Abstract：
UNASSIGNED: MSB11022 is a biosimilar of adalimumab that has been shown comparable bioequivalence, safety, tolerability, and immunogenicity profiles to the reference adalimumab in healthy volunteers or in patients with psoriasis or rheumatoid arthritis (RA). This is the first study conducted under clinical practice conditions evaluating the switch from reference adalimumab to MSB11022 in patients with RA.
UNASSIGNED: Retrospective and multicenter study with data from the medical records of patients with RA who switched from reference adalimumab or another biosimilar to MSB11022 and maintained this treatment for at least 6 months. Information registered comes from baseline visit, the moment of the switch, and the follow-up visits.
UNASSIGNED: Data from 86 patients were evaluated (median age 63.5 years, 75.6% female, 44.2% had erosive RA). Only 3.5% of the patients received biologic therapy prior to adalimumab. At baseline, median DAS28-CRP was 1.77 (80.2% in remission and 96.5% with low disease activity) and median CDAI was 4.00 (44.2% in remission and 90.7% with low disease activity). After a median follow-up of 8 months, median DAS28-CRP was 1.87 (86.0% in remission and 94.2% with low disease activity) and median CDAI was 4.00 (38.5% in remission and 95.3% with low disease activity). Only three patients experienced pain, swelling, and stinging at the injection site or a locally extensive hematoma in the area of administration.
UNASSIGNED: Adalimumab biosimilar MSB11022 maintained the efficacy benefits provided by previous adalimumab treatments with a safety profile in line with that already described for other biosimilars.
UNASSIGNED: Retrospective and multicenter study with data from the medical records of patients with RA who switched from reference adalimumab or another biosimilar to MSB11022 and maintained this treatment for at least 6 months. Information registered comes from baseline visit, the moment of the switch, and the follow-up visits.
UNASSIGNED: Data from 86 patients were evaluated (median age 63.5 years, 75.6% female, 44.2% had erosive RA). Only 3.5% of the patients received biologic therapy prior to adalimumab. At baseline, median DAS28-CRP was 1.77 (80.2% in remission and 96.5% with low disease activity) and median CDAI was 4.00 (44.2% in remission and 90.7% with low disease activity). After a median follow-up of 8 months, median DAS28-CRP was 1.87 (86.0% in remission and 94.2% with low disease activity) and median CDAI was 4.00 (38.5% in remission and 95.3% with low disease activity). Only three patients experienced pain, swelling, and stinging at the injection site or a locally extensive hematoma in the area of administration.
UNASSIGNED: Adalimumab biosimilar MSB11022 maintained the efficacy benefits provided by previous adalimumab treatments with a safety profile in line with that already described for other biosimilars.
摘要：
目的：MSB11022是阿达木单抗的生物仿制药，已显示出相当的生物等效性，安全,耐受性,和在健康志愿者或银屑病或类风湿关节炎（RA）患者中参考阿达木单抗的免疫原性谱。这是在临床实践条件下进行的第一项研究，评估RA患者从参考阿达木单抗转换为MSB11022。方法：回顾性和多中心研究，数据来自RA患者的医疗记录，这些患者从参考阿达木单抗或其他生物仿制药转为MSB11022，并维持该治疗至少6个月。登记的信息来自基线访问，转换的那一刻，以及后续访问。结果：对86例患者的数据进行了评估（中位年龄63.5岁，75.6%女性,44.2%患有侵蚀性RA)。只有3.5%的患者在阿达木单抗之前接受了生物治疗。在基线,DAS28-CRP中位数为1.77(缓解率为80.2%,疾病活动度低的为96.5%),CDAI中位数为4.00(缓解率为44.2%,疾病活动度低的为90.7%).中位随访8个月后，DAS28-CRP中位数为1.87(缓解率为86.0%,疾病活动度低的为94.2%),CDAI中位数为4.00(缓解率为38.5%,疾病活动度低的为95.3%).只有三名患者经历了疼痛，肿胀,并刺痛注射部位或给药区局部广泛的血肿。结论：阿达木单抗生物仿制药MSB11022保持了先前阿达木单抗治疗提供的疗效益处，其安全性与已经描述的其他生物仿制药一致。
