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.