May 1, 2013
Rheumatoid Arthritis Therapy Significantly Reduces
Dry Eye Disease

Boston—A recombinant version of human IL-1Ra approved for treatment of rheumatoid arthritis also significantly reduced symptoms of dry eye disease (DED), according to a new study.

Researchers from the Massachusetts Eye and Ear Infirmary, Harvard Medical School, and Brigham and Women’s hospital demonstrated that topical anakinra, marketed as Kineret by Amgen Inc., was effective in treatment of DED, which affects an estimated 9 million Americans. The study was published online by JAMA Ophthalmology.

“Treatment with topical anakinra, 2.5%, for 12 weeks, was safe and significantly reduced symptoms and corneal epitheliopathy in patients with DED,” according to the authors. “These data suggest that the use of an IL-1 antagonist may have a role as a novel therapeutic option for patients with DED.”

For the study, researchers randomized 75 patients with refractory DED to treatment with topical anakinra, 2.5% (n = 30), anakinra, 5% (n = 15), or eye lubricant (1% carboxymethylcellulose) (n = 30) three times daily for 12 weeks. The primary outcomes were corneal fluorescein staining (CFS), complete bilateral CFS clearance, dry eye–related symptoms as measured by the Ocular Surface Disease Index, tear film breakup time, and meibomian gland secretion quality.

Study authors noted that topical anakinra was well-tolerated with no reports of serious adverse reactions attributable to the therapy. Anakinra at 2.5% was four times more likely than the eye lubricant to bilaterally eliminate corneal staining, according to the authors. Complete bilateral CFS clearance was noted in eight of 28 patients (29%) treated with anakinra, 2.5%, versus in two of 29 patients (7%) treated with the lubricant.

Overall, topical anakinra reduced dry eye symptoms six times more effectively than the eye lubricant, which can independently improve the signs of DED, they reported. By week 12, treatment with anakinra, 2.5%, and treatment with anakinra, 5%, led to significant reductions in symptoms of 30% and 35%, respectively, compared with lubricant treatment, which led to a 5% reduction in symptoms.

The therapeutic effect of anakinra was confirmed when termination of the drug, but not the lubricant, lead to a clear trend toward increased symptoms between weeks 12 and 16, according to the researchers.

“We began looking at the possible therapeutic effects of IL-1Ra over 10 years ago in my laboratory,” said senior author Reza Dana, MD, MSc, MPH. “This clinical trial was a significant milestone in our research. The results clearly show us not only that we can possibly help the millions of people affected by dry eye disease worldwide, but that biologics such as this have the potential to provide targeted therapies for other ocular ailments, as well.”

Earlier studies found that DED was associated with significant overexpression of inflammatory cytokines, including interleukin 1 (IL-1), in the eye, but previous options to treat the inflammatory component of DED have been limited and resulted in adverse effects.

“We have never seen results such as this before in a trial to treat dry eye disease,” Dana noted. “We possibly have found a safe, well-tolerated eye drop that can treat the underlying cause of dry eye rather than just temporarily mask the symptoms. We are excited about the positive results we saw in the data and with our patients who found relief in their symptoms and were able to return to some of their normal daily activities.”

U.S. Pharmacist Social Connect