Feasibility of Reduced Clinical Monitoring in Patients with Inflammatory Bowel Disease Treated with Thiopurine Therapy.
Adverse events
Inflammatory bowel disease
Monitoring
Safety
Thiopurines
Journal
Digestive diseases and sciences
ISSN: 1573-2568
Titre abrégé: Dig Dis Sci
Pays: United States
ID NLM: 7902782
Informations de publication
Date de publication:
07 2023
07 2023
Historique:
received:
16
09
2022
accepted:
06
04
2023
medline:
28
6
2023
pubmed:
3
5
2023
entrez:
2
5
2023
Statut:
ppublish
Résumé
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. 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. 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 €136 per patient. 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.
Sections du résumé
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 €136 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.
Identifiants
pubmed: 37131100
doi: 10.1007/s10620-023-07950-0
pii: 10.1007/s10620-023-07950-0
pmc: PMC10293334
doi:
Substances chimiques
Immunosuppressive Agents
0
Azathioprine
MRK240IY2L
Mercaptopurine
E7WED276I5
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
2936-2945Informations de copyright
© 2023. The Author(s).
Références
Gut. 1993 Aug;34(8):1081-5
pubmed: 8174958
Gastroenterol Hepatol. 2018 Mar;41(3):205-221
pubmed: 29357999
J Crohns Colitis. 2017 Feb;11(2):135-149
pubmed: 27660342
J Crohns Colitis. 2018 Apr 27;12(5):610-620
pubmed: 29293971
Inflamm Bowel Dis. 2013 Jun;19(7):1404-10
pubmed: 23665964
Gut. 2019 Dec;68(Suppl 3):s1-s106
pubmed: 31562236
Ann Intern Med. 1989 Oct 15;111(8):641-9
pubmed: 2802419
Aliment Pharmacol Ther. 2017 Nov;46(10):953-963
pubmed: 28914446
Gut. 2002 Apr;50(4):485-9
pubmed: 11889067
Gastroenterology. 2021 Feb;160(3):935-937.e1
pubmed: 33127390
Expert Rev Gastroenterol Hepatol. 2015 Jul;9(7):891-900
pubmed: 25915575
Can J Gastroenterol. 2001 Jan;15(1):21-8
pubmed: 11173323
Aliment Pharmacol Ther. 2019 Sep;50(5):484-506
pubmed: 31342537
J Crohns Colitis. 2019 Jul 25;13(7):838-845
pubmed: 30698675
J Crohns Colitis. 2017 Jul 1;11(7):769-784
pubmed: 28513805
J Clin Gastroenterol. 2003 Sep;37(3):220-5
pubmed: 12960720
J Chromatogr. 1992 Nov 27;583(1):83-90
pubmed: 1484095
J Gastroenterol Hepatol. 2017 Jun;32(6):1183-1190
pubmed: 27859568
Gut. 2021 Apr;70(4):677-686
pubmed: 33004550
J Crohns Colitis. 2017 Feb;11(2):175-184
pubmed: 27402913
Gastroenterology. 2017 Sep;153(3):827-834
pubmed: 28780013
J Crohns Colitis. 2019 Feb 1;13(2):144-164
pubmed: 30137275
Clin Gastroenterol Hepatol. 2009 Nov;7(11):1195-201; quiz 1141-2
pubmed: 19631285
Inflamm Bowel Dis. 2017 Oct;23(10):1873-1881
pubmed: 28644183
Inflamm Bowel Dis. 2010 Sep;16(9):1541-9
pubmed: 20155846
Am J Gastroenterol. 2008 Jul;103(7):1783-800
pubmed: 18557712
Am J Gastroenterol. 2007 Jul;102(7):1518-27
pubmed: 17391318
Lancet. 2017 Sep 2;390(10098):959-968
pubmed: 28716313
Clin Pharmacokinet. 2007;46(3):187-208
pubmed: 17328579
Semin Radiat Oncol. 2003 Jul;13(3):176-81
pubmed: 12903007
World J Gastroenterol. 2015 Jul 7;21(25):7795-804
pubmed: 26167079
Dig Liver Dis. 2008 Oct;40(10):814-20
pubmed: 18479986
Aliment Pharmacol Ther. 2020 Jun;51(12):1353-1364
pubmed: 32342997
Gastroenterology. 2013 Dec;145(6):1464-78.e1-5
pubmed: 24267475