Apremilast for moderate hidradenitis suppurativa: results of a randomized controlled trial

Publication date: Available online 3 July 2018

Source: Journal of the American Academy of Dermatology

Author(s): Allard R.J.V. Vossen, M.B.A. van Doorn, Hessel H. van der Zee, Errol P. Prens

Abstract

Background

Effective anti-inflammatory treatments for hidradenitis suppurativa (HS) are limited.

Objective

To evaluate the efficacy and short-term safety of apremilast in patients with moderate HS.

Methods

Twenty patients with moderate HS were randomised in a 3 : 1 ratio, to receive blinded treatment with apremilast 30 mg twice daily or placebo for 16 weeks. The primary outcome was the Hidradenitis Suppurativa Clinical Response (HiSCR) at week 16. Linear mixed effects modeling (ANCOVA) was used to assess secondary clinical outcomes between treatment groups.

Results

The HiSCR was met in 8 of 15 (53.3%) patients in the apremilast group and none of 5 patients (0%) in the placebo group (P=0.055) at week 16. Moreover, apremilast-treated patients showed a significantly lower abscess and nodule count (mean difference -2.6; 95% confidence interval -6.0, -0.9; P=0.011), NRS for pain (-2.7; -4.5, -0.9; P=0.009) and itch (-2.8; -5.0, -0.6; P=0.015) over 16 weeks compared with placebo-treated patients. There was no significant difference in the DLQI over time between the two treatment groups (-3.4; -9.0, 2.3; P=0.230). The most frequently reported adverse events in the apremilast-treated patients were mild to moderate headache and gastro-intestinal symptoms, which have not resulted in drop-outs.

Limitations

Small number of patients, relatively short study duration.

Conclusion

Apremilast at a dose of 30 mg twice daily demonstrated clinically meaningful efficacy and was generally well tolerated in patients with moderate HS.