Dermatophagoides pteronyssinus cluster immunotherapy. A controlled trial of safety and clinical efficacy

We designed a cluster schedule of immunotherapy for patients allergic to De rmatophagoides pteronyssinus to reach the maximal recommended dose in 7 wee ks. We compared ifs safety and clinical efficacy with those of a convention al schedule in a controlled trial. Sixty-three patients were randomized as follows: 29 were treated with the cluster schedule, 15 with a conventional schedule and 19 without immunotherapy. A standardized extract was used. Cli nical efficacy was measured by visual analog scale, clinical severity score , symptom/medication diary cards and control of peak expiratory flow (PEF) in asthmatic patients, before immunotherapy (T-0), on reaching the maintena nce phase (T-1), and after 6 (T-2), 12 (T-3) and 18 months of maintenance ( T-4). The safety of immunotherapy was found to be good. Visual analog scale improved significantly at T-4 in the cluster and conventional schedules, a nd clinical severity score also improved from T-1 in these schedules. Diary cards improved from T-1 in the cluster schedule and from T-4 in the conven tional schedule in asthmatic patients. Significant improvements in diary ca rds in rhinitis patients and PEF were found only in the cluster schedule. T here were no changes in the group without immunotherapy. In conclusion, our cluster schedule showed as good tolerance and clinical efficacy as the con ventional schedule in patients allergic to D. pteronyssinus. These clinical improvements did not appear in the group without immunotherapy.