Introduction
Vedolizumab (VDZ), a gut-selective anti-lymphocyte trafficking agent, was approved in Europe and the USA for the treatment of moderate-to-severe Crohn’s disease (CD) in 2014. Real-world evidence is essential for understanding the effectiveness and benefit–risk profile of VDZ for CD outside clinical trial settings. A systematic literature review and meta-analysis published in 2018 confirmed the real-world effectiveness and positive benefit–risk profile of VDZ treatment for up to 12 months in patients with inflammatory bowel disease.1 However, there are limited real-world evidence on the long-term (> 12 months) effectiveness of VDZ in patients with CD.
Aims & Methods
A systematic literature review was performed using MEDLINE, MEDLINE In-Process, Embase, Cochrane Library, clinicaltrials.gov, and the World Health Organization International Clinical Trials Registry Platform to identify relevant studies published from May 2014 to July 2022. In addition, if the congress abstracts were not indexed in Embase, key congresses from 2015 to July 2022 were hand-searched. Data from adults (aged ≥ 18 years) with CD treated with VDZ in a real-world setting were extracted for meta-analysis. Depending on data availability, the analysis was conducted using the DerSimonian-Laird random-effects model to obtain weighted mean rates (percentage of patients) and the corresponding 95% confidence interval (CI) for each outcome of interest, as per the 2018 meta-analysis.1 The aims of the current analysis were to evaluate the rates of treatment persistence at 12 and 24 months and mucosal healing at 12 months (overall and stratified by biologic-naïve versus biologic-experienced patients) to address the paucity of long-term data available on these outcomes.
Results
Overall, data from 78 studies of 30 158 patients with CD had at least one outcome of interest for analysis. Using the reported number of patients as the weight, the baseline weighted mean age was 39.3 years (standard error [SE] 2.7; 15 studies), weighted mean disease duration was 12.5 years (SE 0.5; 8 studies), weighted mean CD activity index score was 177 (SE 4.3; 3 studies), and weighted mean Harvey-Bradshaw index score was 7.9 (SE 0.7; 5 studies). In the 32 and 13 studies that assessed treatment persistence at 12 and 24 months, respectively, the rates of treatment persistence were 62.8% (95% CI 56.6–68.9) and 54.9% (95% CI 44.3–65.4), and were higher in biologic-naïve patients than biologic-experienced patients at both time points (Table). The rate of mucosal healing at 12 months (assessed in 20 studies) was 38.4% (95% CI 30.2–46.5) and was higher in biologic-naïve patients than biologic-experienced patients at both time points (Table).
| Patients with CD | Biologic-naïve patients with CD
| Biologic-experienced patients with CD
|
| Na
(studies)
| %b
(95% CI)
| Na
(studies)
| %b
(95% CI) | Na
(studies)
| %b
(95% CI) |
12-month VDZ treatment persistence
| 6312
(32)
| 62.8
(56.6, 68.9)
| 846
(5)
| 81.0
(70.5–91.6)
| 1653
(6)
| 60.4
(52.9–67.8)
|
24-month VDZ treatment persistence
| 3271
(13)
| 54.9
(44.3–65.4)
| 575
(3)
| 70.4
(61.3–79.6)
| 1060
(2)
| 41.9
(8.3–75.6)
|
12-month mucosal healing
| 1390
(20)
| 38.4
(30.2–46.5) | 164
(6)
| 48.6
(30.5–66.7)
| 239
(5)
| 29.6
(19.3–39.9) |
aNumber of patients assessed in studies that assessed treatment persistence or mucosal healing, respectively.
bEvents per 100 patients.
|
Conclusion
This meta-analysis of real-world studies of VDZ demonstrated high rates of robust, long-term treatment persistence and mucosal healing in patients with CD, particularly in biologic-naïve versus biologic-experienced patients. Over a third of patients achieved mucosal healing at 12 months, confirming the effectiveness of VDZ for achieving this important treatment outcome.
References
- Schreiber S et al. J Gastroenterol 2018;53:1048–64.
Disclosure
This study was funded by Takeda Pharmaceuticals International AG. Medical writing services were provided by Matthew Reynolds, of Oxford PharmaGenesis, and funded by Takeda Pharmaceuticals International AG.
SS: 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 and Theravance Biopharma.
PB: Employee and stockholder of Takeda Pharmaceuticals International AG, Zurich, Switzerland.
RJB: Employee of PHMR Ltd., who received funding for this study from Takeda Pharmaceuticals International AG.
MN: Employee and stockholder of Takeda Pharmaceuticals International AG, Zurich, Switzerland.
SW: Employee and stockholder of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA.
AA Advisory board/lecture fees from AbbVie, Amgen, Arena, Biogen, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Celltrion, Eli Lilly, Ferring, Galapagos, Gilead, Janssen, MSD, Novartis, Pfizer, Protagonist Therapeutics, Roche, Samsung Bioepis, Sandoz, Takeda.
