Evaluation of a Guidelines-Based Approach to the Treatment of Chronic Spontaneous Urticaria.

BACKGROUND

International scientific associations have made recommendations for the management of chronic spontaneous urticaria (CSU) that have been summarized in clinical guidelines.

OBJECTIVE

To evaluate the clinical impact of guideline recommendations for CSU management.

METHODS

A multicenter, triple-blinded, prospective, randomized study (the Urticaria Research of Tropical Impact and Control Assessment project; ClinicalTrials.gov identifier: NCT01940393) was performed. Patients older than 12 years and diagnosed with CSU were recruited and treated according to the European Academy of Allergy and Clinical Immunology/Global Allergy and Asthma European Network/European Dermatology Forum/World Allergy Organization guideline recommendations. The Dermatology Quality of Life Index (DLQI) was assessed every 2 weeks. As a first line of treatment, patients received a daily oral dose of antihistamine. After 4 weeks, in those patients without clinical response (DLQI ≤ 5), a higher dose (up to 4 times) of antihistamine was administered as a second line of therapy. After 2 months of follow-up, unresponsive patients received omalizumab or cyclosporine (as add-on therapy) for 4 months as a third line of treatment.

RESULTS

One hundred fifty patients were enrolled. After the first line of treatment, 88 patients (58.7%) reached a DLQI of 5 or less. With the second line of treatment, disease control rate was 76.7%. With the third line, 12 patients from the omalizumab group (8%) and 11 patients from the cyclosporine group (7.3%) reached a good clinical control (additional 15.3%). Control rate with line 1 treatment was superior at 1 month than at 2 weeks (P < .0001).

CONCLUSIONS

The application of these guideline recommendations for CSU led to a high rate of disease control, assessed by scoring severity and patients' perception of quality of life. These results support the usefulness of guideline recommendations.