Higher maintenance adalimumab levels tied to achievement of remission targets in IBD

Clinical remission, endoscopic remission, and biomarker normalization show a positive association with adalimumab trough levels in patients with inflammatory bowel disease (IBD), reports a study. Moreover, adalimumab levels of ≥8.25 μg/mL correlate with deep remission.

The investigators collected data retrospectively from the patients’ medical records to determine whether higher maintenance adalimumab levels were associated with clinical remission, endoscopic remission, and biomarker normalization.

Clinical remission was defined as a Harvey Bradshaw Index ≤5 or a partial Mayo score ≤2 for Crohn’s disease (CD) and ulcerative colitis (UC), respectively; biomarker normalization as a C-reactive protein <0.5 mg/dL and/or calprotectin <250 mg/kg; endoscopic remission as a (simple endoscopic score-CD) ≤3/4 for ileal/extensive CD, respectively, or an endoscopic Mayo score ≤1 for UC; and deep remission as the combination of clinical and endoscopic remission with normal biomarkers.

Of the 97 patients included, 82 had CD and 15 UC. Patients who achieved clinical remission, endoscopic remission, or biomarker normalization had higher serum trough adalimumab levels than those not in remission (mean, 8.98±0.78 vs 5.92±0.96 μg/mL; p=0.016; 9.38±0.85 vs 5.48±0.87 μg/mL; p=0.002; 9.13±0.88 vs 6.02±0.77 μg/mL; p=0.019, respectively].

In receiver-operating curve analysis, an adalimumab level of ≥8.25 μg/mL correlated with deep remission (sensitivity, 84 percent; specificity, 70 percent; area under the curve, 0.775; p<0.001).

“This study provides additional data to guide therapeutic drug monitoring with adalimumab,” the investigators said.

“Biomarker normalization and endoscopic remission are superior to clinical remission in achieving improved long-term clinical outcomes in patients with IBD,” they noted.