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Humira Levels Linked to Biologic Crohn’s Remission
Patients with optimized Humira drug levels were more likely to achieve biologic remission, according to research published in Inflammatory Bowel Diseases.
“It is increasingly recognized that clinical symptom activity indices correlate poorly with the degree of underlying intestinal inflammation,” Nikolas Plevris, MRCP, of the Edinburgh IBD Unit at Western General Hospital in Edinburgh, Scotland, and colleagues wrote. “In the era of treating beyond symptoms, data are emerging that even higher serum drug levels are required to achieve objective end points like mucosal healing.”
Since regular endoscopic assessment is invasive and expensive, Plevris and colleagues conducted a prospective, cross-sectional study to assess the link between Humira (adalimumab, AbbVie) levels and C-reactive protein and fecal calprotectin biomarkers in patients with CD.
Researchers analyzed data from 152 patients with CD who were prescribed adalimumab therapy for at least 12 weeks after induction and had drug and antibody samples matched with CRP and fecal calprotectin. Biologic remission was defined as a CRP less than 5 mg/L and fecal calprotectin less than 250 µg/g.
Investigators found that patients in biologic remission had significantly higher drug levels compared with other patients (12 µg/mL vs. 8 µg/mL; P < .0001). Adalimumab levels greater than 8.5 µg/mL were associated with biologic remission (OR = 5.27; 95% CI, 2.43–11.44).
“By adopting biologic remission as a surrogate for mucosal healing, we have been able to validate in a larger cohort the positive association of higher [adalimumab] levels,” the researchers wrote. “Although direct comparison cannot be made with others due to assay variability, the optimal [adalimumab] level of [more than] 8.5 µg/mL is in keeping with the published literature.” – by Alex Young
Disclosures: Plevris reports financial ties to AbbVie, Norgine and Takeda. Please see the full study for all other authors’ relevant financial disclosures.