D1.386 - Adverse infusion reactions to biologicals in the treatment of inflammatory bowel diseases

The therapeutic armamentarium for inflammatory bowel disease (IBD) includes several biologic agents. Adverse Infusion Reactions (AIRs) can affect the subsequent clinical approach. The primary aim of the study was to compare the prevalence of AIRs across different biological agents. Secondary aims were to assess potential risk factors for AIRs and their management.

Consecutive IBD patients treated with biologic agents over a 6-year period were included. Demographic and clinical data were collected and  Antidrug antibody (ADA) were detected when available. Furthermore, the timing, site and severity of AIRs, as well as anti-reactive treatments and subsequent modifications of IBD therapy were reported. Additionally, we compared patients with AIRs with disease- and therapy-matched controls in a 1:2 case-to-control ratio, in order to stratify patient risk to reaction. 

51 AIRs were recorded among 2343 patients (2.2%) treated with: infliximab (IFX), adalimumab (ADA), vedolizumab (VED), ustekinumab (UST), golimumab (GOL). Of these, 40/748 (5.3%) were on IFX, 7/611 (1.1%) on ADA, 4/347 (1.1%) on VED. No AIRs were reported with GOL (0/40) and UST (0/597). Moderate reactions or anaphylaxis occurred exclusively in patients receiving intravenous IFX (22/51). 3/22 required adrenaline administration in addition to infusion interruption and anti-reactive treatment. Most AIRs (20/51) occurred during the induction period with a slight increase after the 7th drug administration. Only in 9 out 40 IFX patients ADA were collected and they were positive in 4 cases. History of atopy and premedication were not statistically different between cases and controls (p=0.02 and p=0.04, respectively). Most patients changed therapy after the AIRs (67%). 

In this large real-world IBD cohort, AIRs were infrequent and occured mainly during the induction period with intravenous IFX.  Causative mechanisms of AIRs are not fully elucidated. Atopy history didn’t represent a risk factor for AIR and ADA were detected and found positive only in a minority of them. Premedication did not prove effective in preventing the adverse reaction.