PMID- 30053973
OWN - NLM
STAT- MEDLINE
DCOM- 20181212
LR  - 20181212
IS  - 1532-3064 (Electronic)
IS  - 0954-6111 (Linking)
VI  - 141
DP  - 2018 Aug
TI  - Real-world safety and efficacy of omalizumab in patients with severe allergic 
      asthma: A long-term post-marketing study in Japan.
PG  - 56-63
LID - S0954-6111(18)30219-1 [pii]
LID - 10.1016/j.rmed.2018.06.021 [doi]
AB  - 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.
CI  - Copyright (c) 2018. Published by Elsevier Ltd.
FAU - Adachi, Mitsuru
AU  - Adachi M
AD  - International University of Health and Welfare, Sanno Hospital, Tokyo, Japan.
FAU - Kozawa, Masanari
AU  - Kozawa M
AD  - Novartis Pharma K.K., Tokyo, Japan.
FAU - Yoshisue, Hajime
AU  - Yoshisue H
AD  - Novartis Pharma K.K., Tokyo, Japan.
FAU - Lee Milligan, Ki
AU  - Lee Milligan K
AD  - Novartis Pharma K.K., Tokyo, Japan.
FAU - Nagasaki, Makoto
AU  - Nagasaki M
AD  - Novartis Pharma K.K., Tokyo, Japan.
FAU - Sasajima, Takayoshi
AU  - Sasajima T
AD  - Novartis Pharma K.K., Tokyo, Japan.
FAU - Miyamoto, Terumasa
AU  - Miyamoto T
AD  - Japan Allergy Clinical Research Institute, Tokyo, Japan.
FAU - Ohta, Ken
AU  - Ohta K
AD  - Department of Medicine, Division of Allergy and Respiratory Medicine, National 
      Hospital Organization Tokyo National Hospital, Tokyo, Japan. Electronic address: 
      kenohta@tokyo-hosp.jp.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Observational Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20180628
PL  - England
TA  - Respir Med
JT  - Respiratory medicine
JID - 8908438
RN  - 0 (Anti-Asthmatic Agents)
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 2P471X1Z11 (Omalizumab)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Anti-Asthmatic Agents/*pharmacology
MH  - Antibodies, Monoclonal, Humanized/therapeutic use
MH  - Asthma/*drug therapy/immunology
MH  - Disease Progression
MH  - Female
MH  - Humans
MH  - Hypersensitivity
MH  - Japan/epidemiology
MH  - Male
MH  - Marketing/*methods
MH  - Middle Aged
MH  - Omalizumab/administration & dosage/adverse effects/*pharmacology
MH  - Prospective Studies
MH  - Severity of Illness Index
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Adverse drug events
OT  - Effectiveness
OT  - Exacerbations
OT  - Omalizumab
OT  - Severe asthma
EDAT- 2018/07/29 06:00
MHDA- 2018/12/13 06:00
CRDT- 2018/07/29 06:00
PHST- 2018/04/18 00:00 [received]
PHST- 2018/06/20 00:00 [revised]
PHST- 2018/06/23 00:00 [accepted]
PHST- 2018/07/29 06:00 [entrez]
PHST- 2018/07/29 06:00 [pubmed]
PHST- 2018/12/13 06:00 [medline]
AID - S0954-6111(18)30219-1 [pii]
AID - 10.1016/j.rmed.2018.06.021 [doi]
PST - ppublish
SO  - Respir Med. 2018 Aug;141:56-63. doi: 10.1016/j.rmed.2018.06.021. Epub 2018 Jun 
      28.