Three Year Data on Secukinumab Save

Dr. Philip Mease, MD presented the long-term efficacy and safety data for secukinumab in psoriatic arthritis (PsA) at the ACR Annual meeting in Washington, DC. (abstract 961)

606 patients with PsA were randomly treated with either secukinumab or placebo, the results of which were previously published and lead to FDA approval for use in PsA. After week 104, 457 of the original 606 patients entered into the extension study (including 308 originally secukinumab treated patients) and 435 completed 156 weeks.

After 156 weeks, ACR 20/50/70 response rates were 76.8%, 54.9%, 32.9% in those treated with 150 mg per month and and 65.2%, 39%, and 26% in those treated with 75 mg.

The mean exposure to secukinumab among all patients in the study (1025.1 ± 372.7 days). Over the 3 years of followup, the incidence and severity of adverse events were consistent with those reported previously. Specific frequency of infections included:

• Serious infections/infestations - 1.7 per 100 pt-years
• Candida infections - 1.2 per 100 pt-years
• Crohn’s disease - 0.1 per 100 pt-years
• Malignant/unspecified tumors - 0.9 per 100 pt-years
• Major adverse cardiac events - 0.7 per 100 pt-years, respectively.

In a separate abstract (#962) Dr. Atul Deodhar, presented data on the risk of colitis with secukinumab. Theoretically, IL-17 inhibition may increase the risk of incident colitis or flare of colitis.  The package insert says that based on the clinical trial data there may be a risk of colitis, but in reality the numbers have been very low.

The product label states, "Caution should be used when prescribing COSENTYX to patients with inflammatory bowel disease. Exacerbations, in some cases serious, occurred in COSENTYX treated patients during clinical trials."  New onset inflammatory bowel disease cases occurred in clinical trials wherein patients received secukinumab.

Dr. Deodhar presented data from trials of 3430, 974, and 571 patients taking secukinumab for psoriasis, PsA, and AS, respectively. The rates of CD and UC (0 to 0.5%) were similar in studies of psoriasis, PsA and AS and were the same as that seen in patients taking etanercept for psoriasis. Overall, there was no dose dependency with respect to the incidence of CD or UC with secukinumab, and no pattern in time-to-onset; suggesting either no or a very low risk of such events.