Discrepancy between patient‐ and healthcare provider‐reported adverse drug reactions in inflammatory bowel disease patients on biological therapy

BACKGROUND: Only limited data is available on the extent and burden of adverse drug reactions (ADRs) to biological therapy in inflammatory bowel disease (IBD) patients in daily practice, especially from a patient's perspective. OBJECTIVE: The aim of this study was to systematically assess patient‐reported ADRs during biological therapy in IBD patients and compare these with healthcare provider (HCP)‐reported ADRs. METHODS: This multicentre, prospective, event monitoring study enrolled IBD patients on biological therapy. Patients completed bimonthly comprehensive web‐based questionnaires regarding description of biological induced ADRs, follow‐up of previous ADRs and experienced burden of the ADR using a five‐point Likert scale. The relationship between patient‐reported ADRs and biological therapy was assessed. HCP‐reported ADRs were extracted from the electronic healthcare records. RESULTS: In total, 182 patients (female 51%, mean age 42.2 [standard deviation 14.2] years, Crohn's disease 77%) were included and completed 728 questionnaires. At baseline, 60% of patients used infliximab, 30% adalimumab, 9% vedolizumab and 1% ustekinumab. Fifty percent of participants reported at least one ADR with a total of 239 unique ADRs. Fatigue (n = 26) and headache (n = 20) resulted in the highest burden and a correlation in time with the administration of the biological was described in 56% and 85% respectively. Out of 239 ADRs, 115 were considered biological‐related. HCPs reported 119 ADRs. Agreement between patient‐reported ADRs and HCP‐reported ADRs was only 13%. CONCLUSION: IBD patients often report ADRs during biological therapy. We observed an important significant difference between the type and frequency of patient‐reported ADRs versus HCP‐reported ADRs, leading to an underestimation of more subjective ADRs and patients' ADR‐related burden.