Of 5 Monoclonal Antibodies, Only Dupilumab Shows Negative Anaphylaxis Signal

A real-world investigation of associations between five monoclonal antibodies (mAbs) and anaphylactic reactions found that dupilumab alone showed a negative signal for anaphylaxis. Researchers reported their findings online in Clinical and Translational Allergy. 

“In the current study, dupilumab was the only mAb with a negative anaphylaxis signal, which might be related to its degree of humanization,” researchers wrote. “Among the five mAbs, dupilumab is the only fully human mAb with 99% human component, while the other four mAbs are humanized mAbs with 90% human components.” 

The retrospective study used data from the US Food and Drug Administration Adverse Event Reporting System database for reports of anaphylaxis related to benralizumab, dupilumab, mepolizumab, omalizumab, and reslizumab.  

Researchers mined data for 2006 such voluntary reports between January 2004 and September 2020, most of which occurred in young or middle-aged women. Omalizumab, benralizumab, reslizumab, and mepolizumab showed positive signals for anaphylaxis, according to the study, while dupilumab showed a negative signal. 

The study also found that the risk of initial or prolonged hospitalization for anaphylaxis was significantly higher in patients who received benralizumab (42.86%) compared with those who received omalizumab (28.92%). However, when anaphylaxis to omalizumab did occur, life-threatening outcomes were more common patients with asthma (18%) than those with chronic urticaria (12.9%). 

“In the current real‐world study, omalizumab, benralizumab, reslizumab, and mepolizumab had positive signals for anaphylaxis, suggesting the need for close monitoring of patients after drug use,” researchers wrote. “Increased attention and alerts are especially required for mepolizumab, which had almost no report of anaphylaxis in the literature.” 

Reference:

Li L, Wang Z, Cui L, Xu Y, Guan K, Zhao B. Anaphylactic risk related to omalizumab, benralizumab, reslizumab, mepolizumab, and dupilumab. Clin Transl Allergy. 2021;11(4):e12038. Published 2021 Jun 3. doi:10.1002/clt2.12038