Survival of infliximab and adalimumab biosimilar therapy in patients with Crohn's disease

AIM: to evaluate the two-year survival of therapy with biosimilars of ioftiximab and adalimumab in patients with Crohn's disease (CD).

PATIENTS AND METHODS: survival was assessed by primary medical records (electronic medical records) of patients with CD who started on adalimumab or infliximab therapy in 2017-2019. Forty-nine patients who received infliximab therapy and 39 patients who received adalimumab therapy were included in the study. The main clinical and demographic data, laboratory tests (hemoglobin, leukocyte, platelet, albumin, C-reactive protein and fibrinogen levels) and instrumental checkup (ileocolonoscopy, intestinal ultrasound, CT enterography or MR enterography) at the time of therapy initiation andfor 2 years were estimated. In addition, the needfor therapy optimization during this period, the frequency and reasons for therapy discontinuation are assessed. In the context of the retrospective analysis, the "number of involved segments" (NIS) index was included. By this index, we meant the number of anatomical segments of the intestine to which the active inflammatory process was determined (duodenum, jejunum, ileum, cecum, ascending colon, transverse colon, descending colon, sigmoid colon, rectum).

RESULTS: in patients with infliximab for 2 years, the intensity of the inflammatory process significantly decreased. The number of intestinal segments involved in the inflammatory process and endoscopic activity significantly decreased during all 2 years of therapy (p <0.001 for both indices), the level of hemoglobin and plasma albumin significantly increased (p = 0.004 and p = 0.025, respectively). The median survival of therapy was 19 (9;24) months and the treatment continued for more than 2 years in 44.9% of patients. During adalimumab therapy of patients with CD, a significant decrease in all parameters of the inflammatory process activity was detected, the number of inflamed intestinal segments (p <0.001), intestinal wall thickness (p < 0.001), C-reactive protein (p < 0.001). The median survival of therapy was 24 (12; 24} months, 55.1% of patients continued to receive adalimumab for more than 2 years. At the same time, during infliximab and adalimumab therapy, the frequency of complications of CD increased (p < 0.001) due to strictures (p <0.001). This is probably explained by the healing of transmural ulcerative defects with the formation of cicatricial deformation of the intestine.

CONCLUSION: the study of predictors of high survival of biotherapy in patients with IBD is quite promising. Based on the results of retrospective analysis, several promising areas for prospective studies have been identified.

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