Vasculitis Clinic, Mount Sinai Hospital, Department of Rheumatology, University of Toronto, Ontario, Canada.
Clin Exp Rheumatol. 2020 Mar-Apr;38 Suppl 124(2):171-175. Epub 2020 Mar 11.
To describe the efficacy of conventional immunosuppressants in disease control of relapsing or refractory eosinophilic granulomatosis with polyangiitis (EGPA) compared to recently published mepolizumab and rituximab studies.
A retrospective analysis from the Toronto Vasculitis Clinic was conducted. Patients with relapsing or refractory EGPA with similar entry criteria as the main mepolizumab (MIRRA) or rituximab (case-series) studies, who were started on conventional immunosuppressants, were assessed for remission at 24- and 52-weeks. Remission was defined as a Birmingham Vasculitis Activity Score of 0 and a prednisone dose of ≤4mg/day, ≤7.5mg/day, corresponding to the mepolizumab trial, or any prednisone dose per day, as in the rituximab study.
Among 110 cohort patients, 24 with relapsing or refractory EGPA met eligibility criteria. Conventional immunosuppressants used were methotrexate (n=15), azathioprine (n=8) or leflunomide (n=1). Remission rates at 24-weeks were 8.3% with prednisone ≤4mg/day (vs. 28.0% in the mepolizumab trial); 41.6% with prednisone ≤7.5mg/day (vs. 45% in the mepolizumab trial) and 62.5% with any prednisone dose (vs. 34% in the rituximab study). Remission at 52-weeks was 50.0% with any prednisone dose (vs. 49% in the rituximab study), whereas sustained remission at week 52 (as of week 24) was 4.2% with prednisone ≤4mg/day (vs. 19% in the mepolizumab trial), and 33.3% with prednisone ≤7.5mg/day (vs. 24% in the mepolizumab trial).
Though our study was small and retrospective, rates of remission observed with conventional immunosuppressants were substantial. This should be kept in mind when interpreting results of placebo-controlled or retrospective studies on biologics in EGPA.
描述与最近发表的美泊利珠单抗和利妥昔单抗研究相比,传统免疫抑制剂在控制复发性或难治性嗜酸性肉芽肿性多血管炎(EGPA)疾病方面的疗效。
进行了多伦多血管炎诊所的回顾性分析。根据主要美泊利珠单抗(MIRRA)或利妥昔单抗(病例系列)研究的相同入组标准,纳入接受传统免疫抑制剂治疗的复发性或难治性 EGPA 患者,评估他们在 24 周和 52 周时的缓解情况。缓解定义为伯明翰血管炎活动评分(BVAS)为 0 且泼尼松剂量≤4mg/天、≤7.5mg/天(与美泊利珠单抗试验相对应)或每天任何剂量的泼尼松(与利妥昔单抗研究相对应)。
在 110 例队列患者中,有 24 例复发性或难治性 EGPA 符合入选标准。使用的传统免疫抑制剂包括甲氨蝶呤(n=15)、硫唑嘌呤(n=8)或来氟米特(n=1)。24 周时的缓解率分别为泼尼松≤4mg/天的 8.3%(美泊利珠单抗试验中为 28.0%);泼尼松≤7.5mg/天的 41.6%(美泊利珠单抗试验中为 45%)和泼尼松任何剂量的 62.5%(利妥昔单抗研究中为 34%)。泼尼松任何剂量的缓解率在 52 周时为 50.0%(与利妥昔单抗研究中相同),而 24 周时的持续缓解率(截至 52 周)泼尼松≤4mg/天的为 4.2%(美泊利珠单抗试验中为 19%),泼尼松≤7.5mg/天的为 33.3%(美泊利珠单抗试验中为 24%)。
尽管我们的研究规模较小且为回顾性,但观察到的传统免疫抑制剂缓解率相当可观。在解释 EGPA 中生物制剂的安慰剂对照或回顾性研究结果时,应考虑到这一点。