This randomized clinical trial sought to determine the tolerability and effectiveness of Apremilast and Methotrexate in individuals suffering from palmoplantar psoriasis.

In this parallel-group, prospective, open-label study, participants (aged between 18 and 65 years) battling palmoplantar psoriasis were randomly allocated into two groups: Methotrexate (n = 19) or Apremilast (n = 22) for a duration of sixteen weeks. From week 0 to week sixteen, the decrease in the modified Palmoplantar Psoriasis Area and Severity Index (mPPPASI) score was the key effectiveness outcome.

Secondary outcomes encompassed: (a) Proportion of people achieving mPPPASI75 (75% drop in mPPPASI score) at the end of sixteen weeks, (b) Proportion of people achieving a Static Physician Global Assessment score of 0 (clear) or 1 (almost clear), and (c) Proportion of people exhibiting at least a five-point decrease in the Dermatology Life Quality Index (DLQI) from the baseline.

While there was a noteworthy decline in the m-PPPASI score within each group from week 0 to week 16, the difference in the score reduction between the two groups at 16 weeks was not statistically significant, as depicted in Figure 1:

Comparable results were witnessed with the secondary efficacy parameters. In the Methotrexate group, 24 adverse events were recorded, including abnormal liver function tests in three subjects. In the Apremilast arm, 19 adverse events were documented, with two subjects experiencing upper respiratory tract infections.

Apremilast demonstrated efficiency comparable to Methotrexate in tackling moderate-to-severe palmoplantar psoriasis with improved tolerability. Therefore, it could be considered as an alternative to established drugs for palmoplantar psoriasis-affected people who do not respond to or tolerate other medications.