Anemia is common in patients with rheumatoid arthritis (RA). Higher hemoglobin (Hb) levels may be associated with better clinical outcomes and patient-reported outcomes (PROs). To assess this hypothesis, we conducted two post hoc analyses in three sarilumab phase III studies: TARGET, MOBILITY, and MONARCH. Pooled data from combination therapy from placebo-controlled MOBILITY (sarilumab + methotrexate) and TARGET (sarilumab + conventional synthetic disease-modifying antirheumatic drugs [csDMARDs]) and monotherapy data from active-controlled MONARCH (sarilumab vs. adalimumab) studies were included. Associations between Hb levels and clinical measures and PROs were assessed over 24 weeks. The mean changes from baseline in clinical outcomes and PROs (to week 24) and radiographic outcomes (to week 52) were evaluated between low and normal Hb levels (based on the World Health Organization [WHO] criteria). From TARGET, MOBILITY, and MONARCH, 546, 1197, and 369 patients, respectively, were stratified according to Hb levels (low vs. normal). Over 24 weeks, higher Hb levels were found to be consistently associated with better clinical outcomes and PROs in combination therapy and monotherapy groups and were more pronounced among the patients treated with sarilumab than those treated with placebo and adalimumab. The mean change from baseline to week 24 in clinical efficacy measures and PROs was similar in patients with low vs. normal Hb at baseline. Differences between sarilumab and/or adalimumab, for all outcomes, were larger for low Hb subgroups. In MOBILITY, by week 52, the inhibition of progression of structural damage (assessed via Modified Total Sharp Score [mTSS]) was 84% (sarilumab 200 mg) and 68% (sarilumab 150 mg) vs. placebo in patients with low Hb and 97% (sarilumab 200 mg) and 68% (sarilumab 150 mg) vs. placebo in patients with normal Hb. Similar results were observed for other radiographic outcomes. In these post hoc analyses, a consistent relationship was observed between higher Hb levels and better clinical outcomes and PROs in patients with RA. Irrespective of the baseline Hb levels, sarilumab treatment was associated with improvements in clinical measures and PROs over 24 weeks (improvements were more pronounced than those with adalimumab treatment) and mitigation of joint damage progression over 52 weeks. ClinTrials.gov NCT01061736, NCT01709578, and NCT02332590

中文翻译：

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类风湿性关节炎患者低血红蛋白、临床测量和患者报告结果之间的关联：sarilumab 三项 III 期试验的事后分析结果

贫血在类风湿性关节炎 (RA) 患者中很常见。较高的血红蛋白 (Hb) 水平可能与更好的临床结果和患者报告的结果 (PRO) 相关。为了评估这一假设，我们在三项 sarilumab III 期研究中进行了两项事后分析：TARGET、MOBILITY 和 MONARCH。来自安慰剂对照 MOBILITY（sarilumab + 甲氨蝶呤）和 TARGET（sarilumab + 常规合成疾病缓解抗风湿药 [csDMARDs]）联合治疗的汇总数据以及来自阳性对照 MONARCH（sarilumab 与阿达木单抗）研究的单药治疗数据。在 24 周内评估了 Hb 水平与临床指标和 PRO 之间的关联。在低和正常 Hb 水平（根据世界卫生组织 [WHO] 标准）之间评估临床结果和 PRO（至第 24 周）和影像学结果（至第 52 周）相对于基线的平均变化。TARGET、MOBILITY 和 MONARCH 分别有 546、1197 和 369 名患者根据 Hb 水平（低与正常）进行分层。在超过 24 周的时间里，发现较高的 Hb 水平与联合治疗和单一治疗组的更好的临床结果和 PROs 始终相关，并且在接受 sarilumab 治疗的患者中比接受安慰剂和阿达木单抗治疗的患者更为明显。从基线到第 24 周，临床疗效指标和 PROs 的平均变化在基线时 Hb 较低与正常的患者中相似。对于所有结果，sarilumab 和/或阿达木单抗之间的差异，对于低 Hb 亚组来说更大。在 MOBILITY 中，到第 52 周时，在低 Hb 和在 Hb 正常的患者中，97%（sarilumab 200 mg）和 68%（sarilumab 150 mg）与安慰剂相比。对于其他影像学结果也观察到了类似的结果。在这些事后分析中，观察到较高的 Hb 水平与 RA 患者更好的临床结果和 PRO 之间存在一致的关系。无论基线 Hb 水平如何，sarilumab 治疗与 24 周内临床指标和 PRO 的改善（改善比阿达木单抗治疗更明显）和 52 周内关节损伤进展的缓解相关。ClinTrials.gov NCT01061736，