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Higher vedolizumab trough levels associated with mucosal healing, lower endoscopic subscores in UC

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ORLANDO, Fla. — Ulcerative colitis patients with higher vedolizumab trough concentrations had lower endoscopic subscores and more commonly achieved mucosal healing, according to data from the GEMINI 1 trial presented here.

“In general, endoscopic subscores were lower and mucosal healing was more common in patients with UC who had higher measured vedolizumab trough concentrations at weeks 6 and 46,” Maria Rosario, PhD, from Takeda Pharmaceuticals, said in her presentation at Advances in IBD.

Rosario and colleagues aimed to evaluate the relationship between the pharmacokinetics of vedolizumab and endoscopic outcomes in 693 patients (mean age, 40.2 years; 42% women) with UC who participated in the GEMINI 1 trial. They assessed mucosal healing based on endoscopic subscores at weeks 0, 6 and 52, and measured vedolizumab trough serum concentrations at weeks 6 and 46. Vedolizumab trough level quartiles and associated mucosal healing rates were determined.

Endoscopic subscores were generally lower and mucosal healing occurred more commonly in patients with higher vedolizumab trough levels at weeks 6 and 46, Rosario said. For example, at week 6, 62.9% (95% CI, 55.7% to 70%) of patients in the highest quartile (>35.7 to 140 mcg/mL; n=175) achieved mucosal healing compared with 20.1% (95% CI, 20.2% to 35.4%) of patients in the lowest quartile (≤17.1 mcg/mL; n=169). Likewise, at week 52, 85.3% (95% CI, 77.3% to 93.3%) of patients in the highest quartile (>42.4 to 101 mcg/mL; n=75) achieved mucosal healing compared with 61.1% (95% CI, 49.9% to 72.4%) in the lowest quartile (≤12.1 mcg/mL; n=72).

The relationship between higher endoscopic subscores and faster vedolizumab clearance could be attributable to confounding variables and warrants further investigation, Rosario said.

For more information:

Rosario M. O-003. Presented at: 2014 Advances in Inflammatory Bowel Diseases, Dec. 4-6, 2014; Orlando, Fla.

Disclosures: Rosario is a full-time employee of Takeda Pharmaceuticals.