PMID- 32100944
OWN - NLM
STAT- MEDLINE
DCOM- 20210223
LR  - 20210305
IS  - 2151-4658 (Electronic)
IS  - 2151-464X (Print)
IS  - 2151-464X (Linking)
VI  - 73
IP  - 2
DP  - 2021 Feb
TI  - Low Incidence of Inflammatory Bowel Disease Adverse Events in Adalimumab Clinical 
      Trials Across Nine Different Diseases.
PG  - 289-295
LID - 10.1002/acr.24175 [doi]
AB  - OBJECTIVE: Adalimumab is approved for treatment of Crohn's disease and ulcerative 
      colitis. Thus, we postulated that exacerbation or new-onset of inflammatory bowel 
      disease (IBD) would be rare events in patients treated with adalimumab for 
      non-IBD indications. The objective was to evaluate the incidence of IBD adverse 
      events (AEs) across adalimumab trials. METHODS: IBD AE rates in 75 adalimumab 
      clinical trials in rheumatoid arthritis, polyarticular juvenile idiopathic 
      arthritis, pediatric enthesitis-related arthritis, uveitis, hidradenitis 
      suppurativa, adult and pediatric psoriasis, psoriatic arthritis, nonpsoriatic 
      arthritis peripheral spondyloarthritis (SpA), axial SpA, including 
      nonradiographic axial SpA, and ankylosing spondylitis, were analyzed. Search 
      terms for IBD AEs (new onset or worsening/flare) included IBD, ulcerative 
      colitis, Crohn's disease, and ulcerative proctitis. RESULTS: This analysis 
      included 24,114 patients, representing 36,508 patient-years of adalimumab 
      exposure. The overall rate of IBD AEs in adalimumab-treated patients was 0.1 (95% 
      confidence interval [95% CI] 0.1-0.2)/100 patient-years (41 events), ranging from 
      no events (psoriatic arthritis, uveitis, and pediatric trials) to 0.8 (95% CI 
      0.2-2.2)/100 patient-years in peripheral SpA. The rate of IBD in axial SpA was 
      0.6 (95% CI 0.4-1.0)/100 patient-years. During placebo-controlled trials, the 
      overall IBD rate was 0.1 (95% CI 0.0-0.3)/100 patient-years for adalimumab groups 
      (3 events in 6,781 patients; 2,752 patient-years of exposure) and 0.1 (95% CI 
      0.0-0.4)/100 patient-years for placebo groups (1 event in 3,493 patients; 1,246 
      patient-years of exposure). IBD rates in axial SpA were 0.5 (95% CI 0.1-1.4)/100 
      patient-years for adalimumab and 0.6 (95% CI 0.0-3.1)/100 patient-years for 
      placebo. CONCLUSION: The rates of IBD AEs in adalimumab clinical trials were 
      generally low across the evaluated diseases, including axial SpA; all events 
      occurred in adult patients.
CI  - (c) 2020 The Authors. Arthritis Care & Research published by Wiley Periodicals LLC 
      on behalf of American College of Rheumatology.
FAU - Elewaut, Dirk
AU  - Elewaut D
AUID- ORCID: 0000-0002-7468-974X
AD  - Ghent University Hospital and Ghent University, Ghent, Belgium.
FAU - Braun, Jurgen
AU  - Braun J
AD  - Rheumazentrum Ruhrgebiet, Herne, and Ruhr Universitat Bochum, Bochum, Germany.
FAU - Anderson, Jaclyn K
AU  - Anderson JK
AD  - AbbVie, North Chicago, Illinois.
FAU - Arikan, Dilek
AU  - Arikan D
AD  - AbbVie, North Chicago, Illinois.
FAU - Chen, Su
AU  - Chen S
AD  - AbbVie, North Chicago, Illinois.
FAU - Hojnik, Maja
AU  - Hojnik M
AD  - AbbVie, Ljubljana, Slovenia.
FAU - De Craemer, Ann-Sophie
AU  - De Craemer AS
AD  - Ghent University Hospital and Ghent University, Ghent, Belgium.
FAU - Curtis, Jeffrey R
AU  - Curtis JR
AUID- ORCID: 0000-0002-8907-8976
AD  - University of Alabama at Birmingham.
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Arthritis Care Res (Hoboken)
JT  - Arthritis care & research
JID - 101518086
RN  - 0 (Antirheumatic Agents)
RN  - FYS6T7F842 (Adalimumab)
SB  - IM
MH  - Adalimumab/*adverse effects
MH  - Antirheumatic Agents/*adverse effects
MH  - Clinical Trials as Topic
MH  - Colitis, Ulcerative/*chemically induced/diagnosis/epidemiology
MH  - Crohn Disease/*chemically induced/diagnosis/epidemiology
MH  - Disease Progression
MH  - Humans
MH  - Incidence
MH  - Proctocolitis/*chemically induced/diagnosis/epidemiology
MH  - Risk Assessment
MH  - Risk Factors
MH  - Time Factors
PMC - PMC7898340
EDAT- 2020/02/27 06:00
MHDA- 2021/02/24 06:00
PMCR- 2021/02/22
CRDT- 2020/02/27 06:00
PHST- 2019/01/07 00:00 [received]
PHST- 2020/02/18 00:00 [accepted]
PHST- 2020/02/27 06:00 [pubmed]
PHST- 2021/02/24 06:00 [medline]
PHST- 2020/02/27 06:00 [entrez]
PHST- 2021/02/22 00:00 [pmc-release]
AID - ACR24175 [pii]
AID - 10.1002/acr.24175 [doi]
PST - ppublish
SO  - Arthritis Care Res (Hoboken). 2021 Feb;73(2):289-295. doi: 10.1002/acr.24175.