Department of Dermatology and Venereology All India Institute of Medical Sciences, New Delhi, India.
Department of Biostatistics, All India Institute of Medical Sciences, New Delhi, India.
Indian J Dermatol Venereol Leprol. 2021;87(4):509-514. doi: 10.25259/IJDVL_718_18.
Methotrexate is the most commonly used drug in the treatment of psoriasis with good efficacy and safety. Recently, weekly azathioprine pulse has been shown to be effective in this disease.
The aim of this study is to compare the effectiveness and safety of weekly pulse doses of azathioprine and methotrexate for the treatment of chronic plaque psoriasis.
In this randomized controlled trial, 80 patients with chronic plaque psoriasis were recruited. After detailed clinical and laboratory evaluation, patients were randomized to 2 groups to receive either weekly 300 mg azathioprine (n = 40) or 15 mg methotrexate every week (n = 40) for 20 weeks, following which the response to treatment and adverse effects were assessed. The patients were then followed up every 4 weeks for 3 months to determine any relapse.
Overall, 48 (60%) patients achieved PASI 75, while 36 (45%) and 59 (73.8%) patients achieved PASI 100 and 50, respectively. On intention to treat analysis, PASI ≥ 75 was achieved in 47.5% (19/40) patients in group 1 compared to 85% (34/40) patients in group 2 (p < 0.001). However, on per protocol analysis, PASI ≥ 75 was achieved in 86% (19/22) patients in group 1 and 92% (34/37) patients in group 2 (p = 0.497). Minor clinical and biochemical adverse effects were noted in both the groups, which were comparable. One (7.7%) patient in group 1 and 4 (17.4%) in group 2 relapsed during follow-up.
Limitations of study include small sample size and short follow-up.
Weekly azathioprine pulse appears to be beneficial in the management of chronic plaque psoriasis. However, it is less effective than weekly methotrexate. It can thus be of use as a therapeutic option in patients with contraindication to methotrexate or other similar agents in this disease.
甲氨蝶呤是治疗银屑病最常用的药物，疗效好，安全性高。最近，每周硫唑嘌呤脉冲治疗已被证明对该病有效。
本研究旨在比较每周脉冲剂量的硫唑嘌呤和甲氨蝶呤治疗慢性斑块型银屑病的疗效和安全性。
在这项随机对照试验中，招募了 80 名患有慢性斑块型银屑病的患者。经过详细的临床和实验室评估，患者被随机分为 2 组，分别接受每周 300mg 硫唑嘌呤（n = 40）或每周 15mg 甲氨蝶呤（n = 40）治疗 20 周，然后评估治疗反应和不良反应。然后每 4 周随访 3 个月以确定是否复发。
总体而言，48（60%）名患者达到 PASI75，36（45%）和 59（73.8%）名患者分别达到 PASI100 和 50。在意向治疗分析中，第 1 组有 47.5%（19/40）名患者达到 PASI≥75，而第 2 组有 85%（34/40）名患者达到 PASI≥75（p＜0.001）。然而，在按方案分析中，第 1 组有 86%（19/22）名患者和第 2 组有 92%（34/37）名患者达到 PASI≥75（p=0.497）。两组均有轻微的临床和生化不良反应，且两组间无差异。第 1 组有 1 名（7.7%）患者和第 2 组有 4 名（17.4%）患者在随访期间复发。
研究的局限性包括样本量小和随访时间短。
每周硫唑嘌呤脉冲治疗似乎对慢性斑块型银屑病有益。然而，它不如每周甲氨蝶呤有效。因此，对于对甲氨蝶呤或其他类似药物有禁忌症的患者，它可以作为一种治疗选择。
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