Abstract
Background
The use of biologicals has improved the treatment of IBD but the understanding of adverse drug reactions (ADRs) and the knowledge of patients’ perception on ADRs is poor. Patient-reporting may provide more insight in the extent and burden of ADRs in daily practice which in turn can lead to treatment optimisation. This study aimed to assess systematic patient-reported ADRs during biological therapy in IBD patients.
Methods
This multicentre, prospective, event monitoring study enrolled adult Crohn’s disease (CD) and ulcerative colitis (UC) patients treated with a biological between 1 January 2017 and 31 December 2018. Patients completed bimonthly comprehensive web-based questionnaires regarding indication and use of, description of biological induced ADRs, follow-up of previous ADRs, experienced burden of the ADR using a 5-point Likert scale, contact with a healthcare provider and therapeutic consequences due to the ADR. Patient-reported ADRs were MedDRA coded by trained pharmacovigilance assessors. MedDRA is a multi-hierarchical dictionary used to code reported ADRs into specific unambiguous terms (preferred terms). Preferred terms are subsequently grouped into high-level terms, high-level group terms and system organ classes. In total there are 26 system organ classes.
Results
In total, 182 patients in 4 centres (female 51%, mean (standard deviation) age 42.2 (14.2) years, CD 77%) were included and completed 750 questionnaires. At baseline, 49% used an immunomodulator (43% thiopurines, 6% methotrexate), while biologicals were documented as follows: 59% infliximab, 30% adalimumab, 9% vedolizumab, 1% ustekinumab. At least one ADR was reported by 50% of the participants, and 233 ADRs were reported in total with a median reported ADRs per participant of 2 (interquartile range, 1–3). Fatigue (n = 26), headache (n = 20), injection site reactions (n = 16) and arthralgia (n = 12) were most commonly reported, with a mean burden of 3.31, 1.63, 2.55 and 3.33, and a correlation in time with the administration of the biologic was described in 58%, 85%, 81% and 8% in these ADRs, respectively. Participants contacted a healthcare provider in 62% of all ADRs. In two out of 90 patients who reported an ADR, the biological was discontinued.
Conclusion
We established a patient-reported pharmacovigilance monitoring system and participants in this study frequently reported ADRs due to biologicals. Fatigue and arthralgia resulted in the highest burden. This reporting system may provide more understanding of patient-experienced ADRs which may ultimately lead to increased adherence of therapy and improved quality of life.
Expanding the functionality of automated monitoring systems for traction substations