Campochiaro Corrado, Tomelleri Alessandro, Sartorelli Silvia, Sembenini Camilla, Papa Maurizio, Fallanca Federico, Picchio Maria, Cavalli Giulio, De Cobelli Francesco, Baldissera Elena, Dagna Lorenzo
Unit of Immunology, Rheumatology, Allergy and Rare Diseases, Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) San Raffaele Hospital, Milan, Italy.
Vita-Salute San Raffaele University, Milan, Italy.
Front Med (Lausanne). 2021 Sep 27;8:723506. doi: 10.3389/fmed.2021.723506. eCollection 2021.
Infliximab (IFX) is widely used in patients with refractory Takayasu arteritis (TAK). Recently, the IFX-biosimilar CT-P13 has been introduced for the treatment of inflammatory diseases. The aim of this study was to assess the efficacy and safety of CT-P13 in patients with refractory TAK. In this prospective, open-label, single-center trial, TAK patients either already on treatment with IFX-originator (switch group) or never treated with IFX (naïve group) received CT-P13 for 52 weeks. The primary outcomes of the study were: (i) number of patients with active disease at month 6; (ii) incidence of treatment-emergent adverse events at month 12. Disease activity was assessed at month 6 and month 12 by clinical evaluation (ITAS-2020, ITAS-ESR, and ITAS-CRP scores) and imaging assessment [magnetic resonance angiography (MRA) and (18F)-FDG-PET]. 23 patients were recruited (21 switch, 2 naïve). At baseline, 7 patients (32%) were classified as active. At month 6, one patient voluntarily dropped out and 7 patients were still active (30%), including one patient started on a different bDMARD at month 2 due to poor disease control. Mean daily dose of prednisone equivalent was significantly lower than baseline (4.2 ± 1.9 mg vs. 4.8 ± 2.1 mg, = 0.009). At month 12, another patient was excluded because of pregnancy desire. Five patients were classified as active (24%), including two patients started on a different bDMARD at month 2 and month 6. Mean daily dose of prednisone equivalent was significantly lower than baseline (3.3 ± 2.6, = 0.034). No patient experienced side effects during CT-P13 infusion. Overall, one patient experienced grade 1 adverse event and 9 patients experienced grade 2 adverse events. In no case hospitalization was required. CT-P13 retention rate was 90.9% at month 6 and 90.4% at month 12. In this study, the use of IFX-biosimilar CT-P13 in patients with refractory TAK showed satisfying efficacy and safety profile.
英夫利昔单抗（IFX）广泛应用于难治性大动脉炎（TAK）患者。最近，IFX生物类似药CT-P13已被用于治疗炎症性疾病。本研究的目的是评估CT-P13在难治性TAK患者中的疗效和安全性。在这项前瞻性、开放标签、单中心试验中，正在接受原研IFX治疗的TAK患者（转换组）或从未接受过IFX治疗的TAK患者（初治组）接受CT-P13治疗52周。该研究的主要结局为：（i）第6个月时疾病活动的患者数量；（ii）第12个月时治疗中出现的不良事件的发生率。在第6个月和第12个月通过临床评估（ITAS-2020、ITAS-ESR和ITAS-CRP评分）和影像学评估[磁共振血管造影（MRA）和（18F）-FDG-PET]对疾病活动进行评估。招募了23例患者（21例转换组，2例初治组）。在基线时，7例患者（32%）被分类为疾病活动。在第6个月时，1例患者自愿退出，7例患者仍处于疾病活动状态（30%），其中1例患者由于疾病控制不佳在第2个月开始使用另一种生物制剂改善病情抗风湿药（bDMARD）。泼尼松等效物的平均每日剂量显著低于基线（4.2±1.9mg对4.8±2.1mg，P=0.009）。在第12个月时，另1例患者因有妊娠意愿被排除。5例患者被分类为疾病活动（24%），其中2例患者在第2个月和第6个月开始使用另一种bDMARD。泼尼松等效物的平均每日剂量显著低于基线（3.3±2.6，P=0.034）。在CT-P13输注期间没有患者出现副作用。总体而言，1例患者经历了1级不良事件，9例患者经历了2级不良事件。无一例需要住院治疗。CT-P13在第6个月时的保留率为90.9%，在第12个月时为90.4%。在本研究中，难治性TAK患者使用IFX生物类似药CT-P13显示出令人满意的疗效和安全性。
