Combination therapy commonly used with Entyvio, Stelara
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Entyvio and Stelara were commonly used in combination therapy for the treatment of inflammatory bowel disease, according to research at Digestive Disease Week.
“When used with an immunomodulator (ie, azathioprine, methotrexate), anti-TNFs are associated with lower rates of anti-drug antibodies and increased rates of clinical remission but also with increased rates of infections,” Megan Lutz, MD, fellow at the University of Wisconsin School of Medicine and Public Health, told Healio Gastroenterology. “[Entyvio (vedolizumab, Takeda)] and [Stelara (ustekinumab, Janssen)] are newer biologic therapies that do not seem to carry the same risk for infection as anti-TNFs or immunomodulators. A growing body of evidence also suggests that these newer biologics have lower rates of immunogenicity and are not necessarily more effective when used with an immunomodulator. Further prospective data are needed to determine efficacy and minimize risk for patients initiating combination therapy with vedolizumab or ustekinumab for IBD.”
TARGET-IBD was a longitudinal cohort study of 4,229 patients with IBD, including those with ulcerative colitis and Crohn’s disease. Lutz and colleagues collected data from electronic medical records for patients enrolled between July 2017 and November 2020. Records showed that 18.5% of the patients were taking vedolizumab and 13% were taking ustekinumab. Researchers estimated the rates of anti-TNF, vedolizumab and ustekinumab monotherapy and combination therapy with methotrexate, azathioprine or mercaptopurine from at any time during study and at time of enrollment.
Investigators stratified rates of combination therapy by time from drug approval and previous exposure to other biologic agents. They used bivariate statistics to compare patient characteristics between those on monotherapy and combination therapy at enrollment.
Lutz said combination therapy was used in 28.2% of patients with Crohn’s disease who were taking vedolizumab or ustekinumab and 19% of patients with UC who were taking vedolizumab at enrollment.
According to researchers, patient populations were refractory and had high rates of previous biologic exposure. Study data showed previous anti-TNF exposure among 73.8% of patients treated with vedolizumab and 89.6% of patients treated with ustekinumab, and 30.8% of those patients on ustekinumab also had previous vedolizumab exposure.
Patients with CD on vedolizumab or ustekinumab at time of enrollment with prior exposure to biologics had a greater chance for receiving combination therapy (P = .02 for vedolizumab; P < .001 for ustekinumab). For patients with CD taking ustekinumab at enrollment, combination therapy was common at community sites (P = .03) and in patients aged under 65 years (P = .02).
Lutz and colleagues observed no difference in rates of combination therapy for patients treated with ustekinumab vs. anti-TNF. Vedolizumab compared with anti-TNFs was not as frequently used in combination therapy vs. anti-TNFs. However, vedolizumab was used more in combination therapy in CD vs. UC (P = .045).
Editor’s Note: On June 10, 2021, the headline and lede were altered to better clarify the research results.
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Jessica Philpott, MD, PhD
This is an interesting study that looks at real world practices in management of the newer non–anti-TNF biologics vedolizumab and ustekinumab vis a vis use of concurrent immunomodulator or "dual therapy." It finds that several patients – between 25% and 40% – were on dual therapy or concurrent immunomodulator. I find this study interesting in that the data reported is divided into years 2014-2016 and 2017-2020, and the researchers detected that in the latter group the practice of prescribing dual therapy was decreasing.
This mirrors the growing data we have that largely suggests lack of benefit of concurrent immunomodulator for these biologics although there are a few conflicting studies. I am not surprised that patients with previous anti-TNF exposure were more likely to be treated with concurrent modulator than others. This is a group (previous TNF exposure) more at risk for adverse disease outcomes due to disease phenotype and a portion of them would be expected to have lost response to previous biologic due to antibodies. So that would likely encourage the physician practice of prescribing concurrent immunomodulator with their subsequent biologic. This study demonstrates that physician practices change over time as more data become available and is disseminated in a relatively short time.
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Lutz et al. Poster 3524370. Presented at: Digestive Disease Week; May 21-24, 2021 (virtual meeting).
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