Adults with inflammatory bowel disease were more likely to continue using vedolizumab, compared with anti–tumor necrosis factor (TNF) drugs over 3 years, based on data from a retrospective study of nearly 16,000 patients.
Patient persistence with prescribed therapy is essential to managing chronic inflammatory bowel disease (IBD), but data on the persistence of patients with treatments are limited, wrote Ulf Helwig, MD, of the Practice for Internal Medicine, Oldenburg, Germany, and colleagues. “With the advent of vedolizumab, physicians for the first time had the choice between biologicals with different modes of action,” they wrote.
In a study published in the Journal of Clinical Gastroenterology, the researchers used a national prescription database to identify 15,984 adults aged 18 years and older who were treatment-naive to biologics and received prescriptions between July 2014 and March 2017. Treatment persistence was defined as continuous treatment time of at least 90 days without prescription.
A total of 2,076 vedolizumab patients were matched with 2,076 adalimumab patients; 716 vedolizumab patients were matched with 716 golimumab patients; and 2,055 vedolizumab patients were matched with 2,055 infliximab patients.
Within 3 years after the first prescription, the overall persistence rates were 35.9% for vedolizumab, 27.8% for adalimumab, 20.7% for golimumab, and 29.8% for infliximab.
In matched-pair analysis, 35.2% of vedolizumab patients were persistent, compared with 28.9% of adalimumab patients over a 3-year period; the difference was statistically significant. In addition, 30.5% of vedolizumab patients persisted, compared with 25.4% of golimumab patients, also statistically significant. A matched-pair comparison between vedolizumab and infliximab (35.7% vs. 30.2%) was not statistically significant (P = 0.119).
In addition, vedolizumab patients were significantly less likely to discontinue therapy, compared with both adalimumab and golimumab patients, with hazard ratios of 0.86 and 0.60, respectively, in the matched pair analysis; discontinuation, compared with infliximab, was not statistically significant.
“Several reasons may account for significant rates of discontinuation reported for all biological treatments in IBD,” the researchers noted. “These comprise differences in health care systems in the concerned countries, including differences in availability of biologicals, access to reimbursed drugs, or different patient care settings,” they wrote.
The study findings were limited by several factors including the lack of data on specific IBD diagnoses, IBD severity, disease course, and dose escalation, they noted.
However, the study was strengthened by the large sample size and use of a real-world setting, they said.
“Further studies are needed to identify the reasons for persistence differences between vedolizumab and anti-TNF drugs,” they concluded.
Comparisons inform choices
“There are multiple biologic options for therapy of inflammatory bowel disease, and response to therapy tends to drop off over time in many patients for a variety of reasons including development of antibodies and escape from the mechanism of the action of the drug,” said Kim L. Isaacs, MD, of the University of North Carolina at Chapel Hill, in an interview.
“Intolerance or side effects of medication also may lead to discontinuation of therapy,” said Dr. Isaacs. “This trial looks at therapy discontinuation among four biologics used for inflammatory bowel disease over a 3-year period after initiation of therapy in patients who were previous biologically naive. Reasons for discontinuation cannot be assessed with this data set,” she noted. “There are very few comparative trials with the different biologic therapies in IBD. This trial is important because it compares the two distinct biologic mechanisms of action and continuation of therapy in biologically naive patients,” she said.
Dr. Isaacs said she was not surprised by the study findings. “Discontinuation of anti-TNF therapy was more common, compared to vedolizumab and golimumab. There was no statistical difference in terms of therapy discontinuation with infliximab,” she said. “In general, vedolizumab is felt to be less systemically immunosuppressant with targeting of white blood cell trafficking to the gut, whereas anti-TNF therapy is more systemically immunosuppressant and may be associated with more systemic side effects,” she explained.
The study design does not allow for comment on comparative efficacy, “although the findings are intriguing,” said Dr. Isaacs. “If the discontinuations were caused by lack of efficacy, the findings in this study may help in positioning biologic therapy in the biologic-naive patients,” she said.
The study is “a ‘real-world’ experiment that suggests there is a difference between different biologic therapies for inflammatory bowel disease,” said Dr. Isaacs. “More controlled comparative efficacy trials are needed that can look at reasons for drug discontinuation between different populations. To date, the VARSITY trial comparing vedolizumab to adalimumab in ulcerative colitis is the only published trial to do this,” she added.
The study received no outside funding. Lead author Dr. Helwig disclosed lecture and consulting fees from AbbVie, Amgen, Biogen, Celltrion, Hexal, MSD, Ferring, Falk Foundation, Takeda, Mundipharma, Pfizer, Hospira, and Vifor Pharma. Dr. Isaacs disclosed serving on the Data and Safety Monitoring Board (DSMB) for Janssen.
SOURCE: Helwig U et al. J Clin Gastroenterol. 2021 Jan. doi: 10.1097/MCG.0000000000001323
Story updated Jan. 6, 2021.
