Int J Clin Pharmacol Ther. 2024 Mar;62(3):122-125. doi: 10.5414/CP204388.
The biosimilar CT-P13, the first and only subcutaneous (SC) infliximab formulation, is recommended for patients with psoriatic arthritis (PsA) and can be administered as a maintenance treatment, to be started 4 weeks after the induction treatment with 2 intravenous (IV) infliximab infusions.
To evaluate treatment with SC infliximab without prior IV infusion induction to meet patient needs.
After approval by the ethics review board and based on the schedule approved for rheumatoid arthritis, SC induction was performed with infliximab CT-P13 120 mg weekly for 4 weeks, followed by an injection of 120 mg every 2 weeks.
After 4 months of therapy, joint symptoms were resolved, inflammation parameters were normalized (erythrocyte sedimentation rate) reduced from 42 to 16 mm/h, and C-reactive protein from 1.74 to 0.43 mg/dL), and clinical assessment parameters were improved. After 9 months of therapy, the clinical data remained stable, with no adverse events or local side effects.
SC infliximab was successfully used without previous IV infusion induction. Although, to date, the induction of PsA treatment via the SC route is not foreseen, the known pharmacokinetic properties and the outcome improvements observed in our patient show that subcutaneous treatment induction, as is already done in the treatment of rheumatoid arthritis, is also possible.
CT-P13 是首款也是唯一一款皮下(SC)注射用英夫利昔单抗生物类似药,推荐用于治疗银屑病关节炎(PsA)患者,可以作为维持治疗药物,在接受 2 次静脉(IV)英夫利昔单抗输注诱导治疗后 4 周开始使用。
评估不进行 IV 输注诱导的 SC 英夫利昔单抗治疗,以满足患者的需求。
在伦理审查委员会批准后,根据批准用于类风湿关节炎的方案,每周给予 SC 英夫利昔单抗 CT-P13 120mg 诱导治疗 4 周,然后每 2 周给予 120mg 注射。
经过 4 个月的治疗,关节症状得到缓解,炎症参数恢复正常(红细胞沉降率从 42mm/h 降至 16mm/h,C 反应蛋白从 1.74mg/dL 降至 0.43mg/dL),临床评估参数也得到改善。经过 9 个月的治疗,临床数据保持稳定,无不良事件或局部副作用。
无需预先进行 IV 输注诱导,成功使用了 SC 英夫利昔单抗。尽管目前尚未预见通过 SC 途径诱导治疗 PsA,但我们患者中观察到的已知药代动力学特性和临床改善表明,与已经在类风湿关节炎治疗中应用的皮下治疗诱导一样,SC 治疗诱导也是可能的。