Secukinumab provides long-lasting symptom improvement in HS patients

04 Apr 2023

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

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