POS1532-HPR SEX DIFFERENCES IN THE EXPERIENCED BURDEN OF ADVERSE DRUG REACTIONS ATTRIBUTED TO ADALIMUMAB AND ETANERCEPT BY PATIENTS WITH IMMUNE-MEDIATED INFLAMMATORY DISEASES

Abstract

BackgroundPatients experience burden of adverse drug reactions.1 So far, it is not known whether men and women experience adverse drug reactions (ADRs) with the same burden.ObjectivesTo examine sex differences in regard to the burden of mutually reported ADRs in patients with immune-mediated inflammatory diseases (IMIDs) treated with adalimumab or etanercept.MethodsPatients with rheumatoid arthritis (RA), psoriatic arthritis or (axial) spondyloarthritis using etanercept or adalimumab were included from the Dutch Biologic Monitor (DBM).1 In the DBM, questionnaires concerning experienced ADRs and corresponding burden were filled out bimonthly. ADRs were coded according to Medical Dictionary for Regulatory Activities (MedDRA) terminology.The burden of ADRs (Preferred term level, PT) was reported on a five-point Likert scale ranging from no burden (1) to very high burden (5). If ADRs were present over multiple questionnaires, burden was only assessed the first time the ADR was mentioned. Likert scales reported for burden were compared between male and female patients for mutually reported ADRs that were reported at least four times by both male and female patients, using the Cochran-Armitage test for trend, which considers the ordinal nature of Likert scales.ResultsIn total 748 consecutive patients participated, of which 55% were female (Table 1). Almost half (48%) reported at least one ADR during the study. More than half of female patients (55%) reported at least one ADR as compared to 38% of male patients. In total 882 ADRs were reported comprising 264 distinct ADRs, of which the majority (74%) was reported by female patients. 71 (27%) distinct ADRs were mutually reported by male and female patients and 12 (5%) distinct ADRs were reported at least four times by females and males. Pneumonia and headache impose the highest burden of the mutually reported adverse drug reactions. ‘Arthralgia’ (p=0.052) showed the largest differences burden Likert scale scores between male and female patients. Even though male patients experienced higher burden, these differences were not statistically significant (Figure 1).ConclusionAlthough women reported the majority of the ADRs, there was a trend that that men experienced certain ADRs as more burdensome in comparison to women, albeit this did not reach statistical significance.