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News & Trends - Pharmaceuticals

First meta-analysis advocates first-line use of Takeda’s therapy in ulcerative colitis and Crohn’s disease

Health Industry Hub | March 10, 2023 |

Pharma News: According to the first meta-analysis of real-world effectiveness, Takeda’ s Entyvio (vedolizumab), a monoclonal antibody drug, showed a higher overall 1- and 2-year persistence of use (overall time that a patient stays on a medication) compared with two anti–tumor necrosis factor inhibitors (anti-TNFi) in both Crohn’s disease and ulcerative colitis (UC).

The results mostly applied to bionaive subjects, and the benefit of Entyvio over both TNFi’s – Remicade (infliximab) and Humira (adalimumab), was more evident in ulcerative colitis, compared with Crohn’s disease, noted Dr Tsz Hong Yiu, a clinician and researcher at the University of Sydney.

“It appears that patients are more likely to stay on vedolizumab than either infliximab or adalimumab, especially in bionaive patients, which could suggest either a better tolerance to the treatment or a better response,” Dr Yiu said at European Crohn’s and Colitis Organisation (ECCO) Congress 2023.

In this head-to-head comparison, 15% more patients stayed on Entyvio than anti-TNF alpha drugs overall, at 1-year follow-up for both ulcerative colitis and Crohn’s disease (risk ratio, 1.15). At 2 years of follow-up, 12% more patients remained on Entyvio in comparison with anti-TNF alpha drugs overall (RR, 1.12), again for both forms of inflammatory bowel disease (IBD).

“This may provide early evidence that supports vedolizumab as a first-line biologic agent for inpatients with inflammatory bowel disease,” said Dr Yiu, noting that further research was required to validate the correlation of persistence with clinical effectiveness.

Senior author Professor Rupert Leong, a gastroenterologist at Concord RepatriaKon General Hospital, Sydney, said “We wanted to identify the drug with the highest effectiveness, which is the real-world benefit of the drug to patients, rather than efficacy, which refers to clinical trial data.”

“Importantly, clinical trial data are usually only 1 year, whereas persistence collects data often for several years. This is relevant in chronic diseases that can affect patients over several decades, because the true benefit of a drug cannot be implied from a short-term clinical trial,” he explained.

Persistence was chosen as the primary end-point because it is a measure that incorporates a drug’s efficacy and side-effect profile but also the patient’s perspective, added Dr Yiu.

He said “So, a patient may value mild side effects over treatment effectiveness and decide to cease treatment.”

A prior meta-analysis looking at loss of response found that 33% of people taking Remicade and 41% of people taking Humira became resistant to the biologics after a median follow up of 1 year.

“The most common cause of loss of response to anti-TNF inhibitors is due to immunogenicity,” remarked Dr Yiu “These findings suggested that alternative biologics with high effectiveness should be considered.”

Professor Leong pointed out the difficulty in selecting the correct treatment given the increasing numbers of biological agents available.

“The paucity of head-to-head studies meant use of cohort studies is considered both relevant and informative, not least because long-term follow-up data can reveal secondary loss of response of these monoclonal antibodies, while pooling data further increases the statistical power and determines consistency,” he said.

Overall, the study found that 1-year persistence of vedolizumab was 71.2% in ulcerative colitis and 76% in Crohn’s disease, which was significantly higher than with infliximab (56.4% in ulcerative colitis, 53.7% in Crohn’s disease), and likewise with adalimumab (53.7% in ulcerative colitis, 55.6% in Crohn’s disease).

Results of 2-year persistence were pooled from four studies and found that vedolizumab had a 2-year persistence of 66% in ulcerative colitis and 61% in Crohn’s disease. By comparison, infliximab had a persistence of 49.7% for ulcerative colitis and 59.1% for Crohn’s disease, and adalimumab had a persistence of 31.4% for ulcerative colitis and 56% for Crohn’s disease.

Commenting on the study, Dr Viraj Kariyawasam, gastroenterologist and head of IBD at Blacktown and Mount Druitt hospital in Sydney, said the findings were “very important in defining the place of vedolizumab in the treatment of ulcerative colitis, and more so in Crohn’s disease.”

“Despite vedolizumab being considered a lower-efficacy drug compared to infliximab in Crohn’s disease by most practicing clinicians, and still favouring anti-TNF in the treatment of Crohn’s disease, the study highlights the superior persistence of vedolizumab,” he said in an interview.

“This is likely associated with efficacy over the two most used anti-TNF agents. With the knowledge we have about reduced efficacy of vedolizumab after the use of anti-TNF, or as a second- or third-line agent, and its superior persistence as a first-line biologic with already published safety data, vedolizumab should be considered and preferred as a first-line agent in the treatment of both ulcerative colitis and Crohn’s disease.”


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