Michihiro Hide1, Hae-Sim Park2, Atsuyuki Igarashi3, Young-Min Ye2, Tae-Bum Kim4, Akiko Yagami5, Jooyoung Roh6, Jae-Hyun Lee7, Yuko Chinuki8, Sang Woong Youn9, Soo-Keol Lee10, Naoko Inomata11, Jeong-Hee Choi12, Atsushi Fukunaga13, Junyi Wang14, Soichiro Matsushima14, Steve Greenberg15, Sam Khalil16. 1. Department of Dermatology, Institute of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan. 2. Department of Allergy and Clinical Immunology, Ajou University School of Medicine, Suwon, Korea. 3. Department of Dermatology, NTT Medical Center Tokyo, Tokyo, Japan. 4. Department of Allergy and Clinical Immunology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea. 5. Department of Dermatology, Fujita Health University School of Medicine, Toyoake, Japan. 6. Department of Dermatology, Gachon University Gil Medical Center, Incheon, Korea. 7. Department of Internal Medicine, Institute of Allergy, Yonsei University College of Medicine, Seoul, Korea. 8. Department of Dermatology, Shimane University Faculty of Medicine, Shimane, Japan. 9. Department of Dermatology, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seoul, Korea. 10. Department of Internal Medicine, Dong-A University School of Medicine, Busan, Korea. 11. Department of Environmental Immuno-Dermatology, Yokohama City University Graduate School of Medicine, Yokohama, Japan. 12. Department of Internal Medicine, Hallym University College of Medicine, Chuncheon, Korea. 13. Division of Dermatology, Department of Internal Related, Kobe University Graduate School of Medicine, Kobe, Japan. 14. Novartis Pharma K.K., Tokyo, Japan. 15. Novartis Pharmaceutical Corporation, East Hanover, NJ, USA. 16. Novartis Pharma AG, Basel, Switzerland. Electronic address: sam.khalil@novartis.com.
Abstract
BACKGROUND: Many patients with chronic spontaneous/idiopathic urticaria (CSU/CIU) do not respond adequately to treatment with non-sedating H1 antihistamines (H1AH). There are limited studies on use of omalizumab as add-on therapy for treatment of CSU in an Asian population. OBJECTIVE: The POLARIS study (NCT02329223), representing the first randomized, double-blind, placebo-controlled phase III trial of omalizumab for CSU in an Eastern Asian population, evaluated efficacy and safety of omalizumab as add-on therapy for treatment of CSU. METHODS: This 26-week multicenter (41 Japanese/Korean sites) study enrolled patients (12-75 years) who were symptomatic despite H1AH treatment. Eligible participants (N=218) were randomized 1:1:1 to receive three subcutaneous injections of omalizumab 300mg, 150mg, or placebo every 4 weeks, followed by 12 weeks of follow-up. Primary outcome was change from baseline to Week 12 (Wk12) in weekly itch severity score (ISS7). Safety was assessed through the summary of adverse events (AEs). RESULTS: Baseline demographics and disease characteristics were generally well balanced across treatment groups. At Wk12, statistically significant decreases from baseline were observed in ISS7 with omalizumab vs placebo (mean changes -10.22, -8.80, and -6.51 for omalizumab 300mg, 150mg and placebo; p<0.001 and p=0.006 vs placebo, respectively). Overall AE incidence was similar across treatment groups (54.8%, 57.7%, and 55.4% in omalizumab 300mg, 150mg, and placebo groups, respectively); nasopharyngitis was the most frequently reported AE in all treatment arms. CONCLUSION: The POLARIS study demonstrates that omalizumab is an efficacious and well-tolerated add-on therapy in Japanese and Korean H1AH-refractory patients with CSU.
RCT Entities:
BACKGROUND: Many patients with chronic spontaneous/idiopathic urticaria (CSU/CIU) do not respond adequately to treatment with non-sedating H1 antihistamines (H1AH). There are limited studies on use of omalizumab as add-on therapy for treatment of CSU in an Asian population. OBJECTIVE: The POLARIS study (NCT02329223), representing the first randomized, double-blind, placebo-controlled phase III trial of omalizumab for CSU in an Eastern Asian population, evaluated efficacy and safety of omalizumab as add-on therapy for treatment of CSU. METHODS: This 26-week multicenter (41 Japanese/Korean sites) study enrolled patients (12-75 years) who were symptomatic despite H1AH treatment. Eligible participants (N=218) were randomized 1:1:1 to receive three subcutaneous injections of omalizumab 300mg, 150mg, or placebo every 4 weeks, followed by 12 weeks of follow-up. Primary outcome was change from baseline to Week 12 (Wk12) in weekly itch severity score (ISS7). Safety was assessed through the summary of adverse events (AEs). RESULTS: Baseline demographics and disease characteristics were generally well balanced across treatment groups. At Wk12, statistically significant decreases from baseline were observed in ISS7 with omalizumab vs placebo (mean changes -10.22, -8.80, and -6.51 for omalizumab 300mg, 150mg and placebo; p<0.001 and p=0.006 vs placebo, respectively). Overall AE incidence was similar across treatment groups (54.8%, 57.7%, and 55.4% in omalizumab 300mg, 150mg, and placebo groups, respectively); nasopharyngitis was the most frequently reported AE in all treatment arms. CONCLUSION: The POLARIS study demonstrates that omalizumab is an efficacious and well-tolerated add-on therapy in Japanese and Korean H1AH-refractory patients with CSU.
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