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Men on biologics report fewer adverse events than women

Presented by
Ms Jette van Lint , Pharmacovigilance Centre Lareb, the Netherlands
SPIN 2022
Results from Dutch pharmacovigilance data on biologic treatment showed a significant difference in the frequency of adverse drug reactions (ADR) in men and women. Interestingly, this did not lead to a discrepancy in patient-reported disease burden among the 2 groups.

“In general, we know that women experience more ADRs, and these more often lead to hospitalisation than in men,” Ms Jette van Lint (Pharmacovigilance Centre Lareb, the Netherlands) stated [1]. Around 5% of unplanned hospital admissions are caused by ADRs [2]. Factors contributing to this difference in ADR reporting by men and women may include hormones, pharmacokinetics and pharmacodynamics, besides behavioural variance and social roles [1,3].

“We aimed to investigate differences in nature, frequency, and burden of patient-reported ADRs of biologics,” Ms van Lint explained. The prospective cohort study analysed monitoring data on patients treated with biologics for an immune-mediated inflammatory disease from 9 Dutch hospitals. The most common treatment indications were rheumatic diseases (73%), such as rheumatoid arthritis and psoriatic arthritis. Adalimumab and etanercept accounted for 67% of biologic drugs. Thus, the final study cohort consisted of 748 consecutive patients with a rheumatic disease on adalimumab or etanercept. Among these participants, 59% were women. The mean age of included women and men was 56.6 and 58.2 years, respectively, and 48% of all participants reported at least 1 ADR. As a result, Ms van Lint revealed that a significantly higher proportion of women (55%) reported an ADR compared with 38% of men (P<0.001). The 882 ADRs that were reported were classified into 264 different types, of which 71 were reported by men and women equally. At first, a significant difference in ADR distribution was identified. Ms van Lint further explained that included women reported a higher frequency and a wider variety of injection site reactions, and they more often reported haematoma and cystitis. Yet, after the correction for multiple testing, this statistical significance was no longer present. In terms of ADR burden, a trend towards a higher impact on the male population was observed, but the difference was not statistically significant. Nevertheless, some ADRs stood out, such as pneumonia, which was reported as highly burdensome by both sexes.

“We cannot confirm a causal relationship between the ADR and the biologics. On the one hand, this is a limitation because we cannot be sure that the reported complaints are actually caused by the biologic. Still, on the other hand, this provides insights into the way patients experienced the ADR,” Ms van Lint discussed. “I think, in conclusion, it is very important for clinicians to be aware of these differences,” she highlighted.

  1. Gosselt H, et al. Sex differences in adverse drug reactions from biological use in patients with immune-mediated inflammatory diseases. FS8, SPIN 2022 Congress, 06–08 July, Paris, France.
  2. Hendriksen LC, et al. Biol Sex Differ. 2021;12:34.
  3. De Vries ST, et al. Br J Clin Pharmacol. 2019;85:1507-15.


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