Introduction
Vedolizumab (VDZ) is approved in Europe and the USA for the treatment of moderately to severely active ulcerative colitis (UC). Real-world evidence is needed to assess the effectiveness and benefit–risk profile of VDZ for UC outside clinical trial settings. A systematic literature review (SLR) and meta-analysis published in 2018 confirmed the real-world effectiveness and positive benefit–risk profile of VDZ treatment for up to 1 year in patients with inflammatory bowel disease.1 Further real-world evidence is required to support the long-term (> 1 year) effectiveness of VDZ in patients with UC.
Aims & Methods
The aims of the current meta-analysis based on the SLR were to evaluate the rates of treatment persistence at 1 and at 2 years and of mucosal healing and corticosteroid-free clinical remission at 1 year (overall and stratified by biologic-naive versus biologic-experienced patients). Literature searches identified studies published from 2014 to 2022. For the SLR overall, outcomes of interest included clinical remission, mucosal healing, treatment patterns (including treatment persistence) and safety. Data on adults with UC treated with vedolizumab in a real-world setting were extracted for meta-analysis if there were at least 2 studies for each timepoint and population. Weighted proportions and corresponding 95% confidence intervals (CIs) were calculated using the DerSimonian-Laird random-effects model to account for between-study heterogeneity.
Results
Data from 68 studies of 21 774 patients with UC had at least one outcome of interest for analysis. The mean age ranged from 34.0–53.0 years (16 studies), the mean disease duration ranged from 4.9–10.4 years (5 studies) and the mean partial Mayo score ranged from 4.1–6.1 (6 studies). In the 28 and 9 studies that assessed treatment persistence at 1 and at 2 years, the rates of treatment persistence were 72.4% (95% CI 68.7–75.8) and 64.2% (95% CI 55.3–72.2), respectively. Similar treatment persistence rates at 1 year were observed among biologic-naive vs biologic-experienced patients, but at 2 years higher rates were observed for biologic-naive patients vs overall (Table). The overall mucosal healing rate at 1 year (assessed in 29 studies) was 42.6% (95% CI 37.0–48.3), and similar rates were observed in biologic-naive vs biologic-experienced patients (Table). The corticosteroid-free clinical remission rates at 1 year were 42.7% (95% CI 38.4–47.1; 22 studies) and at 2 years 43.4% (95% CI 27.9–60.2; 5 studies); higher rates were observed among biologic-naive vs biologic-experienced patients at 1 year (Table).
| Overall | Biologic-naive | Biologic-experienced |
| Patientsa (studies) | Rate, % (95% CI)b | Patientsa (studies) | Rate, % (95% CI)b | Patientsa (studies) | Rate, % (95% CI)b |
| 1-year VDZ treatment persistence | 5642 (28) | 72.4
(68.7–75.8) | 1666 (7) | 74.5
(66.8–80.9) | 1368 (5) | 73.1
(62.4–81.6) |
| 2-year VDZ treatment persistence | 1735 (9) | 64.2
(55.3–72.2) | 449 (2) | 77.6
(70.8–83.2) | –c | –c |
| 1-year mucosal healing | 1851 (29) | 42.6
(37.0–48.3) | 376 (3) | 45.7
(31.4–60.7) | 316 (5) | 40.9
(30.9–51.8) |
| 1-year corticosteroid-free clinical remissiond | 2797 (22) | 42.7
(38.4–47.1) | 465 (7) | 45.5
(37.9–53.3) | 580 (8) | 36.6
(30.3–43.5) |
aNumber of patients assessed.
bEvents per 100 patients.
cNo meta-analysis because only one study reported this outcome.
dResolution of symptoms or clinical measures of disease activity without the use of corticosteroids. |
Conclusion
This meta-analysis of real-world studies of VDZ demonstrated high rates of long-term treatment persistence, mucosal healing and corticosteroid-free clinical remission in patients with UC, indicating effective disease management for these outcomes. However, the assessment of mucosal healing rates may not have been systematically conducted across all studies.
This study was funded by Takeda Pharmaceuticals International AG, Zurich, Switzerland.
Writing assistance provided by E Sugrue, PhD, of Oxford PharmaGenesis.
References
Schreiber S et al. J Gastroenterol. 2018;53:1048–64.
Disclosure
MC has served as a speaker or consultant, or has received funding for research or education, from AbbVie, Biogen, Dr Falk Pharma, Eli Lilly, Ferring, Gilead, Hospira, Janssen, MSD, Pfizer, Shire Pharmaceuticals, Takeda and Tillotts Pharma.
AA has received advisory board/lecture fees from AbbVie, Amgen, Arena, AstraZeneca, Biogen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Celltrion Healthcare, Dr Falk Pharma, Eli Lilly, Ferring, Galapagos, Gilead, Janssen, Lion Health, MSD, Nestlé, Novartis, Pfizer, Protagonist Therapeutics, Roche, Samsung Bioepis, Sandoz, Takeda, Teva Pharmaceuticals and Tillots Pharma.
PB is an employee and stockholder of Takeda Pharmaceuticals International AG, Zurich, Switzerland.
MM is an employee and stockholder of Takeda Pharma AG, Zurich, Switzerland.
ER is an employee of Putnam Associates, which received funding for this study from Takeda Pharmaceuticals International AG, Zurich, Switzerland.
CS is an employee of Putnam Associates, which received funding for this study from Takeda Pharmaceuticals International AG, Zurich, Switzerland.
SS has received personal fees from AbbVie, Amgen, Arena, Biogen, Bristol Myers Squibb, Celgene, Celltrion Healthcare, Dr Falk Pharma, Fresenius, Galapagos/Gilead, Hikma, I-Mab, Janssen, MSD, Mylan, Pfizer, Protagonist Therapeutics, ProventionBio, Takeda, Theravance Biopharma and Ventyx.
SV has received financial support for research from AbbVie, Galapagos, J&J, Pfizer and Takeda, and speakers’ and/or consultancy fees from AbbVie, Abivax, AbolerISPharma, AgomAb, Alimentiv, Arena Pharmaceuticals, AstraZeneca, Bristol Myers Squibb, Boehringer Ingelheim, Celgene, Cytoki Pharma, Dr Falk Pharma, Eli Lilly, Ferring, Galapagos, Genentech-Roche, Gilead, GSK, Hospira, Imidomics, Janssen, J&J, Materia Prima, Mestag Therapeutics, MiroBio, Morphic, MrMHealth, Mundipharma, MSD, Pfizer, Prodigest, Progenity, Prometheus, Robarts Clinical Trials, Surrozen, Takeda, Theravance Biopharma, Tillots Pharma AG, VectivBio, Ventyx and Zealand Pharma.
