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Apremilast proven safe, effective for moderate hidradenitis suppurativa

13 Jan 2019

Apremilast (30 mg twice daily) is clinically effective and generally well tolerated in patients with moderate hidradenitis suppurativa (HS), results of a randomized controlled trial have shown.

Eight of 15 patients (53.3 percent) in the apremilast group and none of five (0 percent) in the placebo group met the HS clinical response at week 16 (p=0.055).

In addition, patients treated with apremilast vs placebo had significantly lower abscess and nodule count (mean difference, –2.6; 95 percent CI, –6.0 to –0.9; p=0.011), numerical rating scale for pain (mean difference, –2.7; –4.5 to –0.9; p=0.009) and itch (mean difference, –2.8; –5.0 to –0.6; p=0.015) over 16 weeks.

No significant between-group difference was observed in the Dermatology Life Quality Index over time (mean difference, –3.4; –9.0 to 2.3; p=0.230). The most common adverse events in the apremilast group were mild-to-moderate headache and gastrointestinal symptoms, which did not lead to dropouts.

To assess the efficacy and short-term safety of apremilast, the investigators randomized in a 3:1 ratio a total of 20 patients with moderate HS to receive blinded treatment with apremilast 30 mg twice daily or placebo for 16 weeks.

The primary endpoint was the Hidradenitis Suppurativa Clinical Response at week 16. Secondary clinical outcomes between treatment groups were evaluated using linear mixed effects modeling (analysis of covariance). The study was limited by its small sample size and relatively short duration.

“Effective anti-inflammatory treatments for HS are limited,” the investigators said.

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