125
and anti-drug antibodies. Evidence is also mounting for the use of commercial
assays to perform TDM when patients have recurrence of symptoms or lack of
response to infliximab or adalimumab, and reactive TDM is starting to become the
standard of care with respect to anti-TNF therapy in IBD. Further research is
required to determine the utility of proactive drug level and antibody monitoring for
these two agents. In addition, the role of such methods for and availability of assays
to measure newer anti-TNFs, biosimilars, anti-integrin agents, and newer classes of
biologic therapy remain to be determined.
References
- Chande N, Tsoulis DJ, MacDonald JK. Azathioprine or 6-mercaptopurine for induction of
remission in Crohn’s disease. Cochrane Database Syst Rev. 2013;4:CD000545. - Timmer A, McDonald JW, Tsoulis DJ, Macdonald JK. Azathioprine and 6-mercaptopurine for
maintenance of remission in ulcerative colitis. Cochrane Database Syst Rev. 2012;9:CD000478. - Targan SR, Hanauer SB, van Deventer SJ, et al. A short-term study of chimeric monoclonal
antibody cA2 to tumor necrosis factor alpha for Crohn’s disease. Crohn’s Disease cA2 Study
Group. N Engl J Med. 1997;337(15):1029–35. - Hanauer SB, Feagan BG, Lichtenstein GR, et al. Maintenance infliximab for Crohn’s disease:
the ACCENT I randomised trial. Lancet. 2002;359(9317):1541–9. - Rutgeerts P, Sandborn WJ, Feagan BG, et al. Infliximab for induction and maintenance therapy
for ulcerative colitis. N Engl J Med. 2005;353(23):2462–76. - Panaccione R, Ghosh S, Middleton S, et al. Combination therapy with infliximab and aza-
thioprine is superior to monotherapy with either agent in ulcerative colitis. Gastroenterology.
2014;146(2):392–400.e393. - Colombel JF, Sandborn WJ, Reinisch W, et al. Infliximab, azathioprine, or combination ther-
apy for Crohn’s disease. N Engl J Med. 2010;362(15):1383–95. - Hanauer SB, Sandborn WJ, Rutgeerts P, et al. Human anti-tumor necrosis factor monoclo-
nal antibody (adalimumab) in Crohn’s disease: the CLASSIC-I trial. Gastroenterology.
2006;130(2):323–33; quiz 591. - Sandborn WJ, Feagan BG, Marano C, et al. Subcutaneous golimumab induces clinical response
and remission in patients with moderate-to-severe ulcerative colitis. Gastroenterology.
2014;146(1):85–95; quiz e14-85. - Sandborn WJ, Feagan BG, Stoinov S, et al. Certolizumab pegol for the treatment of Crohn’s
disease. N Engl J Med. 2007;357(3):228–38. - Lichtenstein GR, Thomsen OO, Schreiber S, et al. Continuous therapy with certolizumab pegol
maintains remission of patients with Crohn’s disease for up to 18 months. Clin Gastroenterol
Hepatol. 2010;8(7):600–9. - Sandborn WJ, Colombel JF, Enns R, et al. Natalizumab induction and maintenance therapy for
Crohn’s disease. N Engl J Med. 2005;353(18):1912–25. - Van Assche G, Van Ranst M, Sciot R, et al. Progressive multifocal leukoencephalopathy after
natalizumab therapy for Crohn’s disease. N Engl J Med. 2005;353(4):362–8. - Colombel JF, Sands BE, Rutgeerts P, et al. The safety of vedolizumab for ulcerative colitis and
Crohn’s disease. Gut. 2017;66(5):839–51. - Cassinotti A, Travis S. Incidence and clinical significance of immunogenicity to infliximab in
Crohn’s disease: a critical systematic review. Inflamm Bowel Dis. 2009;15(8):1264–75. - Sandborn WJ, Hanauer SB, Rutgeerts P, et al. Adalimumab for maintenance treatment of
Crohn’s disease: results of the CLASSIC II trial. Gut. 2007;56(9):1232–9.
8 Therapeutic Drug Monitoring of Biologic Agents