Vedolizumab as first-line biological therapy in elderly patients and those with contraindications for anti-TNF therapy: a real-world, nationwide cohort of patients with inflammatory bowel diseases

Abstract

Background

Data from real-life populations about vedolizumab as first-line biological therapy for ulcerative colitis (UC) and Crohn’s disease (CD) are emerging.

Objective

To investigate the efficacy and safety of vedolizumab in bio-naïve patients with UC and CD.

Methods

A Danish nationwide cohort study was conducted between November 2014 and November 2019. Primary outcomes were clinical remission, steroid-free clinical remission, and sustained clinical remission from weeks 14 through 52.

Results

The study included 56 patients (UC:31, CD:25) who initiated treatment with vedolizumab mainly because of contraindications to anti-TNFs, of whom 54.8 and 24.0%, respectively received systemic steroids at the initiation. Rates of clinical remission at weeks 6, 14, and 52 were 32.0, 48.0, and 40.0%, respectively, in UC, and 36.8, 36.8, and 47.4% in CD. Steroid-free clinical remission at week 52 was achieved among 36.0 and 47.4% of UC and CD patients, while sustained clinical remission was achieved in 32.0 and 36.8%. Lack of remission was associated with being female (68.8 vs. 11.1%, p = .01) in UC and non‐structuring, non‐penetrating behavior in CD (90.0 vs. 44.4%, p = .03); however, this was not confirmed in multivariate analysis. Discontinuation due to primary non-response occurred in 20.0 and 5.3% of UC and CD patients, respectively, while rates of secondary loss of response were 12.0 and 5.3% after 52 weeks of follow-up. Vedolizumab was well-tolerated as only one UC patient experienced a serious adverse event.

Conclusion

Vedolizumab is effective in the achievement of short-term, long-term, and steroid-free clinical remission in bio-naïve UC and CD patients.

Keywords:

• Inflammatory bowel disease
• ulcerative colitis
• Crohn’s disease
• vedolizumab
• real-world
• efficacy
• safety
• first-line biologics
• bio-naïve
• nationwide
• population-based

Acknowledgments

We are grateful to Dr. Frank Vinholdt Schioedt (Bispebjerg University Hospital) and Dr. Henning Glerup (Regional Hospital Silkeborg) for their willingness to participate in this study and perform a systematic screening of their patient lists for eligible individuals.

Ethical approval

According to Danish law, this study did not require approval by the Danish National Committee on Health Research Ethics because of its observational and retrospective design.

Author contributions

JB: guarantor of the article. MA: study concept design, data extraction, analysis and interpretation of data, and drafting of the manuscript. JF, CH, KBP, HBH, SW, MDJ, AN, CL, HAJ, AMP, JK, NP, AM, KH, CLAA, TK, WC, and PM: data extraction and critical revision of the manuscript. FB, JS, and JB: study concept design, critical revision of the manuscript, and supervision. All authors approved the final version of the article, including the authorship list.

Disclosure statement

MA: research grants from Takeda. None of these pertain to the research submitted here.

SW: advisory boards: Takeda and Tillotts.

MDJ: personal fee from Tillotts Pharma not pertaining to the research submitted here.

JK: teaching fee from Takeda.

CLAA: advisory boards: Ferring, Tillotts, Takeda, and Janssen.

TK: advisory boards: Janssen, Takeda, Tillotts, speaker fee: Takeda, Pfizer, MSD, Research grant: Takeda.

FB: research grants from Ferring, Tillotts. Neither of these pertains to the research submitted here.

JS: research grants from Takeda and the Capital Region Denmark, national coordinator of studies from AbbVie, Arena Pharmaceuticals, Ely Lilly, and Boehringer Ingelheim. None of these pertain to the research submitted here.

JB: personal fees from AbbVie, Janssen-Cilag, Celgene, MSD, Samsung Bioepis, and Pfizer; grants and personal fees from Takeda and Tillots Pharma. None of these pertain to the research submitted here.

CH, JF, KBP, HBH, AN, CL, HAJ, AMP, NPM AM, KH, WC, PM: none.

Patient consent statement

This retrospective study was conducted as a quality assurance study not requiring patient consent.

Data availability statement

All data are incorporated into the article and its online supplementary material.

Additional information

Funding

This study was funded by an Investigator-Initiated Research grant (no. IISR-2018-102733) from Takeda Pharmaceutical Company Limited. The sponsor was involved in the critical revision of the manuscript.