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Gastroenterologie
a hepatologie

Gastroenterology and Hepatology

Gastroent Hepatol 2016; 70(1): 27–36. doi:10.14735/amgh201627.

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

Tibor Hlavatý Orcid.org  1, Anna Krajčovičová Orcid.org  1, Igor Šturdík Orcid.org  1, Juraj Letkovský2,3, Tomáš Koller Orcid.org  4, Jozef Tóth Orcid.org  4,3, Martin Huorka Orcid.org  4

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Souhrn

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.

Klíčová slova

infliximab, CT-P13, Crohnova choroba, biosimilars, retrospektivní studie, terapie, ulcerózní kolitida

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