Ruhr-Universität Bochum, Bochum, Germany.
Rheumazentrum Ruhrgebiet, Ruhr-Universität Bochum, Claudiusstrasse 45, Herne, 44649, Germany.
Arthritis Res Ther. 2024 Sep 4;26(1):155. doi: 10.1186/s13075-024-03386-7.
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.
分析在炎症性风湿性肌肉骨骼疾病（RMD）患者中，6 个月内非医疗转换从原研阿达木单抗（ADA）到其 ABP501 生物类似药（ABP）的临床结果，以共病作为治疗中断的风险因素。
从 2018 年 10 月起，从一个大型常规数据库中确定了从原研 ADA 转换为 ABP 的 RMD 患者。收集了非医疗转换时（基线）以及 3 个月和 6 个月的记录临床数据。共病采用 Charlson 合并症指数（CCI）表示，根据 CCI>0 对患者进行分类。使用贝叶斯指数回归分析了 6 个月内 CCI=0 和 CCI>0 的患者之间 ABP 保留率的差异。
共确定了 111 名患有中轴型脊柱关节炎（n=68）、类风湿关节炎（n=23）和银屑病关节炎（n=15）的患者，其中 74.8%的患者在 6 个月后继续接受 ABP 治疗，而较小比例的患者要么转换为另一种 ADA 生物类似药（10.8%），要么转换回原研 ADA（7.2%），要么转换为另一种生物制剂（3.6%），或退出治疗（3.6%）。基线时，38%的患者 CCI>0。最常见的合并症是心血管疾病（40%），其次是皮肤疾病（33%）、胃肠道疾病（20%）和眼部疾病（20%）。CCI=0 的患者中有 74%在 6 个月后继续接受 ABP 治疗，CCI>0 的患者中有 76%继续接受 ABP 治疗。贝叶斯分析显示，两组之间 ABP 续用率的差异很小（估计值 0.0012，95%可信区间（CrI）为-0.0337 至 0.0361）。调整年龄、性别和疾病亚型后，CCI>0 的患者的保留率略短，但差异分布包括 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下，6 个月内 ABP 保留率在合并症组之间没有证据表明存在显著差异。
