Study: Secukinumab Is Safe for Long-Term Use
A recent poster study presented at the Winter Clinical Dermatology Conference showed that secukinumab was safe for long-term use among patients with psoriasis and psoriatic arthritis.
In their comprehensive pooled analysis, the researchers examined data on adverse events from 19 studies that included 4674 patients. They calculated the incidence rates for treatment-emergent adverse events per year for participants who received either 300 mg of secukinumab or any dose of secukinumab. In addition, they examined the 1-year incidence rates of participants who received placebo, 50 mg of etanercept, or 45 or 90 mg of ustekinumab.
The duration of exposure to any dose of secukinumab and 300 mg of secukinumab at 1 year was 4093.5 patient-years and 1467.4 patient-years, respectively, at 2 years was 2631.3 and 859.6, at 3 years was 1659.6 and 423, at 4 years was 1392.2 and 377.5, and at 5 years was 261.6 and 90.
Overall, the pooled safety profile of secukinumab remained favorable over 5 years of treatment with no increases in adverse events over time and was similar to the 1-year safety profiles of placebo, etanercept, and ustekinumab. The incidence rates for any dose of secukinumab were 254.1, 169.9, 159.8, 104.1, and 12 at years 1, 2, 3, 4, and 5, respectively. Additionally, the incidence rates of 300 mg of secukinumab were 275.6, 168.1, 160.2, 111.9, and 13.9 at years 1, 2, 3, 4 and 5, respectively.
Nasopharyngitis, headache, and upper respiratory tract infections were the most frequently reported adverse events during the 5-year period. However, opportunistic infections, Candida infections, neutropenia, major adverse cardiovascular events, Crohn disease, ulcerative colitis, and malignant or unspecific tumors, excluding nonmelanoma skin cancer, were not common.
“This comprehensive pooled analysis of 19 phase 2/3 trials supports the favorable long-term safety profile of secukinumab in patients with psoriasis,” the researchers concluded. “No new safety signals were identified for up to 5 years of treatment and there were no increases in yearly adverse event rates from year 1.”
van de Kerkhof PCM, Reich K, Leonardi CL, et al. Secukinumab’s pooled and long-term safety: analysis of 19 psoriasis clinical trials up to 5 years of treatment. Presented at: The Winter Clinical Dermatology Conference; January 12-17, 2018; Maui, Hawaii.