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First results of Dutch Biologic Monitor


25 July 2019

  • 48% of patients experienced at least one adverse drug reaction (ADR) after administration of a biological drug. ADRs most often reported were injection site reactions, followed by infections and skin reactions. Participants experienced the highest burden from infections, followed by fatigue and gastrointestinal reactions. These results were found in a pilot of a national safety monitoring system of biological drug users.

    In January 2017 Lareb started the Dutch Biologic Monitor. Biologicals used for immune-mediated inflammatory disease were used as an inclusion criteria in the monitor. Patients’ experiences were collected using web-based questionnaires through the Lareb Intensive Monitoring (LIM) system. The questionnaires addressed biological drug use and ADRs attributed to these biological drugs. A total of 1.302 patients from eight Dutch hospitals were included in the monitor until the end of 2018.

    A self-reported questionnaire system appears to be an appropriate method to extract health-related data from patients. Analysis demonstrated that the patients with inflammatory rheumatic diseases participating in the Dutch Biologic Monitor represent their reference populations regarding age, gender and prescribed biological. In addition, patients with inflammatory rheumatic diseases can adequately report their medical information, like brand name of the biological drug.

    The first results of the Dutch Biologic Monitor were presented at the 2019 EULAR (European League Against Rheumatism) congress in Madrid, Spain.

    • Find the EULAR poster on the patient perspective on biologic drug-induced ADRs and their burden here.
    • Find the EULAR poster on the quality of patient-reported medical information here.