PMID- 31748904
OWN - NLM
STAT- MEDLINE
DCOM- 20200921
LR  - 20200921
IS  - 1865-8652 (Electronic)
IS  - 0741-238X (Print)
IS  - 0741-238X (Linking)
VI  - 37
IP  - 1
DP  - 2020 Jan
TI  - Long-Term Safety of Adalimumab in 29,967 Adult Patients From Global Clinical 
      Trials Across Multiple Indications: An Updated Analysis.
PG  - 364-380
LID - 10.1007/s12325-019-01145-8 [doi]
AB  - INTRODUCTION: The safety profile of adalimumab was previously reported in 23,458 
      patients across multiple indications. Here we report the long-term safety of 
      adalimumab in adults with plaque psoriasis (Ps), hidradenitis suppurativa (HS), 
      rheumatoid arthritis (RA), ankylosing spondylitis, psoriatic arthritis, 
      non-radiographic axial spondyloarthritis, peripheral spondyloarthritis, Crohn's 
      disease (CD), ulcerative colitis (UC), and non-infectious uveitis (UV). METHODS: 
      Safety data from 77 clinical trials were pooled. Safety assessments included 
      adverse events (AEs) and serious AEs (SAEs) that occurred after the first study 
      dose and within 70 days (5 half-lives) after the last study dose. RESULTS: A 
      total of 29,967 patients were included, representing 56,916 patient-years (PY) of 
      exposure. The most frequently reported SAE of interest was infection (3.7/100 PY) 
      with highest incidences in CD, RA, UV, and UC (3.5/100 PY-6.9/100 PY); serious 
      infections in Ps (1.8/100 PY) and HS (2.8/100 PY) were lower. The observed number 
      of deaths was below what would be expected in an age- and sex-adjusted population 
      for most adalimumab-treated patients (including Ps). Lack of real-life data and 
      limited long-term data (> 5 years) for most patients are limitations of this 
      analysis. CONCLUSION: The safety profile of adalimumab was consistent with 
      previous findings and no new safety signals were observed.
FAU - Burmester, Gerd R
AU  - Burmester GR
AUID- ORCID: 0000-0001-7518-1131
AD  - Charite Universitatsmedizin Berlin, Berlin, Germany. gerd.burmester@charite.de.
FAU - Gordon, Kenneth B
AU  - Gordon KB
AD  - Medical College of Wisconsin, Milwaukee, WI, USA.
FAU - Rosenbaum, James T
AU  - Rosenbaum JT
AD  - Oregon Health and Science University and Legacy Devers Eye Institute, Portland, 
      OR, USA.
FAU - Arikan, Dilek
AU  - Arikan D
AD  - AbbVie, North Chicago, IL, USA.
FAU - Lau, Winnie L
AU  - Lau WL
AD  - AbbVie, North Chicago, IL, USA.
FAU - Li, Peigang
AU  - Li P
AD  - AbbVie, North Chicago, IL, USA.
FAU - Faccin, Freddy
AU  - Faccin F
AD  - AbbVie, North Chicago, IL, USA.
FAU - Panaccione, Remo
AU  - Panaccione R
AD  - University of Calgary, Calgary, AB, Canada.
LA  - eng
SI  - figshare/10.6084/m9.figshare.10070138
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20191120
PL  - United States
TA  - Adv Ther
JT  - Advances in therapy
JID - 8611864
RN  - 0 (Anti-Inflammatory Agents)
RN  - FYS6T7F842 (Adalimumab)
MH  - Adalimumab/*therapeutic use
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Anti-Inflammatory Agents/*therapeutic use
MH  - Arthritis, Psoriatic/*drug therapy
MH  - Arthritis, Rheumatoid/*drug therapy
MH  - Colitis, Ulcerative/*drug therapy
MH  - Crohn Disease/*drug therapy
MH  - Female
MH  - Hidradenitis Suppurativa/*drug therapy
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Uveitis/*drug therapy
PMC - PMC6979455
OTO - NOTNLM
OT  - Adalimumab
OT  - Ankylosing spondylitis
OT  - Crohn's disease
OT  - Hidradenitis suppurativa
OT  - Long-term safety
OT  - Plaque psoriasis
OT  - Psoriatic arthritis
OT  - Rheumatoid arthritis
OT  - Ulcerative colitis
OT  - Uveitis
EDAT- 2019/11/22 06:00
MHDA- 2020/09/22 06:00
PMCR- 2019/11/20
CRDT- 2019/11/22 06:00
PHST- 2019/10/08 00:00 [received]
PHST- 2019/11/22 06:00 [pubmed]
PHST- 2020/09/22 06:00 [medline]
PHST- 2019/11/22 06:00 [entrez]
PHST- 2019/11/20 00:00 [pmc-release]
AID - 10.1007/s12325-019-01145-8 [pii]
AID - 1145 [pii]
AID - 10.1007/s12325-019-01145-8 [doi]
PST - ppublish
SO  - Adv Ther. 2020 Jan;37(1):364-380. doi: 10.1007/s12325-019-01145-8. Epub 2019 Nov 
      20.