Omalizumab in treatment-resistant chronic spontaneous urticaria.

Sir,

According to EAACI/GA2LEN/EDF/WAO guidelines, chronic spontaneous urticaria (CSU) is defined by the spontaneous occurrence of wheals and/or angioedema over more than 6 weeks.[1] GA2LEN task force report mentions that the detrimental effect of CSU on the quality of life is greater than that of most other skin diseases and similar to that of severe coronary artery disease.[2] Guideline mentions omalizumab as the fourth-line option in the treatment of CSU.[3] First-line options are non-sedating antihistamines in fourfold doses, and second-line options include leukotriene antagonist or changing non-sedating antihistamine. There are few reports of success of omalizumab in the treatment of CSU.[45] Omalizumab, a recombinant, humanized, monoclonal antibody against immunoglobulin IgE, represents a unique therapeutic approach for the treatment of allergic diseases.

We treated five patients with treatment-resistant CSU with omalizumab. Dose of omalizumab was calculated according to body weight and serum IgE level. All patients had severe urticaria that required multiple antihistamines, steroids or dapsone to control symptoms. In spite of therapy, they had severe symptoms like urticaria, angioedema and itching. Patients were treated with omalizumab according to the dose schedule of asthma [Table 1]. Treatment study period was 4 months. Treatment response was assessed by urticaria activity score (UAS) and need of antihistamines or other therapies. The UAS was recorded by each patient daily and was obtained from the patients weekly. The number of wheals was scored from 0 to 3: 0, no wheals; 1, less than 20 wheals; 2, 20–50 wheals; 3, >50 wheals almost covered large confluent areas of wheals. Severity of itch was scored as 0, none; 1, mild; 2, moderate; and 3, severe. One has to add both these scores, viz., for both the number of wheals and the severity of itch, on a given day for each of the days in a given week to get the weekly UAS. The possible weekly aggregate UAS thereby ranged from 0 to 42. Daily average score ranged between 0 and 6.

Table 1

Clinical features of five CSU patients

There was significant improvement in all the patients, with reduction in UAS and need of antihistamines. At the end of 4th month, two patients were free from symptoms and other three required antihistamine to control their symptoms. Side effects were recorded in two patients in the form of headache and fatigue.

Study from Germany reported that all nine patients who had severe therapy-resistant urticaria improved with omalizumab.[6] Physical urticaria patients have also shown overall excellent response to omalizumab in the study from Germany.[7]

This paper supports latest EAACI/GA2LEN/WAO/EDF guideline which mentions the use of omalizumab as a fourth-line treatment in CSU.