Abdalla Abuelmagd, Byrne Niamh, Conway Richard, Walsh Thomas, Mannion Geraldine, Hanly Michael, O'Sullivan Miriam, Curran Ann Maria, Carey John J
Department of Rheumatology, Galway University Hospitals, Galway, Ireland.
Open Access Rheumatol. 2017 Mar 7;9:29-35. doi: 10.2147/OARRR.S124975. eCollection 2017.
To evaluate the efficacy and safety of the biosimilar infliximab in adult patients with inflammatory arthritis switched from reference product in our center.
In April 2014, patients attending our rheumatology service for infliximab infusions were switched from reference product to the biosimilar infliximab following consent and hospital approval.
Around 34 patients with inflammatory arthritis were switched from reference product to biosimilar infliximab in 2014: 50% female, mean age 55 years (standard deviation=12.9), mean disease duration 14.79 years (9.7), median duration on infliximab 57 months, and two-thirds on oral disease-modifying antirheumatic drugs. There was no difference in efficacy or safety in the first 6 months of therapy. By the end of 2015, the mean follow-up on biosimilar infliximab was 15.8 (standard deviation=6.3) months. Our results showed no significant difference in Health Assessment Questionnaire score, patient global assessment of disease activity, number of disease flares, or the medication dose between the originator and the biosimilar infliximab. However, reported pain and C-reactive protein values were significantly higher during the longer follow-up period (=0.043, 0.001 respectively). There was no significant difference in the number of adverse events or infusion reactions during follow-up periods. Only five (14.7%) patients discontinued the biosimilar infliximab.
Our patients experienced similar efficacy and safety for managing their arthritis with the biosimilar infliximab as the reference product infliximab, but at a much lower cost.
评估在我们中心从原研产品转换为生物类似药英夫利昔单抗治疗的成年炎性关节炎患者中，该生物类似药的疗效和安全性。
2014年4月，在获得患者同意并经医院批准后，在我们风湿病科接受英夫利昔单抗输注治疗的患者从原研产品转换为生物类似药英夫利昔单抗。
2014年约34例炎性关节炎患者从原研产品转换为生物类似药英夫利昔单抗：50%为女性，平均年龄55岁（标准差=12.9），平均病程14.79年（9.7），英夫利昔单抗治疗的中位时长为57个月，三分之二的患者正在使用口服改善病情抗风湿药物。治疗的前6个月，疗效和安全性方面无差异。到2015年底，生物类似药英夫利昔单抗的平均随访时间为15.8个月（标准差=6.3）。我们的结果显示，在健康评估问卷评分、患者对疾病活动的整体评估、疾病发作次数或原研产品与生物类似药英夫利昔单抗的用药剂量方面无显著差异。然而，在更长的随访期内，报告的疼痛和C反应蛋白值显著更高（分别为P=0.043，P=0.001）。随访期间不良事件或输注反应的数量无显著差异。只有5例（14.7%）患者停用了生物类似药英夫利昔单抗。
我们的患者使用生物类似药英夫利昔单抗治疗关节炎时疗效和安全性与原研产品英夫利昔单抗相似，但成本要低得多。
