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Off-label studies on apremilast in dermatology: a review.

ABSTRACT: Purpose: Apremilast is a phosphodiesterase-4 inhibitor FDA approved for psoriatic arthritis and moderate to severe plaque psoriasis. In recent years, multiple studies have suggested other potential uses for apremilast in dermatology. A summary of these various studies will be a valuable aid to dermatologists considering apremilast for an alternative indication.Materials and methods: The PubMed/MEDLINE and ClinicalTrials.gov databases were queried with the term 'apremilast,' with results manually screened to identify published data on off-label uses of apremilast. The article was structured by the quality of evidence available.Results: Apremilast use in dermatology beyond plaque psoriasis and psoriatic arthritis is frequently described in the literature, with a mixture of positive and negative results. Randomized controlled data is available for Behçet's disease, hidradenitis suppurativa, nail/scalp/palmoplantar psoriasis, alopecia areata, and atopic dermatitis.Conclusion: The relatively safe adverse effect profile of apremilast and its broad immunomodulatory characteristics may make it a promising option in the future for patients with difficult to treat diseases in dermatology, refractory to first line therapies, but further studies will be necessary to clarify its role.

SUBMITTER: Maloney NJ

PROVIDER: S-EPMC6774908 | biostudies-literature | 2020 Mar

REPOSITORIES: biostudies-literature

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Off-label studies on apremilast in dermatology: a review.

Maloney Nolan J NJ Zhao Jeffrey J Tegtmeyer Kyle K Lee Ernest Y EY Cheng Kyle K

The Journal of dermatological treatment 20190402 2

<b>Purpose:</b> Apremilast is a phosphodiesterase-4 inhibitor FDA approved for psoriatic arthritis and moderate to severe plaque psoriasis. In recent years, multiple studies have suggested other potential uses for apremilast in dermatology. A summary of these various studies will be a valuable aid to dermatologists considering apremilast for an alternative indication.<b>Materials and methods:</b> The PubMed/MEDLINE and ClinicalTrials.gov databases were queried with the term 'apremilast,' with re ...[more]

PMID: 30935262

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Project description:BackgroundThis review's goals were to investigate apremilast's efficacy versus placebo in palmoplantar psoriasis (PP) and palmoplantar pustulosis (PPP), and apremilast's efficacy versus methotrexate in PP.MethodsA literature search was conducted in PubMed, clinicaltrials.gov, and Embase in July 2022. Publications investigating subjects with PP or PPP, treated with apremilast, which reported palmoplantar-specific outcomes were used. Exclusion criteria included cases of drug-induced PP/PPP, case studies, non-English texts, omission of palmoplantar-specific outcomes, and incomplete publications. Studies were assessed for risk of bias using Cochrane Review Manager application and CASP checklist. Primary endpoints were a 50% improvement of the Palmoplantar Psoriasis/Pustulosis Area and Severity Index (PPPASI 50) and improvement of the Palmoplantar Physician Global Assessment (PPPGA) to 0 or 1 in patients with baseline PPPGA ≥ 3.ResultsSeventeen original studies including five placebo-controlled randomized clinical trials (RCTs), one phase II clinical trial, two randomized methotrexate comparative trials, six cohort studies, and three case series were analyzed, totaling 1117 participants. Meta-analysis of four placebo-controlled RCTs investigating PP found apremilast treatment to be superior to placebo in achieving a PPPGA of 0/1 (baseline PPPGA of ≥ 3) after 16 weeks of treatment (n = 244; OR = 2.69 [1.39-5.22]). Apremilast was superior to placebo in achieving PPPASI 50 at week 16 in the only placebo-controlled RCT of PPP (78.3 vs. 40.9%) [P = 0.0003]. Apremilast was comparable to methotrexate in achieving PPPASI 50 at week 16 in PP (59.5 vs. 64.3%; n = 84; [P = 0.65]). Non-randomized studies generally showed marked improvement in PPPASI, PPPGA, and DLQI scores following apremilast treatment.DiscussionApremilast treatment in PP and PPP resulted in significant improvement in objective, palmoplantar-specific clinical parameters versus placebo, and comparable efficacy with methotrexate in PP. Limitations in interpreting these results include variations in palmoplantar-specific metrics used and risk of bias of included studies.

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Off-label studies on apremilast in dermatology: a review.

Publications

Off-label studies on apremilast in dermatology: a review.

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