Approximately one-third of patients on biologic therapy for rheumatoid arthritis (RA) receive them as monotherapy. There are few head-to-head randomised control trials comparing biologics as monotherapy. Our aim was to compare the efficacy and persistence of multimodal biologic agents as monotherapy in biologic naïve patients with RA in the real-world setting. A multicentre retrospective observational study was carried out comparing TNF inhibitors (TNFi), IL6 receptor inhibitor (IL6Ri) and CTLA-4 inhibitor (CTLA-4i) monotherapy in biologic naïve RA patients. The primary study outcome was DAS28 score at 6, 12, and 18 months. 126 patients were enrolled; 98 patients (78%) were taking TNFi, 19 patients (15%) IL6Ri and 10 (8%) CTLA-4i with similar baseline characteristics of sex and age across groups. Patients in the CTLA-4i group were more often seropositive and had greater numbers of comorbidities. At 6 and 12 months, patients in the IL6Ri group had a lower DAS28 score compared to TNFi monotherapy. Those on CTLA-4i monotherapy also had a lower DAS28 score at 6 months than the TNFi group, although differences were lost by 12 months. Drug retention at 18 months was highest in the IL6Ri arm (68%) and CTLA-4i arm (80%) compared with only 55% in the TNFi group. Our findings support current guidance that IL6Ri should be considered in biologic naïve patients requiring biologic monotherapy, but also indicated that CTLA-4i could be an option.

中文翻译：

---

生物性类风湿关节炎（RA）初生患者的生物单一疗法：一项观察性研究的结果。

大约有三分之一接受类风湿关节炎（RA）生物治疗的患者接受单药治疗。几乎没有将生物制剂比作单一疗法的头对头随机对照试验。我们的目的是在现实世界中比较多模式生物制剂作为单药治疗在生物学上未经治疗的RA患者中的疗效和持久性。进行了一项多中心回顾性观察性研究，比较了单纯性生物学RA患者中的TNF抑制剂（TNFi），IL6受体抑制剂（IL6Ri）和CTLA-4抑制剂（CTLA-4i）单药治疗。主要研究结果为6、12和18个月时的DAS28评分。招募了126名患者；两组患者中有98例（78％）服用TNFi，19例（15％）IL6Ri和10例（8％）CTLA-4i具有相似的性别和年龄基线特征。CTLA-4i组的患者血清反应阳性，合并症更多。与TNFi单药治疗相比，IL6Ri组在6个月和12个月时的DAS28评分较低。在CTLA-4i单一疗法中，那些在6个月时的DAS28评分也比在TNFi组中更低，尽管差异在12个月后消失了。IL6Ri组（68％）和CTLA-4i组（80％）在18个月时的药物保留最高，而TNFi组仅为55％。我们的发现支持当前的指导意见，即对于需要进行生物单一疗法的初次接受生物学治疗的初生患者应考虑IL6Ri，但也表明CTLA-4i可能是一种选择。在CTLA-4i单一疗法中，那些在6个月时的DAS28得分也比在TNFi组中更低，尽管差异在12个月后消失了。IL6Ri组（68％）和CTLA-4i组（80％）在18个月时的药物保留最高，而TNFi组仅为55％。我们的发现支持当前的指导意见，即对于需要进行生物单一疗法的初次接受生物学治疗的初生患者应考虑IL6Ri，但也表明CTLA-4i可能是一种选择。在CTLA-4i单一疗法中，那些在6个月时的DAS28得分也比在TNFi组中更低，尽管差异在12个月后消失了。IL6Ri组（68％）和CTLA-4i组（80％）在18个月时的药物保留最高，而TNFi组仅为55％。我们的发现支持当前的指导意见，即对于需要进行生物单一疗法的初次接受生物学治疗的初生患者应考虑IL6Ri，但也表明CTLA-4i可能是一种选择。