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

Abstract

BackgroundApremilast 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. MethodsThe 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. ResultsThirty-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 repigmentation 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 addon apremilast group. However, results were comparable between groups. ConclusionsTreatment 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.

A systematic review of case series and clinical trials investigating systemic oral or injectable therapies for the treatment of vitiligo

“…The time interval between the start of apremilast and the beginning of repigmentation was reported to be 4 weeks, and the reduction of Vitiligo Area Scoring Index (VASI) was 1.24. In the control group, the beginning of repigmentation was reported after 7 weeks, and the reduction of VASI was reported to be 0.05 19 . When comparing NB‐UVB therapy alone to the combination of NB‐UVB and Apremilast therapy, there were no significant differences found in the VASI score, Dermatology Life Quality Index, and visual analog scale scores 20 .…”

“…Because of its ability to regulate the immune system and its positive safety record, apremilast is currently being studied as a potential treatment choice for various other inflammatory disorders 10,48 . In three out of the four studies we reviewed, the effectiveness of apremilast in treating vitiligo was confirmed, and no specific side effects were reported 10,19,21 . It is anticipated that this drug will become a widely used treatment option for vitiligo in the future.…”

Up-and-Coming Drugs for the Treatment of Vitiligo

“…However, the efficacy of apremilast, an oral PDE4 inhibitor, appears contradictory. While a phase 2 clinical trial involving 80 vitiligo patients ended up with no additional benefit when combined with conventional phototherapy, several studies have suggested that apremilast may potentiate phototherapy and halt disease progression, particularly advantageous to patients with darker skin 94 95 96 97 98 . There are few case reports supporting the use of crisaborole, a topical PDE4 inhibitor 99 100 .…”

Vitiligo: Pathogenesis and New and Emerging Treatments

“…Regarding apremilast, all selected studies utilize a dose of 30 mg twice daily [57][58][59][60][61][62]. In 2019, a case series [58] and a case report [57] showed the utility of apremilast in monotherapy in vitiligo.…”

“…Two clinical trials compared the improvement with the addition of apremilast to NB-UVB treatment with conflicting results [60,61]. Recently, Sharma et al [62] have reported an improved response of vitiligo after adding apremilast to standard treatment. In most studies, headache and gastrointestinal discomfort have been reported as the main adverse effects of the treatment.…”