Combination of omalizumab and specific immunotherapy is superior to immunotherapy in patients with seasonal allergic rhinoconjunctivitis and co-morbid seasonal allergic asthma
Article first published online: 30 OCT 2008
© 2008 The Authors. Journal compilation © 2008 Blackwell Publishing Ltd
Clinical & Experimental Allergy
Volume 39, Issue 2, pages 271–279, February 2009
How to Cite
Kopp, M. V., Hamelmann, E., Zielen, S., Kamin, W., Bergmann, K.-C., Sieder, C., Stenglein, S., Seyfried, S., Wahn, U. and for the DUAL study group (2009), Combination of omalizumab and specific immunotherapy is superior to immunotherapy in patients with seasonal allergic rhinoconjunctivitis and co-morbid seasonal allergic asthma. Clinical & Experimental Allergy, 39: 271–279. doi: 10.1111/j.1365-2222.2008.03121.x
- Issue published online: 22 JAN 2009
- Article first published online: 30 OCT 2008
- Submitted 7July 2008; revised 20 August 2008; accepted 5 September 2008
- seasonal allergic asthma;
- seasonal allergic rhinitis;
- specific immunotherapy
Background The treatment of allergic asthma by specific immunotherapy (SIT) is hampered by potential side-effects.
Objective The aim of this study was to study the effect of omalizumab, a monoclonal anti-IgE antibody, in combination with SIT in patients with seasonal allergic rhinoconjunctivitis (SAR) and co-morbid seasonal allergic asthma (SAA) incompletely controlled by conventional pharmacotherapy.
Methods A randomized, double-blind, placebo-controlled, multi-centre trial was performed to assess the efficacy and safety of omalizumab (Xolair®) vs. placebo in combination with depigmented SIT (Depigoid®) during the grass pollen season. Omalizumab or placebo was started 2 weeks before SIT; the whole treatment lasted 18 weeks. Primary endpoint was daily ‘symptom load’, the sum of daily scores for symptom severity and rescue medication use.
Results A total of 140 patients (age 11–46 years) were randomized; and a total of 130 finished the study. Combination therapy reduced the symptom load by 39% (P=0.0464, Wilcoxon test) over SIT monotherapy. This difference was mainly due to reduced symptom severity (P=0.0044), while rescue medication use did not change significantly. Combination therapy also improved asthma control (Asthma Control Questionnaire, P=0.0295) and quality of life in the case of asthma (Asthma Quality of Life Questionnaire, P=0.0293) and rhinoconjunctivitis (Rhinoconjunctivitis Quality of Life Questionnaire, P=0.0537). Numbers of patients with ‘excellent or good’ treatment efficacy according to ratings of investigators (75.0% vs. 36.9%) or patients (78.5% vs. 46.1%) were markedly higher in the combination group than under SIT alone.
Conclusion Combination of omalizumab with SIT for treatment of patients with SAR and co-morbid SAA was safe and reduced the symptom load in a statistically significant and clinically meaningful manner.