POS0621 DISEASE-SPECIFIC ADVERSE DRUG REACTION PROFILES OF ADALIMUMAB AND ETANERCEPT AS REPORTED BY IMMUNE-MEDIATED INFLAMMATORY DISEASE PATIENTS

Abstract

Background: Information on adverse drug reactions (ADRs) is generally clustered for all indications of a drug in the patient information leaflet. However, previous research has shown that participants of the Dutch Biologic Monitor (DBM) that use a biologic for their immune-mediated inflammatory disease (IMID) prefer to receive ADR information tailored to their own biologic an IMID (1). Currently, it is unclear whether the ADR profile of a specific biologic may differ between patients with different IMIDs, which would be vital information for health care providers (HCPs) in their patient guidance. Objectives: To determine whether the profiles of ADRs attributed to adalimumab (ADA) and etanercept (ETN) reported by patients in the DBM differ between IMIDs. Methods: The DBM is a prospective cohort event monitoring system for patient-reported ADRs attributed to biologics (2). Study data was extracted from the DBM for the period Jan 2017 – Oct 2020. ADRs were coded according to their corresponding Preferred Term (PT) following MedDRA terminology. Unique PTs were selected per participant and grouped under System Organ Classes (SOCs) (Figure 1) for ADA and ETN. SOCs contributing for Differences in ADR profiles between IMIDs were tested using the Fisher-Freeman-Halton’s Exact Test with Monte Carlo simulation. SOCs of interest were separately tested with the Fisher-Freeman-Halton’s Exact Test (no simulation) and subsequently corrected for multiple comparisons using the Benjamini-Hochberg (BH) correction. Results: A total of 572 ADR reports from 218 participants using ADA and 450 ADR reports from 185 participants using ETN were analyzed (Table 1). Overall, a statistically significant difference in patient-reported ADR profile between the assessed indications was found for ADA (p=0.011), but not for ETN (p=0.057). The following separate tests for selected SOCs of interest showed a significant difference in the frequencies of ‘respiratory, thoracic and mediastinal disorders’ and ‘musculoskeletal and connective tissue disorders’ between the different IMIDs for ADA after BH correction, but none for ETN. Conclusion: Although only ADA shows a statistically significant difference in ADR profile between different IMIDs, more research with a larger sample size might show similar results for ETN. Furthermore, explanations for the differences found, such as disease-drug interactions, must be examined. This would help HCPs in providing disease-specific information and patient guidance.