3089 Clinical baseline characteristics of Asian patients suffering from refractory chronic spontaneous urticaria (CSU) in three phase 3 omalizumab clinical trials

Friday, 16 October 2015
Hall D1 Foyer (Floor 3) (Coex Convention Center)

Chia-Yu CHU, MD, PhD , National Taiwan University Hospital, Taipei, Taiwan

Derrick Aw, MD , National University Hospital, Singapore, Singapore

Young-Min Ye, MD , Ajou University School of Medicine, Suwon, South Korea

Giovanni Bader, MD, PhD , Novartis Pharma AG, Basel, Switzerland

Nathalie Oliveira, MD, PhD , Novartis Pharma AG, Basel, Switzerland

Fabrizio Dolfi, MD, PhD , Novartis Pharma AG, Basel, Switzerland

Jacqueline Liang , Novartis Taiwan, Taiwan

Rationale: The clinical profile of Asian patients suffering from Chronic Spontaneous Urticaria (CSU) is relatively unknown. The demographic and baseline characteristics of Asian versus non-Asian patients of three randomized, placebo-controlled omalizumab trials (ASTERIA I, ASTERIA II and GLACIAL) are described and compared.

Method: The pooled baseline data of Asian and non-Asian patients suffering from CSU that remained symptomatic despite anti H1-antihistamines (ASTERIA 1 and ASTERIA 2) and anti H2-antihistamines and/or leukotriene receptor antagonists (GLACIAL) treatments were assessed in this post-hoc descriptive analysis. Demographic and baseline disease characteristics are described and compared.

Results: Among 975 (mITT population) patients enrolled 32 (3.3%) were Asians. Most of the patients were enrolled in the United States and Europe. There were 22 (68.7%) females in the Asian group and 694 (73.6%) in the non-Asian. Mean age was 41.2 years; mean body weight was 70.3 kg and the mean BMI 26.9 kg/m2 in the Asian subgroup and 42.4 years, 83.2 kg and 29.7 kg/m2, respectively, in the non-Asian subpopulation. Mean duration of the disease was 6.7 years in Asians and 7.0 years in non-Asians. Baseline IgE levels were 163.2 and 169.8 IU/mL in Asians and non-Asians, respectively. Baseline mean urticaria activity score over 7 days (UAS7) was 30.7, weekly itch severity score 13.9, weekly number of hives score 16.8 in Asians and 30.9, 14.1, 16.8, respectively in non-Asians. Angioedema was present in 11 Asian (34.4%) patients and 449 (47.6%) non-Asian. Dermatology Life Quality Index (DLQI) was 11.12 and 13.29 in Asian and non-Asians, respectively. At baseline the Sleep Interference Score was 12.1, and the Daily Activity Interference score was 12.1 in Asians, while in non-Asian, they were and 12.1 and 12.8, respectively. Previous number of CSU medications, such as anti-histamines, LTRA and corticosteroids was 3.8 in Asian and 5.1 in non-Asians.

Conclusions: With the exception of body weight and previous history of CSU treatment, the clinical profile of patients with refractory CSU is similar between Asians and non-Asians.