A Real-world Study to Assess Safety and Effectiveness of Xolair® in Pediatric Chronic Spontaneous Urticaria in China

The type and frequency of adverse event (AE), adverse events of special interest (AESI) and serious adverse event (SAE) will be used as variables to evaluate the primary objective. AESI terms include Anaphylaxis, Churg Strauss Syndrome, Arterial Thromboembolic Events and Malignant neoplasms.

A weekly itch score is derived by adding up the average daily ISS of the 7 days preceding the visit. ISS is ranged on a scale of 0 (none) to 3 (intense/severe), therefore, the possible range of the ISS7 is 0 to 21 where higher scores indicate more intense itch.

The number of hives and intensity of itch score will be recorded by the patient in Urticaria Patient Daily Diary (UPDD), on a scale of 0 (none) to 3 (intense/severe). The Urticaria Severity Score (UAS) is a composite score of the number of wheals (hives) (Hives Severity Scores, HSS); and the severity of the itch (Itch Severity Scores, ISS). A weekly hives score (HSS7) is derived by adding up the average daily HSS of the 7 days preceding the visit. The possible range of the HSS7 is therefore 0 to 21. A weekly itch score (ISS7) is derived by adding up the average daily ISS of the 7 days preceding the visit. The possible range of the ISS7 is therefore 0 to 21. The UAS7 is the sum of the HSS7 score and the ISS7 score. The possible range of the weekly UAS7 score is 0 to 42 (highest activity).

Frequency and percentage will be provided for patients who achieved well-controlled CSU (defined as a UCT score ≥12) at Week 12.

The UCT is a 4-item Patient Reported Outcome measure developed to assess disease control in patients with Chronic Urticaria specifically Chronic Spontaneous Urticaria and Chronic Inducible Urticaria. It has a 7 days recall period and patients respond with how much they were bothered by their urticaria symptoms, what is the impact on QoL, how often the treatment did not control their urticaria and their overall perception of disease control. Each question can be scored on a scale from 0 to 4 and the overall score ranges from 0 (no control) to 16 (maximum control). The cut-off value for disease control was established at 12. Patients with a score above 12 are considered controlled. A minimally important difference of 3 points was validated as reflective of a clinically relevant change of control

The Children's Dermatology Life Quality Index is a 10-item general dermatology disability index designed to assess health-related quality of life in pediatric subjects aged 4 to 16 years. It is self-explanatory and may be completed by the child with assistance from parents or caregivers as necessary. The 10 questions cover six areas of daily activities including symptoms and feelings, leisure, school or holidays, personal relationships, sleep and treatment. The questions are based on the preceding week to permit accurate recall. Each question is answered on a 4-point Likert scale scored from 0 to 3. These are added to give a minimum score of 0 and maximum score of 30. A higher CDLQI score indicates a greater degree of QoL impairment. The CDLQI questionnaire will be completed by all patients independent of age, to ensure consistency.