Gravani Agoritsa, Gaitanis Georgios, Spyridonos Panagiota, Alexis Ioannis, Tigas Stelios, Bassukas Ioannis D
Department of Dermatology, University General Hospital of Ioannina, 45500 Ioannina, Greece.
Department of Skin and Venereal Diseases, Faculty of Medicine, School of Health Sciences, University of Ioannina, 45110 Ioannina, Greece.
J Clin Med. 2022 Jun 2;11(11):3193. doi: 10.3390/jcm11113193.
Monomodal systemic glucocorticoids remain the mainstay of treatment for bullous pemphigoid (BP). In this retrospective, single-arm study, we evaluated the feasibility (efficacy and tolerability) of the combination of methylprednisolone and low-dose (up to 12.5 mg/week) methotrexate (MP + MTX) for BP. At week 12, 53/55 (96.4%) patients initiated on MP + MTX during a five-year period (potential follow up time: ≥4 years) remained on treatment. At this time-point, BP remission was achieved in all compliant patients (including = 24 cases of dipeptidyl peptidase-4 inhibitors-associated BP; 12-week remission rate: 100% [95% CI: 91.9-100.0%]; mean time to remission: 29.5 days, SEM: 2.3 days) at a mean cumulative MP dose to disease control of 678.4 mg (SEM = 49.4 mg). Eight patients relapsed during follow up (10.81 [95% CI: 5.16-21.72] relapses/100 person years, py), and seven manifested a severe adverse event (6.80 [95% CI: 3.00-14.28] severe adverse events/100 py); however, 73.4% (±7.9%) had suffered neither a relapse nor a SAE at the three-years follow up. Continuing low dose MP intake (≤8 mg/day) beyond week 12 in combination with MTX minimized the risk of a feasibility limiting event ( = 0.013). Conclusively, the combination of methylprednisolone with methotrexate is a promising, safe, and efficient modality for BP patients, which enables rapid glucocorticoid tapering.
单药全身使用糖皮质激素仍然是大疱性类天疱疮（BP）治疗的主要手段。在这项回顾性单臂研究中，我们评估了甲泼尼龙与低剂量（每周最高12.5 mg）甲氨蝶呤（MP + MTX）联合治疗BP的可行性（疗效和耐受性）。在第12周时，55例在五年期间开始使用MP + MTX治疗的患者中有53例（96.4%）仍在接受治疗（潜在随访时间：≥4年）。在这个时间点，所有依从性良好的患者均实现了BP缓解（包括24例与二肽基肽酶-4抑制剂相关的BP；12周缓解率：100% [95% CI：91.9 - 100.0%]；平均缓解时间：29.5天，标准误：2.3天），达到疾病控制时MP的平均累积剂量为678.4 mg（标准误 = 49.4 mg）。8例患者在随访期间复发（10.81 [95% CI：5.16 - 21.72]次复发/100人年，人年），7例出现严重不良事件（6.80 [95% CI：3.00 - 14.28]次严重不良事件/100人年）；然而，在三年随访时，73.4%（±7.9%）的患者既没有复发也没有发生严重不良事件。在第12周后继续低剂量MP摄入（≤8 mg/天）并联合MTX可将限制可行性事件的风险降至最低（P = 0.013）。总之，甲泼尼龙与甲氨蝶呤联合使用对于BP患者是一种有前景、安全且有效的治疗方式，能够快速减少糖皮质激素用量。
