Efficacy of Omalizumab in Mastocytosis: Allusive Indication Obtained from a Prospective, Double-Blind, Multicenter Study (XOLMA Study)
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Le résumé fourni par la source
BACKGROUND: Patients with mastocytosis often suffer from a variety of symptoms caused by mast cell mediators where treatments remain difficult, showing various success rates. Omalizumab, a monoclonal anti-IgE antibody, has been postulated to have a positive impact on mastocytosis-associated symptoms such as flush, vertigo, gastrointestinal problems, or anaphylaxis. OBJECTIVE: To investigate the efficacy and safety of omalizumab in systemic mastocytosis. METHODS: Patients with histologically proven mastocytosis were investigated in a multicenter prospective double-blind placebo-controlled trial to receive either omalizumab or placebo, dosed according to IgE and body weight. The primary endpoint was change in the AFIRMM activity score after 6 months of treatment. Different laboratory parameters were analyzed. RESULTS: Sixteen patients were analyzed: 7 to omalizumab and 9 to placebo (mean age 47.7 ± 13.8 vs. 45.4 ± 8.8 years; 66.6 vs. 85.7% were female; mean disease duration 10.0 ± 5.1 vs. 4.5 ± 2.9 years, respectively). After 6 months the median AFIRMM score decreased 50% from 52.0 to 26.0 in the omalizumab group versus 104.0-102.0 in the placebo group (p = 0.286); however, the difference was not significant (p = 0.941). Secondary endpoints, including the number of allergic reactions, changes in major complaints, wheal-and-flare reaction due to mechanical irritation (Darier's sign), and frequency of the use of mastocytosis-specific drugs improved in the omalizumab group, but not significantly. Adverse events like urticaria, bronchospasm, and anaphylactic shock showed no significant difference between the groups. No severe adverse events occurred. FcεRI (Fc-epsilon receptor) expression on basophils decreased after receiving omalizumab versus placebo. CONCLUSION: Omalizumab was safe and showed a tendency to improve mastocytosis-related symptoms, in particular diarrhea, dizziness, flush, and anaphylactic reactions, including the AFIRMM score and secondary endpoints; however, the difference was not significant. Due to the small study size and difference at baseline between the study groups, further studies are required to confirm our findings.
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Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.
- Titre Crossref
- Efficacy of Omalizumab in Mastocytosis: Allusive Indication Obtained from a Prospective, Double-Blind, Multicenter Study (XOLMA Study)
- Date Crossref
- 01/01/2020
- Éditeur
- S. Karger AG
- Type
- journal-article
Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.
Où se fait cette recherche
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University Hospital Zurich Department of Dermatology pays non établi dans la noticeÉtablissement de santé
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University Hospital of Bern pays non établi dans la noticeÉtablissement de santé
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University Hospital of Geneva pays non établi dans la noticeÉtablissement de santé
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ADR-AC (Switzerland) pays non établi dans la noticeEntreprise
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University Hospital of Basel pays non établi dans la noticeÉtablissement de santé
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LMU Klinikum pays non établi dans la noticeÉtablissement de santé
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Ludwig-Maximilians-Universität München pays non établi dans la noticeUniversité ou école supérieure
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University Hospital Berne Department of Rheumatology pays non établi dans la noticeUniversité ou école supérieure
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Geneva University Hospital Department of Medical Specialties pays non établi dans la noticeUniversité ou école supérieure
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Graf Biostatistics pays non établi dans la noticeInstitution
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ADR-AC GmbH Berne pays non établi dans la noticeEntreprise
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University Hospital Basel Department of Dermatology pays non établi dans la noticeUniversité ou école supérieure
Department of Dermatology — University Hospital Zurich, University Hospital of Bern et University Hospital of Geneva, avec 9 autres affiliations.
Une affiliation ne permet pas de déduire la nationalité d’un auteur.