ORLANDO – Vedolizumab therapy was associated with significant improvements in social satisfaction scores and steroid-free remission rates in biologic-naive patients with inflammatory bowel diseases (IBD) in a large prospective cohort.
The Internet-based cohort – Crohn’s & Colitis Foundation of America (CCFA) Partners – includes more than 15,000 IBD patients. For the current study, researchers evaluated 348 participants with Crohn’s disease or ulcerative colitis who initiated vedolizumab therapy between 2014 and 2017 and who had at least 6 months’ follow-up.
Dr. Millie D. Long
In 20 Crohn’s disease patients and 32 ulcerative colitis patients who were biologic-naive at the time of vedolizumab initiation, social satisfaction T scores, as measured by the patient-reported outcome measurement information system, improved significantly (46.1 before treatment vs. 51.0 after 6 months), Millie D. Long, MD, reported in a poster at the World Congress of Gastroenterology at ACG 2017.
The difference in social satisfaction T scores was also improved among biologic-exposed patients (45.8 vs. 47.2, respectively), but the difference did not reach statistical significance, said Dr. Long of the University of North Carolina, Chapel Hill.
Improvements were also seen for numerous other measures, including anxiety, depression, fatigue, pain interference, and sleep disturbance – for both biologic-naive and -exposed patients – but the differences were not significant.
“But these [patient-reported outcomes] are clearly improving,” she said, explaining that trends toward minimally clinically important differences were seen for multiple measures.
As for steroid-free remission, the rate improved from 20% to 45% from baseline to 6-12 months among biologic-naive patients, and from 24% to 30% among biologic-exposed patients, Dr. Long said.
Vedolizumab in this real-world cohort was predominantly used in patients with refractory disease and prior biologic exposure.
The CCFA cohort provides an important glimpse into the effects of vedolizumab on patient-reported outcomes in real-world settings, Dr. Long said, noting that while vedolizumab has demonstrated important quality of life improvements in IBD clinical trials, little has been known about the effects of vedolizumab on quality of life in real-world settings.
The finding with respect to social satisfaction is particularly important, she said.
“These are sick patients. [These scores show that] they’re able to leave the house, they’re able to do the things they want to do,” she said. “It has made a big impact to be able to address this.”
This study was funded by Takeda Pharmaceuticals USA. CCFA Partners is supported by the Crohn’s & Colitis Foundation and the Patient Centered Outcomes Research Institute.