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Efficacy and Safety of Letibotulinum Toxin A for the Treatment of Essential Blepharospasm
본태눈꺼풀연축 환자에서 Letibotulinum Toxin A의 유효성과 안전성 평가
JKOS 2020 Mar;61(3):227-34
Published online March 15, 2020;  https://doi.org/10.3341/jkos.2020.61.3.227
Copyright © 2020 The Korean Ophthalmological Society.
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Ji Hyun Kim, MD1, Doh Hoon Chung, MD1, Sung Eun Kim, MD1, Ji-Sun Paik, MD, PhD1, Namju Kim, MD, PhD2, Tae Yoon La, MD, PhD3, Jun Hyuk Son, MD, PhD4, Hee Bae Ahn, MD, PhD5, Jae Wook Yang, MD, PhD6, Kyung In Woo, MD, PhD7, Helen Lew, MD, PhD8, Jin Sook Yoon, MD, PhD9, Sang Un Lee, MD, PhD10, Sung Bok Lee, MD, PhD11, Jeong Kyu Lee, MD, PhD12, Jae Woo Jang, MD, PhD13, Ho Kyung Choung, MD, PhD14, Mijung Chi, MD, PhD15, Suk-Woo Yang, MD, PhD1
김지현1⋅정도훈1⋅김성은1⋅백지선1⋅김남주2⋅나태윤3⋅손준혁4⋅안희배5⋅양재욱6⋅우경인7⋅유혜린8⋅윤진숙9⋅이상언10⋅이성복11⋅이정규12⋅장재우13⋅정호경14⋅지미정15⋅양석우1

Department of Ophthalmology, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea1, Seoul, Korea
Department of Ophthalmology, Seoul National University Bundang Hospital, Seoul National University College of Medicine2, Seongnam, Korea
Department of Ophthalmology, St. Vincent's Hospital, College of Medicine, The Catholic University of Korea3, Suwon, Korea
Department of Ophthalmology, Yeungnam University College of Medicine4, Daegu, Korea
Department of Ophthalmology, Dong-A University College of Medicine5, Busan, Korea
Department of Ophthalmology, Busan Paik Hospital, Inje University College of Medicine6, Busan, Korea
Department of Ophthalmology, Samsung Medical Center, Sungkyunkwan University School of Medicine7, Seoul, Korea
Department of Ophthalmology, CHA Bundang Medical Center, CHA University8, Seongnam, Korea
Department of Ophthalmology, Yonsei University College of Medicine9, Seoul, Korea
HanGil Eye Hospital10, Incheon, Korea
Department of Ophthalmology, Chungnam National University School of Medicine11, Daejeon, Korea
Department of Ophthalmology, Chung-Ang University Hospital, Chung-Ang University College of Medicine12, Seoul, Korea
Myung-Gok Eye Research Institute, Department of Ophthalmology, Kim’s Eye Hospital, Konyang University College of Medicine13, Seoul, Korea
Department of Ophthalmology, Seoul Metropolitan Government Seoul National University Boramae Medical Center14, Seoul, Korea
Department of Ophthalmology, Gachon University Gil Medical Center15, Incheon, Korea
가톨릭대학교 의과대학 서울성모병원 안과학교실1, 서울대학교 의과대학 분당서울대학교병원 안과학교실2, 가톨릭대학교 의과대학 성빈센트병원 안과학교실3, 영남대학교 의과대학 안과학교실4, 동아대학교 의과대학 안과학교실5, 인제대학교 의과대학 부산백병원 안과학교실6, 성균관대학교 의과대학 삼성서울병원 안과학교실7, 차의과학대학교 분당차병원 안과학교실8, 연세대학교 의과대학 안과학교실9, 한길안과병원10, 충남대학교 의학전문대학원 안과학교실11, 중앙대학교 의과대학 중앙대학교병원 안과학교실12, 건양대학교 의과대학 김안과병원 안과학교실 명곡안연구소13, 서울대학교병원운영 서울특별시 보라매병원 안과14, 가천대학교 길병원 안과학교실15
Received May 22, 2019; Revised August 19, 2019; Accepted February 21, 2020.
This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
 Abstract
Purpose: To evaluate the efficacy and safety of BOTULAX® in subjects with essential blepharospasm.
Methods: In this study, a total of 250 subjects with essential blepharospasm were enrolled at 15 investigational sites and a total of 220 subjects completed the study. The efficacy and safety were evaluated at weeks 4 and 16 after treatment compared with baseline. In total, 240 subjects were enrolled, treated with the investigational product, and evaluable for the primary efficacy assessment at week 4 after treatment; these subjects were included in the intention-to-treat (ITT) population. With the ITT set as the main efficacy set, efficacy assessment included Jankovic rating scale (JRS), functional disability score, investigator evaluation of global response and quality of life. Safety assessment including the incidence of adverse events was also performed.
Results: In terms of the primary efficacy endpoint (i.e., change in JRS total score at week 4 after treatment from baseline [ITT set]), mean change indicated a statistically significant reduction (p < 0.0001) and demonstrated the non-inferiority of the test drug to similar drugs. In terms of the secondary efficacy endpoints, mean change in JRS total score at week 16 after treatment and mean change in functional disability score at weeks 4 and 16 after treatment both exhibited a statistically significant reduction compared with baseline (p < 0.0001 for all). Among the 249 subjects treated with the investigational product in this study, 44 (17.67%) experienced 76 treatment emergent adverse events but no serious adverse events were observed.
Conclusions: Based on the study results, BOTULAX® is considered to be an effective and safe treatment for essential blepharospasm.
Keywords : BOTULAX®, Botulinum neurotoxin type A, Essential blepharospasm, Letibotulinum Toxin A

 

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