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Risk of Serious Infection With Triple Drug Therapy for IBD


June 07, 2018

Patients with inflammatory bowel disease (IBD) who are taking triple therapy with vedolizumab, steroids, and a immunomodulator have a higher risk of serious infections and other side effects vs those on monotherapy, according to new findings presented at Digestive Disease Week 2018.

For their review, the researchers assessed data from a multicenter, US-based consortium of Crohn disease (n = 650) and ulcerative colitis (n = 437) patients treated with vedolizumab with 302-day follow-up data.

The researchers tracked serious infections—those requiring antibiotics or hospitalization or those resulting in discontinuation of vedolizumab or death—and serious adverse events—serious infections or adverse events resulting in discontinuation of vedolizumab or death.

Results of the analysis showed that serious infections, including Clostridium difficile infection and abscess, were reported in 3.7% of participants taking vedolizumab monotherapy, 6.1% taking vedolizumab plus a steroid or an immunomodulator, and 9.8% taking vedolizumab plus a steroid and an immunomodulator.

Serious adverse events were reported in 4.3% of participants taking vedolizumab monotherapy, 6.7% taking vedolizumab plus a steroid or an immunomodulator, and 10.7% taking vedolizumab plus a steroid and an immunomodulator.

“[Vedolizumab] is well tolerated in clinical practice, with [serious infections] and [serious adverse events] being reported in 6% and 7% of patients, respectively,” the researchers concluded.

“The strongest predictor of [serious infections] or [serious adverse events] is the use of concomitant steroids or immunomodulators, with the greatest risk seen in patients on triple therapy with [vedolizumab], steroids, and immunomodulator therapy. Further studies are needed to identify patients who will most benefit from concomitant immunosuppressive therapy use with [vedolizumab] to optimize the safety profile in clinical practice.”

—Amanda Balbi


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