Comparative evaluation of efficacy and tolerability of apremilast and methotrexate in patients of moderate-to-severe palmoplantar psoriasis: A randomized, parallel, open-label clinical trial

Abstract

Abstract: BACKGROUND: Variable results about efficacy as well as safety of apremilast compared to methotrexate are reported in different trials. Hence, it is necessary to collect more evidence to prove the role of Apremilast in palmoplantar psoriasis. METHODOLOGY: The study was a randomized, prospective, parallel-group, open-label study conducted in patients with moderate-to-severe palmoplantar psoriasis. They were randomized into two groups, methotrexate (n = 19) or apremilast (22) for 16 weeks. Primary efficacy parameter was reduction in modified palmoplantar psoriasis area and severity index (mPPPASI) score from week 0 to week 16. Other parameters were proportion of patients attaining Static Physician Global Assessment score of 0 (clear) or 1 (almost clear), proportion of patients attaining mPPPASI75 (75% reduction in mPPPASI score) at the end of 16 weeks, and proportion of patients showing at least 5-point decline in dermatology life quality index from baseline. RESULTS: Decline in m-PPPASI score from 0 week to 16 weeks within the group was significant statistically though decline in score of m-PPPASI between these two groups was not statistically significant at 16 weeks. Similar results were obtained with the secondary efficacy parameters. In methotrexate group, there were 24 adverse events recorded including abnormal liver function tests in three patients. In apremilast group, 19 adverse events were recorded, in which two patients suffered from upper respiratory tract infection. CONCLUSION: Apremilast is as effective as methotrexate for the management of moderate-to-severe palmoplantar psoriasis with better tolerability. Hence, it can be considered alternative to established drugs in patients having palmoplantar psoriasis not responding to or tolerating other drugs. REGISTRATION: The study was registered with Clinical Trial Registry of India (CTRI/2020/05/025198).