Efficacy and safety of biosimilar IFX (CT-P13) and adalimumab in patients with active fistulizing perianal Crohn’s disease naďve to anti-TNF therapy: preliminary results from the POLIBD study

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 naive 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.