Examining Biologic-Related Adverse Events in CRS With Nasal Polyps

Headaches, injection site reactions, and pharyngitis were the most common adverse events associated with the biologic therapies dupilumab, omalizumab, mepolizumab, and reslizumab in the treatment of chronic rhinosinusitis (CRS) with nasal polyps.

A recent review shows that adverse events are common in clinical trials investigating biologic therapies for the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP), but further research is needed to address potential study limitations. Results were published in the American Journal of Otolaryngology–Head and Neck Medicine and Surgery.

As a chronic inflammatory condition that affects the nose and paranasal sinuses, CRSwNP is associated with a significant impact on health-related quality of life (QOL). Biologics have proved effective in the management of the condition, with a generally better safety profile compared with other treatment modalities such as endoscopic sinus surgery, but adverse events have been reported nonetheless.

“The management of CRSwNP is challenging due to disease recurrence and adverse effects. Although adverse events are not as common with these management modalities [biologics] as with the previous ones, they still exist and might constitute a burden that might impact the QOL of the treated patients,” the study authors wrote. “​​Some studies have reported that adverse events were common with [biologics]. However they were not specific and self-limited.”

Seeking to further assess safety and adverse events associated with different biological therapies for the management CRSwNP, they conducted a comprehensive systematic review of 13 studies, including 12 randomized controlled trials (RCTs) and one cross-sectional study, of which 6 were for dupilumab, 3 for omalizumab, 3 for mepolizumab, and only 1 investigated reslizumab. A total of 2282 patients with CRSwNP were included in the systematic review.

Overall, headaches, injection site reactions, and pharyngitis were the most common adverse events found in the investigated studies. Incidence of specific adverse events were cited for each biologic:

  • Dupilumab: pharyngitis was reported in 225 patients (22.4%), followed by erythema and allergy in 95 patients (9.4%), headache in 82 patients (8.1%), epistaxis in 52 patients (5.1%), and asthma in 18 patients (1.7%)
  • Omalizumab: headache, nasopharyngitis, and injection-site reactions were reported to be the most common adverse events, with estimated prevalence rates of 8.1%, 5.9%, and 5.2%, respectively
  • Mepolizumab and reslizumab: studies reported that 40% of patients were complicated by nasal polyps/congestion/pharyngitis/infections, 14 had a headache (15.5%), 2 developed asthma (2.2%), and only 1 patient (1.1%) had epistaxis as an adverse event

Researchers acknowledged that the review might be limited by the small number of included studies as some are based on data from previous investigations which added no actual value to the intended outcomes. The small sample size in some studies was also cited as a limitation of the study findings.

“Although the literature's current investigations indicate the safety of the biologic treatment modalities, further studies are needed as some uncertainty among the trials have been reported,” concluded researchers.


Aldajani A, Alroqi A, Alromaih S, Aloulah MO, Alsaleh S. Adverse events of biological therapy in chronic rhinosinusitis with nasal polyps: a systematic review. Am J Otolaryngol. 2022;43(6):103615. doi:10.1016/j.amjoto.2022.103615