The study indicated that the new treatment will not help all of the estimated 120,000 to 180,000 Americans with this most severe type of gout. In fact, the medication appeared to elicit an all-or-nothing response, greatly helping some patients while having almost no effect on others.
Ultimately, the research team found that 42 percent of the bi-weekly pegloticase patients maintained normal uric acid levels for a minimum of 80 percent of the half-year study period. The same was true among 35 percent of the monthly pegloticase patients. Those given saline solutions saw no improvement at all.
Overall, the quality of life went up among both sets of pegloticase patients, as did mobility and function; there was also a reduction in pain. What's more, many of the lumps typically associated with long-term gout (called "tophi") resolved in roughly 40 percent and 20 percent of the bi-weekly and monthly pegloticase patients, respectively.
However, the authors said 90 percent of pegloticase patients experienced at least one side effect, most commonly a brief flare-up of gout. Such flare-up side effects are also a common feature among allopurinol patients in the immediate period following treatment launch.
More seriously, about one-quarter of the bi-weekly pegloticase patients and 42 percent who had monthly injections experienced infusion-related immune responses at the drug injection site. In 5 percent to 8 percent of patients, the reaction was serious, and five patients experienced anaphylaxis.
Dr. Tuhina Neogi, an associate professor of medicine at Boston University School of Medicine, said: "The vast majority of patients can be appropriately and adequately managed with existing medications. The target for this new approach is clearly not the run-of-the-mill gout patient."
"But for that very small group of patients for whom none of the other options work, or for whom there are intolerances, this is a new way to go," Neogi said.
"And what's worth pointing out," she added, "is that this works by way of a completely different mechanism of action than our existing drugs. Rather than turning off the uric acid faucet or pulling open a drain, this drug goes in there like a bucket and simply removes the stuff. So this is truly unique and exciting."
For more on gout, visit the U.S. National Library of Medicine.
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