Secukinumab for Patients with Moderate-to-Severe Hidradenitis Suppurativa: Post Hoc Analyses of Efficacy Endpoints, Draining Tunnels, Skin Pain, and Work Productivity

Abstract

Hidradenitis suppurativa (HS) is a chronic, recurrent follicular skin disease characterised by deep and painful dermal inflammatory nodules, abscesses, and draining tunnels. HS is one of the dermatological diseases with the greatest unmet medical need. Post hoc analyses from two identically designed Phase III trials of secukinumab in patients with moderate-to-severe HS (SUNSHINE and SUNRISE) were featured in multiple poster and oral presentations at the 32nd annual European Academy of Dermatology and Venereology (EADV) Congress in Berlin, Germany. The SUNSHINE and SUNRISE studies represent the largest Phase III trials conducted in HS to date. In these studies, secukinumab demonstrated sustained efficacy with a favourable safety profile, with both trials meeting the primary endpoint. The analyses presented at the EADV Congress were conducted to assess concordance between efficacy endpoints (55% reduction in Hidradenitis Suppurativa Severity Scoring System [IHS4-55] response and Hidradenitis Suppurativa Clinical Response [HiSCR]); the impact of secukinumab on HiSCR 75, HiSCR 90, and HiSCR 100 endpoints; and the effect of secukinumab on draining tunnels and HS-related pain, as well as work productivity and activity impairment (WPAI). Strong concordance between IHS4-55 and HiSCR was found, and IHS4-55 was considered to be a suitable efficacy outcome for HS. Secukinumab also provided clinically meaningful improvements compared with placebo, as determined by HiSCR 75, HiSCR 90, and HiSCR 100 endpoints by Week 16. These effects were sustained through Week 52. Furthermore, at Week 16, >80% of patients treated with secukinumab experienced no increase in the number of draining tunnels from baseline. Secukinumab also improved HS-related skin pain, and reduced the use of pain medication compared with placebo. Finally, treatment with secukinumab had a beneficial and sustained effect on presenteeism, absenteeism, and general work impairment due to HS. These data, taken together, indicate that secukinumab provides sustained disease control, sustained reduction in pain, and sustained improvement in WPAI and occupational performance up to Week 52.