Objective Sarilumab, as monotherapy or in combination with conventional synthetic DMARDs, such as MTX, has demonstrated improvement in clinical outcomes in patients with RA. The primary objective of this post hoc analysis was to compare the efficacy of sarilumab (200 mg every 2 weeks) monotherapy (MONARCH study) with that of sarilumab and MTX combination therapy (MOBILITY study) at week 24. Methods The endpoints assessed were mean change from baseline in the Clinical Disease Activity Index (CDAI), 28-joint Disease Activity using CRP (DAS28-CRP), CRP, haemoglobin (Hb), pain visual analogue scale (VAS) and Functional Assessment of Chronic Illness Therapy (FACIT)–Fatigue. Least square (LS) mean change from baseline (95% CI) at week 24 for all endpoints was compared between the treatment arms for adjusted comparisons. Results This analysis included 184 patients on sarilumab monotherapy and 399 patients on sarilumab plus MTX. Differences (P < 0.05) were observed in ethnicity, region, body mass index group, rheumatoid factor, anti-cyclic citrullinated peptide antibodies, swollen joint count, CRP, CDAI and oral glucocorticoid use between these treatment groups. After adjusting for these differences in a mixed-effect model repeated measure, LS mean change from baseline for all assessments was similar between the treatment groups with overlapping CIs: CDAI, −28.79 vs −26.21; DAS28-CRP, −2.95 vs −2.81; CRP, −18.31 vs −16.46; Hb, 6.59 vs 8.09; Pain VAS, −33.62 vs −31.66; FACIT-Fatigue, 9.90 vs 10.24. Conclusion This analysis demonstrated that the efficacy of sarilumab monotherapy was similar to that of sarilumab and MTX combination therapy.

中文翻译：

---

Sarilumab 单药治疗与 sarilumab 和甲氨蝶呤联合治疗在类风湿性关节炎患者中的疗效

目的 Sarilumab 作为单一疗法或与常规合成 DMARDs（如 MTX）联合使用，已证明可改善 RA 患者的临床结果。这项事后分析的主要目的是在第 24 周比较 sarilumab（每 2 周 200 mg）单药治疗（MONARCH 研究）与 sarilumab 和 MTX 联合治疗（MOBILITY 研究）的疗效。方法评估的终点是平均变化从临床疾病活动指数 (CDAI) 的基线开始，使用 CRP (DAS28-CRP)、CRP、血红蛋白 (Hb)、疼痛视觉模拟评分 (VAS) 和慢性疾病治疗功能评估 (FACIT) 的 28 个关节疾病活动–疲劳。在治疗组之间比较所有终点在第 24 周时从基线 (95% CI) 的最小二乘 (LS) 平均变化，以进行调整比较。结果 该分析包括 184 名接受 sarilumab 单药治疗的患者和 399 名接受 sarilumab 加 MTX 的患者。在种族、地区、体重指数组、类风湿因子、抗环瓜氨酸肽抗体、肿胀关节计数、CRP、CDAI 和口服糖皮质激素使用方面，这些治疗组之间观察到差异 (P < 0.05)。在对混合效应模型重复测量中的这些差异进行调整后，具有重叠 CI 的治疗组之间所有评估的 LS 平均变化与基线相似：CDAI，-28.79 与 -26.21；DAS28-CRP，-2.95 对 -2.81；CRP，-18.31 对 -16.46；血红蛋白，6.59 对 8.09；疼痛 VAS，-33.62 对 -31.66；FACIT-疲劳，9.90 对 10.24。结论 该分析表明，sarilumab 单药治疗的疗效与 sarilumab 和 MTX 联合治疗的疗效相似。