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American Journal of Clinical Dermatology

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01-05-2021 | Methotrexate | Original Research Article

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

Authors: Soufila KT, Vishal Thakur, Tarun Narang, Sunil Dogra, Sanjeev Handa

Published in: American Journal of Clinical Dermatology | Issue 3/2021

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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Title: Comparison of the Efficacy and Safety of Apremilast and Methotrexate in Patients with Palmoplantar Psoriasis: A Randomized Controlled Trial
Authors: Soufila KT
Vishal Thakur
Tarun Narang
Sunil Dogra
Sanjeev Handa
Publication date: 01-05-2021
Publisher: Springer International Publishing
Keywords: Methotrexate
Vulgar Psoriasis
Methotrexate
Published in: American Journal of Clinical Dermatology / Issue 3/2021
Print ISSN: 1175-0561
Electronic ISSN: 1179-1888
DOI: https://doi.org/10.1007/s40257-021-00596-6

Keynote webinar | Spotlight on medication adherence

Springer Medicine

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

Abstract

Background

Objective

Methods

Results

Conclusions

Clinical Trial Registration

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Objective

Methods

Results

Conclusions

Clinical Trial Registration

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