PMID- 30221573
OWN - NLM
STAT- MEDLINE
DCOM- 20200210
LR  - 20200210
IS  - 1439-7609 (Electronic)
IS  - 1439-7595 (Linking)
VI  - 29
IP  - 6
DP  - 2019 Nov
TI  - Real-world effectiveness and safety of adalimumab for treatment of ankylosing 
      spondylitis in Japan.
PG  - 1007-1012
LID - 10.1080/14397595.2018.1525024 [doi]
AB  - Objective: To evaluate the real-world effectiveness and safety of adalimumab for 
      the treatment of ankylosing spondylitis (AS) in Japan.Methods: All AS patients 
      initiated on adalimumab from 27 October 2010 to 28 May 2015, were enrolled. 
      Patient characteristics at baseline, changes in Bath Ankylosing Spondylitis 
      Disease Activity Index (BASDAI) scores, and adverse drug reactions (ADRs) for 
      24 weeks from the first adalimumab treatment were evaluated.Results: Of 403 
      enrolled patients, 396 and 374 comprised the safety and effectiveness analysis 
      sets, respectively. In the safety analysis set, 266/396 (67.2%) were males, with 
      a mean +/- standard deviation (SD) age of 46.3 +/- 15.6 years and mean +/- SD disease 
      duration of 9.8 +/- 9.8 years. Of 236 patients examined for human leukocyte antigen 
      (HLA)-B27, 131 (55.5%) were HLA-B27-positive. In the effectiveness analysis set, 
      the mean +/- SD BASDAI score was 4.9 +/- 2.3 at baseline (n = 292). Overall, 216 
      patients had BASDAI data pre- and post-baseline. At 24 weeks, 143 patients had 
      BASDAI scores, and the mean +/- SD decrease was -2.0 +/- 2.6 (p < .0001). Fifteen 
      serious ADRs occurred in 15 (3.79%) patients; 30 (7.58%) ADRs of infections were 
      reported, of which, five (1.26%) were serious.Conclusion: Safety and 
      effectiveness of adalimumab in this postmarketing observational study were 
      similar to that in previous clinical trials.
FAU - Kobayashi, Shigeto
AU  - Kobayashi S
AD  - Department of Internal Medicine, Rheumatology, Juntendo Koshigaya Hospital, 
      Juntendo University School of Medicine, Saitama, Japan.
FAU - Kashiwagi, Tomoko
AU  - Kashiwagi T
AD  - Medical, AbbVie GK, Tokyo, Japan.
FAU - Kimura, Junko
AU  - Kimura J
AD  - Medical, AbbVie GK, Tokyo, Japan.
LA  - eng
PT  - Journal Article
PT  - Observational Study
DEP - 20181101
PL  - England
TA  - Mod Rheumatol
JT  - Modern rheumatology
JID - 100959226
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 0 (HLA-B27 Antigen)
RN  - FYS6T7F842 (Adalimumab)
SB  - IM
MH  - Adalimumab/*adverse effects/therapeutic use
MH  - Adult
MH  - Antibodies, Monoclonal, Humanized/*adverse effects/therapeutic use
MH  - Female
MH  - HLA-B27 Antigen/blood
MH  - Humans
MH  - Japan
MH  - Male
MH  - Middle Aged
MH  - Product Surveillance, Postmarketing
MH  - Spondylitis, Ankylosing/blood/*drug therapy
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Adalimumab
OT  - ankylosing spondylitis
OT  - effectiveness
OT  - postmarketing surveillance
OT  - safety
EDAT- 2018/09/18 06:00
MHDA- 2020/02/11 06:00
CRDT- 2018/09/18 06:00
PHST- 2018/09/18 06:00 [pubmed]
PHST- 2020/02/11 06:00 [medline]
PHST- 2018/09/18 06:00 [entrez]
AID - 10.1080/14397595.2018.1525024 [doi]
PST - ppublish
SO  - Mod Rheumatol. 2019 Nov;29(6):1007-1012. doi: 10.1080/14397595.2018.1525024. Epub 
      2018 Nov 1.