To analyse clinical outcomes of a non-medical switch from originator adalimumab (ADA) to its ABP501 biosimilar (ABP) over 6 months in patients with inflammatory rheumatic musculoskeletal diseases (RMD) in relation to comorbidity as a risk factor for therapy discontinuation. RMD patients switching from originator ADA to ABP were identified from a large routine database from October 2018 onwards. Documented clinical data at the time of non-medical switching (baseline), and at 3 and 6 months were collected. Comorbidities were represented by the Charlson Comorbidity Index (CCI) at baseline and patients were categorized based on CCI > 0. Differences in the ABP retention rate over 6 months between patients with CCI = 0 and patients with CCI > 0 were analysed using Bayesian exponential regression. A total of 111 patients with axial spondyloarthritis (n = 68), rheumatoid arthritis (n = 23) and psoriatic arthritis (n = 15), were identified, 74.8% of whom had continued treatment with ABP after 6 months, while a smaller proportion had either switched to another ADA biosimilar (10.8%), switched back to originator ADA (7.2%), switched to a different biologic (3.6%), or dropped out (3.6%). At baseline, a CCI > 0 was found in 38% of patients. Cardiovascular comorbidities (40%) were most prevalent followed by diseases of the skin (33%), the gastrointestinal tract (20%) and the eye (20%). ABP treatment was continued after 6 months in 74% of patients with CCI = 0 and in 76% with CCI > 0. Bayesian analysis showed only a small difference (months) in the APB continuation rate between groups (estimate 0.0012, 95% credible interval (CrI) -0.0337 to 0.0361). Adjusting for age, sex, and disease subtype revealed somewhat shorter retention rates for patients with CCI > 0, but the distribution of the difference included 0 (estimate -0.0689, 95% CrI -0.2246 to 0.0234). In a non-medical switch scenario of RMD patients, there was no evidence for a considerable difference in ABP retention rates over 6 months between comorbidity groups.

中文翻译：

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贝叶斯模型用于分析炎症性风湿性肌肉骨骼疾病患者非医疗转换情况下合并症与生物仿制药治疗保留之间的关系


分析炎症性风湿性肌肉骨骼疾病 (RMD) 患者从原研药阿达木单抗 (ADA) 转用 ABP501 生物仿制药 (ABP) 6 个月以上的非医疗临床结果与作为治疗中断危险因素的合并症的关系。自 2018 年 10 月起，从大型常规数据库中识别出从原始药物 ADA 转为 ABP 的 RMD 患者。收集非医疗转换时（基线）以及 3 个月和 6 个月时的记录临床数据。合并症以基线时的查尔森合并症指数 (CCI) 表示，并根据 CCI > 0 对患者进行分类。使用贝叶斯分析 CCI = 0 患者和 CCI > 0 患者之间 6 个月内 ABP 保留率的差异指数回归。总共确定了 111 名中轴型脊柱关节炎 (n = 68)、类风湿性关节炎 (n = 23) 和银屑病关节炎 (n = 15) 患者，其中 74.8% 在 6 个月后继续接受 ABP 治疗，而较小比例的患者要么改用另一种 ADA 生物仿制药 (10.8%)，要么改回原研药 ADA (7.2%)，要么改用另一种生物制剂 (3.6%)，要么退出 (3.6%)。基线时，38% 的患者发现 CCI > 0。心血管合并症（40%）最常见，其次是皮肤疾病（33%）、胃肠道疾病（20%）和眼睛疾病（20%）。 6 个月后，74% 的 CCI = 0 患者和 76% 的 CCI > 0 患者继续 ABP 治疗。贝叶斯分析显示，各组之间 APB 持续率仅存在微小差异（月）（估计值 0.0012，95% 可信）区间 (CrI) -0.0337 至 0.0361)。 调整年龄、性别和疾病亚型后发现，CCI > 0 患者的保留率稍短，但差异的分布包括 0（估计值 -0.0689，95% CrI -0.2246 至 0.0234）。在 RMD 患者的非医疗转换情况中，没有证据表明合并症组之间 6 个月内的 ABP 保留率存在显着差异。