The effect of infliximab and its biosimilars on colectomy-free survival in steroid refractory severe ulcerative colitis

Öz

Background and Aims: One-third of patients with acute severe ulcerative colitis necessitate corticosteroid treatment. This study aimed to evaluate the efficacy of infliximab and its biosimilars on colectomy-free survival as a rescue therapy in corticosteroid-refractory patients. Materials and Methods: This retrospective study evaluated 48 patients meeting the criteria for severe colitis according to the Truelove-Witts activity index. The study group included patients refractory to intravenous corticosteroid therapy who received rescue treatment with infliximab. Progression was defined as clinical deterioration, the need for new treatment, and the need for colectomy. The primary outcomes were short-term (3 months) and long-term (12 months) colectomy-free survival. The efficacy of originator and biosimilar infliximab was also compared. Results: Fourteen patients were treated with originator Infliximab and 34 with biosimilar infliximab. Both short-term and long-term survival outcomes showed no immediate need for colectomy. Two patients in the biosimilar infliximab group underwent total colectomy operation more than two years after treatment. Survival times was statistically different according to the presence of progression (p < 0.001). However, there was no significant difference in overall survival between the groups (p > 0.05). Conclusions: Both originator and biosimilar infliximab are effective in achieving colectomy-free survival in patients with severe ulcerative colitis refractory to corticosteroids.

Anahtar Kelimeler

• Acute severe ulcerative colitis
• infliximab
• biosimilars

İnfliksimab ve biyobenzerlerinin steroide refrakter şiddetli ülseratif kolitte kolektomisiz sağ kalıma etkisinin incelenmesi

Öz

Giriş ve Amaç: Ülseratif kolitli hastaların üçte biri akut şiddetli ülseratif kolit ile başvurmakta ve kortikosteroid tedavisi gerekmektedir. Çalışmada kortikosteroide yanıtsız hastalarda infliksimab ve biyobenzerlerinin kurtarma tedavisinde kolektomisiz sağ kalım üzerine etkisi araştırılmıştır. Gereç ve Yöntem: Truelove-Witts aktivite indeksine göre şiddetli kolit kriterlerini karşılayan ve intravenöz kortikosteroid tedavisine yanıtsız olması nedeniyle infliksimab kurtarma tedavisi verilen 48 hasta retrospektif olarak değerlendirildi. Klinik kötüleşme, yeni tedaviye geçilme gerekliliği ve kolektomi ihtiyacı progresyon olarak tanımlandı. Kısa süreli (3 ay) ve uzun süreli (12 ay) kolektomisiz sağ kalım primer sonlanım olarak kabul edildi. Ayrıca orijinal ve biyobenzer infliksimab etkinlik açısından karşılaştırıldı. Bulgular: 14 hastaya orijinal infliksimab, 34 hastaya biyobenzer infliksimab tedavisi verilmişti. Kısa ve uzun süreli sonlanımda hiçbir hastada kolektomi ihtiyacı saptanmadı. İki yıl ve üzerinde biyobenzer infliksimab tedavisi alan iki hastaya kolektomi uygulanmış olduğu saptandı. Progresyon varlığına göre sağ kalım sürelerinin istatistiksel olarak farklılık gösterdiği belirlendi (p < 0.001). Genel sağ kalım süresinin ise farklılık göstermediği saptandı (p > 0.05). Sonuç: Kortikosteroide refrakter şiddetli ülseratif kolitli hastalarda kolektomisiz sağ kalım için hem orijinal hem de biyobenzer infliksimab etkili bulundu.

Anahtar Kelimeler

• Akut şiddetli ülseratif kolit
• infliksimab
• biyobenzer

Kaynakça

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