Becciolini Andrea, Parisi Simone, Caccavale Rosalba, Bravi Elena, Lumetti Federica, Andracco Romina, Volpe Alessandro, Gardelli Lucia, Girelli Francesco, Di Donato Eleonora, Santilli Daniele, Lucchini Gianluca, Ditto Maria Chiara, Platè Ilaria, Arrigoni Eugenio, Mozzani Flavio, Riva Michele, Marchetta Antonio, Fusaro Enrico, Sandri Gilda, Salvarani Carlo, Paroli Marino, Ariani Alarico
Rheumatology Unit, Department of Medicine and Internal Medicine, University Hospital of Parma, 43121 Parma, Italy.
Rheumatology Unit, Department of General and Specialistic Medicine, Azienda Ospedaliero-Universitaria, Città della Salute e della Scienza di Torino, 10126 Turin, Italy.
J Pers Med. 2022 Feb 23;12(3):335. doi: 10.3390/jpm12030335.
The recent introduction of ABP 501, an adalimumab biosimilar, in the treatment of rheumatic diseases was supported by a comprehensive comparability exercise with its originator. On the other hand, observational studies comparing adalimumab and ABP 501 in inflammatory arthritis are still lacking. The main aim of this study is to compare the clinical outcomes of the treatment with adalimumab, both the originator and ABP 501, in a large cohort of patients affected by autoimmune arthritis in a real life setting. We retrospectively analysed the baseline characteristics and the retention rate in a cohort of patients who received at least a course of adalimumab (originator or ABP 501) from January 2003 to December 2020. We stratified the study population according to adalimumab use: naive to original (oADA), naive to ABP 501 (bADA) and switched from original to ABP 501 (sADA). The oADA, bADA and sADA groups included, respectively, 724, 129 and 193 patients. In each group, the majority of patients had a diagnosis of rheumatoid arthritis. The total observation period was 9805.6 patient-months. The 18-month retentions rate in oADA, bADA and sADA was, respectively, 81.5%, 84.0% and 88.0% (p > 0.05). The factors influencing the adalimumab retention rate were an axial spondylarthritis diagnosis (Hazard Ratio (HR) 0.70; p = 0.04), switch from oADA to ABP 501 (HR 0.53; p = 0.02) and year of prescription (HR 1.04; p = 0.04). In this retrospective study, patients naive to the adalimumab originator and its biosimilar ABP 501 showed the same retention rate. Patients switching from the originator to biosimilar had a higher retention rate, even though not statistically significant, when compared to naive.
阿达木单抗生物类似药ABP 501近期被引入用于治疗风湿性疾病，这一应用得到了与原研药全面的相似性研究的支持。另一方面，在炎症性关节炎中比较阿达木单抗和ABP 501的观察性研究仍然缺乏。本研究的主要目的是在现实生活环境中，比较原研阿达木单抗和ABP 501治疗一大群自身免疫性关节炎患者的临床结局。我们回顾性分析了2003年1月至2020年12月期间接受至少一个疗程阿达木单抗（原研药或ABP 501）治疗的患者队列的基线特征和留存率。我们根据阿达木单抗的使用情况对研究人群进行分层：原研药初治（oADA）、ABP 501初治（bADA）以及从原研药转换为ABP 501（sADA）。oADA、bADA和sADA组分别包括724例、129例和193例患者。在每组中，大多数患者被诊断为类风湿关节炎。总观察期为9805.6患者月。oADA、bADA和sADA组的18个月留存率分别为81.5%、84.0%和88.0%（p>0.05）。影响阿达木单抗留存率的因素包括轴向脊柱关节炎诊断（风险比（HR）0.70；p = 0.04）、从oADA转换为ABP 501（HR 0.53；p = 0.02）以及处方年份（HR 1.04；p = 0.04）。在这项回顾性研究中，阿达木单抗原研药初治患者及其生物类似药ABP 501初治患者的留存率相同。与初治患者相比，从原研药转换为生物类似药的患者留存率更高，尽管差异无统计学意义。
