SAN FRANCISCO (FRONTLINE MEDICAL NEWS)– Secukinumab met its primary endpoint in a head-to-head trial, achieving 21% more PASI 90 responses than ustekinumab in patients with moderate to severe plaque psoriasis, according to interim, week 16 results from the phase IIIb CLEAR trial.
Patients’ responses to the two biologic agents had diverged by four weeks of treatment, when half the secukinumab group had achieved the secondary endpoint of PASI 75, compared with 20.6% of the ustekinumab group (P < .0001), Dr. Diamant Thaci said at the annual meeting of the American Academy of Dermatology.
“Secukinumab was superior to ustekinumab, even at early time points,” said Dr. Thaci of the Comprehensive Center for Inflammation Medicine at University Medical School Schleswig-Holstein, Lübeck, Germany. “This was very remarkable. Especially remarkable was the early difference for PASI 75.”
The biologic agents also showed similar safety profiles, and secukinumab yielded no new safety signals besides those observed in its pivotal phase III studies. “The most common adverse events were what we have seen in daily practice, including headache, nasopharyngitis, diarrhea, fatigue, and arthralgia,” , Dr. Thaci said.
Secukinumab works by binding specifically to the interleukin-17A cytokine, thereby blocking its interaction with its receptor. The 52-week, phase IIIb CLEAR trial, which is underway at 134 sites in 24 countries, is comparing the safety and efficacy of secukinumab and ustekinumab in 679 patients with moderate to severe plaque psoriasis. Patients had baseline PASI scores of at least 12 and at least 10% body surface area involvement, no previous exposure to either biologic agent, and inadequate responses to topical treatments or phototherapy. Researchers randomized the patients to either 300 mg secukinumab given subcutaneously at baseline, at weeks one through four, and every four weeks thereafter, or to ustekinumab, dosed according to label.
The study cohorts resembled one another demographically at baseline. At week 16, 79% of patients given secukinumab had achieved a PASI 90 response, compared with 57.6% of the ustekinumab group (P < .0001). Furthermore, 44.3% of the secukinumab arm had achieved the secondary endpoint of completely clear skin (a PASI 100 response), compared with 28.4% of the ustekinumab group (P < .0001), Dr. Thaci reported.
After an average of 110 to 111 days of treatment, infections and infestations developed in 29.3% of the secukinumab group and 25.3% of ustekinumab group. Three percent of each group developed serious but non-fatal adverse events, with no deaths reported to date.
“Secukinumab treatment – even at early time points – has demonstrated superiority to ustekinumab in clearing the skin of subjects with moderate to severe psoriasis, with a comparable safety profile,” Dr. Thaci concluded. “It is very clear that we will be able to show and to observe that his agent is leading to improved quality of life.”
Dr. Thaci reported receiving research support from Dignity Sciences.