Novartis Announced Positive Phase III Psoriasis Results for Secukinumab


Novartis announced results from its head-to-head Phase III FIXTURE study showing secukinumab (AIN457), an interleukin-17A (IL-17A) inhibitor, was significantly superior to etanercept (Enbrel) in moderate-to-severe plaque psoriasis. These new results were presented at the 22nd Congress of the European Association of Dermatology and Venereology (EADV) in Istanbul, Turkey.

The pivotal FIXTURE study met all primary and pre-specified key secondary endpoints (p<0.0001 for placebo comparisons and p=0.0250 for etanercept comparisons), according to Novartis. Both doses of secukinumab showed improved efficacy to etanercept throughout the 52-week study, beginning as early as week 2 and confirmed by week 12 when the primary endpoints were assessed. Importantly, more secukinumab patients experienced PASI 90 and PASI 100 compared to etanercept.

FIXTURE compared two doses of secukinumab (300mg and 150mg) with etanercept 50mg and placebo. The co-primary endpoints were assessed at week 12 and compared secukinumab efficacy versus placebo according to the Psoriasis Area and Severity Index 75 (PASI 75) and the Investigator's Global Assessment (IGA mod 2011).

The study showed that 72 percent of secukinumab 300mg patients experienced at least a 90 percent reduction in skin redness, thickness and scaling (PASI 90) by week 16 of the study. More than half (54 percent) of secukinumab 300mg patients achieved PASI 90 as early as week 12, compared to 21 percent of etanercept patients. Secukinumab 300mg patients were also more likely to experience completely clear skin compared to those taking etanercept in the study, as measured by PASI 100 at week 12 (24 percent versus 4 percent).

Novartis reported that secukinumab-treated patients had their symptoms resolved faster than those treated with etanercept in the study. Clinically relevant differences were observed as early as week 2, and, on average, secukinumab 300mg patients had their symptoms halved by week 3, compared to week 8 for etanercept patients.

Secukinumab efficacy was sustained over the full one year duration of the study. In FIXTURE, nearly twice as many patients treated with secukinumab 300mg had a PASI 90 response at week 52 compared to etanercept (65 percent vs. 33 percent).

There were no major safety signals identified in FIXTURE or the broader secukinumab Phase III clinical trial program in moderate-to-severe plaque psoriasis. In FIXTURE, the incidence of adverse events (AEs) was similar between both secukinumab treatment arms (300mg and 150mg), and was comparable to etanercept. The most common AEs in any treatment group (including placebo) throughout the 52-week treatment period were nasopharyngitis and headache (occurring in between 12-36 patients per 100 patient years in all groups). At the same time point, serious AEs (SAEs) were experienced by 6 percent of secukinumab 300mg, 5 percent of secukinumab 150mg, and 6 percent of etanercept patients. There were no deaths reported during the study.

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