Efficacy of Treatment With Secukinumab in Patients With Hidradenitis Suppurativa

Hidradenitis suppurativa is a chronic inflammatory skin condition, characterized by recurrent nodules, abscesses, and draining tunnels. There are several validated tools that help characterize hidradenitis suppurativa disease severity and response to treatments in both the clinic and clinical trial settings. Some of the most commonly used tools have clear limitations. The Hurley staging system, for example, is a static snapshot of disease that grades severity based primarily on the extent of tissue destruction but does not measure disease activity and is, therefore, not appropriate for monitoring treatment response. Hidradenitis Suppurativa Clinical Response, ie, HiSCR, which is the most widely used outcome measure in hidradenitis suppurativa clinical trials, does not account for improvements in draining tunnels, which may have an even greater impact on the quality of life than inflammatory nodules.

The authors of this post hoc analysis of data from the SUNSHINE and SUNRISE trials used the International Hidradenitis Suppurativa Severity Scoring System (IHS4) and IHS4-55 (a 55% reduction in the IHS4 score from baseline) to determine the efficacy of secukinumab. The IHS4 assessment tool includes draining tunnels and accounts for lesion severity, weighing them accordingly (the number of nodules [multiplied by 1 point], number of abscesses [multiplied by 2 points], and number of draining tunnels [multiplied by 4 points]). Treatment with secukinumab (every 2 weeks and every 4 weeks) resulted in greater reductions in the IHS4 score at week 16 compared to placebo, and the reduction was maintained through week 52. In addition, a greater proportion of patients in the secukinumab treatment groups achieved an IHS4-55 response at week 16 compared with those in the placebo group. IHS4-55 demonstrated strong concordance with HiSCR.

Interestingly, among patients with Hurley stage I disease (traditionally thought of as "mild" hidradenitis suppurativa), 45% and 55% had moderate and severe disease, respectively, based on the IHS4 classification. This highlights the importance of not relying on the Hurley stage to determine biologic candidacy for patients with hidradenitis suppurativa. A patient with one abscess and two inflammatory nodules but no scarring or tunnels has Hurley stage I disease but would be considered to have moderate disease severity using tools such as IHS4 and the Hidradenitis Suppurativa Physician's Global Assessment scale. In addition, beyond disease activity, factors such as treatments tried and failed and the impact on functional status and quality of life must also be taken into account when considering biologic candidacy. Timely intervention with appropriate long-term therapeutic strategies should be implemented to try to prevent disease progression and irreversible tissue damage. Continued research regarding outcome measures is needed to ensure that our clinical trial endpoints capture meaningful change.