title: Long-term efficacy of omalizumab in seven patients with treatment-resistant chronic spontaneous urticaria.
abstract: BACKGROUND
  Monoclonal anti-IgE antibody omalizumab is a promising therapeutic option in patients with chronic urticaria (CU) resistant to non-sedating H1-antihistamines (nsAH). However, data about its long-term efficacy and safety are still scant.
  
  
  OBJECTIVE
  We retrospectively analysed the clinical course of patients with severe recalcitrant CU that were treated in our department with omalizumab for a period greater than 24 months.
  
  
  METHODS
  Seven patients (six females, median 43 years) treated for a median of 35 months have been evaluated. Before treatment, all suffered from persistent symptoms despite receiving high doses of nsAH [4×/day], leukotriene antagonists and prednisolone (10-30 mg/day for a median duration of 48 months). Response to treatment was assessed using urticaria activity score (UAS) and a combined symptom/medication score.
  
  
  RESULTS
  There was a complete remission of disease in four patients after the first dose of omalizumab. Before the 5th administration, all patients had a UAS of 0. We found a significant improvement in UAS between pre-treatment and first dose (p=0.017) and a gradual decrease in the symptom/medication score over the course of the first five administrations. Tapering of prednisolone was possible in all patients. Administration intervals were gradually increased, although all experienced resurgence of symptoms in cycles greater than six weeks. There were no reported adverse reactions attributable to the drug.
  
  
  CONCLUSIONS
  Omalizumab was a safe and effective corticosteroid alternative for maintaining long-term remission of symptoms in these patients. Treatment intervals required individual patient-by-patient determination. The drug did not seem to alter the natural history of the disease.
authors.affiliation: Department of Immunoallergology, Hospital de Santa Maria, Centro Hospitalar Lisboa Norte EPE, Lisbon, Portugal. Electronic address: pedrotiagosilva@gmail.com.
authors.forename: P M
authors.initials: PM
authors.lastname: Silva
authors.affiliation: Department of Immunoallergology, Hospital de Santa Maria, Centro Hospitalar Lisboa Norte EPE, Lisbon, Portugal.
authors.forename: A C
authors.initials: AC
authors.lastname: Costa
authors.affiliation: Department of Immunoallergology, Hospital de Santa Maria, Centro Hospitalar Lisboa Norte EPE, Lisbon, Portugal.
authors.forename: A
authors.initials: A
authors.lastname: Mendes
authors.affiliation: Department of Immunoallergology, Hospital de Santa Maria, Centro Hospitalar Lisboa Norte EPE, Lisbon, Portugal.
authors.forename: M P
authors.initials: MP
authors.lastname: Barbosa
mesh_terms: D000328:Adult; D002908:Chronic Disease; D004351:Drug Resistance; D005260:Female; D006634:Histamine H1 Antagonists / Q000627:therapeutic use*; D006801:Humans; D007073:Immunoglobulin E / Q000276:immunology; D008297:Male; D000069444:Omalizumab / Q000008:administration & dosage* / Q000009:adverse effects; D012008:Recurrence; D012074:Remission Induction; D012189:Retrospective Studies; D013997:Time Factors; D016896:Treatment Outcome; D014581:Urticaria / Q000188:drug therapy*
chemical_list: D006634:Histamine H1 Antagonists; D000069444:Omalizumab; D007073:Immunoglobulin E
keywords: Anti-IgE; Chronic spontaneous urticaria; Omalizumab