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The following is a summary of “Long-term efficacy and safety of secukinumab in patients with moderate-to-severe hidradenitis suppurativa: Week 104 results from the SUNSHINE and SUNRISE extension trial,” published in the November 2024 issue of Dermatology by Kimball et al. 

The SUNSHINE and SUNRISE trials demonstrated the clinical efficacy of secukinumab over 52 weeks in patients with hidradenitis suppurativa (HS). Patients who completed the core trials were eligible to enter a 4-year extension trial.  

Researchers conducted a retrospective study to assess the long-term efficacy, safety, tolerability, and maintenance of clinical response of secukinumab for 104 weeks in the extension trial.  

They randomized patients with HS clinical response (HiSCR) at Week 52 of the core trials to a withdrawal period, HiSCR responders receiving subcutaneous secukinumab 300 mg every 2/4 weeks (SECQ2W/SECQ4W) through Week 52 in the core trials were randomized 2:1 to continue secukinumab (SECQ2W-R-Q2W or SECQ4W-R-Q4W) or receive placebo (SECQ2W-R-PBO or SECQ4W-R-PBO) through Week 104. The primary endpoint was time to loss of response (LOR) through Week 104 in Week 52 HiSCR responders (SECQ2W-R-Q2W vs SECQ2W-R-PBO and SECQ4W-R-Q4W vs SECQ4W-R-PBO). The Time to LOR was tested at 1.25% (one-sided) for each comparison (one-sided familywise alpha of 2.5%) through Week 104. If LOR was met, patients could continue open label secukinumab. The additional endpoints included safety and HiSCR. 

The results showed 84.3% of patients who completed the core trials enrolled in the extension trial and 55.9% of these patients were HiSCR responders at Week 52. Neither secukinumab dosing regimen met the primary endpoint. The estimated risk reduction for LOR was 13% (SECQ2W-R-Q2W vs SECQ2W-R-PBO; one-sided P=0.250) and 30% (SECQ4W-R-Q4W vs SECQ4W-R-PBO; one-sided P =0.044). The median time to LOR was numerically longer in the secukinumab arms compared to placebo (SECQ2W-R-Q2W [283 days; 95% CI: 176, –] vs SECQ2W-R-PBO [239 days; 95% CI: 120, –]; SECQ4W-R-Q4W [365 days 95% CI: 225, –] vs SECQ4W-R-PBO [171 days; 95% CI: 113, 337]). Among Week 52 HiSCR responders experiencing LOR, 43.8% (SECQ2W-R-Q2W), 57.5% (SECQ2W-R-PBO), 39.7% (SECQ4W-R-Q4W), and 34.1% (SECQ4W-R-PBO) achieved HiSCR at the time of LOR. Overall, secukinumab demonstrated a safety profile consistent with previous trials. 

Investigators concluded the primary endpoint of maintaining HiSCR at the time of LOR was not met, secukinumab demonstrated a safety profile consistent with previous trials. 

Source: academic.oup.com/bjd/advance-article/doi/10.1093/bjd/ljae469/7913451