Introduction
Vedolizumab (VDZ) is approved in Europe and the USA for the treatment of moderately to severely active ulcerative colitis (UC). A previous systematic literature review (SLR) and meta-analysis published in 2018 demonstrated the real-world effectiveness and positive benefit–risk profile of VDZ treatment for up to 1 year in patients with inflammatory bowel disease.1 There is limited real-world evidence on the long-term (> 1 year) treatment persistence and safety of VDZ compared with anti-tumour necrosis factor-alpha (TNFα) treatment in biologic-naive patients with UC.
Aims & Methods
The aims of this meta-analysis were to assess the real-world effectiveness and treatment persistence of VDZ in patients with UC. We report an exploratory analysis of treatment persistence and serious adverse events (SAEs) among biologic-naive patients with UC treated with VDZ compared with anti-TNFα treatment at 1 and at 2 years. Literature searches were conducted to identify studies published from 2014 to 2022. For the primary analysis, outcomes of interest included clinical remission, mucosal healing, treatment patterns (including treatment persistence) and safety. Data on adults with UC treated with VDZ or anti-TNFα treatment in a real-world setting were extracted 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. No formal statistical significance testing between treatments was applied.
Results
Among comparative studies of VDZ and anti-TNFα treatment, 8 studies were identified (10 486 biologic-naive patients with UC). Of these, 5 and 2 studies, respectively, reported the rates of treatment persistence in biologic-naive patients at 1 and at 2 years. The rate of treatment persistence at 1 year was 74.9% with VDZ (95% CI 64.3–83.3) and 59.0% with anti-TNFα treatment (47.2–69.8). Similarly, the rate of treatment persistence at 2 years was 77.6% with VDZ (70.8–83.2) and 60.0% with anti-TNFα treatment (48.3–70.7). Three retrospective cohort studies of 775 biologic-naive patients with UC treated with VDZ (n=465) versus anti-TNFα treatment (n=310) reported SAEs. In the first study, safety outcomes were followed from treatment initiation up to five half-lives after treatment discontinuation; 6.8% treated with VDZ experienced SAEs compared with 19.2% with anti-TNFα treatment.2 In the second study, the rate of SAEs was similar between patients treated with VDZ (4.5%) and anti-TNFα treatment (5.0%).3 In the third study that reported SAEs within the first year of treatment; the rates of SAEs were 14.3% and 10.9% among patients who received VDZ and anti-TNFα treatment, respectively.4
Conclusion
This analysis of comparative studies in biologic-naive patients with UC suggested that treatment persistence rates were higher with VDZ than with anti-TNFα treatment both at 1 and at 2 years. In addition, these data support a comparable safety profile, with similar rates of SAEs between VDZ and anti-TNFα treatment.
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.
- Bressler B et al. J Crohn's Colitis. 2021;15:1694–706.
- Helwig et al. BMC Gastroenterol. 2020;20:211.
- Moens et al. Inflamm Bowel Dis. 2022;28:1135–1142.
Disclosure
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.
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.
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.
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 Pharmaceutical and Tillots Pharma.
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.
