An open-label, randomised, parallel clinical research evaluating the safety and efficacy of methotrexate and apremilast in patients with moderate to severe palm plantar psoriasis

Abstract

Comparing apremilast to methotrexate, many studies have produced conflicting results on its efficacy and safety. Therefore, additional study is needed to determine how Apremilast works in palmoplantar psoriasis.A randomised, prospective, parallel-group, open-label
study was conducted on patients with moderate to severe palmoplantar psoriasis. They were randomised to either the apremilast group (n = 22) or the methotrexate group (n = 19) for a duration of 16 weeks. The main efficacy parameter was decreased scores on the modified palmoplantar psoriasis severity index (mPPPASI) between weeks 0 and 16. The proportion of patients who showed a dermatology life quality index decline of at least 5àpoints from the start, the percentage of patients who achieved mPPPASI75 (75%
reduction in mPPPASI score), and the percentage of patients who obtained a Static Physician Global Assessment score of 0 (clear) or 1 (almost clear) were additional metrics.Although there was a substantial reduction from week 0 to week 16 within the group, there was no statistically significant difference in the drop in m-PPPASI scores between the two groups at 16 weeks. The results of the secondary efficacy measures were the same. Three people had abnormal liver function tests out of the twenty-four adverse events reported in the methotrexate group. Two individuals had an upper respiratory tract infection out of the 19 adverse events reported in the apremilast group.Apremilast is more tolerated than methotrexate when used to treat moderate to severe palmoplantar psoriasis. Static Physician Global Assessment, Dermatology Life Quality Index, Palmoplantar Psoriasis, Palmoplantar Psoriasis Area and Severity Index, Apremilast.