The following article is a part of conference coverage from the 2019 Advances in Inflammatory Bowel Diseases (AIBD) Meeting, being held in Orlando, Florida. The team at MPR will be reporting on the latest news and research conducted by leading experts gastroenterology. Check back for more from the 2019 AIBD Meeting.
ORLANDO – Treatment with etrolizumab in patients with histologically active ulcerative colitis (UC) at baseline experienced an improvement in histologic disease activity at Week 14, according to findings presented at the 2019 Advances in Inflammatory Bowel Diseases (AIBD) Annual Meeting, held December 12-14, 2019 in Orlando, FL.
Investigators utilized data from the open label induction (OLI) cohort of the HICKORY trial to evaluate the correlation between histologic changes and established disease activity measures at the end of etrolizumab induction. HICKORY is an ongoing randomized, multicenter, double-blind, placebo-controlled phase 3 study evaluating the efficacy and safety of etrolizumab during induction and maintenance of remission in patients with moderate to severe UC previously exposed to anti-tumor necrosis factors.
Histologic, clinical, and endoscopic assessments were performed based on data from patients in the OLI cohort who received at least 1 dose of etrolizumab 105mg SC every 4 weeks during the 14-week induction phase and had active baseline histology (Nancy histological index [NHI] >1 and Robarts histopathology index [RHI] >3) and complete scoring at Week 14. Histologic outcomes were assessed for the presence or absence of neutrophils. Clinical outcomes were defined as clinical remission (Mayo Clinic Score [MCS] ≤2, rectal bleeding [RB] = 0), clinical response (reduction from baseline MCS of at least 3 and 30% and either reduction from baseline RB of at least 1 or RB ≤1), and symptomatic remission (RB and SF remission). Endoscopic remission, improvement and response were also measured and analyzed.
At Week 14, 22% of patients achieved resolution of neutrophilic inflammation, defined as NHI ≤1 or RHI ≤3 plus Geboes subgrades 2B.0/3.0. In the 13 patients who achieved clinical remission and 32 patients who achieved symptomatic remission, 77% and 44%, respectively, also achieved neutrophilic resolution. In the 22 patients who achieved endoscopic improvement, 55% achieved neutrophilic resolution. In the 8 patients who achieved endoscopic remission, 75% achieved a resolution of neutrophilic inflammation. However, changes in histologic scores did not correlate well with endoscopic and symptomatic outcomes at Week 14.
Etrolizumab is an investigational humanized monoclonal anti-ß7 antibody with a dual mechanism of action, selectively inhibiting α4β7 and αEβ7 integrins found on cells that play a key role in IBD. It is formulated as a once monthly subcutaneous injection.
Peyrin-Biroulet L, Feagan B, Pai RK, et al. Correlation Between Histologic Indices and Ulcerative Colitis Activity Measures Among Patients in the HICKORY (Etrolizumab) Open-Label Induction Cohort. Presented at the 2019 AIBD Annual Meeting on December 12-14 in Orlando, FL.