During Digestive Disease Week (May 16-19) in Washington, D.C., Bruce E. Sands, MD, of the Division of Gastroenterology at the Icahn School of Medicine in Mount Sinai, New York presented results where a new monoclonal antibody called MEDI2070 (MedImmune) led to improvements in clinical outcomes in 121 patients with Crohn’s disease.
Dr. Sands and colleagues investigated in a double blind trial the effects of the drug that targets IL-23 by selectively binding to its p19 subunit. Patients taking part in the study were all adults with a Crohn’s Disease Activity Index (CDAI) score of more than 220 and 450 or less, had active inflammation, and who had failed or were intolerant to anti-TNF therapy.
“This was a fairly ill population with a mean CDAI score above 300,” Sands said in a recent news release.
Many patients had been exposed to adalimumab and infliximab prior to study entry. Patients were assigned to receive MEDI2070 700 mg IV or placebo at weeks 0 and 4 and then followed through week 12. Patient stratification was conducted according to the number of anti-TNF agents they previously had.
A total of 59 patients were assigned to receive the active drug, and 60 patients were assigned to receive the placebo. “This was a simple study design,” Sands said in the news release.
The primary endpoint of the study was the number of patients that clinically responded to the drug, defined by a 100-point or more decrease from baseline CDAI score or clinical remission (CDAI <150) at week 8. “One or the other of these things was defined as clinical effect,” Sands added.
After a 12-week follow-up, the researchers found that in 49.2% of the patients in the drug group, the drug had clinical effect in comparison with 26.7% of those in the placebo group.
Clinical remission at week 8 occurred in a total of 27.1% of patients in the drug group in comparison with 15% in the placebo group. The researchers found a clinical response in 45.8% of the patients under the drug in comparison with 25.0% of those taking the placebo.
The researchers found a reduction of 50% or more from baseline in fecal calprotectin or C-reactive protein, with the study drug reaching a 42.4% rate of this outcome, compared with 10% for placebo.
About two-thirds of patients experienced treatment emergent adverse events, and these were similar between the two groups of patients. “Importantly, there were no differences in infections or infestations that resulted in discontinuation,” Sands stated.
“MEDI2070 demonstrated a clinical effect at 8 weeks in patients with active [Crohn’s disease] who have failed anti-TNF therapy,” he concluded.