People with Crohn’s disease who take the medication vedolizumab (Entyvio) might not only treat their Crohn’s-specific symptoms but also garner joint health benefits.
Treatment with vedolizumab (Entyvio) among patients with Crohn’s disease may be associated with some benefits for the disease’s extraintestinal manifestations, although statistically significant differences compared with placebo were not seen in a post hoc analysis.
By week 52, the hazard ratio for resolution of any extraintestinal manifestation on the Crohn’s disease Activity Index was 1.4 (95% CI 0.7-2.79), according to David T. Rubin, MD, of the University of Chicago Inflammatory Bowel Disease Center.
And the HR for the resolution of arthritis or arthralgia by week 52 was 1.84 (95% CI 0.91-3.71), he reported in a poster session at the Advances in Inflammatory Bowel Diseases meeting here.
“Although this post hoc analysis did not show statistically a significant benefit of vedolizumab over the placebo for the resolution of estraintestinal manifestations in Crohn’s disease, favorable trends were observed,” Rubin and colleagues stated.
Almost one-third of patients with Crohn’s disease develop extraintestinal manifestations, which can involve almost any organ system. These manifestations may not necessarily occur at the same time as intestinal inflammation and related symptoms, and little is known about the effects of treatment on them.
The study known as GEMINI 2 found the gut-selective α4β7 integrin receptor antagonist vedolizumab to be more effective than placebo for inducing remission in patients with active Crohn’s disease. The study included 814 patients who were randomized to vedolizumab and 148 who received placebo.
At baseline, 61% of patients in the active treatment group had any extraintestinal manifestation, as did 72% of the placebo group. In the two groups, 82% and 83% had a history of any extraintestinal manifestation.
Arthritis was the most common manifestation, being present in 45% of the vedolizumab group and 53% of the placebo group. Other manifestations included fevers, iritis or uveitis, erythema nodosum, pyoderma gangrenosus, and abscesses.
Because of the frequency of arthritis/arthralgias at baseline, the investigators also looked at treatment-emergent adverse events related to the musculoskeletal and connective tissue organ system.
In the vedolizumab group, 28% of patients had treatment-emergent events relating to this organ system during the 52 weeks of the study, as did 30% of the placebo group. In 7% of cases in both groups, the adverse event was considered treatment related.
Treatment-emergent arthritis was seen in 3% of the vedolizumab group and in 6% of the placebo group, and in most cases this was mild.
For treatment-emergent arthralgias, the numbers again were similar in the two groups, occurring in 14% of the vedolizumab group and 13% of the placebo group.
Other adverse events in the musculoskeletal and connective tissue system, including arthropathy, spondyloarthropathy, sacroiliitis, and ankylosing spondylitis occurred in fewer than 1% of patients receiving the active treatment.
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