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Comparison of the Efficacy and Safety of Apremilast and Methotrexate in Patients with Palmoplantar Psoriasis: A Randomized Controlled Trial

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Abstract

Background

Placebo-controlled studies have reported the efficacy of apremilast in the management of palmoplantar psoriasis but studies comparing efficacy with a conventional agent are lacking.

Objective

The objective of this article was to  compare the efficacy and safety of apremilast and methotrexate in patients with palmoplantar psoriasis.

Methods

In this prospective, randomized, active-controlled, observer-blinded clinical trial, conducted at a psoriasis clinic of a tertiary care institute in India from 1 July, 2019 to 1 June, 2020, 84 patients with palmoplantar psoriasis were randomized (1:1) to receive either methotrexate (0.4 mg/kg/week orally) or apremilast (30 mg twice daily). The treatment protocol was continued for 16 weeks or until achieving a ≥ 75% improvement in the Modified Palmoplantar Psoriasis Area and Severity Index (m-PPPASI 75), whichever was earlier. Changes in m-PPPASI and Dermatology Life Quality Index scores from baseline, the proportion of patients achieving m-PPPASI 75, and adverse events were assessed.

Results

Eighty-four patients were included (76 palmoplantar psoriasis and 8 palmoplantar pustulosis). The mean age (standard deviation) was 44.5 (12.9) years and 53 (63%) were women. The m-PPPASI score [median (interquartile range)] after 16 weeks of treatment showed a significant improvement from baseline in both apremilast [− 6.3 (10.9), p < 0.001] and methotrexate groups [− 8.5 (9.9), p < 0.001]. The estimated median difference between the groups was − 1.2 (p = 0.39, 95% confidence interval − 4.2 to 2.1). At 16 weeks, m-PPPASI 75 was achieved by 14/42 (33%) and 17/42 (41%) patients in the apremilast and methotrexate groups, respectively (p = 0.49). A significant reduction in the Dermatology Life Quality Index score [median (interquartile range)] was observed in both groups [apremilast: − 3.0 (6.0), p < 0.001; methotrexate: − 3.0 (6.3), p < 0.001] with an estimated median difference of 0.0 (p = 0.99, 95% confidence interval − 1.0 to 2.0). The proportion of patients experiencing adverse events was comparable (p = 0.49).

Conclusions

Apremilast showed a comparable efficacy and safety profile to methotrexate in the management of palmoplantar psoriasis.

Clinical Trial Registration

CTRI/2019/06/019830, date of registration: 24 June, 2019; trial registered prospectively.

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Authors and Affiliations

  1. Department of Dermatology, Venereology and Leprology, Postgraduate Institute of Medical Education and Research, Sector 12, Chandigarh, India

    Soufila KT, Vishal Thakur, Tarun Narang, Sunil Dogra & Sanjeev Handa

Authors
  1. Soufila KT
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  2. Vishal Thakur
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  3. Tarun Narang
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  4. Sunil Dogra
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  5. Sanjeev Handa
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Corresponding author

Correspondence to Tarun Narang.

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Funding

No sources of funding were received for the conduct of this study or the preparation of this article.

Conflict of Interest

Soufila KT, Vishal Thakur, Tarun Narang,Sunil Dogra, and Sanjeev Handa have no conflicts of interest that are directly relevant to the content of this article.

Ethics Approval

This study was performed in line with the principles of the Declaration of Helsinki. Approval was granted by the institutional ethics committee.

Consent to Participate

Informed consent was obtained from all individual participants included in the study.

Availability of Data and Material

The datasets generated and analyzed during the current study are available from the corresponding author on reasonable request.

Author Contributions

Study concept and design: SKT, VT, TN, SD, SH. Analysis and interpretation of data: SKT, VT, TN, SD. Drafting of the manuscript: SKT, VT, TN. Critical revision of the manuscript for important intellectual content: TN, SD, SH. Statistical analysis: SKT, VT. Study supervision: TN, SD, SH.

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KT, S., Thakur, V., Narang, T. et al. Comparison of the Efficacy and Safety of Apremilast and Methotrexate in Patients with Palmoplantar Psoriasis: A Randomized Controlled Trial. Am J Clin Dermatol 22, 415–423 (2021). https://doi.org/10.1007/s40257-021-00596-6

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  • DOI: https://doi.org/10.1007/s40257-021-00596-6

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