Real-life, long-term data on efficacy, safety, response and discontinuation patterns of omalizumab in a Greek population with chronic spontaneous urticaria.


Journal

European journal of dermatology : EJD
ISSN: 1952-4013
Titre abrégé: Eur J Dermatol
Pays: France
ID NLM: 9206420

Informations de publication

Date de publication:
01 Dec 2020
Historique:
pubmed: 2 12 2020
medline: 25 2 2021
entrez: 1 12 2020
Statut: ppublish

Résumé

Omalizumab is approved for the treatment of chronic spontaneous urticaria (CSU) not responding to antihistamines. Data on omalizumab use in real-world settings and in different populations are lacking. To record our five-year experience of omalizumab use in patients with refractory CSU in a real-world setting. A retrospective analysis of medical records of 80 patients with refractory CSU was performed. Demographic, and clinical characteristics, patterns of response, discontinuation strategies and rate of recurrence were analysed. Eighty individuals were included. UAS7 and DLQI significantly decreased from baseline. Complete response was achieved in 86.3%. Late response was observed at 27.5% of the patients. After discontinuation, 21.7% of patients reinitiated omalizumab due to relapse. The mean number of omalizumab administrations up to first discontinuation was 6.8 (based on an approach to shorten the treatment interval). Only 15.0% of patients experienced adverse events during treatment. Omalizumab, with long-term management, was highly effective and safe in achieving control of refractory CSU, with more favourable responses compared to Phase III clinical trials.

Sections du résumé

BACKGROUND BACKGROUND
Omalizumab is approved for the treatment of chronic spontaneous urticaria (CSU) not responding to antihistamines. Data on omalizumab use in real-world settings and in different populations are lacking.
OBJECTIVES OBJECTIVE
To record our five-year experience of omalizumab use in patients with refractory CSU in a real-world setting.
MATERIALS & METHODS METHODS
A retrospective analysis of medical records of 80 patients with refractory CSU was performed. Demographic, and clinical characteristics, patterns of response, discontinuation strategies and rate of recurrence were analysed.
RESULTS RESULTS
Eighty individuals were included. UAS7 and DLQI significantly decreased from baseline. Complete response was achieved in 86.3%. Late response was observed at 27.5% of the patients. After discontinuation, 21.7% of patients reinitiated omalizumab due to relapse. The mean number of omalizumab administrations up to first discontinuation was 6.8 (based on an approach to shorten the treatment interval). Only 15.0% of patients experienced adverse events during treatment.
CONCLUSION CONCLUSIONS
Omalizumab, with long-term management, was highly effective and safe in achieving control of refractory CSU, with more favourable responses compared to Phase III clinical trials.

Identifiants

pubmed: 33258453
pii: ejd.2020.3919
doi: 10.1684/ejd.2020.3919
doi:

Substances chimiques

Anti-Allergic Agents 0
Omalizumab 2P471X1Z11

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

716-722

Auteurs

Zoe Apalla (Z)

State Dermatology Department, Hippokratio General Hospital of Thessaloniki, Greece.

Theodoros Sidiropoulos (T)

State Dermatology Department, Hippokratio General Hospital of Thessaloniki, Greece.

Evaggelia Kampouropoulou (E)

State Dermatology Department, Hippokratio General Hospital of Thessaloniki, Greece.

Marina Papageorgiou (M)

State Dermatology Department, Hippokratio General Hospital of Thessaloniki, Greece.

Aimilios Lallas (A)

First Dermatology Department, Aristotle University of Thessaloniki, Greece.

Elizabeth Lazaridou (E)

Second Dermatology Department, Aristotle University of Thessaloniki, Greece.

Maria Smaragdi (M)

State Dermatology Department, Hippokratio General Hospital of Thessaloniki, Greece.

Florentina Delli (F)

State Dermatology Department, Hippokratio General Hospital of Thessaloniki, Greece.

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Classifications MeSH