Link Hartmut, Kerkmann Markus, Holtmann Laura
Internal Medicine, Hematology and Medical Oncology, Kaiserslautern, Finkenhain 8, D-67661, Kaiserslautern, Germany.
MMF GmbH, Lindberghweg 132, D-48155, Münster, Germany.
Support Care Cancer. 2022 Jun;30(6):5187-5200. doi: 10.1007/s00520-022-06920-y. Epub 2022 Mar 7.
In secondary immunodeficiency, immunoglobulin replacement therapy (IgRT) is recommended by guidelines (GL) for patients with IgG level < 4 g/l and more than 3 infections or a severe infection. IgRT may be appropriate if IgG level < 4 g/l and/or 1-3 less severe infections (≤ grade 2).
This was a retrospective sample analysis representative for practices and hospitals in Germany. The treatments and infection data were collected from patients with chronic lymphocytic leukemia (CLL) and multiple myeloma (MM). GL adherence (GLAD) was analyzed.
Data from 1086 patients (CLL 490, MM 596) were collected from 86 centers. Of all patients, 34.8% developed IgG deficiency during therapy (CLL 35.5%; MM 34.2%). IgRT was given in 23.5% of CLL and 14.4% of MM patients. GLAD in hypogammaglobulinemia and indication to IgRT was 23.3% of 86 CLL and 22.1% of 77 MM patients. Without GLAD, the hazard ratio (HR) for any infection was 4.49 (95% CI 3.72-5.42; p < 0.001) and for severe infections (grade ≥ 3) 10.64 (95% CI 7.54-15.00; p < 0.001). Significant independent risk factors for infections were a higher Charlson Comorbidity Index, IgG deficiency, and 3 + line treatment, as well as therapy with BTK inhibitors or chemotherapy in CLL. Multivariable analysis showed a significantly lower risk of severe infections after start of IgRT with a HR of 0.47 (95% CI 0.28-0.77; p = 0.003).
Guideline adherence correlated with fewer and less severe infections but was low in patients with indication to IgRT. Risk factors for infection can be identified. Risk of severe infections was significantly lower in patients with IgRT.
在继发性免疫缺陷中,对于IgG水平低于4g/l且发生3次以上感染或一次严重感染的患者,指南推荐进行免疫球蛋白替代疗法(IgRT)。如果IgG水平低于4g/l和/或发生1 - 3次不太严重的感染(≤2级),IgRT可能是合适的。
这是一项对德国诊所和医院具有代表性的回顾性样本分析。收集慢性淋巴细胞白血病(CLL)和多发性骨髓瘤(MM)患者的治疗及感染数据,并分析其对指南的依从性(GLAD)。
从86个中心收集了1086例患者的数据(CLL 490例,MM 596例)。所有患者中,34.8%在治疗期间出现IgG缺乏(CLL为35.5%;MM为34.2%)。23.5%的CLL患者和14.4%的MM患者接受了IgRT。86例CLL患者中有23.3%以及77例MM患者中有22.1%在低丙种球蛋白血症及IgRT适应证方面符合指南。未遵循指南时,任何感染的风险比(HR)为4.49(95%置信区间3.72 - 5.42;p < 0.001),严重感染(≥3级)的风险比为10.64(95%置信区间7.54 - 15.00;p < 0.001)。感染的显著独立危险因素包括较高的Charlson合并症指数(CCI)、IgG缺乏、三线及以上治疗,以及CLL患者使用BTK抑制剂或化疗。多变量分析显示,开始IgRT后严重感染风险显著降低,HR为0.47(95%置信区间0.28 - 0.77;p = 0.003)。
指南依从性与感染次数减少及严重程度降低相关,但在有IgRT适应证的患者中依从性较低。可识别感染的危险因素。接受IgRT的患者严重感染风险显著降低。