Comparison of the clinical efficacy of subcutaneous vs. oral administration of methotrexate in patients with psoriasis vulgaris: a randomized controlled trial.

ABSTRACT

BACKGROUND: Evidence demonstrates that parenteral administration of methotrexate (MTX) has a higher drug bioavailability than oral administration. This difference is even more pronounced for medium to high dosages. AIM: To compare the efficacy, safety, and tolerability of oral and subcutaneous (SC) MTX for treatment of psoriasis. METHODS: A randomized, comparative, single-blind, 32-week study was conducted. The clinical response was evaluated using the Psoriasis Area Severity Index (PASI) and patient global satisfaction was assessed using a visual analogue scale (VAS). RESULTS: In total, 77 completed the study 38 in the SC and 39 in the oral MTX group. No significant between-group differences were found in the number attaining PASI improvement of 75% (PASI75), 90% (PASI90) and 100% (PASI100) at Weeks 16 and 32 PASI75 (P = 0.14 and P = 0.21, respectively), PASI90 (P = 0.23 and P = 0.18) and PASI100 (P = 0.62 and P = 0.22). According to the mean VAS, no significant differences between the groups were found at any time points except at Week 32 that the mean VAS was significantly higher in the SC group (P = 0.03). Adverse events were comparable in both groups. CONCLUSION: SC and oral administration of MTX had similar efficacies in improving the PASI score even at the highest tolerable dose; however, the SC MTX group had higher overall patient satisfaction than the oral MTX group. No difference in tolerability was found.