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Dr. John Botson speaks on the new FDA approval of this combination therapy and its strength regarding increased efficacy and safety.
Last week, the US Food and Drug Administration (FDA) approved the co-treatment of pegloticase (Krystexxa) injection plus methotrexate (MTX) for uncontrolled gout, a decision bolstered by data from phase 4 of the MIRROR study.
In that study, 71% of patients who were treated with this combination therapy achieved a complete response over the course of 6 months. Comparatively, only 38.5% of patients who received pegloticase plus placebo achieved a complete response.
In a recent statement, John Botson, MD, RPh, Rheumatology Director at Orthopedic Physicians Alaska stated that the medical community had been “actively engaged” in findings therapeutic options for uncontrolled gout via pelgoticase therapy.
As one of the primary investigators of the MIRROR study, Botson was keenly aware of the implications of this new FDA decision, noting that this new co-treatment option could allow clinicians to “change outcomes for many uncontrolled gout patients, most of whom have no other treatment option."
For this episode of DocTalk, Botson sat down with Associate Editor Giuliana Grossi and spoke of how combination therapy for gout has led to less infusion reactions and increased efficacy, as well as how clinicians have safely incorporated low dose methotrexate, and what he feels will be the future of gout research.
“In the previous studies, about a quarter of the patients would have infusion reactions and lead to some of the side effects that came from getting the medication, and in this case we had 30.6% of the patients on the placebo who didn't take the methotrexate, and only 4.2% of the ones that got the combination,” Botson said. “So basically, there was a 90% or so improvement in safety and a doubling of the efficacy by using the combination. Those were huge, huge takeaways.”