Department of Geriatric and Environmental Dermatology, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.
Quality and Pharmacovigilance Division, Pharmaceuticals Group, Nippon Kayaku Co., Ltd., Tokyo, Japan.
J Dermatol. 2022 Oct;49(10):957-969. doi: 10.1111/1346-8138.16508. Epub 2022 Jul 7.
Based on extrapolation of similar clinical outcomes in rheumatoid arthritis to the originator infliximab (IFX) in randomized clinical trials, the first biosimilar antibody CT-P13 was approved for the treatment of psoriasis. To evaluate the safety, efficacy, and drug survival of CT-P13 for psoriasis in real-world clinical practice, prospective post-marketing surveillance was conducted in 165 Japanese psoriasis patients. During a 1-year follow-up period, adverse drug reactions (ADRs) occurred in 29 patients (17.6%). Infusion reaction was the most frequent ADR (6.7%), and mild pneumonia was reported as the only case of infection. Serious ADRs were reported in two patients (1.2%): acute cholecystitis and interstitial pneumonia. The interstitial pneumonia developed after a single infusion of CT-P13 and the patient died of respiratory failure. In naive patients to biologic therapy (n = 44), the Psoriasis Area Severity Index (PASI) decreased rapidly after the start of CT-P13 treatment, and response rate achieving an absolute PASI score <1 was 55% at 30 weeks. The response rate was high (78%) in patients with psoriatic arthritis, and 40% and 20% in those in plaque psoriasis and pustular psoriasis, respectively. Of patients switched from IFX to CT-P13 mainly for nonmedical reasons (n = 105), 57% had already reached PASI <1 by pretreatment with IFX and CT-P13 maintained this status. The incidence of ADRs in this patient group was low and the drug survival rate was as high as 74%, even at 1 year, which was significantly higher than that in the naïve patient group (47%). Patients switched from other biologics for medical reasons (n = 16) responded similarly to biologic-naïve patients, but drug survival was lower (24%). In conclusion, CT-P13 showed excellent effectiveness as a first-line therapy, no clinical difficulties in switching from IFX, and usefulness in patients who failed other biologics. CT-P13 could be a cost-effective alternative to IFX for the treatment of psoriasis.
基于类风湿关节炎类似临床结局的外推，在随机临床试验中，首创的英夫利昔单抗（IFX）获批用于治疗银屑病。为评估 CT-P13 在真实世界临床实践中治疗银屑病的安全性、疗效和药物生存情况，对 165 例日本银屑病患者进行了前瞻性上市后监测。在 1 年的随访期间，29 例（17.6%）患者发生药物不良反应（ADR）。输液反应是最常见的 ADR（6.7%），报道的唯一感染病例为轻度肺炎。2 例（1.2%）患者报告严重 ADR：急性胆囊炎和间质性肺炎。间质性肺炎发生在单次输注 CT-P13 后，患者死于呼吸衰竭。在首次接受生物治疗的患者（n=44）中，CT-P13 治疗开始后银屑病面积严重程度指数（PASI）迅速下降，30 周时达到绝对 PASI 评分<1 的应答率为 55%。在有银屑病关节炎的患者中应答率较高（78%），斑块型银屑病和脓疱型银屑病的应答率分别为 40%和 20%。因非医学原因从 IFX 转换为 CT-P13 的患者（n=105）中，57%在 IFX 和 CT-P13 预处理时已达到 PASI<1，且这一状态得以维持。该患者组的 ADR 发生率较低，药物生存率高达 74%，甚至在 1 年时也显著高于首次接受生物治疗的患者组（47%）。因医学原因从其他生物制剂转换而来的患者（n=16）与首次接受生物治疗的患者应答相似，但药物生存率较低（24%）。总之，CT-P13 作为一线治疗具有优异的疗效，从 IFX 转换无临床困难，对其他生物制剂治疗失败的患者也有用。CT-P13 可能是治疗银屑病的一种具有成本效益的 IFX 替代药物。
