Vedolizumab safe, effective against Crohn’s disease

Vedolizumab induces endoscopic and histologic remission of Crohn’s disease (CD), a recent study has found.

Researchers prospectively assessed 110 patients (median age, 36 years; 77 percent female) with active CD who received 300 mg of open-label vedolizumab infusions. Ileocolonoscopies with biopsy collections were performed at baseline and at weeks 26 and 52 for the assessment of endoscopic and histologic outcomes. Treatments were given at weeks 0, 2 and 6, and every 8 weeks thereafter through week 52.

After 26 weeks of treatment, 40 percent (n=44) of the participants showed endoscopic response, while 33 percent (n=36) were positive for endoscopic remission. At 52 weeks, the corresponding rates climbed slightly to 45 percent (n=50) and 36 percent (n=40), respectively.

Results of the Simple Endoscopic Score for CD (SES-CD) changed by 4.05 and 4.65 points from baseline to weeks 26 and 52, respectively.

For the histologic analysis, a total of 132 paired biopsies in 65 patients were analysed. Sixty-seven biopsies were positive for inflammation at baseline, as measured by the Geboes score. Of these, 43 (64 percent) showed signs of remission by week 26.

In comparison, Robarts Histopathology Index-defined active inflammation at baseline was reported in 56 biopsies. After 26 weeks of treatment, 66 percent (n=37) of these samples had undergone histological remission.

Vedolizumab had a good safety profile. Only two serious adverse events were reported, and only three patients had to discontinue the treatment due to side effects. The most common adverse events were headaches, nasopharyngitis and skin-related problems.