Aralik 2024
Infliksimab ve biyobenzerlerinin steroide refrakter siddetli ülseratif kolitte kolektomisiz sag kalima etkisinin incelenmesi
The effect of infliximab and its biosimilars on colectomy-free survival in steroid refractory severe ulcerative colitis
- Ana Sayfa
- Sayılar
- Aralik 2024
- Infliksimab ve biyobenzerlerinin steroide refrakter siddetli ülseratif kolitte kolektomisiz sag kalima etkisinin incelenmesi...
3Uludag Üniversitesi Saglik Bilimleri Enstitüsü Biyoistatistik Bölümü, Bursa
Özet
ÖZET • Giris ve Amaç: Ülseratif kolitli hastalarin üçte biri akut siddetli ülseratif kolit ile basvurmakta ve kortikosteroid tedavisi gerekmektedir. Çalismada kortikosteroide yanitsiz hastalarda infliksimab ve biyobenzerlerinin kurtarma tedavisinde kolektomisiz sag kalim üzerine etkisi arastirilmistir. Gereç ve Yöntem: Truelove-Witts aktivite indeksine göre siddetli kolit kriterlerini karsilayan ve intravenöz kortikosteroid tedavisine yanitsiz olmasi nedeniyle infliksimab kurtarma tedavisi verilen 48 hasta retrospektif olarak degerlendirildi. Klinik kötülesme, yeni tedaviye geçilme gerekliligi ve kolektomi ihtiyaci progresyon olarak tanimlandi. Kisa süreli (3 ay) ve uzun süreli (12 ay) kolektomisiz sag kalim primer sonlanim olarak kabul edildi. Ayrica orijinal ve biyobenzer infliksimab etkinlik açisindan karsilastirildi. Bulgular: 14 hastaya orijinal infliksimab, 34 hastaya biyobenzer infliksimab tedavisi verilmisti. Kisa ve uzun süreli sonlanimda hiçbir hastada kolektomi ihtiyaci saptanmadi. Iki yil ve üzerinde biyobenzer infliksimab tedavisi alan iki hastaya kolektomi uygulanmis oldugu saptandi. Progresyon varligina göre sag kalim sürelerinin istatistiksel olarak farklilik gösterdigi belirlendi (p < 0.001). Genel sag kalim süresinin ise farklilik göstermedigi saptandi (p > 0.05). Sonuç: Kortikosteroide refrakter siddetli ülseratif kolitli hastalarda kolektomisiz sag kalim için hem orijinal hem de biyobenzer infliksimab etkili bulundu.
Abstract
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.
