Michihiro Hide1, Atsuyuki Igarashi2, Akiko Yagami3, Yuko Chinuki4, Naoko Inomata5, Atsushi Fukunaga6, Guenther Kaiser7, Junyi Wang8, Soichiro Matsushima8, Steven Greenberg9, Sam Khalil10. 1. Department of Dermatology, Institute of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan. 2. Department of Dermatology, NTT Medical Center Tokyo, Tokyo, Japan. 3. Department of Dermatology, Fujita Health University School of Medicine, Toyoake, Japan. 4. Department of Dermatology, Shimane University Faculty of Medicine, Shimane, Japan. 5. Department of Environmental Immuno-Dermatology, Yokohama City University Graduate School of Medicine, Yokohama, Japan. 6. Division of Dermatology, Department of Internal Related, Kobe University Graduate School of Medicine, Kobe, Japan. 7. Novartis Pharma AG, Basel, Switzerland. 8. Novartis Pharma K.K., Tokyo, Japan. 9. Novartis Pharmaceutical Corporation, East Hanover, NJ, USA. 10. Novartis Pharma AG, Basel, Switzerland. Electronic address: sam.khalil@novartis.com.
Abstract
BACKGROUND:Omalizumab, a humanized anti-IgE monoclonal antibody, proved efficacious and well tolerated in patients with chronic spontaneous urticaria (CSU) refractory to H1 antihistamines (H1AH) in the POLARIS study (NCT02329223), a randomized, double-blind, placebo-controlled trial in East Asian patients. However, data in Japanese patients, who have specific baseline characteristics (e.g., low angioedema incidence, different background medications) that may impact clinical outcomes, are lacking. This pre-specified analysis presents additional patient-level data over time, pharmacokinetic and pharmacodynamics data for omalizumab and IgE, and efficacy and safety data for omalizumab in Japanese patients. METHODS:Japanese patients (N = 105) were randomized 1:1:1 to omalizumab 300 mg, 150 mg, or placebo by subcutaneous injection every 4 weeks. Efficacy and safety were assessed primarily based on changes from baseline to Week 12 in weekly itch-severity scores (ISS7) and weekly urticaria activity scores (UAS7), and incidence of adverse events (AEs), respectively. Patient-level UAS7 data over time were also reviewed. RESULTS: At Week 12, least squares mean (LSM) changes from baseline in ISS7 were greater with omalizumab vs. placebo (-9.54 and -7.29 for omalizumab 300 mg and 150 mg, respectively, vs. placebo [-5.17]). Corresponding LSM changes from baseline in UAS7 were -21.61 and -15.59 (vs. placebo [-10.88]). Most responders in the omalizumab 300 mg group displayed improvement of disease activity within 2-4 weeks and had well-controlled symptoms during the treatment period. Overall AE incidence was similar across treatment arms. CONCLUSIONS: This subgroup analysis demonstrated that omalizumab is a well-tolerated, beneficial option for treatment of CSU in H1AH-refractory Japanese patients.
RCT Entities:
BACKGROUND:Omalizumab, a humanized anti-IgE monoclonal antibody, proved efficacious and well tolerated in patients with chronic spontaneous urticaria (CSU) refractory to H1 antihistamines (H1AH) in the POLARIS study (NCT02329223), a randomized, double-blind, placebo-controlled trial in East Asian patients. However, data in Japanese patients, who have specific baseline characteristics (e.g., low angioedema incidence, different background medications) that may impact clinical outcomes, are lacking. This pre-specified analysis presents additional patient-level data over time, pharmacokinetic and pharmacodynamics data for omalizumab and IgE, and efficacy and safety data for omalizumab in Japanese patients. METHODS: Japanese patients (N = 105) were randomized 1:1:1 to omalizumab 300 mg, 150 mg, or placebo by subcutaneous injection every 4 weeks. Efficacy and safety were assessed primarily based on changes from baseline to Week 12 in weekly itch-severity scores (ISS7) and weekly urticaria activity scores (UAS7), and incidence of adverse events (AEs), respectively. Patient-level UAS7 data over time were also reviewed. RESULTS: At Week 12, least squares mean (LSM) changes from baseline in ISS7 were greater with omalizumab vs. placebo (-9.54 and -7.29 for omalizumab 300 mg and 150 mg, respectively, vs. placebo [-5.17]). Corresponding LSM changes from baseline in UAS7 were -21.61 and -15.59 (vs. placebo [-10.88]). Most responders in the omalizumab 300 mg group displayed improvement of disease activity within 2-4 weeks and had well-controlled symptoms during the treatment period. Overall AE incidence was similar across treatment arms. CONCLUSIONS: This subgroup analysis demonstrated that omalizumab is a well-tolerated, beneficial option for treatment of CSU in H1AH-refractory Japanese patients.
Authors: Désirée E S Larenas-Linnemann; Claudio A S Parisi; Carla Ritchie; Ricardo Cardona-Villa; Ivan Cherrez-Ojeda; Annia Cherrez; Luis Felipe Ensina; Elizabeth Garcia; Iris V Medina; Mónica Rodríguez-González; Jorge Mario Sánchez Caraballo Journal: Curr Allergy Asthma Rep Date: 2018-05-09 Impact factor: 4.806