Valuable data
“The early study results, such as the VEGA study, appear promising for combination biologics with a good safety profile,” Jean-Paul Achkar, MD, staff physician in the Center for Inflammatory Bowel Disease at Cleveland Clinic and the Kenneth Rainin Endowed Chair for IBD Research, said when asked to comment.
“These data are particularly valuable as we have seemingly reached a therapeutic response ceiling for single-biologic therapy, and we need to determine the added benefit and safety profile of a combination of two biologics or the combination of a biologic and a small molecule,” added Dr. Achkar, who served as the session comoderator.
A meeting attendee asked about the likelihood of regulatory approval for this combination based on evidence like this study.
“I think they have to,” Dr. Feagan said. “We’ve probably seen our best results yet in Crohn’s disease, and we’re still at 50% [response rate for monotherapy]. If we’re ever going to come to terms with IBD, I don’t think it’s monotherapy.”
Dr. Feagan added that with combination therapy, “physicians will often worry about economics, but I think that’s a surrogate for their concerns about infection.”
However, he noted that “the better the agents we have, the better the incremental cost effectiveness. So, I don’t think economics is the issue; the issue is safety.”
Another meeting attendee asked if the results might apply to other biologic combinations.
“This model was picked to show the additive effect of the anti-p19 and the TNF antagonist,” Dr. Feagan said.
Similar results could be expected with a combination of treatments from the same classes, he said, but the treatment potential of other drug-class combination is unclear.
The study was funded by Janssen Research and Development. Dr. Feagan reports being a consultant for Janssen. Dr. Achkar reports no relevant financial relationships.
A version of this article first appeared on Medscape.com.