title: Omalizumab therapy for chronic spontaneous urticaria: the Israeli experience.
abstract: BACKGROUND
  Chronic spontaneous urticaria (CSU) is a common, debilitating disease that is frequently resistant to standard therapy. Omalizumab, anti-immunoglobulin-E humanized monclonal antibody, was recently shown to be effective in treating resistant CSU.
  
  
  OBJECTIVE
  To investigated the treatment of CSU with omalizumab in Israel.
  
  
  METHODS
  We conducted a multicenter retrospective analysis of patients with refractory CSU treated with omalizuamb in Israel during 2012-2013. Complete improvement was defined as resolution of symptoms with no need for other medications, or satisfactory when patients' condition improved but required regular or intermittent doses of antihistamines.
  
  
  RESULTS
  Forty-three patients received omalizumab off-label for refractory CSU. Their mean age was 45 +/- 12 years and CSU duration was 4.3 +/- 4 years. In this cohort, 98% were unsuccessfully treated with high dose H(1)-antihistamines, 88% with systemic glucocorticoids and 30% with cyclosporine and/ or other immune-modulators. Fourteen patients received only one injection of omalizumab, while the other 29 received on average of 4.3 +/- 3.2 injections; 30 patients received 150 mg/ month and 13 received 300 mg/month. Following omalizumab therapy, disease remitted within weeks in 86% of patients, of whom half achieved complete remission. The latter was associated with usage of high dose omalizumab, 300 mg/month vs. 150 mg/month (P = 0.02) and repeated therapy (i.e., multiple injections vs. a single injection) (P = 0.0005).
  
  
  CONCLUSIONS
  Omalizumab is an effective and safe treatment for refractory CSU with rapid onset of action for inducing and maintaining remission. Treating CSU patients mandates an individual approach, because while low dose omalizumab will suffice for some patients others might need higher doses and prolonged therapy.
authors.forename: Menachem
authors.initials: M
authors.lastname: Rottem
authors.forename: Ramit
authors.initials: R
authors.lastname: Segal
authors.forename: Shmuel
authors.initials: S
authors.lastname: Kivity
authors.forename: Laliv
authors.initials: L
authors.lastname: Shamshines
authors.forename: Yael
authors.initials: Y
authors.lastname: Graif
authors.forename: Meir
authors.initials: M
authors.lastname: Shalit
authors.forename: Aharon
authors.initials: A
authors.lastname: Kessel
authors.forename: Josef
authors.initials: J
authors.lastname: Panasoff
authors.forename: Shai
authors.initials: S
authors.lastname: Cohen
authors.forename: Elias
authors.initials: E
authors.lastname: Toubi
authors.forename: Nancy
authors.initials: N
authors.lastname: Agmon-Levin
mesh_terms: D000328:Adult; D018926:Anti-Allergic Agents / Q000008:administration & dosage / Q000009:adverse effects; D000888:Antibodies, Anti-Idiotypic / Q000008:administration & dosage / Q000009:adverse effects; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage / Q000009:adverse effects; D002908:Chronic Disease; D004305:Dose-Response Relationship, Drug; D004351:Drug Resistance; D004357:Drug Synergism; D005260:Female; D006633:Histamine Antagonists / Q000627:therapeutic use*; D006801:Humans; D007073:Immunoglobulin E / Q000276:immunology; D007279:Injections, Subcutaneous; D007557:Israel; D008297:Male; D008875:Middle Aged; D000069444:Omalizumab; D012189:Retrospective Studies; D012720:Severity of Illness Index; D016896:Treatment Outcome; D014581:Urticaria / Q000188:drug therapy / Q000276:immunology / Q000503:physiopathology
chemical_list: D018926:Anti-Allergic Agents; D000888:Antibodies, Anti-Idiotypic; D061067:Antibodies, Monoclonal, Humanized; D006633:Histamine Antagonists; D000069444:Omalizumab; D007073:Immunoglobulin E