PMID- 36272899
OWN - NLM
STAT- MEDLINE
DCOM- 20230404
LR  - 20230404
IS  - 1440-1592 (Electronic)
IS  - 1323-8930 (Linking)
VI  - 72
IP  - 2
DP  - 2023 Apr
TI  - Real-world safety and effectiveness of omalizumab in Japanese patients with 
      chronic spontaneous urticaria: A post-marketing surveillance study.
PG  - 286-296
LID - S1323-8930(22)00115-0 [pii]
LID - 10.1016/j.alit.2022.09.003 [doi]
AB  - BACKGROUND: The safety and efficacy of omalizumab in chronic spontaneous 
      urticaria (CSU) patients has been established, but real-world long-term data 
      remain scarce, especially in Japan. METHODS: 52-week, open-label, single-arm, 
      observational study evaluated the safety and effectiveness of first-time 
      omalizumab in Japanese CSU patients responding inadequately to conventional 
      therapies. RESULTS: Overall, 235 of 280 patients completed the study. Most 
      patients were aged >/= 18 and < 65 years; adolescents (>/= 12 and </= 18 years) 
      accounted for 9.6% of the total population. The mean +/- standard deviation (SD) 
      duration of CSU at baseline was 1.6 +/- 3.1 years; 46.1% of patients had had CSU 
      for < 6 months. At baseline, the mean +/- SD of Urticaria Control Test (UCT) score, 
      Weekly Urticaria Activity Score (UAS7), and Dermatology Life Quality Index (DLQI) 
      were 5.1 +/- 3.2, 25.2 +/- 11.9, and 8.4 +/- 5.9, respectively. The mean +/- SD duration 
      of the observation period was 330.3 +/- 86.2 days. Relapse was reported in 65 
      patients, 51, 9, and 5 of whom required retreatment with omalizumab 1, 2, and >/= 3 
      times, respectively. The incidence of adverse events (AEs), serious AEs, and 
      adverse drug reactions (ADRs) was reported in 11.8%, 1.4%, and 3.9% of patients, 
      respectively. The most common AEs were urticaria (1.8%) and eczema (1.1%). No 
      adolescents experienced ADRs. A cumulative of 92.8% of patients responded in the 
      Physician's Global Impression of Change, with 81.3%, 75.0%, and 95.1% of patients 
      achieving UCT >/= 12, UAS7 </= 6, and DLQI </= 5 up to Week 52, respectively. 
      CONCLUSIONS: This study supports the safety and effectiveness of omalizumab in 
      CSU patients who responded inadequately to conventional therapies in real-world 
      clinical practice in Japan.
CI  - Copyright (c) 2022 Japanese Society of Allergology. Published by Elsevier B.V. All 
      rights reserved.
FAU - Hide, Michihiro
AU  - Hide M
AD  - Department of Dermatology, Hiroshima City Hiroshima Citizens Hospital, Hiroshima, 
      Japan.
FAU - Fukunaga, Atsushi
AU  - Fukunaga A
AD  - Division of Dermatology, Department of Internal Medicine, Kobe University 
      Graduate School of Medicine, Kobe, Japan.
FAU - Suzuki, Takayuki
AU  - Suzuki T
AD  - Novartis Pharma K.K., Tokyo, Japan.
FAU - Nakamura, Noriko
AU  - Nakamura N
AD  - Novartis Pharma K.K., Tokyo, Japan.
FAU - Kimura, Mine
AU  - Kimura M
AD  - Novartis Pharma K.K., Tokyo, Japan.
FAU - Sasajima, Takayoshi
AU  - Sasajima T
AD  - Novartis Pharma K.K., Tokyo, Japan.
FAU - Kiriyama, Junna
AU  - Kiriyama J
AD  - Novartis Pharma K.K., Tokyo, Japan. Electronic address: 
      junna.kiriyama@novartis.com.
FAU - Igarashi, Atsuyuki
AU  - Igarashi A
AD  - Department of Dermatology, NTT Medical Center Tokyo, Tokyo, Japan.
LA  - eng
PT  - Journal Article
PT  - Observational Study
DEP - 20221020
PL  - England
TA  - Allergol Int
JT  - Allergology international : official journal of the Japanese Society of 
      Allergology
JID - 9616296
RN  - 2P471X1Z11 (Omalizumab)
RN  - 0 (Anti-Allergic Agents)
SB  - IM
MH  - Humans
MH  - Omalizumab/adverse effects
MH  - *Anti-Allergic Agents/adverse effects
MH  - East Asian People
MH  - *Chronic Urticaria/drug therapy
MH  - *Urticaria/drug therapy/chemically induced
MH  - Chronic Disease
MH  - *Drug-Related Side Effects and Adverse Reactions
MH  - Product Surveillance, Postmarketing
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Chronic spontaneous urticaria
OT  - Japan
OT  - Omalizumab
OT  - Real-world
OT  - Safety
EDAT- 2022/10/23 06:00
MHDA- 2023/04/04 06:42
CRDT- 2022/10/22 22:06
PHST- 2022/04/12 00:00 [received]
PHST- 2022/08/23 00:00 [revised]
PHST- 2022/09/16 00:00 [accepted]
PHST- 2023/04/04 06:42 [medline]
PHST- 2022/10/23 06:00 [pubmed]
PHST- 2022/10/22 22:06 [entrez]
AID - S1323-8930(22)00115-0 [pii]
AID - 10.1016/j.alit.2022.09.003 [doi]
PST - ppublish
SO  - Allergol Int. 2023 Apr;72(2):286-296. doi: 10.1016/j.alit.2022.09.003. Epub 2022 
      Oct 20.