IBD patients may accept riskier drugs to get durable remissions

Last Updated: 2015-11-02

By Laura Newman

NEW YORK (Reuters Health) - Patients with inflammatory bowel disease may be willing to accept as much as a 28% risk of a serious infection and a 1.8% chance of developing lymphoma with a newer, more effective therapy than currently exists, a new study suggests.

They will accept those risks if they can avoid a disease flare for five years or more, but if the remission was shorter, say 1.5 years or less, then patients were not so eager to take a similar medication risk, the researchers found.

"The results of the study challenge the assumption that patients are unwilling to accept risks associated with disease-modifying drugs. Additionally, it also gives us a marker for what magnitude of risks patients are willing to accept in a new IBD drug," lead author Dr. Meenakshi Bewtra told Reuters Health.

Dr. Bewtra pointed out that the findings fit with goals of treatment for inflammatory bowel disease. "We want them to value long-term remission and recognize the importance of early, aggressive treatment even if they are feeling well," she said.

As reported online October 20 in the American Journal of Gastroenterology, Dr. Bewtra, from the University of Pennsylvania in Philadelphia, and colleagues asked 202 patients with IBD to choose among competing treatments based on their view of maximum acceptable risk of medication-related serious adverse event (SAE) risks to avoid a future relapse.

Initially, 374 patients were contacted and 231 (62%) responded to the survey.

The research team used a relatively new discrete-choice experiment method to determine patient preferences. In deciding what treatments they would select, patients were asked to choose between two different medication regimens that were described in terms of time until next disease flare, side-effect risks of lymphoma, and the risk of a serious infection.

Patients were told that medications might pose between and 0% and 1% risk of developing lymphoma and a 0% to 40% risk of developing a serious infection within 10 years, but would likely produce remissions ranging from a few months to 10 years. Essentially, patients had to choose between continuing their current therapy, or trying another one, with specific risks and time to relapse.

On average, avoiding a serious infection was the most important attribute associated with a medication choice, and the second most important attribute was increasing the length of time to a relapse.

A counterintuitive finding was that patients with active disease were less willing to accept additional risk for future gain, Dr. Bewtra said, adding that "We really need to investigate this further. It may be because these patients were already failing therapies."

In their article, the researchers note that aggressive treatment of IBD often entails immunosuppressant use, which carries the risk of serious adverse events. "Although mathematical models support the use of combination therapy with anti-TNF and immunosuppressant agents for most patients, arguments against this more aggressive approach have included concern that patients would be unwilling to accept increased risk to prevent future complications, especially in the absence of current symptoms."

"Our findings show that patients, particularly those in remission, are willing to accept risk levels comparable to or higher than actual risk levels to avoid a future relapse if the duration of remission is five years or longer," they write.

Dr. Mark Helfand, President of the Society for Medical Decision-Making, praised the study's approach. "This is a very strong method for determining what characteristics in a new drug's benefits and harms are consistent with patient preferences," he told Reuters Health. Increasingly, the U.S. Food and Drug Administration is looking at patient preferences and experiences in the drug approval process, and this is a contribution, he explained.

Even so, Dr. Helfand pointed out: "In this case, the study is not the last word. Patient stories might give a clearer picture" of how patients view their disease process and what tradeoffs they will accept down the road. "With that reservation, it gives us a ballpark of the kind of remission patients are looking for."

SOURCE: http://bit.ly/1WtXix9

Am J Gastroenterol 2015.