Desloratadine ameliorates QOL burden of CIU

Toronto - The nonsedating, selective H1-receptor antagonist desloratadine improves signs and symptoms of chronic idiopathic urticaria (CIU), but also has a positive effect on quality of life (QOL) for affected patients, according to Charles W. Lynde, M.D.

A multicenter, open-label study - Assessment and Evaluation of Relief of Idiopathic Urticaria Symptoms (AERIUS) - was undertaken in Canada to investigate the impact of desloratadine treatment in patients with CIU. Aerius is the tradename of desloratadine in Canada; it is marketed in the United States as Clarinex (F. Hoffmann-La Roche Ltd., Basel, Switzerland).

Designed as a "real-world" study, Aerius involved 157 Canadian physicians, including dermatologists, allergists and general practitioners. They enrolled 348 patients (70 percent females) aged 18 years and older (mean age 44 years).

"The placebo-controlled, double-blind studies that support desloratadine's indication for treatment of CIU showed it to be safe and effective for rapidly relieving the signs and symptoms of CIU, including pruritus and hives. However, a negative impact on quality of life is the greatest burden felt by patients with this chronic, disfiguring skin disorder," says Dr. Lynde, assistant professor of dermatology, University of Toronto, Ontario, Canada.

"This study confirms the findings of the pivotal trials, but it also extends them in showing desloratadine treatment improves all domains of quality of life."

The open-label study was conducted between May, 2002 and January, 2003. Dr. Lynde was a principal co-investigator, together with allergist Harold Kim, M.D., department of medicine, faculty of health sciences, McMaster University, Ontario, Canada. Dr. Lynde presented the data at the 2004 annual meeting of the Canadian Dermatology Association in June.

Patients evaluated their treatment response using a four-point CIU symptom severity rating scale (0 best; 3 worst) to grade pruritus, the number of hives, and the size of the largest hive during the day and at night. In addition, they rated their sleep and daily activities. At baseline and weekly visits, patients and physicians jointly rated pruritus, number of wheals, overall disease condition and treatment response, and the patients also completed QOL questionnaires.

At study conclusion, desloratadine was associated with significant reductions in the jointly rated mean scores for itching, hives and overall condition. The mean score for each of those parameters was about two at baseline, and the value of each was reduced by about 50 percent at day 14. Patient diary reports also indicated patients benefited with a nearly 50 percent reduction in the overall negative impact of CIU, Dr. Lynde reports.

"The consistency between the patient and physician assessments provides concurrent validity of the treatment benefit," Dr. Lynde notes.

The clinical response was judged as moderate or better in 74 percent of patients, with about 17 percent of patients experiencing complete relief and 28 percent benefiting with marked relief. Only 14 percent of patients considered the treatment to have failed.

The study results also showed skin disease-related interference with daily activities and sleep was reduced significantly within one week after starting treatment and improved slightly further thereafter. Similar rapid benefits were seen in QOL analyses of treatment effects on patient bother, self-consciousness about skin appearance, relationship problems and disease interference with leisure activities, outdoor activities, sports, sexual activity and work/studies ability. The improvement in skin appearance was also accompanied by a significant change in how patients dressed.

Concomitant medication use also decreased significantly by more than 50 percent. While the vast majority of patients (>80 percent) were using at least one other concomitant medication to manage their CIU pretreatment, by study conclusion, 60 percent were using no additional medications.

Disclosure: The study was sponsored by Schering, manufacturer of desloratadine. Dr. Lynde has acted as a consultant and a speaker's bureau member for Schering Canada.