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Monitoring adalimumab levels predicted remission after dose optimization in IBD patients
A drug-monitoring algorithm predicted clinical response after dose optimization in patients with inflammatory bowel disease who had experienced loss of clinical response to adalimumab, according to recent study data.
Researchers in France performed a prospective observational study of 82 patients (mean age, 43 years) with Crohn’s disease (CD; n=46) or ulcerative colitis (UC; n=36) who had clinical relapse while on adalimumab (ADA) maintenance therapy (40 mg biweekly), and followed up every 2 months from January 2011 to June 2013.
Inclusion criteria required patients to be ADA primary responders and anti-tumor necrosis factor (TNF) naive. Before post-relapse ADA optimization at 40 mg weekly, patients underwent blood testing for residual trough levels of ADA (TRA) and antibodies against ADA levels (AAA). If clinical remission (CR) was not achieved within 4 months, patients were switched to infliximab (IFX). Participants were assigned to group A (n=41; TRA>4.9 mcg/mL), group B (n=24; TRA<4.9 mcg/mL and AAA<10 ng/mL) or group C (n=17; TRA<4.9 mcg/mL and AAA>10 ng/mL).
After ADA optimization, 29.2% (95% CI, 15-43) of group A patients achieved CR, as did 67% (95% CI, 45-82) of group B and 12% (95% CI, 0-28) in group C. Mean time to relapse after optimization was superior in group B (15 months) compared with groups A (5 months) and C (4 months; P<.01 between groups.
Of the 52 patients switched to IFX, 6.9% (95% CI, 0-14) of group A achieved CR, as did 25% (95% CI, 0-55) of group B and 80% (95% CI, 69-100) of group C. Mean time to relapse was superior in group C (14 months) compared with groups A (3 months) and B (5 months; P<.01 between groups). Only TRA and AAA predicted CR after IFX (groups A, P=.03; B, P=.04; and C, P=.05.)
“The presence of low [TRA] without AAA is strongly predictive of a favorable response to ADA optimization in 67% of cases,” the researchers wrote. “Conversely, a switch to IFX should be considered in patients with low TRA with detectable AAA” as this correlated with ADA failure. High TRA correlated with ADA and IFX failure in 90% of cases, and for such patients the researchers recommended considering a different drug class.
Disclosure: See the study for a full list of relevant financial disclosures.