Mitsuru Adachi1, Masanari Kozawa2, Hajime Yoshisue2, Ki Lee Milligan2, Makoto Nagasaki2, Takayoshi Sasajima2, Terumasa Miyamoto3, Ken Ohta4. 1. International University of Health and Welfare, Sanno Hospital, Tokyo, Japan. 2. Novartis Pharma K.K., Tokyo, Japan. 3. Japan Allergy Clinical Research Institute, Tokyo, Japan. 4. Department of Medicine, Division of Allergy and Respiratory Medicine, National Hospital Organization Tokyo National Hospital, Tokyo, Japan. Electronic address: kenohta@tokyo-hosp.jp.
Abstract
BACKGROUND: Omalizumab (anti-IgE monoclonal antibody) is an approved add-on therapy for Japanese patients with severe allergic asthma. As directed by the Ministry of Health, Labor and Welfare Japan, a post-marketing surveillance (PMS) study on omalizumab was conducted between 2009 and 2017. METHODS: The PMS observed safety and efficacy of omalizumab in patients treated with open-label omalizumab for 52 weeks (with optional 2-year extension period). Primary safety outcomes included incidence and severity of adverse events (AEs) and adverse drug reactions (ADRs). Primary efficacy outcomes included physician-assessed global evaluation of treatment effectiveness (GETE). Asthma-exacerbation-related events including requirement for additional systemic steroid therapy, hospitalization, emergency room visits, unscheduled doctor visits, and absenteeism were also evaluated. RESULTS: Of 3893 patients registered, 3620 (age [mean ± SD] 59.3 ± 16.11 years) were evaluated for 52 weeks; 44.12% were aged ≥65 years and 64.45% were women. Overall, 32.24% reported AEs and 15.30% reported serious AEs. ADRs were seen in 292 (8.07%) patients. GETE results showed that the majority of patients experienced clinical improvements (58.29% at 16 weeks and 62.40% at 52 weeks). Nearly half of all patients (47.96%) were free from asthma exacerbations after therapy. Omalizumab also reduced all events related to asthma exacerbations. No specific ADRs were observed in the elderly population. CONCLUSIONS: This post-marketing study confirmed the clinically meaningful benefits of omalizumab in a majority of patients from Japan, and showed safety and efficacy in a real-life clinical setting to be consistent with previous reports.
BACKGROUND:Omalizumab (anti-IgE monoclonal antibody) is an approved add-on therapy for Japanese patients with severe allergic asthma. As directed by the Ministry of Health, Labor and Welfare Japan, a post-marketing surveillance (PMS) study on omalizumab was conducted between 2009 and 2017. METHODS: The PMS observed safety and efficacy of omalizumab in patients treated with open-label omalizumab for 52 weeks (with optional 2-year extension period). Primary safety outcomes included incidence and severity of adverse events (AEs) and adverse drug reactions (ADRs). Primary efficacy outcomes included physician-assessed global evaluation of treatment effectiveness (GETE). Asthma-exacerbation-related events including requirement for additional systemic steroid therapy, hospitalization, emergency room visits, unscheduled doctor visits, and absenteeism were also evaluated. RESULTS: Of 3893 patients registered, 3620 (age [mean ± SD] 59.3 ± 16.11 years) were evaluated for 52 weeks; 44.12% were aged ≥65 years and 64.45% were women. Overall, 32.24% reported AEs and 15.30% reported serious AEs. ADRs were seen in 292 (8.07%) patients. GETE results showed that the majority of patients experienced clinical improvements (58.29% at 16 weeks and 62.40% at 52 weeks). Nearly half of all patients (47.96%) were free from asthma exacerbations after therapy. Omalizumab also reduced all events related to asthma exacerbations. No specific ADRs were observed in the elderly population. CONCLUSIONS: This post-marketing study confirmed the clinically meaningful benefits of omalizumab in a majority of patients from Japan, and showed safety and efficacy in a real-life clinical setting to be consistent with previous reports.
Authors: Andras Bikov; Ipek Kivilcim Oğuzülgen; Ilaria Baiardini; Marco Contoli; Alexander Emelyanov; Omar Fassio; Juan Carlos Ivancevich; Igor Kaidashev; Krzysztof Kowal; Marina Labor; Lies Lahousse; Stefan Mihaicuta; Silviya Novakova; Alicia Padilla Galo; Alexander Simidchiev; Angelica Tiotiu; Ignacio J Ansotegui; Jonathan A Bernstein; Louis Philippe Boulet; Giorgio Walter Canonica; Lawrence Dubuske; Nelson Rosario; Pierachille Santus; Fulvio Braido Journal: World Allergy Organ J Date: 2020-07-31 Impact factor: 4.084
Authors: Hiromasa Inoue; Masanari Kozawa; Ki Lee Milligan; Minako Funakubo; Ataru Igarashi; Emil Loefroth Journal: NPJ Prim Care Respir Med Date: 2019-04-29 Impact factor: 2.871