PMID- 33469728
OWN - NLM
STAT- MEDLINE
DCOM- 20210818
LR  - 20210818
IS  - 1613-2246 (Electronic)
IS  - 0021-5155 (Linking)
VI  - 65
IP  - 1
DP  - 2021 Jan
TI  - Intravenous immunoglobulin treatment for steroid-resistant optic neuritis: a 
      multicenter, double-blind, randomized, controlled phase III study.
PG  - 122-132
LID - 10.1007/s10384-020-00790-9 [doi]
AB  - PURPOSE: To evaluate the efficacy and safety of intravenous "freeze-dried 
      sulfonated human normal immunoglobulin (GGS)" in patients with steroid-resistant 
      optic neuritis (ON). STUDY DESIGN: Multicenter, prospective, double-blind, 
      parallel-group, randomized controlled trial. METHODS: Patients with 
      steroid-resistant acute ON were randomly assigned to receive either intravenous 
      GGS (GGS group) or intravenous methylprednisolone (steroid pulse [SP] group). 
      Visual acuity (logarithm of the minimum angle of resolution [logMAR]), mean 
      deviation (MD) value of the Humphrey Field Analyzer, and critical flicker fusion 
      frequency were measured as efficacy endpoints; adverse events (AEs) were assessed 
      as the safety endpoint. RESULTS: Thirty-two patients (16 patients/group) received 
      the study drugs. The primary endpoint, change in logMAR at week 2 compared to 
      baseline, showed no statistically significant intergroup difference. However, 
      compared with the SP group, change in the GGS group was increasingly indicative 
      of visual improvement, with least squares mean difference of > 0.3 logMAR. On 
      post-hoc analyses, the percentage of patients in the GGS and SP groups with 
      improvement by >/= 0.3 logMAR at week 2 were 75.0% and 31.3%, respectively. Changes 
      in MD values at week 2 compared to baseline were 9.258  +/-  8.296 (mean +/- standard 
      deviation) dB and 3.175  +/-  6.167 dB in the GGS and SP groups, respectively. 
      These results showed statistically significant intergroup differences (visual 
      acuity improvement, P = 0.032; change in MD values, P = 0.030). No clinically 
      significant AEs were observed. CONCLUSION: Our results suggest that intravenous 
      immunoglobulin could be a safe and efficacious therapeutic option for prompt 
      treatment of steroid-resistant acute ON. TRIAL REGISTRATION: JapicCTI-132080.
FAU - Mimura, Osamu
AU  - Mimura O
AD  - Department of Ophthalmology, Hyogo College of Medicine, Nishinomiya, Japan. 
      omimurahomburg@gmail.com.
FAU - Ishikawa, Hitoshi
AU  - Ishikawa H
AD  - Department of Orthoptics and Visual Science, School of Allied Health Sciences, 
      Kitasato University, Sagamihara, Japan.
FAU - Kezuka, Takeshi
AU  - Kezuka T
AD  - Department of Ophthalmology, Tokyo Medical University, Shinjuku, Japan.
FAU - Shikishima, Keigo
AU  - Shikishima K
AD  - Department of Ophthalmology, The Jikei University School of Medicine, Minato, 
      Japan.
FAU - Suzuki, Tone
AU  - Suzuki T
AD  - Department of Ophthalmology, Dokkyo Medical University Saitama Medical Center, 
      Koshigaya, Japan.
FAU - Nakamura, Makoto
AU  - Nakamura M
AD  - Division of Ophthalmology, Department of Surgery, Kobe University Graduate School 
      of Medicine, Kobe, Japan.
FAU - Chuman, Hideki
AU  - Chuman H
AD  - Department of Ophthalmology, University of Miyazaki, Miyazaki, Japan.
FAU - Inoue, Kenji
AU  - Inoue K
AD  - Inoue Eye Hospital, Chiyoda, Japan.
FAU - Kimura, Akiko
AU  - Kimura A
AD  - Department of Ophthalmology, Hyogo College of Medicine, Nishinomiya, Japan.
FAU - Yamagami, Akiko
AU  - Yamagami A
AD  - Inoue Eye Hospital, Chiyoda, Japan.
FAU - Mihoya, Maki
AU  - Mihoya M
AD  - Pharmaceutical Development Administration Department, Teijin Pharma Limited, 
      Chiyoda, Japan.
FAU - Nakao, Yuzo
AU  - Nakao Y
AD  - Department of Ophthalmology, Kindai University Faculty of Medicine, Osakasayama, 
      Japan.
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20210120
PL  - Japan
TA  - Jpn J Ophthalmol
JT  - Japanese journal of ophthalmology
JID - 0044652
RN  - 0 (Immunoglobulins, Intravenous)
RN  - 0 (Steroids)
RN  - X4W7ZR7023 (Methylprednisolone)
SB  - IM
MH  - Double-Blind Method
MH  - Humans
MH  - *Immunoglobulins, Intravenous
MH  - Methylprednisolone
MH  - *Optic Neuritis/diagnosis/drug therapy
MH  - Prospective Studies
MH  - Steroids
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Anti-aquaporin-4 antibody
OT  - Intravenous immunoglobulin
OT  - Optic neuritis
OT  - Phase III
OT  - Steroid-resistant
EDAT- 2021/01/21 06:00
MHDA- 2021/08/19 06:00
CRDT- 2021/01/20 05:56
PHST- 2019/12/24 00:00 [received]
PHST- 2020/10/12 00:00 [accepted]
PHST- 2021/01/21 06:00 [pubmed]
PHST- 2021/08/19 06:00 [medline]
PHST- 2021/01/20 05:56 [entrez]
AID - 10.1007/s10384-020-00790-9 [pii]
AID - 10.1007/s10384-020-00790-9 [doi]
PST - ppublish
SO  - Jpn J Ophthalmol. 2021 Jan;65(1):122-132. doi: 10.1007/s10384-020-00790-9. Epub 
      2021 Jan 20.