(RxWiki News) Gout, formerly linked with Europe's royal families, has made its way to middle America. Since 1990, U.S. cases have increased by 50 percent, making it a modern-day royal pain in the joints.
Most patients can receive some symptom relief from drugs currently prescribed to treat gout, but 3 percent of gout cases aren't treatable or treatment side effects cannot be tolerated by patients. These suffering patients can now look forward to a new gout drug, pegloticase (Krystexxa).
Two recent clinical trials indicate that Krystexxa injections every two weeks helps 42 percent of patients with treatment-resistant gout turn back time on their disease.
"Ask your rheumatologist about Krystexxa injections to treat gout."
Senior author Michael A. Becker, M.D., professor of medicine at the University of Chicago reports that this new therapy is the first effective treatment for patients who have no other treatment options. Patients with severe gout often experience debilitating levels of pain and swelling.
This quick remedy of some patients tested is very unusual, according to Dr. Becker. He also explains that this drug isn't a cure, but does a "reset" on gout progression.
John S. Sunday, M.D., Ph.D., director of Duke Clinical Research Unit and lead author of the study reports interestingly, this drug has an all or none effect on patients, but the ones who benefit do so greatly.
Two clinical trials enrolled 212 patients with severe, treatment-resistant gout and high uric-acid. These patients weren't helped by or able to tolerate standard treatments in the past.
Patients were randomly placed into one of three groups: The first group was injected with 8 milligrams of Krystexxa every two weeks, the second group received Krystexxa once a month and the last group got placebo injection of saline. All three groups were enrolled for six months of treatment.
Of the patients who received the Krystexxa injection every two weeks, 42 percent had their uric-acid levels stay within the normal range at least 80 percent of the time during the six month study. In this group of patients, 80 percent also had a complete resolution of at least one of their swollen joints. Their quality of life was also significantly better.
Of the group of patients who received a Krystexxa shot once every month, 35 percent had their uric-acid levels adjust to a normal range during at least 80 percent of the study period. Those who received a placebo shot had no change in their uric-acid levels.
In the group receiving the twice monthly injections, 40 percent had at least one swollen joint resolve. Of those receiving a monthly injection, 21 percent had the same result. Only seven percent of the patients receiving a placebo had one or more swollen joints diminish. Patients who received the drug also reported improved physical function and quality of life.
In the group of participants receiving Krystexxa injections, 90 percent had at least one adverse reaction including brief periods of pain and inflammation. After three months, these gout flare ups declined.
In Krystexxa injection groups, 26 percent developed an infusion-related adverse reaction. Most of those experiencing this reaction had already quit responding to the drug. In total, eight percent of the patients on a twice-monthly regimen and five percent on a monthly regimen had serious reactions, but all completely resolved.
Also, seven percent of patients died that were receiving Krystexxa shots, so, for future patients, the researchers recommend stabilizing cardiovascular risks prior to initiation of the therapy.
Almost all patients eventually developed antibodies which would present challenges if the patients were to receive the drug again.