Safety of Biological Therapies for Severe Asthma: An Analysis of Suspected Adverse Reactions Reported in the WHO Pharmacovigilance Database

The study analyzed the safety of five biologics (omalizumab, mepolizumab, reslizumab, benralizumab, and dupilumab) for severe asthma using the WHO pharmacovigilance database, VigiBase. Out of 31,724,381 individual case safety reports (ICSRs), 167,282 (0.5%) were related to these biologics, with 29.4% (48,440) concerning asthma. The most reported adverse drug reactions (ADRs) included asthma, dyspnea, and headache. Notably, biologics were associated with serious ADRs more frequently than other drugs (41.3% vs. 32.3%). Some less documented ADRs, such as malignancies, pulmonary embolism, and alopecia, were identified, suggesting the need for further investigation. The study concluded that while most ADRs were known, some new potential safety signals require additional assessment.