High treatment persistence rate and significant endoscopic healing among real-life patients treated with vedolizumab – a Finnish Nationwide Inflammatory Bowel Disease Cohort Study (FINVEDO)^*

Abstract

Objectives: The efficacy and tolerability of vedolizumab in the treatment of inflammatory bowel diseases (IBD) has been demonstrated in an extensive GEMINI clinical trial programme. Clinical trials represent highly selected patient populations and, therefore, it is important to demonstrate effectiveness in real-life clinical practice. We set out to assess real-world treatment outcomes of vedolizumab in a nationwide cohort of treatment refractory Finnish Crohn’s disease (CD) and ulcerative colitis (UC) patients.

Methods: This was a nationwide, retrospective, non-interventional, multi-centre chart review study. All adult patients from 27 Finnish gastroenterology centers with a diagnosis of UC or CD who had at least one vedolizumab infusion since the availability of the product in Finland, were included in the study. Data were collected retrospectively from medical charts at baseline, week 14, and month 6. The primary outcome measure was treatment persistence 24 weeks post-vedolizumab initiation.

Results: A total of 247 patients were included (108 CD, 139 UC). A total of 75.0% (n = 81) of all CD patients and 66.2% (n = 92) of all UC patients, were persistent on vedolizumab therapy for 6 months post treatment initiation. At month 6, 41.8% (28/67) of the treatment persistent CD patients and 73.3% (63/86) of the treatment persistent UC patients achieved clinical remission. Significant improvement in endoscopic scores were observed among treatment persistent patients (CD, n = 17, ΔSES-CD=−5.5, p = .008; UC, n = 26, ΔMayo endoscopic score =−0.5, p = .003) at month 6.

Conclusions: Vedolizumab provides an effective and well-tolerated treatment option in real-world clinical practice even among treatment refractory IBD patients.

Keywords:

• Biological therapy
• Crohn’s disease
• endoscopy
• real-world effectiveness
• ulcerative colitis
• vedolizumab

Acknowledgements

Harlan Barker from MedEngine Oy is acknowledged for language review, which was funded by Takeda Oy.

Disclosure statement

T. Y. is owner of MedEngine Oy and consultant for Takeda Oy. J. A. and K. T. are employees of Takeda Oy. J. J. and S. H. are employees of MedEngine Oy. T. S. has received speaker fees from Abbvie, Ferring, Janssen-Cilag, MSD, Pfizer, Takeda, and Tillotts Pharma; has received consulting fees from Hospira, Janssen-Cilag, Tillotts Pharma, Takeda, and MSD; and has received a research grant from Takeda. A. J. has received speaker fees from Abbvie, Ferring, Jansen-Cilab, MSD, Pfizer, Takeda, Tillotts Pharma; has received consulting fees from Abbvie, Jansen-Cilab, Pfizer, MSD, Takeda, Pfizer. V. M. has received travel support from Takeda for attending a conference. P. M. has received speaker fees and travel support from Abbvie, Ferring, MSD, Shire and Tillotts Pharma; has received consulting fees from Abbvie, Allergan, Janssen-Cilag, MSD, Tillotts Pharma, and Takeda. H. R. has received travel support from MSD and Abbvie for attending conferences; has received speaker fees from Abbvie. K. S. has received speaker fees from Abbvie, Takeda, MSD, and Tillots Pharma. M. Pe. has received travel support from Takeda, Ferring, Tillots, MSD, and Abbvie; has received speaker fees from Abbvie, MSD, Ferring, and Tillots. M. K. has received travel support from Gilead and Takeda, speaker fees from Tillots, and consulting fees from Gilead and Takeda. P. M. has received speaker fees from MSD and Tillots Pharma and travel support from MAS, AbbVie and Norigene. C. N. has received travel support from Takeda, Pfizer, and Abbvie for attending conferences; has received speaker fees from Ferring and Abbvie. H. H. has received travel support from Takeda, Tillots, Ferring, and Abbvie for attending conferences; has received speaker fees from MSD and Tillots. V. L. has received travel support and speaker fees from Tillots Pharma, AbbVie, Pfizer. J. S. has received travel support from Abbvie, Meda, Tillotts, Takeda, MSD, and Vifor Pharma for attending conferences; has received speaker fees from Ratiopharm, MSD, Ferring; has received consulting fees from Abbvie, Tillotts, Ferring, and Janssen; M. Pa. has received travel support and speaker fees from Takeda, Ferring, MSD, and Abbvie. K. H. has received speaker fees from Tillotts Pharma, Takeda, MSD, Boehringer-Ingelheim; has received consulting fees from MSD, Allergan; and has received travel support from Tillotts Pharma, Gilead Sciences, Takeda.

Additional information

Funding

This study was supported by Takeda Oy (Finland).