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

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: A total of 20 patients with moderate HS were randomized 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 at week 16. Linear mixed effects modeling (analysis of covariance) was used to assess secondary clinical outcomes between treatment groups.

Results: The HS clinical response was met in 8 of 15 patients in the apremilast group (53.3%) and none of 5 patients in the placebo group (0%) (P = .055) at week 16. Moreover, the apremilast-treated patients showed a significantly lower abscess and nodule count (mean difference, -2.6; 95% confidence interval, -6.0 to -0.9; P = .011), NRS for pain (mean difference, -2.7; 95% -4.5 to -0.9; P = .009), and itch (mean difference, -2.8; 95% confidence interval, -5.0 to -0.6; P = .015) over 16 weeks compared with the placebo-treated patients. There was no significant difference in the Dermatology Life Quality Index over time between the 2 treatment groups (mean difference, -3.4; 95% confidence interval, -9.0 to 2.3; P = .230). The most frequently reported adverse events in the apremilast-treated patients were mild-to-moderate headache and gastrointestinal symptoms, which did not result in dropouts.

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.

Keywords: PDE4; acne inversa; efficacy; phosphodiesterase 4 inhibitor; randomized controlled trial; safety; tolerability; treatment.