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  1. L. Kosse1,
  2. N. Jessurun1,
  3. E. Van Puijenbroek1,2,
  4. A. Van Tubergen3,4,
  5. H. Vonkeman5,6
  1. 1Netherlands Pharmacovigilance Centre Lareb, ‘s-Hertogenbosch, Netherlands
  2. 2University of Groningen, Groningen, Netherlands
  3. 3Maastricht University Medical Center+, Maastricht, Netherlands
  4. 4Maastricht University, Maastricht, Netherlands
  5. 5Medisch Spectrum Twente, Enschede, Netherlands
  6. 6University of Twente, Enschede, Netherlands


Background: Patient registries are a valuable tool to monitor a patient’s health status. However, these systems operate primarily from the healthcare provider (HCP) perspective, which makes it difficult to collect detailed information on the nature, frequency and personal impact of adverse drug reactions (ADRs).

Objectives: Determining whether the distribution of patient-reported ADRs attributed to bDMARDs differs from ADR registrations by HCPs.

Methods: Patient reported ADRs were derived from the Dutch Biologic Monitor (DBM), a multi-centre cohort event monitoring system based on web-based questionnaires for bDMARD-using patients. ADR reports of the Dutch Rheumatic Arthritis Monitoring Registry (DREAM-RA) were used to outline the HCP perspective. ADR reports from foundation up to 31 October 2019 were coded according to MedDRA terminology. Fisher-Freeman-Halton test with Monte Carlo simulation was used to measure discrepancies between the distributions of High Level Group Terms (HLGT). The prevalence of the top 15 HLGTs were compared using Chi-Square Goodness-of-Fit tests.

Results: ADR reports of 404 DBM participants (1,977 ADRs) and 341 DREAM-RA patients (679 ADRs) were analysed. Patients and HCPs reported a different ADR distribution (p<.001). Administration site reactions were most frequently reported by patients, followed by infections and (epi)dermal conditions. HCPs most often reported (epi)dermal conditions, infections and general system disorders. Moreover, the distribution of ADRs that patients allegedly discussed with HCPs varied considerably from the distribution of HCP-reported ADRs (p<.001).

Table 1.

Patient characteristics

Table 2.

Distribution of patient-and HCP-reported ADRs

Conclusion: Patients and HCPs report a different distribution of ADRs attributed to bDMARDs. Therefore, patient-reported ADRs should ideally be combined with HCP reports, as the combination of both perspectives gives a more complete picture of a patient’s health status.

Disclosure of Interests: Leanne Kosse: None declared, Naomi Jessurun: None declared, Eugène van Puijenbroek: None declared, Astrid van Tubergen Consultant of: Novartis, Harald Vonkeman: None declared

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