Skúsenosti s liečbou biosimilárnym infliximabom CT-P13 u pacientov s nešpecifickými zápalovými ochoreniami čreva – retrospektívna štúdia

English version

Authors: T. Hlavatý; A. Krajcovicova; I. Sturdik; J. Letkovský; T. Koller; J. Tóth; M. Huorka
Authors‘ workplace: IBD Center, Subdepartment of Gastroenterology and Hepatology, 5th Department of Internal Medicine, Faculty of Medicine, Comenius University and University Hospital Bratislava, Slovak Republic
Published in: Gastroent Hepatol 2016; 70(1): 27-36
Category: Original Article
doi: https://doi.org/10.14735/amgh201627

Overview

Úvod:
CT-P13 je prvým schváleným biosimilárom infliximabu. Jeho ekvivalencia s infliximabom bola potvrdená v reumatologických štúdiách avšak skúsenosti s jeho použitím pri liečbe nešpecifických črevných zápalov sú obmedzené.

Cieľ:
Zhodnotiť účinnosť a bezpečnosť liečby CT-P13 u pacientov s nešpecifickými črevnými zápalmi počas prvého roka jeho klinického používania.

Metódy:
Realizovali sme retrospektívnu štúdiu, do ktorej boli zaradení všetci konzekutívni pacienti s Crohnovou chorobou (CD) alebo ulceróznou kolitídou (UC), ktorí boli liečení v období od marca 2014 do apríla 2015 a boli im podané aspoň tri infúzie CT-P13 alebo ukončili liečbu skôr z dôvodu nežiaducej reakcie. Klinická remisia bola zhodnotená v 14. týždni po zahájení indukčnej liečby. U časti pacientov bol CT-P13 zamenený za IFX, ktorý užívali ako udržiavaciu liečbu (switch), v čase zámeny boli všetci v klinickej remisii. Pretrvávajúca klinická odpoveď bola hodnotená každých osem týždňov u pacientov, ktorí zahájili liečbu aj u tých, ktorým bola liečba zamenená.

Výsledky:
Kohorta pozostávala z 25 pacientov s nešpecifickými črevnými zápalmi (19 CD, šesť UC). Spolu bolo podaných 128 infúzií, medián podaných infúzií bol 5 (rozmedzie 2–9) . Trinásť pacientov (deväť CD, štyri UC) dostávalo CT-P13 ako indukčnú liečbu a 84 % (7/ 9 CD, 4/ 4 UC) dosiahlo klinickú remisiu do týždňa 14 a spomedzi tých, čo dosiahli remisiu malo pretrvávajúcu klinickú odpoveď v 30. týždni 85 % (3/ 3 CD, 3/ 4 UC) pacientov. U 12 pacientov (10 CD, dva UC) bol infliximab zmenený na CT-P13, spomedzi nich malo pretrvávajúcu klinickú odpoveď 100 % v 24. týždni, 87,5 % (6/ 7 CD, 1/ 1 UC) v týždni 32 a 75 % (5/ 7 CD, 1/ 1 UC) v týždni 48. U štyroch pacientov s CD bola liečba CT-P13 ukončená pre infúzne reakcie, psoriatiformné kožné lézie a stratu odpovede.

Záver:
Naše skúsenosti naznačujú, že biosimilárny infliximab CT-P13 vykazuje porovnateľnú účinnosť a bezpečnosť ako originálny infliximab.

Kľúčové slová:
Crohnova choroba – ulcerózna kolitída – terapia – infliximab – biosimilár – CT-P13 – retrospektívna štúdia

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Doručeno:
8. 12. 2015

Přijato:
12. 1. 2016

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