PMID- 37131100
OWN - NLM
STAT- MEDLINE
DCOM- 20230628
LR  - 20230701
IS  - 1573-2568 (Electronic)
IS  - 0163-2116 (Print)
IS  - 0163-2116 (Linking)
VI  - 68
IP  - 7
DP  - 2023 Jul
TI  - Feasibility of Reduced Clinical Monitoring in Patients with Inflammatory Bowel 
      Disease Treated with Thiopurine Therapy.
PG  - 2936-2945
LID - 10.1007/s10620-023-07950-0 [doi]
AB  - BACKGROUND: Outpatient visits and laboratory assessments are routinely scheduled 
      every 3 to 4 months in thiopurine-treated patients with inflammatory bowel 
      disease (IBD) to timely detect thiopurine-related adverse events (AEs). AEs that 
      require therapy adjustment beyond 12 months of treatment are rare. AIM AND 
      METHODS: This single-center prospective cohort study evaluated the safety of a 
      reduced 6-monthly monitoring strategy in steroid-free patients with quiescent IBD 
      on stable dose of azathioprine, mercaptopurine, or thioguanine monotherapy. The 
      primary outcome was thiopurine-related AEs requiring therapy adjustments during a 
      follow-up period of 24 months. Secondary outcomes included all AEs including 
      laboratory toxicity, disease flares until 12 months, and the net monetary benefit 
      from this strategy concerning IBD-related health care use. RESULTS: We enrolled 
      85 patients with IBD (median age 42 years, 61% Crohn's disease, 62% female), with 
      a median disease duration of 12.5 years and median thiopurine treatment duration 
      of 6.7 years. During follow-up, 3 patients (4%) ceased thiopurines due to AEs: 
      recurrent infections, non-melanoma skin cancer, and gastrointestinal complaints 
      (nausea, vomiting). At 12 months, 25 laboratory toxicities were observed 
      (including 13% myelotoxicity, 17% hepatotoxicity); none required therapy 
      adjustments and all were transient. A reduced monitoring strategy had a net 
      benefit of euro136 per patient. CONCLUSION: Three patients (4%) ceased thiopurine 
      therapy due to thiopurine-related AEs, while no laboratory toxicity required 
      therapy adjustments. Monitoring frequency of every 6 months seems feasible in 
      patients with stable IBD on long-term (median duration > 6 years) maintenance 
      thiopurine therapy and may contribute to reduced patient-burden and health care 
      costs.
CI  - (c) 2023. The Author(s).
FAU - Jansen, Fenna M
AU  - Jansen FM
AUID- ORCID: 0000-0001-5454-4335
AD  - Department of Gastroenterology and Hepatology, Radboud University Medical Center, 
      Nijmegen, The Netherlands. fenna.jansen@radboudumc.nl.
FAU - Smits, Lisa J T
AU  - Smits LJT
AD  - Department of Gastroenterology and Hepatology, Radboud University Medical Center, 
      Nijmegen, The Netherlands.
FAU - Thomas, Pepijn W A
AU  - Thomas PWA
AD  - Department of Gastroenterology and Hepatology, Radboud University Medical Center, 
      Nijmegen, The Netherlands.
FAU - de Jong, Dirk J
AU  - de Jong DJ
AD  - Department of Gastroenterology and Hepatology, Radboud University Medical Center, 
      Nijmegen, The Netherlands.
FAU - Kreijne, Joany E
AU  - Kreijne JE
AD  - Department of Gastroenterology and Hepatology, Erasmus University Medical Center, 
      Rotterdam, The Netherlands.
FAU - van Dop, Willemijn A
AU  - van Dop WA
AD  - Department of Gastroenterology and Hepatology, Radboud University Medical Center, 
      Nijmegen, The Netherlands.
FAU - den Broeder, Nathan
AU  - den Broeder N
AD  - Department of Gastroenterology and Hepatology, Radboud University Medical Center, 
      Nijmegen, The Netherlands.
FAU - Hoentjen, Frank
AU  - Hoentjen F
AD  - Department of Gastroenterology and Hepatology, Radboud University Medical Center, 
      Nijmegen, The Netherlands.
AD  - Division of Gastroenterology, Department of Medicine, University of Alberta, 
      Edmonton, Canada.
LA  - eng
PT  - Journal Article
DEP - 20230502
PL  - United States
TA  - Dig Dis Sci
JT  - Digestive diseases and sciences
JID - 7902782
RN  - 0 (Immunosuppressive Agents)
RN  - MRK240IY2L (Azathioprine)
RN  - E7WED276I5 (Mercaptopurine)
SB  - IM
MH  - Humans
MH  - Female
MH  - Adult
MH  - Male
MH  - *Immunosuppressive Agents/adverse effects
MH  - Prospective Studies
MH  - Feasibility Studies
MH  - Azathioprine/adverse effects
MH  - Mercaptopurine/adverse effects
MH  - *Inflammatory Bowel Diseases/drug therapy/chemically induced
PMC - PMC10293334
OTO - NOTNLM
OT  - Adverse events
OT  - Inflammatory bowel disease
OT  - Monitoring
OT  - Safety
OT  - Thiopurines
COIS- D.J. de Jong received consulting fees from Synthon, Pharma, Abbvie, and MSD, and 
      travel fees from Falk Pharma, Takeda, Abbvie, MSD, Ferring, Vifor Pharma, and 
      Cablon Medical. F. Hoentjen has served on advisory boards, or as speaker or 
      consultant for Abbvie, Celgene, Janssen-Cilag, MSD, Takeda, Teva, Sandoz, and Dr. 
      Falk, and has received unrestricted grants from Dr. Falk, Janssen-Cilag, Abbvie, 
      Takeda. Other authors have no potential conflict of interest to disclose.
EDAT- 2023/05/03 00:41
MHDA- 2023/06/28 06:42
PMCR- 2023/05/02
CRDT- 2023/05/02 23:28
PHST- 2022/09/16 00:00 [received]
PHST- 2023/04/06 00:00 [accepted]
PHST- 2023/06/28 06:42 [medline]
PHST- 2023/05/03 00:41 [pubmed]
PHST- 2023/05/02 23:28 [entrez]
PHST- 2023/05/02 00:00 [pmc-release]
AID - 10.1007/s10620-023-07950-0 [pii]
AID - 7950 [pii]
AID - 10.1007/s10620-023-07950-0 [doi]
PST - ppublish
SO  - Dig Dis Sci. 2023 Jul;68(7):2936-2945. doi: 10.1007/s10620-023-07950-0. Epub 2023 
      May 2.