PMID- 35914662
OWN - NLM
STAT- MEDLINE
DCOM- 20221108
LR  - 20221110
IS  - 1534-4436 (Electronic)
IS  - 1081-1206 (Linking)
VI  - 129
IP  - 5
DP  - 2022 Nov
TI  - Omalizumab for treatment of idiopathic angioedema.
PG  - 605-611.e1
LID - S1081-1206(22)00609-3 [pii]
LID - 10.1016/j.anai.2022.07.017 [doi]
AB  - BACKGROUND: Omalizumab has been found to improve outcomes in patients with 
      chronic spontaneous urticaria (CSU). Idiopathic angioedema (IAE) is increasingly 
      being recognized as a condition with similar underlying mechanisms as CSU and a 
      form of CSU. We hypothesized that add-on therapy with omalizumab would benefit 
      patients with uncontrolled IAE. OBJECTIVE: To study the safety and efficacy of 
      omalizumab for the treatment of IAE in adults. METHODS: We conducted a 
      randomized, placebo-controlled trial to study the efficacy of omalizumab in 
      adults with 2 or more episodes of angioedema (AE) in the past 6 months for which 
      no clinical or laboratory cause of AE could be found. A total of 10 patients were 
      randomized on a 1:1 basis to receive omalizumab 300 mg subcutaneously or placebo 
      every 4 weeks for 24 weeks with a 12-week follow-up period. The primary endpoint 
      was the change in the Angioedema Activity Score. Secondary endpoints included the 
      Angioedema Quality of Life Questionnaire, the Visual Analogue Scale, and the 
      number of angioedema episodes per month. RESULTS: We observed improvement in the 
      Angioedema Activity Score (-2.93 ln odds; 95% confidence interval [CI], -4.84 to 
      -1.02; P = .003), Visual Analogue Scale (-3.49 ln odds; 95% CI, -6.58 to -0.40; 
      P = .03), Angioedema Quality of Life Questionnaire (-9.43 score; 95% CI, -17.63 
      to -1.24; P = .03), and number of angioedema episodes per month (-1.93 ln count; 
      95% CI, -3.23 to -0.63; P = .005) in patients who received omalizumab vs placebo. 
      CONCLUSION: This study provides preliminary prospective evidence that omalizumab 
      improves outcomes in patients with IAE. TRIAL REGISTRATION: ClinicalTrials.gov 
      Identifier: NCT02966314. CLINICALTRIALS: gov 
      URL:https://clinicaltrials.gov/ct2/show/NCT02966314?term=omalizumab&cond=Angioedema&draw=2&rank=1.
CI  - Copyright (c) 2022 American College of Allergy, Asthma & Immunology. Published 
      by Elsevier Inc. All rights reserved.
FAU - Goswamy, Vinay P
AU  - Goswamy VP
AD  - Division of Allergy, Pulmonary and Critical Care, Department of Medicine, 
      University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin. 
      Electronic address: vgoswamy@wisc.edu.
FAU - Lee, Kristine E
AU  - Lee KE
AD  - Department of Biostatistics and Medical Informatics, University of Wisconsin 
      School of Medicine and Public Health, Madison, Wisconsin.
FAU - McKernan, Elizabeth M
AU  - McKernan EM
AD  - Division of Allergy, Pulmonary and Critical Care, Department of Medicine, 
      University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin.
FAU - Fichtinger, Paul S
AU  - Fichtinger PS
AD  - Division of Allergy, Pulmonary and Critical Care, Department of Medicine, 
      University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin.
FAU - Mathur, Sameer K
AU  - Mathur SK
AD  - Division of Allergy, Pulmonary and Critical Care, Department of Medicine, 
      University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin.
FAU - Viswanathan, Ravi K
AU  - Viswanathan RK
AD  - Division of Allergy, Pulmonary and Critical Care, Department of Medicine, 
      University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin.
LA  - eng
SI  - ClinicalTrials.gov/NCT02966314
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20220730
PL  - United States
TA  - Ann Allergy Asthma Immunol
JT  - Annals of allergy, asthma & immunology : official publication of the American 
      College of Allergy, Asthma, & Immunology
JID - 9503580
RN  - 2P471X1Z11 (Omalizumab)
RN  - 0 (Anti-Allergic Agents)
SB  - IM
CIN - Ann Allergy Asthma Immunol. 2022 Nov;129(5):539. PMID: 36333057
MH  - Adult
MH  - Humans
MH  - Omalizumab/adverse effects
MH  - *Urticaria/drug therapy
MH  - *Anti-Allergic Agents
MH  - Quality of Life
MH  - Prospective Studies
MH  - Chronic Disease
MH  - *Angioedema/chemically induced
MH  - *Chronic Urticaria
MH  - Treatment Outcome
EDAT- 2022/08/02 06:00
MHDA- 2022/11/09 06:00
CRDT- 2022/08/01 19:14
PHST- 2022/02/23 00:00 [received]
PHST- 2022/07/10 00:00 [revised]
PHST- 2022/07/19 00:00 [accepted]
PHST- 2022/08/02 06:00 [pubmed]
PHST- 2022/11/09 06:00 [medline]
PHST- 2022/08/01 19:14 [entrez]
AID - S1081-1206(22)00609-3 [pii]
AID - 10.1016/j.anai.2022.07.017 [doi]
PST - ppublish
SO  - Ann Allergy Asthma Immunol. 2022 Nov;129(5):605-611.e1. doi: 
      10.1016/j.anai.2022.07.017. Epub 2022 Jul 30.