Department of Rheumatology, Clinical Immunology Center, Peking Union Medical College Hospital, Beijing, China.
Department of Gastroenterology, Peking Union Medical College Hospital, Beijing, China.
Rheumatology (Oxford). 2019 Jan 1;58(1):52-60. doi: 10.1093/rheumatology/key227.
This randomized, controlled clinical trial aims to compare the efficacy and safety of glucocorticoid combined with MMF and glucocorticoid monotherapy for patients with IgG4-related disease.
Sixty-nine patients newly diagnosed with IgG4-related disease were randomly divided into two groups (35 patients in Group I and 34 patients in Group II). Patients in Group I received glucocorticoid monotherapy (0.6-0.8 mg/(kg·day) and tapered gradually); patients in Group II received glucocorticoid combined with MMF therapy (1-1.5 g/day). All the patients were followed up at 1, 3, 6 and 12 months. The primary endpoint was response rate in 12 months and the secondary endpoints were relapse, remission rate and adverse reactions.
Group I and Group II shared almost the same efficacy at the 1 month treatment, but during the follow-up, the complete response rate in Group II was much higher than that in Group I at different time points, and the cumulative relapse rate during 1 year of therapy was much higher in Group I than that in Group II (40.00 vs 20.59%). The remission rate was lower in Group I (51.42 vs 76.47%). Relapses were more likely to happen in lung, lacrimal gland, salivary gland, paranasal sinus and kidney. MMF could reduce relapse, especially organs recurrence. No serious adverse reactions occurred in the two groups.
Combination treatment with glucocorticoid and MMF was more effective than the monotherapy, and the relapse of IgG4-related disease might be associated with the elevated levels of serum IgG4 and the low glucocorticoid maintenance dose.
ClinicalTrials.gov, www.clinicaltrials.gov, NCT02458196.
本随机对照临床试验旨在比较糖皮质激素联合 MMF 与糖皮质激素单药治疗 IgG4 相关疾病患者的疗效和安全性。
69 例新诊断为 IgG4 相关疾病的患者被随机分为两组（I 组 35 例，II 组 34 例）。I 组患者接受糖皮质激素单药治疗（0.6-0.8mg/（kg·d）并逐渐减量）；II 组患者接受糖皮质激素联合 MMF 治疗（1-1.5g/d）。所有患者均随访 1、3、6 和 12 个月。主要终点为 12 个月时的缓解率，次要终点为复发、缓解率和不良反应。
I 组和 II 组在治疗 1 个月时疗效几乎相同，但在随访过程中，II 组在不同时间点的完全缓解率明显高于 I 组，1 年治疗期间的累积复发率也明显高于 I 组（40.00%比 20.59%）。I 组的缓解率较低（51.42%比 76.47%）。复发更可能发生在肺、泪腺、唾液腺、副鼻窦和肾脏。MMF 可降低复发率，特别是器官复发率。两组均未发生严重不良反应。
糖皮质激素联合 MMF 治疗比单药治疗更有效，IgG4 相关疾病的复发可能与血清 IgG4 水平升高和糖皮质激素维持剂量低有关。
ClinicalTrials.gov，www.clinicaltrials.gov，NCT02458196。
