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.

Background: SUNSHINE and SUNRISE demonstrated sustained clinical efficacy of secukinumab in patients with moderate-to-severe hidradenitis suppurativa (HS) through 52 weeks. Patients completing the core trials could enter a 4-year extension trial.

Objectives: To evaluate the long-term efficacy, safety/tolerability, and maintenance of clinical response of secukinumab through Week 104 in the extension trial.

Methods: Patients with a HS clinical response (HiSCR) at Week 52 of the core trials (extension trial baseline visit) entered a randomised withdrawal period. HiSCR responders receiving subcutaneous (s.c.) secukinumab 300 mg every 2/4 weeks (SECQ2W/SECQ4W) through Week 52 in the core trials were randomised 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; newly-defined for this trial) through Week 104 in Week 52 HiSCR responders (SECQ2W-R-Q2W vs. SECQ2W-R-PBO and SECQ4W-R-Q4W vs. SECQ4W-R-PBO). 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 remain in the trial on open-label secukinumab treatment. Additional endpoints included safety and HiSCR.

Results: Overall, 84.3% of patients completing the core trials entered the extension trial; 55.9% were Week 52 HiSCR responders. The primary endpoint was not met for either secukinumab dosing regimen. 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 secukinumab arms versus 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]). In Week 52 HiSCR responders reporting LOR, 43.8% (SECQ2W-R-Q2W), 57.5% (SECQ2W-R-PBO), 39.7% (SECQ4W-R-Q4W) and 34.1% (SECQ4W-R-PBO) were achieving HiSCR at the time of LOR. Overall, the safety of secukinumab was consistent with the core trials.

Conclusions: The primary endpoint of this trial was not met. HiSCR was maintained in many patients at the time of LOR. The safety of secukinumab was consistent with the previously characterised safety profile in the core trials.

Trial Registration: Clinicaltrials.gov ID NCT04179175.