Dermatologie et vénérologie, Hôpital Saint-Louis, Université Paris Cité, Paris, France.
Maladies infectieuses et tropicales, Hôpital Pitié-Salpêtrière, Paris, France.
PLoS Negl Trop Dis. 2023 Apr 20;17(4):e0011238. doi: 10.1371/journal.pntd.0011238. eCollection 2023 Apr.
Leprosy reactions (LRs) are inflammatory responses observed in 30%-50% of people with leprosy. First-line treatment is glucocorticoids (GCs), often administered at high doses with prolonged courses, resulting in high morbi-mortality. Methotrexate (MTX) is an immunomodulating agent used to treat inflammatory diseases and has an excellent safety profile and worldwide availability. In this study, we describe the efficacy, GCs-sparing effect and safety of MTX in LRs.
We conducted a retrospective multicentric study in France consisting of leprosy patients receiving MTX for a reversal reaction (RR) and/or erythema nodosum leprosum (ENL) since 2016. The primary endpoint was the rate of good response (GR) defined as the complete disappearance of inflammatory cutaneous or neurological symptoms without recurrence during MTX treatment. The secondary endpoint was the GCs-sparing effect, safety and clinical relapse after MTX discontinuation.
Our study included 13 patients with LRs (8 men, 5 women): 6 had ENL and 7 had RR. All patients had had at least one previous course of GCs and 2 previous treatment lines before starting MTX. Overall, 8/13 (61.5%) patients had GR, allowing for GCs-sparing and even GCs withdrawal in 6/11 (54.5%). No severe adverse effects were observed. Relapse after MTX discontinuation was substantial (42%): the median relapse time was 5.5 months (range 3-14) after stopping treatment.
MTX seems to be an effective alternative treatment in LRs, allowing for GCs-sparing with a good safety profile. Furthermore, early introduction during LRs may lead to a better therapeutic response. However, its efficacy seems to suggest prolonged therapy to prevent recurrence.
麻风反应（LR）是 30%-50%麻风患者中观察到的炎症反应。一线治疗是糖皮质激素（GCs），通常高剂量、长疗程给药，导致高病死率。甲氨蝶呤（MTX）是一种免疫调节剂，用于治疗炎症性疾病，具有极好的安全性和全球可用性。本研究描述了 MTX 在 LR 中的疗效、GCs 节约作用和安全性。
我们在法国进行了一项回顾性多中心研究，包括自 2016 年以来接受 MTX 治疗逆转反应（RR）和/或结节性红斑麻风（ENL）的麻风患者。主要终点是良好反应（GR）的发生率，定义为在 MTX 治疗期间炎症性皮肤或神经症状完全消失且无复发。次要终点是 GCs 节约作用、安全性和 MTX 停药后的临床复发。
我们的研究包括 13 例 LR 患者（8 名男性，5 名女性）：6 例有 ENL，7 例有 RR。所有患者至少有一次 GCs 治疗史，且在开始 MTX 治疗前有 2 次以上的治疗线。总体而言，13 例患者中有 8 例（61.5%）获得 GR，从而节约 GCs，甚至在 11 例患者中有 6 例（54.5%）停用 GCs。未观察到严重不良反应。MTX 停药后复发率较高（42%）：停药后中位复发时间为 5.5 个月（范围 3-14 个月）。
MTX 似乎是 LR 的有效替代治疗方法，可节约 GCs 且安全性良好。此外，在 LR 早期引入 MTX 可能会导致更好的治疗反应。然而，其疗效似乎表明需要延长治疗以预防复发。
