THU0173 DIFFERENCES BETWEEN PATIENT-REPORTED AND PHYSICIAN-REPORTED ADVERSE DRUG REACTIONS ATTRIBUTED TO BDMARDS
Authors: L. Kosse, N. Jessurun, E. Van Puijenbroek, A. Van Tubergen, H. Vonkeman
Journal: Annals of the Rheumatic Diseases (2020)

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&lt;.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&lt;.001). Table 1. Patient characteristics Dutch Biologic Monitor n=404 DREAM-RA n=341 Age, median (IQR), years 57.0 (49.0-65.0) 56.0 (46.0-65.0) Female, n (%) 279 (73.5) 240 (70.4) Indication for bDMARD therapy, n (%) Rheumatoid arthritis 299 (74.0) 381 (89.4) Psoriatic arthritis 105 (26.0) 45 (10.6) bDMARD use, n (%) Etanercept 164 (40.6) 152 (34.9) Adalimumab 134 (33.2) 119 (44.6) Tocilizumab 32 (7.9) 48 (14.1) Other 100 (24.8) 107 (31.4) Table 2. Distribution of patient-and HCP-reported ADRs Patient HCP p-value High Level Group Term Burden (1-5 ) Reports (% ) HCP contact (% ) Reports (% ) All patient vs HCP reports HCP contact vs HCP reports Administration site reactions 1.7 402 (20.3) 93 (11.1) 20 (2.9) &lt;.001 &lt;.001 Infections - pathogen unspecified 2.9 229 (11.6) 130 (15.5) 93 (13.7) 0.153 0.344 Epidermal and dermal conditions 2.6 218 (11.0) 96 (11.4) 111 (16.3) &lt;.001 0.007 General system disorders NEC 2.8 175 (8.9) 82 (9.8) 52 (7.7) 0.382 0.172 Gastrointestinal signs and symptoms 2.4 81 (4.1) 17 (2.0) 29 (4.3) 0.824 0.015 Respiratory disorders NEC 2.4 77 (3.9) 33 (3.9) 26 (3.8) 1.0 1.0 Headaches 2.9 55 (2.8) 23 (2.7) 19 (2.8) 1.0 1.0 Joint disorders 3.3 55 (2.8) 32 (3.8) 3 (0.4) 0.093 0.006 Respiratory tract signs and symptoms 2.2 47 (2.4) 22 (2.6) 7 (1.0) 0.039 0.036 Skin appendage conditions 3.0 44 (2.2) 14 (1.7) 12 (1.8) 0.538 1.0 Musculoskeletal and connective tissue disorders NEC 3.1 40 (2.0) 16 (1.9) 4 (0.6) 0.009 0.039 Oral soft tissue conditions 2.4 33 (1.7) 12 (1.4) 7 (1.0) 0.277 0.644 Gastrointestinal motility and defaecation conditions 2.6 29 (1.5) 12 (1.4) 16 (2.4) 0.123 0.186 Ocular infections, irritations and inflammations 3.1 29 (1.5) 22 (2.6) 4 (0.6) 0.106 0.002 Therapeutic and nontherapeutic effects (excl toxicity) 2.9 27 (1.4) 16 (1.9) 3 (0.4) 0.057 0.010 Other 2.9 436 (22.1) 221 (26.3) 273 (40.2) &lt;.001 &lt;.001 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