Introduction
Vedolizumab (VDZ), a gut-selective anti-lymphocyte trafficking agent, was approved for the treatment of moderate-to-severe Crohn’s disease (CD) in Europe and the USA in 2014. We conducted a systematic literature review and meta-analysis of studies reporting real-world effectiveness of VDZ in patients with CD. Here we describe treatment persistence in biologic-naïve patients with CD treated with VDZ compared with anti-tumor necrosis factor-alpha (TNFα) treatment at 12 and 24 months to address the gap of long-term data available on patients with CD.
Aims & Methods
Systematic literature reviews were 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 observational/real-world studies were extracted for meta-analysis. The analysis was conducted using the DerSimonian-Laird random-effects method to obtain weighted mean rates (percentage of patients) and the corresponding 95% confidence interval (CI) for each treatment persistence or serious adverse event (SAE) as performed for a meta-analysis published in 2018.1
Results
Overall, data from 78 studies of 30 158 patients with CD had at least one outcome of interest for analysis. Four and three studies of 7082 and 5040 patients with CD, respectively, reported the rate of treatment persistence in biologic-naïve patients treated with VDZ versus anti-TNFα treatment at 12 and 24 months. The rate of treatment persistence was higher with VDZ (83.8% [95% CI 71.4–96.1]) compared with anti-TNFα treatment (75.3% [69.9–80.7]) at 12 months. Similarly, the rate of treatment persistence was higher with VDZ (70.4% [95% CI 61.3–79.6]) compared with anti-TNFα treatment (64.5% [56.9–72.2]) at 24 months. Two studies of 491 and 86 biologic-naïve patients with CD treated with VDZ versus anti-TNFα treatment reported SAEs. In a retrospective study, safety outcomes were followed from treatment initiation up to five half-lives post-treatment discontinuation; 8.3% treated with VDZ experienced SAEs compared with 19.0% with anti-TNFα treatment.2 In an additional retrospective study that reported SAEs within the first 12 months of treatment; the rate of SAEs was comparable between patients treated with VDZ (18.2%) and anti-TNFα treatment (17.0%).3 Among these patients, only those receiving anti-TNFα treatment experienced drug-induced SAEs (3.8%; pancreatitis and systemic lupus erythematosus).3
Conclusion
This meta-analysis of real-world studies demonstrated higher rates of long-term treatment persistence and suggests that VDZ may have a favorable safety profile compared with anti-TNFα treatment in biologic-naïve patients with CD.
References
1. Schreiber S et al. J Gastroenterol 2018;53:1048–64.
2. Bressler B et al. J Crohns Colitis 2021;15:1694–706.
3. Moens A et al. Inflamm Bowel Dis 2021;28:1135–42.
Disclosure
This study was funded by Takeda Pharmaceuticals International AG. Medical writing services were provided by Elena Sugrue, PhD, of Oxford PharmaGenesis, and funded by Takeda Pharmaceuticals International AG.
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.
RJB is an employee of PHMR Ltd., who received funding for this study from Takeda Pharmaceuticals International AG.
PB is an employee and stockholder of Takeda Pharmaceuticals International AG, Zurich, Switzerland.
MN is an employee and stockholder of Takeda Pharmaceuticals International AG, Zurich, Switzerland.
SW is an employee and stockholder of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA.
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 and Theravance Biopharma.