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GEMA 2009
 

Bilastine and Quality of Life
 
I Jáuregui1, J Bartra2, A del Cuvillo3, I Dávila4, M Ferrer5, J Montoro6, J Mullol7, J Sastre8, A Valero2
1Department of Allergy, Basurto Hospital. Bilbao, Spain
2Allergy Unit. Department of Pneumology and Respiratory Allergy. Clinic Institute of Thorax (ICT). Clinical and Experimental Respiratory Immunoallergy (IDIBAPS). Clinic Hospital. Barcelona, Spain. Biomedical Research Centre of Respiratory Diseases (CIBERES)
3Astarté ENT Centre. Cádiz, Spain
4Department of Immunoallergy, Salamanca University Healthcare Complex, Salamanca, Spain
5Department of Allergy. Clínica Universidad de Navarra. Medical School. Pamplona, Spain
6Allergy Section, Elda General Hospital, Alicante, Spain
7Rhinology Unit & Smell Clinic, ENT Department. Clinical and Experimental Respiratory Immunoallergy (IDIBAPS). Clinic Hospital. Barcelona, Spain. Biomedical Research Centre Network for Respiratory Diseases (CIBERES)
8Department of Allergy, Jiménez Díaz Foundation, Madrid, Spain. Biomedical Research Centre Network for Respiratory Diseases (CIBERES)

J Investig Allergol Clin Immunol 2011; Vol. 21, Suppl. 3: 16-23
 

 Abstract


The evaluation of quality of life (QoL) and its modification through therapeutic interventions has become a prioritary concern in recent years and a requirement on the part of regulatory agencies for the authorization of new drugs. In clinical studies of allergic disorders, particularly allergic rhinitis and urticaria, different types of generic questionnaires have been used – especially disease specific instruments such as
the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) or skin disease specific tools such as the Dermatology Life Quality Index (DLQI).
Throughout its clinical development, bilastine has been shown to be more effective than placebo and at least as effective as cetirizine,
levocetirizine, fexofenadine or desloratadine in controlling the symptoms of seasonal allergic rhinitis and chronic urticaria. QoL has been studied as a secondary objective in three allergic rhinitis clinical trials, using the RQLQ, in a total of 2335 patients. Likewise, in chronic urticaria, QoL has been evaluated using the DLQI in a total of 525 patients, versus levocetirizine and placebo. The improvement in the QoL parameters in these studies (RQLQ or DLQI domains) at all times proved proportional to the symptoms improvement. In general, the data obtained relating to changes in QoL are concordant with the mean global visual analog scale (VAS in mm) values and their changes, from
the beginning until the end of the treatment period, for all of the trials, for bilastine and all its comparators.

Key words: H1 antihistamines. Bilastine. Quality of life.Visual analog scale. Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ). Dermatology Life Quality Index (DLQI). Allergic rhinitis. Chronic urticaria.