Amsterdam Rheumatology and Immunology Center, Reade, Rheumatology, Amsterdam, The Netherlands.
Reade, Rheumatology, Pharmacy, Amsterdam, The Netherlands.
Int J Rheum Dis. 2019 May;22(5):869-873. doi: 10.1111/1756-185X.13512. Epub 2019 Feb 14.
To evaluate the transition from reference infliximab Remicade to biosimilar Remsima in patients with rheumatoid arthritis (RA) or psoriatic arthritis (PsA).
Patients were informed through a letter about the transition to a biosimilar and were subsequently contacted for possible additional questions and whether they agreed upon the transition. Once agreed, Remsima was administered at the same dosage and interval as previous treatment with Remicade. Data on the transition were analyzed in January 2018. The primary outcome was the percentage of patients continuing treatment with Remsima and secondary outcome was the change in disease activity measured with the Disease Activity Score in 28 joints using erythrocyte sedimentation rate (DAS28-ESR). In addition, the reasons for discontinuation with infliximab or restarting Remicade were recorded.
In total 47 patients were approached, 45 patients switched from Remicade to Remsima, two patients disagreed upon transition and continued Remicade. At the end of the follow-up period of 2 years, 39 patients (87%) continued with Remsima, three patients (7%) restarted Remicade due to inefficacy according to the patient (this was not objectified by the rheumatologist) 2 (4%) patients switched to another biological due to lack of effect and in one patient (2%) infliximab was stopped because of lung malignancy. Furthermore, the DAS28-ESR remained comparable before and after the switch, with a mean (SD) of 2.34 (±1.02) and 2.31 (±1.11) respectively.
In our population, 87% of patients continued Remsima during the follow-up period of approximately 2 years. Three patients restarted Remicade, while retaining stable DAS28-ESR.
评估类风湿关节炎（RA）或银屑病关节炎（PsA）患者从参照性英夫利昔单抗（Remicade）过渡到生物类似药瑞西单抗（Remsima）的情况。
通过一封信告知患者有关过渡到生物类似药的信息，随后与他们联系，以了解他们是否有其他问题，并征求他们对过渡的意见。一旦达成一致，就按照之前使用 Remicade 的相同剂量和间隔给予 Remsima。于 2018 年 1 月分析有关过渡的数据。主要结局是继续接受 Remsima 治疗的患者比例，次要结局是使用红细胞沉降率（DAS28-ESR）评估的 28 个关节疾病活动度评分（DAS28-ESR）的变化。此外，还记录了停用英夫利昔单抗或重新开始使用 Remicade 的原因。
共接触了 47 例患者，其中 45 例从 Remicade 转为 Remsima，2 例患者不同意过渡并继续使用 Remicade。在 2 年的随访期结束时，39 例（87%）患者继续使用 Remsima，3 例（7%）患者因患者（未经风湿病医生客观化）认为疗效不佳而重新开始使用 Remicade，2 例（4%）患者因疗效不佳而改用另一种生物制剂，1 例（2%）患者因肺癌而停用英夫利昔单抗。此外，转换前后 DAS28-ESR 保持相似，分别为 2.34（±1.02）和 2.31（±1.11）。
在我们的人群中，大约 2 年的随访期间，87%的患者继续使用 Remsima。3 例患者重新开始使用 Remicade，同时保留稳定的 DAS28-ESR。
