Omalizumab Re-Treatment and Step-Up in Patients with Chronic Spontaneous Urticaria: OPTIMA Trial.
Chronic spontaneous urticaria
Omalizumab
Re-treatment
Relapse
Step-up
Journal
The journal of allergy and clinical immunology. In practice
ISSN: 2213-2201
Titre abrégé: J Allergy Clin Immunol Pract
Pays: United States
ID NLM: 101597220
Informations de publication
Date de publication:
Historique:
received:
06
12
2019
revised:
05
03
2020
accepted:
13
03
2020
pubmed:
10
4
2020
medline:
15
5
2021
entrez:
10
4
2020
Statut:
ppublish
Résumé
Omalizumab shows greater clinical benefit with 300 mg dose than with the 150 mg dose. To determine outcomes postwithdrawal, relapse, and re-treatment in omalizumab responders, and from stepping up to 300 mg after insufficient symptom control with 150 mg. This was a prospective, randomized (3:4), open-label, noncomparator study (clinicaltrials.gov: NCT02161562). A total of 314 adult patients with chronic spontaneous urticaria and symptomatic on H Overall, 115 of 314 patients had adequate symptom control at week 24 (end of the initial dosing period) and 56 were re-treated after relapse postwithdrawal; 87.8% (95% CI, 78.6%-96.9%) regained symptomatic control (UAS7 ≤ 6). Most (141 of 178) patients initially treated with 150 mg required step-up to 300 mg, which resulted in a 9.5-point (95% CI, 7.6-11.3) improvement in UAS7 over the mean change observed initially on 150 mg. Step-up to 300 mg helps a greater proportion of patients achieve symptom control, and re-treatment with omalizumab is as effective as initial therapy.
Sections du résumé
BACKGROUND
Omalizumab shows greater clinical benefit with 300 mg dose than with the 150 mg dose.
OBJECTIVE
To determine outcomes postwithdrawal, relapse, and re-treatment in omalizumab responders, and from stepping up to 300 mg after insufficient symptom control with 150 mg.
METHODS
This was a prospective, randomized (3:4), open-label, noncomparator study (clinicaltrials.gov: NCT02161562). A total of 314 adult patients with chronic spontaneous urticaria and symptomatic on H
RESULTS
Overall, 115 of 314 patients had adequate symptom control at week 24 (end of the initial dosing period) and 56 were re-treated after relapse postwithdrawal; 87.8% (95% CI, 78.6%-96.9%) regained symptomatic control (UAS7 ≤ 6). Most (141 of 178) patients initially treated with 150 mg required step-up to 300 mg, which resulted in a 9.5-point (95% CI, 7.6-11.3) improvement in UAS7 over the mean change observed initially on 150 mg.
CONCLUSIONS
Step-up to 300 mg helps a greater proportion of patients achieve symptom control, and re-treatment with omalizumab is as effective as initial therapy.
Identifiants
pubmed: 32272284
pii: S2213-2198(20)30282-8
doi: 10.1016/j.jaip.2020.03.022
pii:
doi:
Substances chimiques
Anti-Allergic Agents
0
Omalizumab
2P471X1Z11
Banques de données
ClinicalTrials.gov
['NCT02161562']
Types de publication
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
2372-2378.e5Informations de copyright
Copyright © 2020 The Authors. Published by Elsevier Inc. All rights reserved.