Monoclonal Antibodies Potential New Treatment Option for Gastrointestinal Disorders

Monoclonal antibodies may be an effective new drug for the treatment of gastrointestinal disorders, a new study has found.

Researchers from MassBiologics and the University of Massachusetts discovered that infliximab (IFX) plus azathioprine (AZA) and infliximab monotherapy “increase the likelihood of patients achieving long-term steroid-free clinical remission in patients with moderate to severe Crohn’s disease,” according to the research.

The study, which took place over 30 weeks with the option of continuing in a blinded study extension until week 50, found that steroid-free remission occurred in 72.2% of patients being given IFX plus AZA, 60.8% with IFX monotherapy and 54.7% with AZA monotherapy, patients who all continued with the study extension. The researchers then “assumed that participants who did not enroll in the extension trial did not experience steroid-free remission at week 50,” which resulted in steroid-free remission for 46.2% of patients given IFX plus AZA, 34.9% of patients given IFX monotherapy, and 24.1% of patients given AZA monotherapy.

According to the researchers, the number of patients in the overall trial who developed serious infections “was similar in all treatment groups.” Throughout the course of the study extension, “no new opportunistic infections, malignancies or deaths occurred.” In addition, because the study was done as a comparative effectiveness trial, “patients were started on biologics earlier in the course of their Crohn’s disease than would occur in typical practice.”

In a second study, Mayo Clinic researchers found that CDA1 and CDB1, two monoclonal antibodies, reduced “the risk of recurrence of C. difficile diarrhea” when given together in addition to standard of care antibiotics. This combination of drug therapy was also effective in “reducing the severity of infection of the first episode of disease, and reduction of additional hospitalizations.”

The randomized, double blind, placebo-controlled phase II study divided patients into one group of 101 patients who received CDA1+CDB1 and a second group of 99 patients who received placebo. Both groups received standard of care antibiotics.

Of the patients who received the monoclonal antibodies for the first occurrence of C. difficile 29.7% “experienced severe diarrhea,” compared with “43.4% of those in the placebo group.”

Both studies were presented earlier this week at Digestive Disease Week.

Check out our earlier coverage of monoclonal antibodies in treating gastrointestinal problems.