Headache, injection site reaction, 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. The results were published in American Journal of Otolaryngology – Head and Neck Medicine and Surgery.
As a chronic inflammatory disease affecting the nose and paranasal sinuses, CRSwNP is associated with a significant impact on health-related quality of life (QOL). Biologics have been shown to be effective in treating the condition, with a generally better safety profile compared to other treatment modalities such as endoscopic sinus surgery, but adverse events have nonetheless been reported.
“The management of CRSwNP is challenging due to disease recurrence and side effects. Although adverse events are not as common with these treatment modalities [biologics] As with the previous ones, they still exist and could represent a burden that could impact the QOL of treated patients,” the study authors wrote. “Some studies have reported that side effects were common [biologics]. However, they were non-specific and self-limiting.”
To further assess the safety and adverse events associated with different biologic therapies for the management of CRSwNP, they performed a comprehensive systematic review of 13 studies, including 12 randomized controlled trials (RCTs) and one cross-sectional study, 6 of which were on dupilumab . 3 for omalizumab, 3 for mepolizumab and only 1 examined reslizumab. A total of 2282 patients with CRSwNP were included in the systematic review.
Overall, headache, injection site reactions, and pharyngitis were the most common side effects found in the studies reviewed. The occurrence of specific adverse events was reported 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 as 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 headaches (15.5%), 2 developed asthma (2.2%) and only 1 patient (1.1 %) had nosebleeds as an adverse event
The researchers acknowledged that the review may be limited by the small number of included studies, as some are based on data from previous investigations that did not add actual value to the intended results. The small sample size in some studies was also cited as a limitation of the study results.
“Although the current review of the literature indicates the safety of the biological treatment modalities, further studies are needed as some uncertainties in the studies have been reported,” the researchers concluded.
Aldajani A, Alroqi A, Alromaih S, Aloulah MO, Alsaleh S. Adverse effects 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