Service de rhumatologie, hôpital Pellegrin, centre hospitalier universitaire de Bordeaux, place Amélie-Raba-Léon, 33076 Bordeaux, France; Université de Bordeaux, 146, rue Léo-Saignat, 33076 Bordeaux, France; CNRS-UMR 5164 Immuno ConcEpT, 146, rue Léo-Saignat, 33076 Bordeaux, France.
Service de rhumatologie, hôpital Pellegrin, centre hospitalier universitaire de Bordeaux, place Amélie-Raba-Léon, 33076 Bordeaux, France; Université de Bordeaux, 146, rue Léo-Saignat, 33076 Bordeaux, France.
Joint Bone Spine. 2018 Oct;85(5):561-567. doi: 10.1016/j.jbspin.2017.10.003. Epub 2017 Nov 14.
To explore acceptance and retention rate of biosimilar CT-P13 after switching from originator infliximab (OI) in patients with various rheumatic diseases.
Patients with stable rheumatoid arthritis (RA), ankylosing spondylitis (AS) or psoriatic arthritis (PsA) under OI were proposed to switch to CT-P13 at the same regimen. A prospective cohort of infliximab-naïve patients beginning CT-P13 and a retrospective cohort of patients treated with OI were used as controls. The primary outcome was to evaluate the retention rate of CT-P13. Secondary outcomes were the switch acceptance rate, reasons of failure and safety.
Switch was proposed to 100 patients and accepted by 89 of them (63 AS, 12 PsA and 14 RA). After a median follow-up of 33 weeks, 72% of patients were still treated with CT-P13. This retention rate was significantly lower than the one found in our retrospective and prospective control cohorts: 88% and 90% respectively (P-value=0.0002). Within patients who asked to be reswitched to OI, 13/25 (52%) presented clinical disease activity, one developed serum sickness and 11 (44%) presented no objective activity. A subanalysis excluding these 11 patients abrogated difference in retention rates between the 3 cohorts (P-value=0.453). After reswitching to OI, patients without objective disease activity claimed to recover original efficacy.
Retention rate was lower after switching from OI to CT-P13 compared to our control cohorts. However, this difference faded after excluding patients without objective clinical activity, suggesting a reluctance of patients to the switch and a negative perception of the biosimilar.
探索不同风湿病患者从原研英夫利昔单抗（OI）转换为生物类似药 CT-P13 的接受率和保留率。
建议稳定期的类风湿关节炎（RA）、强直性脊柱炎（AS）或银屑病关节炎（PsA）患者在相同方案下转换为 CT-P13。将生物类似药初治患者的前瞻性队列和 OI 治疗患者的回顾性队列作为对照组。主要结局是评估 CT-P13 的保留率。次要结局是转换接受率、失败原因和安全性。
共向 100 名患者提出了转换建议，其中 89 名患者（63 例 AS、12 例 PsA 和 14 例 RA）接受了转换。中位随访 33 周后，72%的患者仍接受 CT-P13 治疗。与我们的回顾性和前瞻性对照组相比，这一保留率显著降低：分别为 88%和 90%（P 值=0.0002）。在要求重新转换为 OI 的患者中，13/25（52%）患者出现临床疾病活动，1 例发生血清病，11 例（44%）患者无客观活动。排除这 11 例患者后，3 组间的保留率差异消失（P 值=0.453）。重新转换为 OI 后，无客观疾病活动的患者声称恢复了原有疗效。
与对照组相比，从 OI 转换为 CT-P13 的保留率较低。然而，排除无客观临床活动的患者后，这种差异消失，这表明患者对转换的不情愿和对生物类似药的负面看法。
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