FDA approves pegloticase, methotrexate combo in patients with uncontrolled gout
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The FDA has approved the supplemental biologics license application for pegloticase, expanding the drug’s label to include co-administration with methotrexate in patients with uncontrolled gout, according to a press release.
“Today’s approval for Krystexxa with methotrexate is the culmination of more than 5 years of effort and demonstrates Horizon’s commitment to working together with the gout community to improve the patient experience and outcomes,” Elizabeth H.Z. Thompson, PhD, executive vice president of research and development at Horizon Therapeutics, said in the company release.
The approval for pegloticase (Krystexxa, Horizon Therapeutics) with methotrexate in patients with uncontrolled gout is based on results from the MIRROR trial, in which patients were randomized to receive 15 mg of methotrexate per week or placebo for 4 weeks before receiving pegloticase with methotrexate or pegloticase with placebo for an additional 52 weeks, the release said.
The study’s primary endpoint was defined as the proportion of serum uric acid responders (serum uric acid levels < 6 mg/dL at least 80% of the time) at 6 months.
According to study results, 71% of patients who received pegloticase plus methotrexate reached the primary endpoint at 6 months compared with 39% of patients who received pegloticase plus placebo (P < .0001). Additionally, 60% of patients receiving pegloticase plus methotrexate achieved complete response (serum uric acid levels < 6 mg/dL at least 80% of the time at 12 months) compared with 31% of patients who received pegloticase plus placebo (P < .001).
Further, only 4% of patients who received pegloticase plus methotrexate had infusion reactions compared with 31% of patients who received pegloticase plus placebo. In patients who had validated tophi at baseline, 54% of patients in the test group saw complete resolution of at least one tophus, with no new tophus or tophus progression, compared with 31% of patients in the control group, the release said.
“Through multiple in-practice case series, the open-label trial and the randomized controlled trial, the medical community has been actively engaged in finding ways to reduce the impact of uncontrolled gout by maximizing the use of Krystexxa,” study investigator John K. Botson, MD, RPh, CCD, president of Alaska Rheumatology Alliance and rheumatologist at Orthopedic Physicians Alaska, said in the release. “The expanded labeling reflects robust data on this treatment approach, which can allow us to change outcomes for many uncontrolled gout patients, most of whom have no other treatment option.”
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