcerative colitis that were reported in the five-year data, consistent with what is already known regarding the association between IL-17 inhibitors and inflammatory bowel disease (IBD).
“There seems to be this very low rate of both new onset IBD and exacerbation of preexisting disease with this (IL-17) mechanism,” Dr. Crowley said. “The rates are low, but this is something that I think we need to discuss with patients and inquire about potential signs and symptoms of IBD over time.”
Dr. Crowley has served as a consultant, investigator, and speaker for Novartis, Lilly and Janssen.