Long-term effectiveness of vedolizumab in inflammatory bowel disease: a national study based on the Swedish National Quality Registry for Inflammatory Bowel Disease (SWIBREG)

Abstract

Objectives: Clinical trials have demonstrated the efficacy of vedolizumab in inflammatory bowel disease (IBD). However, these findings may not reflect the clinical practice. Therefore, we aimed to describe a vedolizumab-treated patient population and assess long-term effectiveness.

Materials and methods: Patients initiating vedolizumab between 1 June 2014 and 30 May 2015 were identified through the Swedish National Quality Registry for IBD. Prospectively collected data on treatment and disease activity were extracted. Clinical remission was defined as Patient Harvey Bradshaw index <5 in Crohn’s disease (CD) and Patient Simple Clinical Colitis Activity index <3 in ulcerative colitis (UC).

Results: Two-hundred forty-six patients (147 CD, 92 UC and 7 IBD-Unclassified) were included. On study entry, 86% had failed TNF-antagonist and 48% of the CD patients had undergone ≥1 surgical resection. After a median follow-up of 17 (IQR: 14–20) months, 142 (58%) patients remained on vedolizumab. In total, 54% of the CD- and 64% of the UC patients were in clinical remission at the end of follow-up, with the clinical activity decreasing (p < .0001 in both groups). Faecal-calprotectin decreased in CD (p < .0001) and in UC (p = .001), whereas CRP decreased in CD (p = .002) but not in UC (p = .11). Previous anti-TNF exposure (adjusted HR: 4.03; 95% CI: 0.96–16.75) and elevated CRP at baseline (adjusted HR: 2.22; 95% CI: 1.10–4.35) seemed to be associated with discontinuation because of lack of response. Female sex was associated with termination because of intolerance (adjusted HR: 2.75; 95% CI: 1.16–6.48).

Conclusion: Vedolizumab-treated patients represent a treatment-refractory group. A long-term effect can be achieved, even beyond 1 year of treatment.

Keywords:

• Vedolizumab
• clinical practice
• inflammatory bowel disease
• Crohn’s disease
• ulcerative colitis

Acknowledgements

We acknowledge the assistance of Malin Olsson, SWIBREG-registry coordinator (Linköping University Hospital). We thank all the patients and gastroenterologists for entering information into the SWIBREG. Special thanks to the SWIBREG Vedolizumab Study Group.

C. E., J. H. and J. F. L. planned and conducted the study. C. E., C. S., D. B., D. S., E. H., H. S., J. B., J. H., J. M., L. V., M. E., M. T., P. K., P. K., P. M., S. A. and the SWIBREG Vedolizumab Study Group collected the data. C. E. and Y. C. performed the data analyses. C. E., D. B., J. H., Y. C. interpreted the data. C. E. and J. H. drafted the manuscript. C. E., C. S., D. B., D. S., E. H., H. S., J. B., J. H., J. F. L., J. M., L. V., M. E., M. T., P. K., P. K., P. M., S. A. and Y. C. revised the manuscript. C. E., C. S., D. B., D. S., E. H., H. S., J. B., J. H., J. F. L., J. M., L. V., M. E., M. T., P. K., P. K., P. M., S. A., Y. C. and the SWIBREG Vedolizumab Study Group approved the final draft of the manuscript.

Disclosure statement

C. E.: Research grant from the Swedish government’s agreement on medical training and research and speaker’s fee from Takeda.

J. M.: Has served as consultant for AbbVie, BMS, Ferring, Hospira/Pfizer, MSD, Otsuka, Takeda, Tillotts, UCB-Pharma; and received IIS grants from AbbVie, Ferring, Hospira.

D. B.: Research grants from Bengt Ihre research foundation and from the Swedish government’s agreement on medical training and research.

L. V.: Speaker’s and/or consultancy fees from Tillott, MSD and AbbVie.

J. B.: Speaker’s and/or consultancy fees from AbbVie and Ferring.

M. E.: Research grants from MSD and AbbVie. Speaker’s and/or consultancy fees from Takeda, MSD, AbbVie, ITH, Otsuka, Tillotts and Ferring.

P. K.: Has nothing to disclose

C. S.: Has nothing to disclose.

P. M.: Speaker’s and consultancy fees from AbbVie

Y. C.: Has nothing to disclose.

D. S.: Has nothing to disclose.

M. T.: Consultancy fee from Takeda.

P. K.: Scientific advisory board fees from AbbVie, MSD, Takeda, Otsuka; and speaker’s fees from AbbVie, Takeda and Otsuka.

E. H.: Consultant fees from Abbvie, MSD and Takeda

H. S.: Has nothing to disclose.

J. F. L.: Has nothing to disclose.

S. A.: Research grants from AbbVie and consultancy fees from Takeda and Hospira.

J. H.: Research grants from the Swedish Research Council, the Örebro University Hospital Research Foundation, the Swedish Foundation for Strategic Research and speaker’s and/or consultancy fees from Abbvie, Hospira, Janssen, Medivir, MSD, Pfizer, RenapharmaVifor, Takeda.

Additional information

Funding

This work was supported by the Swedish Government’s Agreement on Medical Training and Research [OLL-549221 to C. E.; OLL-526131 to D. B. and ALFSKANE-539811 to J. M.]; the Hedlund Foundation and the Österlund Foundation to J. M.