Secukinumab effectively reduces symptoms and signs of hidradenitis suppurativa

Secukinumab, when administered every two weeks, was clinically successful at reducing the symptoms and signs of hidradenitis suppurativa while maintaining a favourable safety profile and a sustained response for up to 52 weeks, says an article published in The Lancet.

Patients with mild-to-severe hidradenitis suppurativa have few treatment choices. In order to determine the effectiveness of secukinumab in patients with moderate-to-severe hidradenitis suppurativa, Alexa Kimball and team conducted two randomised trials.

SUNSHINE and SUNRISE were identical phase 3 trials conducted across 219 primary sites in 40 different countries. They were multicentre, randomised, placebo-controlled, and double-blind. Patients with mild-to-severe hidradenitis suppurativa for at least a year were required to be at least 18 years old, capable of giving written informed consent, and eligible for inclusion. While receiving research medication, the included patients additionally consented to applying topical over-the-counter antiseptics to the regions where hidradenitis suppurativa lesions were present every day. Patients were disqualified if they had at least 20 fistulae at baseline, had active conditions that required continuous drug use, or satisfied other exclusion requirements.

Based on the quantity of abscesses, draining fistulae, inflammatory nodules, total fistulae, and other lesions in the hidradenitis suppurativa affected areas, the clinical response to hidradenitis suppurativa was estimated. According to the standard language criteria for adverse events, which were classified using the Medical Dictionary for Regulatory Activities terminology, the existence of adverse events and major adverse events was evaluated in order to determine safety.

The key findings of the study were:

1. In the SUNSHINE trial, hidradenitis suppurativa clinical response occurred in considerably more patients receiving secukinumab every two weeks compared to the placebo group.

2. The total number of individuals in the secukinumab every 4 weeks group and the placebo group did not differ significantly, nevertheless.

3. In the SUNRISE trial, there were noticeably more patients who experienced a hidradenitis suppurativa clinical response in the secukinumab every 2 weeks and secukinumab every 4 weeks groups compared to the placebo group.

4. Patient responses persisted through week 52 of the trials, when they came to an end.

5. In both the SUNSHINE and SUNRISE trials, headache was the most frequent adverse event according to the preferred term up to week 16.

Reference:

Kimball, A. B., Jemec, G. B. E., Alavi, A., Reguiai, Z., Gottlieb, A. B., Bechara, F. G., Paul, C., Giamarellos Bourboulis, E. J., Villani, A. P., Schwinn, A., Ruëff, F., Pillay Ramaya, L., Martorell, A., Mendes-Bastos, P., Kokolakis, G., … Muscianisi, E. (2023). Secukinumab in moderate-to-severe hidradenitis suppurativa (SUNSHINE and SUNRISE): week 16 and week 52 results of two identical, multicentre, randomised, placebo-controlled, double-blind phase 3 trials. In The Lancet (Vol. 401, Issue 10378, pp. 747–761). Elsevier BV. https://doi.org/10.1016/s0140-6736(23)00022-3