Omalizumab therapy for mast cell-mediator symptoms in patients with ISM, CM, MMAS, and MCAS
Open accessAbstract
BACKGROUND: Patients with mast cell diseases may suffer from various distressing symptoms, which can be insufficiently controlled with available therapies, severely affecting their quality of life. There is a need for new and safe treatment options for these patients. OBJECTIVES: We aimed to evaluate safety and efficacy of omalizumab administration in patients with a symptomatic mast cell disorder. METHODS: We included 55 patients with a mast cell disorder associated with debilitating symptoms who received omalizumab treatment between January 2015 and December 2017, after a multidisciplinary team meeting at the French National Reference Center for Mastocytosis. RESULTS: A complete response was achieved for 1 patient (1.8%), a major response for 30 patients (54.5%), and a partial response for 12 patients (21.8%), resulting in an overall best response rate of 78.2% (43 of 55 patients). The response was persistent at least 3 months in 33 of 43 responding patients (76.7%). At the last follow-up, the final overall response rate was 58.2% (32 of 55 patients). Median time to first response was 2 months and median time to best response was 6 months. Omalizumab was dramatically effective on all superficial and general vasomotor symptoms and on most gastrointestinal or urinary symptoms, and partially effective on most neuropsychiatric symptoms. Safety profile was acceptable, except for one severe adverse event (edema of the larynx and dyspnea after the first injection of omalizumab). Side effects were reported in 16 patients (29%), mainly of low to mild intensity, yet causing interruption of treatment in 5 patients (9%). CONCLUSION: Omalizumab seems to be a useful therapeutic option to control mast cell-mediator symptoms and displays a favorable safety profile.
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Response to additional drugs, including multitargeted tyrosine kinase inhibitors (in patients with SM, such as midostaurin) and anti-IgE therapy (omalizumab), may be considered an indirect sign of MCA or MCAS.
“Response to additional drugs, including multitargeted tyrosine kinase inhibitors (in patients with SM, such as midostaurin) and anti-IgE therapy (ie, omalizumab) may be considered an indirect sign of MCA or MCAS.”
From Selecting the Right Criteria and Proper Classification to Diagnose Mast Cell Activation Syndromes: A Critical Review (2021) · cites this paper as [87]
The Results (page not provided) report symptom improvement with omalizumab in patients already diagnosed with mast-cell disorders, including MCAS. The Patients section describes diagnostic response to histamine blockers or cromolyn, not omalizumab; the paper does not say that response to omalizumab or midostaurin is an indirect sign of MCA or MCAS. (LLM, conf=0.84)
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“Response to additional drugs, including multitargeted tyrosine kinase inhibitors (in patients with SM, such as midostaurin) and anti-IgE therapy (ie, omalizumab) may be considered an indirect sign of MCA or MCAS.(80-88) Agents targeting growth and activation of neoplastic MCs, such as KIT-targeting kinase blockers, ar…”
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Idiopathic mast cell activation syndrome in real-life practice: clinical features and management
İğde, M. H., Korkmaz, P., Toprak, İ. D., Karabacak, D. E., Demir, S., Ünal, D., & Gelincik, A. A. (2025) · Allergy and Asthma Proceedings · doi:10.2500/aap.2025.46.250025 · Cited by 3 · see citing works
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Approach to Idiopathic Anaphylaxis in Adolescents
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Livideanu, C. B., Lairez, O., & Paul, C. F. (2021) · Springer eBooks · doi:10.1007/978-3-030-54779-0_20
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- Authors
- Lemal, R., Fouquet, G., Terriou, L., Vaes, M., Livideanu, C. B., Frenzel, L., Barete, S., Canioni, D., Lhermitte, L., Rossignol, J., Arock, M., Dubreuil, P., Lortholary, O., & Hermine, O.
- Affiliations
- Université Clermont Auvergne (FR)
- Centre National de la Recherche Scientifique (FR)
- Centre Hospitalier Universitaire de Lille (FR)
- Université Libre de Bruxelles (BE)
- Centre Hospitalier Universitaire de Toulouse (FR)
- Hôpital Necker-Enfants Malades (FR)
- École Normale Supérieure Paris-Saclay (FR)
- Inserm (FR)
- Corresponding author
- Lemal, Richard
- ORCID
- Venue
- The Journal of Allergy and Clinical Immunology In Practice
- Publisher
- Elsevier BV
- Published
- 2019-09
- Volume
- 7
- Issue
- 7
- Pages
- 2387-2395.e3
- ISSN
- 2213-2198 (ISSN-L)
- OpenAlex
- W2927283647
- Cited by
- 70
- References
- 34
- Citations by year
- 2026: 5 · 2025: 12 · 2024: 6 · 2023: 9 · 2022: 13 · 2021: 9 · 2020: 7 · 2019: 9
- FWCI
- 3.79
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- The Journal of Allergy and Clinical Immunology In Practice (acceptedVersion, other-oa)
- PubMed (publishedVersion)
- HAL (submittedVersion, cc-by-nc)
- Dépôt institutionnel de l'Université libre de Bruxelles (Université Libre de Bruxelles) (submittedVersion)
- LillOA (Université de Lille (University Of Lille)) (submittedVersion, other-oa)
- Topics
- Life Sciences › Immunology and Microbiology › Immunology › Mast cells and histamine
- Health Sciences › Medicine › Immunology and Allergy › Food Allergy and Anaphylaxis Research
- Health Sciences › Medicine › Physiology › Asthma and respiratory diseases
- Keywords
- omalizumab, mast cell disease, mast cell activation syndrome, mast cell mediators, treatment efficacy, drug safety, vasomotor symptoms, gastrointestinal symptoms, neuropsychiatric symptoms, quality of life
- MeSH terms
- Omalizumab, Adolescent, Adult, Aged, Aged, 80 and over, Female, Humans, Immunoglobulin E, Male, Mast Cells, Mastocytosis, Middle Aged, Treatment Outcome, Anti-Allergic Agents, Young Adult
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