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

医学 耐受性 银屑病 甲氨蝶呤 银屑病面积及严重程度指数 不利影响 随机对照试验 剂量 口服 生物利用度 内科学 临床试验 可视模拟标度 透皮 胃肠病学 麻醉 药理学 皮肤病科
作者
Charoen Choonhakarn,Suteeraporn Chaowattanapanit,Narachai Julanon,Panita Limpawattana
出处
期刊:Clinical and Experimental Dermatology [Wiley]
卷期号:47 (5): 942-948 被引量:9
标识
DOI:10.1111/ced.15102
摘要

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.
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