Outcomes with the use of rituximab in patients with refractory lupus nephritis in a Colombian cohort

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Abstract

Introduction/Objective

To describe the safety and response to treatment with RTX, estimating its impact on the health state utility (HSU) of patients with refractory lupus nephritis (LN) treated in referral centres in several cities in Colombia.

Materials and methods

A registry-based follow-up study. Patients aged between 16 and 75 years, who were refractory to first-line management and had ISN / RPS class III-IV (+/- V) LN, were included. Our primary outcome was total or partial response to treatment; secondary outcomes were HSU measured with the EQ-5D-3 L, and safety of treatment with RTX. The impact analysis of response to RTX on HSU were performed by mean difference estimated by robust regression.

Results

Forty-six patients (44 women) were included, with a median age of 34 years (IQR = 13), the median SDI was 1 (IQR = 1) and the median activity measured by SLEDAI was 4.5 (IQR = 5.9). Response to RTX was observed in 27 (58.7%) patients. Adjusted for SLEDAI and co-interventions, the patients who responded to RTX obtained a higher mean HSU by 0.162 (95% CI 0.006–0.317). Which is equivalent to 1.9 (95% CI 0.2–3.8) more months lived in ideal health conditions for each year with refractory LN. In 54.3% of the patients, RTX had adequate safety.

Conclusion

From the patient's perspective, the response to treatment with RTX in patients with refractory LN implies a significant impact on their quality of life.

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哥伦比亚队列中难治性狼疮肾炎患者使用利妥昔单抗的疗效
引言/目的描述在哥伦比亚多个城市的转诊中心接受治疗的难治性狼疮性肾炎(LN)患者使用 RTX 治疗的安全性和反应,并估计其对健康状态效用(HSU)的影响。研究对象包括年龄在 16 至 75 岁之间、对一线治疗无效且患有 ISN / RPS III-IV 级(+/- V 级)LN 的患者。我们的主要结果是对治疗的全部或部分反应;次要结果是用 EQ-5D-3 L 测量的 HSU 以及 RTX 治疗的安全性。结果纳入了 46 名患者(44 名女性),中位年龄为 34 岁(IQR = 13),中位 SDI 为 1(IQR = 1),SLEDAI 测量的中位活动度为 4.5(IQR = 5.9)。27例(58.7%)患者对RTX有反应。根据SLEDAI和联合干预调整后,对RTX有反应的患者的平均HSU提高了0.162(95% CI 0.006-0.317)。这相当于难治性 LN 患者每多活一年,就能在理想的健康状况下多活 1.9 个月(95% CI 0.2-3.8)。结论从患者的角度来看,难治性 LN 患者对 RTX 治疗的反应意味着他们的生活质量会受到显著影响。
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