Immune-Based Drug May Ease Chronic Eye Condition
"Humira doesn't cure uveitis, but it does cause it to become quiet," said lead researcher Dr. Glenn Jaffe. He's a professor of ophthalmology at Duke University School of Medicine in Durham, N.C., and a consultant for Humira's maker, AbbVie.
"The hope is while the disease is in a quiet state, the disease activity just burns itself out -- but it can also come back," he said.
The U.S. Food and Drug Administration approved Humira for the treatment of uveitis in June.
The results of the study were published Sept. 8 in the New England Journal of Medicine. The study was funded by AbbVie.
Uveitis -- a term used to describe a group of inflammatory diseases inside the eye -- can cause loss of vision and potentially lead to blindness, Jaffe explained. The condition may also be painful, he said.
Uveitis happens to about 40 people in 100,000 and tends to occur when patients are in their 20s to 40s, according to Jaffe.
The current standard treatment for uveitis is corticosteroids. But this treatment comes with a significant risk of side effects, the researchers said. Side effects may include weight gain, mood changes, fatigue, acne and more, according to the U.S. National Library of Medicine.
Humira reduces inflammation by blocking proteins that cause inflammation, Jaffe said.
One concern with Humira is an increased chance of infections. For this reason, doctors need to be sure patients don't have tuberculosis or multiple sclerosis before taking the drug, he said.
When the inflammation is quiet, patients are usually treated for about two years. "If the eye is quiet over that time, we will consider to start tapering the treatment to see is the disease has burned itself out," said Jaffe.
"This is the first time that we have an FDA-approved drug other than steroids to treat uveitis," he stated.
For this phase 3 trial, Jaffe and colleagues randomly assigned more than 200 patients with uveitis to Humira or an inactive placebo. Patients given the drug received an initial dose of 80 milligrams followed by 40 milligrams every two weeks.
Patients were also given an initial dose of the steroid prednisone, which was decreased over 15 weeks.
The researchers found that people receiving Humira were less likely to experience flare-ups of uveitis than those on placebo.
Among those taking Humira, the average time to a flare-up with the condition was 24 weeks, compared with 13 weeks for those taking the placebo, the investigators found.
During the study, researchers looked for signs of returning inflammation.
"Humira decreased the percentage of people by about half who had a flare-up of inflammation," Jaffe said.
"Among patients who had a flare-up, it delayed the time to flare-up and it also prevented flare-ups to a significantly greater extent than placebo," he said.
In addition, those taking Humira had significantly fewer vision problems than those taking placebo, the study authors reported.
According to Dr. Mark Fromer, an ophthalmologist at Lenox Hill Hospital in New York City, "Humira effectively achieved disease control after stopping steroid treatment." Fromer was not involved with the study but was familiar with the findings.
"Further investigation into alternative therapies for uveitic disease is necessary to attempt to save the sight of the many patients that suffer from this sight-threatening group of diseases," Fromer said.
See Easy On The Eye: 8 Tips for Maintaining Good Eyesight for more information.
For more about uveitis, visit the U.S. National Eye Institute.
Posted: September 2016