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. 2024 Jul 30:17:17562848241258372.
doi: 10.1177/17562848241258372. eCollection 2024.

Long-term outcomes and predictors of vedolizumab persistence in ulcerative colitis

Beatriz Gros  1   2 , Hannah Ross  1 , Maureen Nwabueze  1 , Nathan Constantine-Cooke  3   4 , Lauranne A A P Derikx  5   6 , Mathew Lyons  1 , Claire O'Hare  1   7 , Colin Noble  1 , Ian D Arnott  1 , Gareth-Rhys Jones  1   8 , Charlie W Lees  9   4 , Nikolas Plevris  1
Affiliations

Long-term outcomes and predictors of vedolizumab persistence in ulcerative colitis

Beatriz Gros et al. Therap Adv Gastroenterol. .

Abstract

Background: Long-term vedolizumab (VDZ) outcomes in real-world cohorts have been largely limited to 1-year follow-up, with few bio-naïve patients or objective markers of inflammation assessed.

Objectives: We aimed to assess factors affecting VDZ persistence including clinical, biochemical and faecal biomarker remission at 1, 3 and 5 years.

Design: We performed a retrospective, observational, cohort study.

Methods: All adult inflammatory bowel disease (IBD) patients who had received VDZ induction for ulcerative colitis (UC)/IBD-unclassified (IBDU) were included. Baseline phenotype and follow-up data were collected via a review of electronic medical records.

Results: We included 290 patients [UC n = 271 (93.4%), IBDU n = 19 (6.6%)] with a median time on VDZ of 27.6 months (interquartile range: 14.4-43.2). At the end of follow-up, a total of 157/290 (54.1%) patients remained on VDZ. The median time to discontinuation was 14.1 months (7.0-23.3). Previous exposure to ⩾1 advanced therapy, steroid use at baseline and disease extension (E3 and E2 versus E1) were independent predictors for worse VDZ persistence. Clinical remission (partial Mayo < 2) was 75.7% (171/226), 72.4% (157/217) and 70.2% (127/181) at years 1, 3 and 5, respectively. Steroid use during maintenance VDZ therapy occurred in 31.7% (92/290), hospitalization in 15.5% (45/290) and surgery in 3.4% (10/291). The rate of serious adverse events was 1.2 per 100 patient-years of follow-up.

Conclusion: VDZ effectiveness appears enduring with favourable long-term safety profile. VDZ persistence was influenced by previous exposure to biologics/small molecules, disease distribution and steroid use at baseline in our study.

Keywords: real-world evidence; ulcerative colitis; vedolizumab.

Plain language summary

Vedolizumab long-term use in ulcerative colitis What was this study done? • Vedolizumab efficacy and safety in ulcerative colitis have been firmly established by existing evidence. • Long-term data from the GEMINI trial further corroborate the favourable safety profile over an extended duration but there is little data on long-term vedolizumab use over 1 year. What did the researches do? • We performed a retrospective, observational, cohort study. All adult IBD patients who ever received vedolizumab induction from November 2014 to December 2021 for ulcerative colitis/IBDU were included. What did the researchers find? • This real-world study demonstrates that vedolizumab persistence exceeds 80% at 1 year and remains nearly 50% at 5 years with no new safety signals. • Worse vedolizumab persistence is associated with prior exposure to biologics/small molecules, more extensive disease involvement and steroid use at vedolizumab initiation. What do the findings mean? • These findings have important implications for drug positioning and sequencing, as well as for optimizing outcomes when vedolizumab is utilized as first-line therapy. Furthermore, it also emphasizes the long-term safety profile.

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Conflict of interest statement

BG has served as acted as consultant to Galapagos and Abbvie and as speaker for Abbvie, Jansen, Takeda, Pfizer and Galapagos. NP has served as a speaker for Janssen, Takeda and Pfizer. Professor CWL has acted as a consultant to Abbvie, Janssen, Takeda, Pfizer, Galapagos, Bristol Myers Squibb, B.I., Sandoz, Novartis, GSK, Gilead, ViforPharma, Dr Falk, Trellus Health and Iterative Scopes; he has received speaking fees and travel support from Pfizer, Janssen, Abbvie, Galapagos, MSD, Takeda, Shire, Ferring, Hospira and Dr Falk. G-RJ has served as a speaker for Takeda, Janssen, Abbvie, Fresnius and Ferring. LAAPD has served on advisory board for Sandoz and Abbvie, and as a speaker for Janssen. CN has acted as a consultant to Galapagos. None of the other authors reported any conflicts of interest.

Figures

Figure 1.
Figure 1.
(a) Kaplan–Meier curve for vedolizumab persistence across the total cohort. (b) Kaplan–Meier curve for vedolizumab persistence excluding primary non-response. (c) Kaplan–Meier curve stratified by a number of previous biologic/small molecules. (d) Kaplan–Meier curve stratified depending on the need for steroids at baseline. (e) Kaplan–Meier curve stratified depending on disease extension.
Figure 2.
Figure 2.
Clinical, biochemical and FC biomarker remission at year 1, year 3 and year 5 from vedolizumab initiation. CRP, C-reactive protein; FC, faecal calprotectin.
Figure 3.
Figure 3.
CRP, faecal calprotectin and partial Mayo score, at baseline, year 1, year 3, year 5 from vedolizumab prescription. Violin plots show median (solid line), IQR (dotted line), maximum and minimum. CRP outliers were removed for graph representation but accounted for statistical comparison: at baseline, there were 34 outliers; 10 at year 1; none at year 3; 1 at year 5. Mann–Whitney U test was used to compare each baseline median compared to years 1, 3 and 5. CRP, C-reactive protein; FC, faecal calprotectin.
See this image and copyright information in PMC

References

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