The latest results of the SUNSHINE and SUNRISE trials showed that the treatment response with secukinumab among patients with hidradenitis suppurativa (HS) continued to improve during the long-term follow-up.¹ The positive findings gave great promise in delivering a new treatment option for patients living with HS.¹

HS is a chronic inflammatory skin condition deriving from hair follicles, affecting 1% of the global population.² It causes lesions in intertriginous areas rich in apocrine glands, leading to severe pain, pruritus, malodorous discharge and scarring in sensitive locations.² The disease also causes sleep and sexual dysfunction, low self-esteem, and psychosocial impacts, with many patients reporting increased rates of depression and social isolation.^2,3 Despite the debilitating nature of HS, adalimumab, a tumor necrosis factor-alpha (TNFα) inhibitor, is currently the only approved therapy for moderate-to-severe HS.³ Hence, a huge unmet need in HS patients remains.

Secukinumab is the first and only fully human biologic interleukin (IL)-17A inhibitor.¹ Since IL-17A plays a central role in the pathogenesis of HS, the use of secukinumab for the treatment of HS patients was thought to be highly promising.⁴ The safety and efficacy of secukinumab among patients with moderate-to-severe HS were then evaluated in SUNSHINE (n=541) and SUNRISE (n=543), which were 2 identical phase 3, multicenter, randomized, double-blind trials conducted across 219 primary sites in 40 countries.⁴ These trials enrolled adult patients with moderate-to-severe HS, defined by ≥5 inflammatory lesions affecting ≥2 distinct anatomical areas for at least 1 year.⁴ Participants were assigned 1:1:1 to receive secukinumab 300mg every 2 weeks (Q2W), secukinumab 300mg every 4 weeks (Q4W), and placebo respectively.⁴  The primary endpoint was the proportion of patients achieving clinical response, defined as a decrease in abscess and inflammatory nodule count by ≥50% with no increase in the number of abscesses or draining fistulas, at week 16.⁴  

Results showed that the primary endpoint was met for both trials in the secukinumab Q2W groups.⁴ In SUNSHINE, 45% of participants in the Q2W dosing group vs. 34% in the placebo group achieved an HS clinical response (OR=1.8; 95% CI: 1.1-2.7; p=0.0070) at week 16; while in SUNRISE, it was 42% vs. 31% (OR=1.6; 95% CI: 1.1-2.6; p=0.015).⁴ For the Q4W group, the primary endpoint was not met in the SUNSHINE trial (Q4W: 42% vs. placebo: 60.7%; OR=1.5; 95% CI: 1.0-2.3; p=0.042) but was met in the SUNRISE trial (Q4W: 46% vs. placebo: 31%; OR=1.9; 95% CI: 1.2-3.0; p=0.0022).⁴ With a longer treatment duration of 1 year, the clinical efficacy of secukinumab observed at week 16 was sustained through week 52 in both trials.⁴ In a post-hoc analysis of SUNRISE and SUNSHINE, the majority of patients with a clinical response at week 16 maintained the response at week 52 in both the SUNSHINE (76% in the Q2W group; 81% in the Q4W group) and SUNRISE trials (84% in the Q2W group; 77% in the Q4W group).⁴

In both trials, secukinumab was well tolerated.⁴ The rates of adverse events (AEs) were similar across all the study arms.⁴ The most frequently reported AEs by preferred term in both trials were headache, nasopharyngitis, and worsening of hidradenitis up to week 16.⁴ No new safety signals were identified up to week 52.⁴

In summary, secukinumab 300mg Q2W was effective in rapidly improving signs and symptoms of HS within 16 weeks, with the response sustained up to 52 weeks of the treatment.⁴ The encouraging results might soon offer patients with moderate-to-severe HS a much-needed alternative to better control their disease and improve their quality of life.⁴