A conceptual framework may offer practical solutions when dealing with adverse drug reactions (ADRs) in immune-mediated inflammatory diseases (IMIDs). Researchers identified 6 main themes, which influence the timecourse of ADRs.
Many patients with IMIDs suffer from ADRs during chronic drug treatment. Usually, only ADRs that occur with drug use are reported. However, the Dutch pharmacist and researcher Ms Jette van Lint (Pharmacovigilance Centre Lareb, the Netherlands) proposed that the patient-reported medical information on the common patterns in the course and timeframe of ADRs, which are often overlooked, may provide valuable further insights for finding practical solutions when dealing with ADRs in patients with IMIDs .
Ms van Lint and her team used qualitative data from the Dutch Biologic Monitor (DBM) to assess the patient’s descriptions of the course of ADRs they experienced. Of consecutive patients using biologics mainly for IMIDs, 53% (n=730) reported 2,035 ADRs and elaborated on the course of those reactions in an open-ended text field in a web-based questionnaire, which they completed bi-monthly. Two pharmacovigilance assessors analysed these answers, ultimately visualising the findings on an Ishikawa diagram. “We developed a conceptual framework with 4 themes including descriptive items and 2 other themes including the factors which influence the course of ADRs,” stated Ms van Lint (see Figure). The descriptive themes were the moment or period of ADR occurrence, its frequency, duration, and the time associated with the administration moment. The identified influencing factors were categorised either under the theme of triggering factors for ADR occurrence or aggravation or improving factors.
Figure: Conceptual framework of descriptions of the course of adverse drug reactions reported by patients using a biologic for immune-mediated inflammatory diseases 
ADR, adverse drug reaction.
The conceptual framework of the patient-reported descriptions of the course of ADRs of biologics provides information on a broader level and supplements the currently available information on the nature and frequency of ADRs. It will support the healthcare professionals dealing with ADRs to find practical solutions and may thereby optimise the medical treatment of patients with IMIDs.
- Van Lint J, et al. A conceptual framework of the course and timeframe of patient-reported adverse drug reactions of biologics in immune-mediated inflammatory diseases. DP19, SPIN 2022 Congress, 06–08 July, Paris, France.
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