Effects of omalizumab on chronic urticaria not responding to recommended therapy

  • Hébert J
  • Caron-Guay R
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Abstract

Background: The efficacy of omalizumab, at dose of 300 mg monthly, in the treatment patients with chronic urticaria (CU) is well established. However, the recently published pivotal studies included patients only on antihistamines as rescue medication during the run-in period: so, a milder CU population was selected. This study assesses the effects of omalizumab in the more severe patients, symptomatic in spite of maximum therapy. Methods: Patients [#35, seven males, age ranging from 7 to 64 years with a diagno- sis of CSU (29), cold urticarial (5) and urticarial vasculitis (1)] to receive omalizumab experienced minimal response to first and second line treatments, except with high dose of oral steroid (OC). Most of them did not respond or tolerate cyclosporine and have been on short (all) or long (11) term OC. The clinical outcome was assessed using a) the Urticaria Activity Scores for 7 days (UAS7), where the symptoms were scored (0-3) daily in terms of numbers of wheals and the intensity of the pruritus, b) the Medication Score, composed of the weighted scores for use of antihistamine at regular or high dose (49), antileukotriene, immunomodulator, prednisone low-to high doses and c) Total Combined Scores. Routine hematology and biochemistry were done before omalizumab as well as ANA and anti-TPO levels to identify the autoimmune subgroup and tryptase levels. Results: The clinical outcome measured before (#35) and at 1 (#33), 3 (#27), 6 (#18) and 12 (#11) months after initiation of therapy gave for UAS7 respectively 22.5, 9.2, 6, 4.5 and 2.3 points; forMedication Scores 4.9, 4.3, 3.3, 2.5 and 2.3 points and finally for the Total Combined Scores 26.2, 13, 9.6, 7, 4.8 points. The clinical response was significant at 1 month and continued to improve with time. Two patients improved only slightly and omalizumab was increased to 300 mg at 3 months. One patient did not respond at all and OC were reintroduced at 12 months. The five patients with cold urticaria were at least type II according to Wanderer's classification, with daily symptoms: all became symptom-free on omalizumab with significant reduction of their ice cube test. Autoimmune status did not affect the outcome. Conclusion: Our results showed that recommended treatment-resistant and severe CU patients improved significantly on omalizumab, even at low dose (150 mg), in terms of clinical symptomatology (UAS7) and drug reduction in a real life setting. None of the patients reported drug-related adverse effects.

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Hébert, J., & Caron-Guay, R.-M. (2012). Effects of omalizumab on chronic urticaria not responding to recommended therapy. Allergy, Asthma & Clinical Immunology, 8(S1). https://doi.org/10.1186/1710-1492-8-s1-a17

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