Strategies for recombinant allergen vaccines and fruitful results from first clinical studies.

Recombinant DNA technology has delivered the prospect of a new generation of preparations for allergen-specific immunotherapy. The first clinical studies with recombinant allergens have yielded encouraging results, suggesting that there is a good chance that such preparations will become available for use in the routine management of allergic disease.

Prospective validation of the "rhino conjunctivitis allergy-control-SCORE©" (RC-ACS©).

BACKGROUND: Recently we reported the validation of the "Allergy-Control-SCORE© (ACS)" which assesses symptom severity as well as medication use on three dimensions lung, nose and eyes. The aim of this study was to test the validity of the score for eyes and nose. METHODS: One-hundred-twenty-one consenting subjects (age 19-65y), including 81 patients with allergic rhino-conjunctivitis (RC) and 40 healthy controls, participated in the study. Patients rated daily nasal and eye symptoms using a 4-point scale (none, mild, moderate, and severe) and their use of anti-symptomatic medication. Validation criteria were pollen counts in the course of the study period. Discrimination capacity was analyzed by comparing the rhino-conjunctivitis Allergy-Control-SCORE© (RC-ACS©) values of allergic patients and healthy controls. Convergent reliability was assessed by correlating RC-ACS© values with the global severity of allergy, the quality of life, and the allergy-related medical consultations. Retest reliability was assessed by the correlation of the repeated measured RC-ACS© scores during each of two consecutive weeks. RESULTS: Convergent reliability analysis indicated a significant correlation between RC-Allergy-Control-SCORE© and global severity of allergy (r = 0.691; p < 0.0001), quality of life (r = 0.757; p < 0.0001) and allergy-related medical consultations (r = 0.329; p = 0.0019). RC-Allergy-Control-SCORE© showed a good retest reliability (r = 0.813; p < 0.001) and discriminated extremely well between allergic patients and healthy controls (Median: 3.7 range: 0; 14.1 vs. Median: 0 range: 0; 2.9; p < 0.001), with a sensitivity of 93.8% and a specificity of 92.5% at a score value of 0.786. CONCLUSIONS: The RC-ACS© can be considered as valid and reliable to assess the severity of rhino-conjunctivitis severity in clinical trials and observational studies.