First clinical experience with biosimilar adalimumab FKB327 in patients with inflammatory bowel disease
2020
Abstract
Aim of our study was to compare clinical efficacy and safety of biosimilar adalimumab FKB327 (Hulio(R)) with the original (Humira(R)). In total, 62 patients (35 treated with FKB327 and 27 treated with originál adalimumab) were followed for the period of 14 weeks.
In both groups, we observed decrease of inflammatory parameters (C-reactive protein, fecal calprotectin) and clinical activity (Harvey-Bradshaw index) without a statistically significant difference between biosimilar and original adalimumab. The proportion of patients in which clinically significant infections led to an early treatment withdrawal was low and similar in both groups (FKB327 - 5.7%, original adalimumab - 3.7%).