Apremilast for moderate hidradenitis suppurativa: Results of a randomized controlled trial - 13/12/18
, Martijn B.A. van Doorn, MD, PhD, Hessel H. van der Zee, MD, PhD, Errol P. Prens, MD, PhDAbstract |
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.
Le texte complet de cet article est disponible en PDF.Key words : acne inversa, efficacy, PDE4, phosphodiesterase 4 inhibitor, randomized controlled trial, safety, tolerability, treatment
Abbreviations used : AE, AN, DLQI, HiSCR, HS, HS-PGA, NRS
Plan
| Funding sources: Sponsored by Celgene. |
|
| Disclosure: Dr van der Zee is an advisory board member for AbbVie, InflaRX, and Galderma. Dr Prens is a consultant, speaker, and/or principal investigator and/or has received grants from Abbvie, Amgen, Biogen, Celgene, Eli Lilly and Company, Janssen-Cilag, Novartis, Pfizer, and UCB. Dr van Doorn is a consultant, speaker, and/or principal investigator and/or has received grants from Abbvie, Celgene, Eli Lilly and Company, Janssen-Cilag, Novartis, Pfizer, Cutanea Life Sciences, and Idera Pharmaceuticals. Dr Vossen has no conflicts of interest to disclose. |
|
| Reprints not available from the authors. |
Vol 80 - N° 1
P. 80-88 - janvier 2019 Retour au numéro
Article précédent
- Ixekizumab provides superior efficacy compared with ustekinumab over 52 weeks of treatment: Results from IXORA-S, a phase 3 study
- Carle Paul, Christopher E.M. Griffiths, Peter C.M. van de Kerkhof, Lluís Puig, Yves Dutronc, Carsten Henneges, Martin Dossenbach, Kristin Hollister, Kristian Reich
- A phase 2, randomized dose-finding study of tapinarof (GSK2894512 cream) for the treatment of atopic dermatitis
- Johnny Peppers, Amy S. Paller, Tomoko Maeda-Chubachi, Sterling Wu, Kevin Robbins, Kelly Gallagher, John E. Kraus
Bienvenue sur EM-consulte, la référence des professionnels de santé.
L’accès au texte intégral de cet article nécessite un abonnement.
Déjà abonné à cette revue ?