PMID- 30791804
OWN - NLM
STAT- MEDLINE
DCOM- 20200601
LR  - 20200601
IS  - 1439-7609 (Electronic)
IS  - 1439-7595 (Linking)
VI  - 30
IP  - 1
DP  - 2020 Jan
TI  - Safety and tolerability of sifalimumab, an anti-interferon-alpha monoclonal antibody, 
      in Japanese patients with systemic lupus erythematosus: A multicenter, phase 2, 
      open-label study.
PG  - 93-100
LID - 10.1080/14397595.2019.1583832 [doi]
AB  - Objectives: To evaluate the safety of sifalimumab in Japanese patients with 
      systemic lupus erythematosus (SLE).Methods: This phase 2, open-label study 
      consisted of a 52-week initial stage (Stage I) and a long-term extension (Stage 
      II). In Stage I, sequential cohorts of patients received ascending doses of 
      sifalimumab (intravenous [IV] 1.0, 3.0, and 10.0 mg/kg or subcutaneous 100 mg 
      every 2 weeks; IV 600 and 1200 mg every 6 weeks). In Stage II, patients enrolled 
      before June 2012 received the same dose of sifalimumab as during Stage I for up 
      to 157 weeks or sifalimumab 600 mg IV every 4 weeks if they enrolled later. The 
      safety of sifalimumab was assessed by adverse events (AEs).Results: Thirty 
      patients enrolled in Stage I and 21 patients entered Stage II. The majority of 
      patients experienced AEs (96.7% in Stage I and 100% in Stage II); most were mild 
      or moderate in severity. Serious AEs occurred in 30.0% and 57.1% of patients in 
      Stage I and II, respectively; most were instances of SLE flares. The proportion 
      of patients in Stage I and II who had AEs leading to discontinuation was 10.0% 
      and 28.6%, respectively.Conclusion: Sifalimumab was well tolerated in Japanese 
      patients with SLE.
FAU - Takeuchi, Tsutomu
AU  - Takeuchi T
AD  - Division of Rheumatology, Department of Internal Medicine, Keio University School 
      of Medicine, Tokyo, Japan.
FAU - Tanaka, Yoshiya
AU  - Tanaka Y
AD  - First Department of Internal Medicine, School of Medicine, University of 
      Occupational and Environmental Health Japan, Kitakyushu, Japan.
FAU - Matsumura, Ryutaro
AU  - Matsumura R
AD  - Department of Allergy, National Hospital Organization, Chiba-East Hospital, 
      Chiba, Japan.
FAU - Saito, Kazuyoshi
AU  - Saito K
AD  - First Department of Internal Medicine, School of Medicine, University of 
      Occupational and Environmental Health Japan, Kitakyushu, Japan.
FAU - Yoshimura, Mitsuhiro
AU  - Yoshimura M
AD  - Department of Internal Medicine, National Hospital Organization, Kanazawa Medical 
      Center, Ishikawa, Japan.
FAU - Amano, Koichi
AU  - Amano K
AD  - Department of Rheumatology and Clinical Immunology, Saitama Medical Center, 
      Saitama Medical University, Saitama, Japan.
FAU - Atsumi, Tatsuya
AU  - Atsumi T
AD  - Department of Rheumatology, Endocrinology and Nephrology, Hokkaido University 
      Hospital, Hokkaido, Japan.
FAU - Suematsu, Eiichi
AU  - Suematsu E
AD  - Department of Internal Medicine and Rheumatology, National Hospital Organization, 
      Kyushu Medical Center, Fukuoka, Japan.
FAU - Hayashi, Nobuya
AU  - Hayashi N
AD  - Department of Research and Development, AstraZeneca K.K, Osaka, Japan.
FAU - Wang, Liangwei
AU  - Wang L
AD  - AstraZeneca, Gaithersburg, MD, USA.
FAU - Tummala, Raj
AU  - Tummala R
AD  - AstraZeneca, Gaithersburg, MD, USA.
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20190325
PL  - England
TA  - Mod Rheumatol
JT  - Modern rheumatology
JID - 100959226
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 0 (Immunologic Factors)
RN  - 0 (Interferon-alpha)
RN  - XOY1YA7RMC (sifalimumab)
SB  - IM
MH  - Adult
MH  - Antibodies, Monoclonal, Humanized/*therapeutic use
MH  - Dose-Response Relationship, Drug
MH  - Drug Administration Routes
MH  - Female
MH  - Humans
MH  - Immunologic Factors/therapeutic use
MH  - Interferon-alpha/*immunology
MH  - Japan
MH  - Lupus Erythematosus, Systemic/*drug therapy
MH  - Male
MH  - Middle Aged
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Dose escalation
OT  - intravenous
OT  - safety
OT  - sifalimumab
OT  - subcutaneous
OT  - systemic lupus erythematosus
EDAT- 2019/02/23 06:00
MHDA- 2020/06/02 06:00
CRDT- 2019/02/23 06:00
PHST- 2019/02/23 06:00 [pubmed]
PHST- 2020/06/02 06:00 [medline]
PHST- 2019/02/23 06:00 [entrez]
AID - 10.1080/14397595.2019.1583832 [doi]
PST - ppublish
SO  - Mod Rheumatol. 2020 Jan;30(1):93-100. doi: 10.1080/14397595.2019.1583832. Epub 
      2019 Mar 25.