Allergy to Omalizumab: Lessons from a Reaction to the Coronavirus 2019 Vaccine

Matsumoto, Takeshi; Sakurai, Y; Fujiki, Takahiro; Kusakabe, Yusuke; Nakayama, Emi; Tanaka, Ayaka; Yamamoto, Naoki; Aihara, Kensaku; Yamaoka, Shinpachi; Mishima, Michiaki

doi:10.2169/internalmedicine.1169-22

Cited by 5 publications

(2 citation statements)

References 17 publications

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“…Omalizumab and benralizumab contain Polysorbate 20, whereas polysorbate 80 is used in mepolizumab and dupilumab. In contrast, reslizumab does not contain polysorbate [25]. As inducers of anaphylactic reactions, there are no differences between polysorbates 20 and 80 [24].…”

Section: Discussionmentioning

confidence: 95%

Biologics for asthma have risk of anaphylactic reactions and serious? : A pharmacovigilance study based on a global real-world database

Park

Kim

Lee

et al. 2023

Preprint

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Asthma is a chronic inflammatory condition that affects the lung airways. Chronic use of oral glucocorticoids in patients with severe asthma is associated with several adverse events (AEs). Biologics (omalizumab, benralizumab, mepolizumab, reslizumab, and dupilumab) have been developed as alternative therapies for the treatment of asthma. The aim of this study was to evaluate the risk of anaphylactic reactions associated with these five biologics based on a large global database. We utilized individual case reports from the Uppsala Monitoring Center from 1968 to December 29, 2019. A disproportionality analysis of all drugs and monoclonal antibodies. Anaphylactic reactions were defined according to the "anaphylactic reaction” of the standardized MedDRA queries. Contrary to dupilumab, omalizumab, benralizumab, and mepolizumab demonstrated positive signals related to anaphylactic reactions among all drugs and monoclonal antibodies. Reslizumab, which represented only 315 cases of all AEs, required more reports to determine its association with anaphylactic reactions. This was an important study since the majority (96.2%) of the cases of anaphylactic reactions were reported serious. In conclusion, the results indicate that omalizumab, benralizumab, and mepolizumab are associated with a high risk of anaphylactic reactions, and careful monitoring in the post-injection period is recommended.

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Section: Discussionmentioning

confidence: 95%

Biologics for asthma have risk of anaphylactic reactions and serious? : A pharmacovigilance study based on a global real-world database

Park

Kim

Lee

et al. 2023

Preprint

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show abstract

“…Particular attention should also be paid to excipients. Following the administration of omalizumab, a case of angioedema with positive skin prick tests for polysorbate was recently reported [52]. Interestingly, no statistically significant differences were found between patients treated with high and low doses of omalizumab.…”

Section: Discussionmentioning

confidence: 99%

Long-Term Safety of Omalizumab in Children with Asthma and/or Chronic Spontaneous Urticaria: A 4-Year Prospective Study in Real Life

Galletta

Caminiti

Lugarà

et al. 2023

JPM

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Background: Insufficient data are available on the long-term “real-life” safety profile of omalizumab in children. This study evaluated the long-term safety of omalizumab in a pediatric cohort with severe asthma or chronic spontaneous urticaria (CSU). Methods: A monocentric, prospective study evaluated the long-term safety of omalizumab in patients aged 6–18 years. Each patient completed the standardized MedDRA questionnaire to identify adverse events (AEs). Results: In total, 23 patients, median age 15 (14–18) years, affected by severe asthma (60.8%) or CSU (39.2%), treated with omalizumab for 2 (1–4) years were enrolled. The most common AEs belong to the system organ class (SOC) of general disorders and administration-site conditions (37.17%). Skin and subcutaneous tissue problems represent the second most frequently reported AEs (24.35%). Central nervous system and musculoskeletal disorders were quite frequent (15.38% and 8.97%, respectively). Other adverse events were tachycardia (5.12%), vertigo and abdominal pain (2.60% and 3.86%, respectively), and dry eye (1.3%). Only one patient reported herpes virus infection during treatment (1.3%). No cases of anaphylaxis, hemopathies, uronephropathies, respiratory, psychiatric, hepatobiliary, or oncological pathologies were reported. Conclusions: Long-term “real-life” treatment with omalizumab in children appears well tolerated. Its safety and efficacy profile makes omalizumab an excellent alternative in severe asthma and CSU in children.

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Multiple drugs

2023

Reactions Weekly

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Allergy to Omalizumab: Lessons from a Reaction to the Coronavirus 2019 Vaccine

Cited by 5 publications

References 17 publications

Biologics for asthma have risk of anaphylactic reactions and serious? : A pharmacovigilance study based on a global real-world database

Biologics for asthma have risk of anaphylactic reactions and serious? : A pharmacovigilance study based on a global real-world database

Long-Term Safety of Omalizumab in Children with Asthma and/or Chronic Spontaneous Urticaria: A 4-Year Prospective Study in Real Life

Multiple drugs

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