PMID- 31553630
OWN - NLM
STAT- MEDLINE
DCOM- 20200804
LR  - 20200804
IS  - 1502-7708 (Electronic)
IS  - 0036-5521 (Linking)
VI  - 54
IP  - 10
DP  - 2019 Oct
TI  - High anti-TNF alfa drugs trough levels are not associated with the occurrence of 
      adverse events in patients with inflammatory bowel disease.
PG  - 1220-1225
LID - 10.1080/00365521.2019.1666914 [doi]
AB  - Objectives: Up to 40% of inflammatory bowel disease (IBD) patients treated with 
      anti-TNF drugs lose response within 1 year of treatment, therefore requiring drug 
      optimization. Although higher drug trough levels (TLs) are associated with 
      sustained clinical outcomes, there are concerns that they may be associated with 
      a higher risk of adverse events (AEs). The aim was to evaluate the presence of a 
      possible association between drug TLs and the occurrence of AEs in IBD patients 
      treated with anti-TNF drugs.Methods: We retrospectively studied a cohort of 113 
      IBD patients treated with adalimumab or infliximab, of whom 27 were in 
      combination therapy with immunosuppressants. TLs were measured using a 
      homogeneous mobility shift assay.Results: During a median follow-up of 16 months 
      (range 1-144), we observed 103 AEs occurring in 58 patients. We found no 
      statistically significant difference (p = .21) in median TLs between patients who 
      did 6.7 mcg/mL; range 0.0-36.2) or did not (7.7 mcg/mL; range 0.0-20.7) 
      experience an AE. No difference was observed in the rate of AEs between patients 
      in mono- or combination therapy (p = .38), as well as between elderly (i.e., 
      >65 years) and younger patients (p = .32). Considering a TL cutoff of 7 mcg/mL 
      for infliximab and 12 mcg/mL for adalimumab, or even double these TL values, we 
      observed no statistically significant difference in the rate of AEs 
      occurrence.Conclusion: Our study suggests that, when clinically required, 
      anti-TNF drug dosage may be increased without particular concerns regarding the 
      risk of AEs occurrence in IBD patients, even in patients on combination therapy 
      and elderly ones.
FAU - Bodini, Giorgia
AU  - Bodini G
AD  - Gastroenterology Unit, Department of Internal Medicine, University of Genoa, 
      Genoa, Italy.
FAU - Demarzo, Maria Giulia
AU  - Demarzo MG
AD  - Gastroenterology Unit, Department of Internal Medicine, University of Genoa, 
      Genoa, Italy.
FAU - Saracco, Margherita
AU  - Saracco M
AD  - Gastroenterology Unit, Department of Internal Medicine, University of Genoa, 
      Genoa, Italy.
FAU - Coppo, Claudia
AU  - Coppo C
AD  - Gastroenterology Unit, Department of Internal Medicine, University of Genoa, 
      Genoa, Italy.
FAU - De Maria, Costanza
AU  - De Maria C
AD  - Gastroenterology Unit, Department of Internal Medicine, University of Genoa, 
      Genoa, Italy.
FAU - Baldissarro, Isabella
AU  - Baldissarro I
AD  - Gastroenterology Unit, Department of Internal Medicine, University of Genoa, 
      Genoa, Italy.
FAU - Savarino, Edoardo
AU  - Savarino E
AD  - Gastroenterolgy Unit, Department of Surgery, Oncology and Gastroenterology, 
      University of Padua, Padua, Italy.
FAU - Savarino, Vincenzo
AU  - Savarino V
AUID- ORCID: 0000-0001-6803-1952
AD  - Gastroenterology Unit, Department of Internal Medicine, University of Genoa, 
      Genoa, Italy.
FAU - Giannini, Edoardo G
AU  - Giannini EG
AUID- ORCID: 0000-0001-8526-837X
AD  - Gastroenterology Unit, Department of Internal Medicine, University of Genoa, 
      Genoa, Italy.
LA  - eng
PT  - Journal Article
PT  - Observational Study
DEP - 20190925
PL  - England
TA  - Scand J Gastroenterol
JT  - Scandinavian journal of gastroenterology
JID - 0060105
RN  - 0 (Immunosuppressive Agents)
RN  - B72HH48FLU (Infliximab)
RN  - FYS6T7F842 (Adalimumab)
SB  - IM
MH  - Adalimumab/*adverse effects/blood/*pharmacokinetics/therapeutic use
MH  - Adult
MH  - Aged
MH  - Dose-Response Relationship, Drug
MH  - Drug Administration Schedule
MH  - Drug Therapy, Combination
MH  - Female
MH  - Follow-Up Studies
MH  - Humans
MH  - Immunosuppressive Agents/*adverse effects/blood/*pharmacokinetics/therapeutic use
MH  - Inflammatory Bowel Diseases/blood/*drug therapy
MH  - Infliximab/*adverse effects/blood/*pharmacokinetics/therapeutic use
MH  - Male
MH  - Middle Aged
MH  - Retrospective Studies
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Infliximab
OT  - adalimumab
OT  - loss of response
OT  - therapeutic drug monitoring
EDAT- 2019/09/26 06:00
MHDA- 2020/08/05 06:00
CRDT- 2019/09/26 06:00
PHST- 2019/09/26 06:00 [pubmed]
PHST- 2020/08/05 06:00 [medline]
PHST- 2019/09/26 06:00 [entrez]
AID - 10.1080/00365521.2019.1666914 [doi]
PST - ppublish
SO  - Scand J Gastroenterol. 2019 Oct;54(10):1220-1225. doi: 
      10.1080/00365521.2019.1666914. Epub 2019 Sep 25.