a parallel, randomised, open-label clinical trial evaluating the safety and efficacy of methotrexate with apremilast in patients with moderate to severe palmoplantar psoriasis

Shilpadas ,Shazia ,G.Rajan ,Mojahidul Islam

» doi: http://https://ijpsl.co.in//.2021.v10.i01.pp01-011

Abstract

Various studies have revealed varying outcomes regarding the safety and effectiveness of apremilast in comparison to methotrexate. Therefore, more research into the function of Apremilast in palmoplantar psoriasis is required.Patients with moderate to severe palmoplantar psoriasis were the subjects of a randomized, prospective, parallel-group, open-label trial. For 16 weeks, they were randomly assigned to either the methotrexate group (n = 19) or the apremilast group (n = 22). Reduced scores on the modified palmoplantar psoriasis severity index (mPPPASI) from week 0 to week 16 served as the primary effectiveness metric. Additional metrics included the percentage of patients who achieved a Static Physician Global Assessment score of 0 (clear) or 1 (almost clear), the percentage of patients who achieved mPPPASI75 (75% reduction in mPPPASI score) by the end of 16 weeks, and the proportion of patients who demonstrated a dermatology life quality index decline of at least 5àpoints from the beginning.At 16 weeks, there was no statistically significant difference between the two groups in terms of m- PPPASI score drop, however there was a significant decline from week 0 to week 16 within the group. The secondary efficacy measures had identical outcomes. Out of the twenty-four adverse events documented in the methotrexate group, three individuals had abnormal liver function tests. Out of the 19 adverse events documented in the apremilast group, 2 patients had an infection of the upper respiratory tract.In the treatment of moderate to severe palmoplantar psoriasis, apremilast is just as effective as methotrexate, but it is more tolerable.Static Physician Global Assessment, Dermatology Life Quality Index, Palmoplantar Psoriasis, Palmoplantar Psoriasis Area and Severity Index, Apremilast