Anna Pękala
David Aebisher
Piotr Pardak
Rafal Filip
Efficacy and safety of biosimilar IFX (CT-P13) and adalimumab in patients with active fistulizing perianal Crohn’s disease naïve to anti-TNF therapy: preliminary results from the POLIBD study
Anna Pękala
David Aebisher
Piotr Pardak
Rafal Filip
Department of Gastroenterology with IBD Unit, Clinical Hospital No. 2, Rzeszów, Poland
Department of Photomedicine and Physical Chemistry, Medical College of Rzeszów University, Rzeszów, Poland
Department of Gastroenterology with IBD Unit, Clinical Hospital No. 2, Rzeszów, Poland
Department of Gastroenterology, Institute of Medical Sciences, Medical College of Rzeszow University, Rzeszow, Poland
Received: 3 January 2019 / Accepted: 12 February 2019 / Published: 30 March 2019
Abstract
Introduction. The development of perianal fistulas are a risk factor in colonic and rectal disease. Perianal CD treatment requires a combination of surgical and therapeutic treatments aimed to prevent septic complications, reduce fistula discharge and ultimately heal fistulas.
Aim. The purpose of the study was to evaluate the efficacy and safety of biosimilar IFX (CT-P13) and adalimumab in active fistulizing perianal Crohn’s disease (CD) in patients from the Subcarpathian Region (South-Eastern Poland).
Material and methods. Thirty patients with CD with perianal fistulas naïve to anti-TNF therapy were enrolled (13 females/ 17males) ranging from 18 to 64 years of age. Twenty-one were treated with biosimilar infliximab (CT-P13), nine were treated with adalimumab (ADA). The treated patients had ileal CD (4), ileo-colonic CD (13) or colonic CD (13). All of them received standard immunosuppression with no additional steroid therapy. Response was evaluated at week 16 and 40 after the first CT-P13 dose, and 16 and 40 weeks after the first ADA dose. Remission was defined as the complete closure of all fistulas and partial response as a reduction (≥50%) in the number of draining fistulas.
Results. Treatment outcomes with CT-P13 and ADA were both effective and similar in the percentage of patients with perianal fistula improvement, perianal fistula remission, no effect or observed adverse events.
Conclusion. In patients with active fistulizing CD, both CT-P13 and ADA were effective and safe, however a slight superiority of CT-P13 was visible.
Cite
Pękala A, Aebisher D, Pardak P, Filip R. Efficacy and safety of biosimilar IFX (CT-P13) and adalimumab in patients with active fistulizing perianal Crohn’s disease naïve to anti-TNF therapy: preliminary results from the POLIBD study. Eur J Clin Exp Med. 2019;17(1):12–15. doi: 10.15584/ejcem.2019.1.2
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