Real-world safety and efficacy of omalizumab in patients with severe allergic asthma: A long-term post-marketing study in Japan

• Published in: Respiratory medicine Vol. 141; pp. 56 - 63
• Main Authors: Adachi, Mitsuru, Kozawa, Masanari, Yoshisue, Hajime, Lee Milligan, Ki, Nagasaki, Makoto, Sasajima, Takayoshi, Miyamoto, Terumasa, Ohta, Ken
• Format: Journal Article
• Language: English
• Published: England Elsevier Ltd 01.08.2018; Elsevier Limited
• Subjects: Absenteeism; Adult; Adverse drug events; Aged; Allergies; Anaphylaxis; Anti-Asthmatic Agents - pharmacology; Antibodies, Monoclonal, Humanized - therapeutic use; Asthma; Asthma - drug therapy; Asthma - immunology; Autoimmune diseases; Disease Progression; Effectiveness; Emergency medical care; Emergency medical services; Exacerbations; Female; Geriatrics; Health surveillance; Humans; Hypersensitivity; Immunoglobulin E; Immunotherapy; Japan - epidemiology; Male; Marketing; Marketing - methods; Middle Aged; Monoclonal antibodies; Older people; Omalizumab; Omalizumab - administration & dosage; Omalizumab - adverse effects; Omalizumab - pharmacology; Patients; Population studies; Prospective Studies; Safety; Severe asthma; Severity of Illness Index; Side effects; Therapy; Treatment Outcome; Japan; Effectiveness; Adverse drug events; IgE; Omalizumab; SABA; IU; GETE; JGL; AEs; Q; SD; GINA; LTRA; LABA; PMS; ICS; Exacerbations; ADRs; SAEs; Severe asthma; OCS; HCRU; PMDA
• ISSN: 0954-6111; 1532-3064
• DOI: 10.1016/j.rmed.2018.06.021

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. 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. 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. 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.