Soufila Kt1, Vishal Thakur1, Tarun Narang2, Sunil Dogra1, Sanjeev Handa1. 1. Department of Dermatology, Venereology and Leprology, Postgraduate Institute of Medical Education and Research, Sector 12, Chandigarh, India. 2. Department of Dermatology, Venereology and Leprology, Postgraduate Institute of Medical Education and Research, Sector 12, Chandigarh, India. narangtarun@yahoo.co.in.
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.
RCT Entities:
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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