Risk Factors for Relapse in Antineutrophil Cytoplasmic Antibody-Associated Vasculitis Among Patients With Relapse After Induction of Remission With Rituximab.

Methods

This is a post hoc analysis of the RITAZAREM clinical trial. Patients aged 15 years or older with AAV and a positive test for anti-proteinase-3 or anti-myeloperoxidase-ANCA who achieved remission after reinduction with rituximab and glucocorticoids were randomized at month 4 to receive continued rituximab or azathioprine for a maintenance period up to 24 months, followed by observation until relapse or up to 48 months.

这是RITAZAREM临床试验的事后分析。15岁或以上的AAV患者，抗蛋白酶-3或抗髓过氧化物酶-ANCA检测呈阳性，并在使用利妥昔单抗和糖皮质激素重新诱导后达到缓解，这些患者在第4个月被随机分配接受持续的利妥昔单抗或硫唑嘌呤维持治疗，最长可达24个月，随后观察至复发或最长48个月。

Generalized estimating equations logistic regression identified baseline and time-varying risk factors for relapse by the next visit for the two study phases: maintenance (months 4-24) and off-treatment (months 24-48).

广义估计方程逻辑回归分析确定了两个研究阶段的复发基线和随时间变化的风险因素：维持期（第4-24个月）和停药期（第24-48个月）。

Results

Among 170 patients (median [interquartile range] age 59 [48-68] years, disease duration 5 [2-10] years), 99 relapses occurred (46 during maintenance).

在170名患者中（中位年龄59岁，四分位数范围[48-68]岁，疾病持续时间5年，四分位数范围[2-10]年），发生了99次复发（其中46次发生在维持期）。

During maintenance, musculoskeletal involvement (odds ratio [OR]: 2.8, 95% confidence interval[CI]: 1.1-7.2; P = 0.03) and higher patient global assessment (OR: 1.1, 95% CI: 1.0-1.2; P = 0.04) were associated with relapse.

在维持治疗期间，肌肉骨骼受累（比值比[OR]：2.8，95%置信区间[CI]：1.1-7.2；P = 0.03）和患者总体评估较高（OR：1.1，95% CI：1.0-1.2；P = 0.04）与复发相关。

During the off-treatment phase, presence of CD19+ B cells (OR: 2.5, 95% CI: 1.2-5.1; P = 0.01) and reappearance of ANCA (OR: 3.2, 95% CI: 1.3-7.7; P = 0.01) were each associated with higher relapse risk.

在停药阶段，CD19+ B细胞的存在（OR：2.5，95% CI：1.2-5.1；P = 0.01）和ANCA的重新出现（OR：3.2，95% CI：1.3-7.7；P = 0.01）均与较高的复发风险相关。

Multivariable analysis identified markers of inflammation (changes in platelets, white blood cells, and IgA) associated with relapse.

多变量分析确定了与复发相关的炎症标志物（血小板、白细胞和IgA的变化）。

Conclusions

Risk factors for relapse in AAV vary by treatment phase.

AAV复发的风险因素因治疗阶段而异。

Monitoring markers of inflammation and immune reconstitution may identify patients at risk for relapse, particularly after treatment withdrawal.

监测炎症标志物和免疫重建指标可能识别出复发风险患者，特别是在治疗撤除后。