Effectiveness and safety of adalimumab biosimilar in patients with inflammatory bowel disease.

Abstract

Background: Adalimumab biosimilar MSB11022 (Idacio®) has been approved for the same indications as its originator (Humira®), based on findings from clinical trials in plaque psoriasis. Data on its efficacy and safety in inflammatory bowel disease, however, are scarce.

Methods: Retrospective, observational study of 44 patients with inflammatory bowel disease: 30 were treated with originator adalimumab, five were directly started on MSB11022, and nine switched from originator to biosimilar adalimumab. To evaluate the effectiveness of the use of adalimumab in inflammatory bowel disease, both laboratory markers (fecal calprotectin and C-reactive protein) and scales that measure the activity of inflammatory bowel disease using specific scales (Harvey-Bradshaw Index [HBI] have been used for Crohn's disease and Mayo Score for ulcerative colitis). Efficacy was evaluated by recording the adverse effects that could occur with the administration of adalimumab (original or biosimilar). The success of the switch was determined by analyzing meaningful differences in effectiveness and safety criteria. Concomitant therapy and the need for dose intensification were also analyzed. Objective of this study was to assess the effectiveness and safety of biosimilar adalimumab in adalimumab-naïve patients and patients switched from originator adalimumab.

Results: No significant differences were observed in clinical disease activity (p = 0.317) or biochemical parameters (fecal calprotectin [p = 0.445] and C-reactive protein [p = 0.661]) after the switch from the originator adalimumab to MSB11022. There was not a significant reduction in the concomitant use of corticosteroids and thiopurines (p = 0.157). No emergency room visits or hospitalizations were observed during the study period and none of the patients experienced serious adverse effects.

Conclusions: Between originator adalimumab and biosimilar-start cohorts no differences were observed, between originator adalimumab and switch cohorts no significant differences were found either, and with the pre- and post-switch to biosimilar comparison two of the nine patients experienced adverse effects after the switch. The biosimilar showed a favorable safety profile (one patient with a serious adverse effect [rash] with biosimilar discontinued treatment) and no significant changes to clinical or biochemical parameters were observed after the switch.