A recent study evaluated the long-term safety and efficacy of secukinumab in patients with moderate-to-severe hidradenitis suppurativa over a 104-week period.
In the study, published in the British Journal of Dermatology, researchers examined the outcomes of the SUNSHINE and SUNRISE phase III trials. The trials involved 1,084 patients, with 84.3% of them completing the core trials and 55.9% of them achieving a week 52 hidradenitis suppurativa (HS) clinical response (HiSCR). Although the primary endpoint of time to loss of response (LOR) was not met, significant clinical benefits were observed in the patients receiving secukinumab. The estimated risk reduction for LOR was 13% for the secukinumab 300 mg every 2 weeks (SECQ2W) group compared with placebo, and 30% for the 300 mg every 4 weeks (SECQ4W) group. The median time to LOR was numerically longer in the secukinumab arms, with SECQ2W showing 283 days and SECQ4W showing 365 days compared with 239 days and 171 days for their respective placebo groups.
"The predefined primary endpoint of time to LOR through week 104 was not met for either secukinumab dosing regimen vs placebo. However, the median time to LOR was numerically longer for both secukinumab arms compared with their placebo counterparts, and clinical benefits were observed in patients who met LOR," stated lead study author Alexa B. Kimball, of Harvard Medical School and the Clinical Laboratory for Epidemiology and Applied Research in Skin in the Department of Dermatology, and her colleagues.
The researchers also found that 44% of the patients in the SECQ2W-R-Q2W arm and 58% of those in the SECQ2W-R-PBO arm achieved HiSCR at the time of LOR. Safety data indicated that the overall safety profile of secukinumab was consistent with previous findings, with adverse events (AE) reported in 56.9% of patients in the SECQ2W-R-Q2W group and 58.6% in the SECQ2W-R-PBO group. The most common AEs included COVID-19 infections, hidradenitis, and nasopharyngitis, with no deaths reported during the trial.
Additionally, 76.5% of the patients in the SECQ2W arm and 87.5% of those in the SECQ4W arm maintained HiSCR at week 104, indicating sustained clinical benefits. The researchers emphasized the importance of improvements in skin pain and quality of life among patients with HS, which have been extensively documented in the literature.
While the primary endpoint of time to LOR was not statistically significant, the study offered valuable insights into the long-term safety and efficacy of secukinumab for managing moderate-to-severe HS, supporting its continued use as a treatment option for this challenging condition.
Full disclosures are available in the study.