Apremilast Add-On Benefits Over Conventional Drugs (ABCD) in Unstable Non-segmental Vitiligo: A 12-Week Single-Center Randomized Controlled Trial.

apremilast autoimmune diseases bsa dlqi non-segmental vitiligo phosphodiesterase 4 inhibitors unstable vitiligo vasi

Journal

Cureus
ISSN: 2168-8184
Titre abrégé: Cureus
Pays: United States
ID NLM: 101596737

Informations de publication

Date de publication:
Apr 2023
Historique:
accepted: 05 04 2023
medline: 8 5 2023
pubmed: 8 5 2023
entrez: 8 5 2023
Statut: epublish

Résumé

Background Apremilast is an oral phosphodiesterase-4 enzyme inhibitor that modulates the immune system by increasing intracellular cyclic adenosine monophosphate levels and inhibiting inflammatory cytokines synthesis. We aimed to compare the efficacy and safety of add-on apremilast in combination therapy with standard treatment in patients with unstable, non-segmental vitiligo. Methods The study was a 12-week randomized, controlled, parallel-group, open-labeled trial. The control group received standard treatment (n=15), and the intervention group received 30 mg apremilast twice daily in addition to standard treatment (n= 16). Time to the first sign of re-pigmentation, halt in progression, and change in vitiligo area scoring index (VASI) score is the primary outcomes. Normality was assessed, and appropriate parametric and nonparametric tests were undertaken. Results Thirty-seven participants were randomized into two groups, and analysis was done on thirty-one participants. Over the treatment duration of 12 weeks, the median time to observe the first sign of re-pigmentation was four weeks in the add-on apremilast group compared to seven weeks in the control group (p=0.018). The halt in progression was observed more in the add-on Apremilast group (93.75%) compared to the control group (66.66%) (p=0.08). The VASI score decreased by 1.24 in the add-on apremilast group and 0.05 in the control group (p= 0.754). Parameters including body surface area, dermatology life quality index, and body mass index reduced significantly, while the visual analog scale increased significantly in the add-on apremilast group. However, results were comparable between groups. Conclusions Treatment with add-on apremilast accelerated clinical improvement. It also reduced disease progression and improved the disease index among participants. However, add-on apremilast had a lower tolerability profile than the control group.

Identifiants

pubmed: 37153322
doi: 10.7759/cureus.37180
pmc: PMC10162885
doi:

Types de publication

Journal Article

Langues

eng

Pagination

e37180

Informations de copyright

Copyright © 2023, Sharma et al.

Déclaration de conflit d'intérêts

The authors have declared that no competing interests exist.

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Auteurs

Sakshi Sharma (S)

Pharmacology, All India Institute of Medical Sciences, Jodhpur, IND.

Abhishek Bhardwaj (A)

Dermatology, All India Institute of Medical Sciences, Jodhpur, IND.

Pradeep Dwivedi (P)

Pharmacology, All India Institute of Medical Sciences, Jodhpur, IND.

Suraj Singh Yadav (SS)

Pediatrics, All India Institute of Medical Sciences, Jodhpur, IND.

Muhammad Aaqib Shamim (MA)

Pharmacology, All India Institute of Medical Sciences, Jodhpur, IND.

Surjit Singh (S)

Pharmacology, All India Institute of Medical Sciences, Jodhpur, IND.

Prem Prakash Sharma (PP)

Community and Family Medicine, All India Institute of Medical Sciences, Jodhpur, IND.

Sneha Ambwani (S)

Pharmacology, All India Institute of Medical Sciences, Jodhpur, IND.

Kuldeep SIngh (K)

Pediatrics, All India Institute of Medical Sciences, Jodhpur, IND.

Classifications MeSH