Efficacy and safety of omalizumab in Japanese and Korean patients with chronic idiopathic/spontaneous urticaria (CIU/CSU): results from the Phase III POLARIS study
Presenters: Hide M1, Park HS 2, Igarashi A3, Ye YM2, Kim TB4, Yagami A5, Roh JY6, Lee JH7, Fukunaga A8, Khalil S9
Affiliations: 1Department of Dermatology, Institute of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan; 2Department of Allergy and Clinical Immunology, Ajou University School of Medicine, Suwon, Korea; 3Department of Dermatology, NTT Medical Center Tokyo, Tokyo, Japan; 4Department of Allergy and Clinical Immunology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea; 5Department of Allergology, Fujita Health University Second Educational Hospital, Nagoya, Japan; 6Department of Dermatology, Gachon University Gil Medical Center, Incheon, Korea; 7Department of Internal Medicine, Institute of Allergy, Yonsei University College of Medicine, Seoul, Korea; 8Department of Internal Related, Kobe University Graduate School of Medicine, Kobe, Japan; 9Novartis Pharma AG, Basel, Switzerland
Background/Objective: To date, the effect of omalizumab treatment on CIU/CSU has not been extensively assessed in an Asian population. POLARIS represents the first randomized, double-blind, placebo-controlled clinical trial of omalizumab for CIU/CSU in an Eastern Asian population.
Methods: Efficacy and safety of omalizumab as add-on therapy for treatment of CIU/CSU were evaluated in patients aged 12 to 75 years who were refractory to approved doses of nonsedating H1 antihistamines. This 26-week study comprised a two-week screening, 12-week randomized treatment, and 12-week follow up epochs. Patients (n=218) were randomized 1:1:1 to omalizumab 300mg, 150mg, or placebo by subcutaneous injection every four weeks. Primary outcome was changed from baseline (BL) to Week 12 (W12) in weekly itch severity score (ISS7). Secondary endpoints included change from BL in weekly urticaria activity score (UAS7) and weekly number of hives score (HSS7), proportion of patients achieving a UAS7 score between 0 and 6, and change in the Dermatology Life Quality Index (DLQI). Safety was assessed through the summary of adverse events (AEs).
Results: Most disease characteristics were well balanced across treatment arms. At W12, statistically significant decreases were observed from BL in ISS7 with omalizumab versus placebo (mean changes -10.22 and -8.80 for omalizumab 300mg and 150mg; p<0.001 and p=0.006 vs. placebo [-6.51], respectively). The corresponding mean changes from BL in UAS7 were -22.44 and -18.79 (p<0.001 and p=0.007 vs. placebo [?13.90], respectively). At W12, the proportions of patients treated with omalizumab 300mg or 150mg who achieved UAS7 scores of 6 or less were 57.5 percent and 42.9 percent (p<0.001 and p=0.002 vs. placebo [18.9%]), and for UAS7=0 were 35.6 percent and 18.6 percent (p<0.001 and p=0.013 vs. placebo [4.1%]), respectively. Mean changes in HSS7 at W12 were -12.17 and -10.04 with omalizumab 300mg and 150mg (p<0.001 and p=0.016 vs. placebo [-7.41]), respectively. Mean DLQI changes at W12 from BL were -8.4 and -7.2 with omalizumab 300mg and 150mg (p<0.001 and p=0.011 vs. placebo [-5.3]), respectively. Overall incidence of AEs was similar across treatment arms (54.8%, 57.7%, and 55.4% of subjects with omalizumab 300mg, 150mg, and placebo, respectively). Nasopharyngitis was the most frequently reported AE with all treatments.
Conclusion: POLARIS demonstrated that omalizumab treatment results in significant clinical benefits with no new safety concerns in patients with H1 antihistamine-refractory CIU/CSU in Japan and Korea.