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By Michael Smith, North American Correspondent, MedPage Today Reviewed by Robert Jasmer, MD; Associate Clinical Professor of Medicine, University of California, San Francisco and Dorothy Caputo, MA, BSN, RN, Nurse PlannerEye drops containing an interleukin-1 antagonist were safe and efficacious for patients with dry eye disease.Note that anakinra, a recombinant interleukin-1 receptor antagonist, is approved to treat rheumatoid arthritis and is used off-label for other conditions in which interleukin-1 plays a role.Eye drops containing an interleukin-1 antagonist were safe and efficacious for patients with dry eye disease, researchers reported.
Patients suffered no serious adverse events from drops containing anakinra (Kineret) in a 12-week randomized phase I/II trial, according to Reza Dana, MD, of the Massachusetts Eye and Ear Infirmary in Boston, and colleagues.
Compared with a commercial eye drop preparation, the anakinra drops significantly reduced the signs and symptoms of dry eye disease, Dana and colleagues reported online in JAMA Ophthalmology.
Using a topical protein-based biologic agent is "unprecedented" in dry eye disease, the researchers concluded, and the findings offer "proof-of-concept support" that it's efficacious.
Dry eye disease is one of the most common ophthalmic conditions, Dana and colleagues noted, but experts do not completely understand its pathogenesis. However, they added, the cytokine interleukin-1 plays a central role in ocular surface inflammation, and animal studies have shown the benefits of blocking the substance.
Anakinra, a recombinant interleukin-1 receptor antagonist, is approved to treat rheumatoid arthritis and is used off-label for other conditions in which interleukin-1 plays a role.
To see if it would be useful in dry eye disease, Dana and colleagues enrolled 75 patients with the condition and randomly assigned them to one of two doses of anakinra (2.5% and 5%) or to a vehicle eye drop containing 1% carboxymethylcellulose (marketed as Refresh Liquigel). They were instructed to put in one drop three times a day for 12 weeks.
The primary efficacy endpoints of the study included reduction in corneal epitheliopathy as measured by corneal fluorescein staining (CFS), the proportion of patients in whom the CFS cleared from both eyes within 3 minutes, and reduction in symptoms as measured by the Ocular Surface Disease Index.
At 12 weeks, the researchers found: The average reduction in the CFS scores was 46% in the 30 low-dose anakinra patients, 17% in the high-dose group, and 19% in the vehicle group.The difference from baseline was significant only for the low-dose anakinra patients, at P<0.001.The low-dose patients also did better in achieving complete bilateral CFS clearance – 29% versus 7% in the high-dose and vehicle groups. The difference from vehicle was significant at P=0.03.Dry eye symptoms – such as dryness and a burning sensation -- were reduced by 30% in the low-dose anakinra group, by 35% in the high-dose group, and by 5% in the vehicle group. The differences from vehicle were significant at P=0.02 and P=0.01, respectively.
Dana and colleagues weren't able to attribute any serious adverse reactions to the drug. Participants also said all types of discomfort associated with using the drops were more common in the vehicle group.
Finally, the researchers couldn't explain why the higher dose was less effective. One possible explanation is that the lower dose is enough to occupy almost all interleuklin-1 receptors, but Dana and colleagues said it might also be that the 5% dose is less stable.
The study was supported by the NIH. Dana is a co-inventor in a patent application pertaining to use of IL-1 blockers for ophthalmic use. The patent is licensed to Eleven Biotherapeutics; Dana reported holding equity in the company.
Primary source: JAMA Ophthalmology
Source reference:
Amparo F, et al "Topical interleukin 1 receptor antagonist for treatment of dry eye disease: A randomized clinical trial" JAMA Ophthalmol 2013; DOI: 10.1001/jamaophthalmol.2013.195.
Michael Smith
North American Correspondent
North American Correspondent for MedPage Today, is a three-time winner of the Science and Society Journalism Award of the Canadian Science Writers' Association. After working for newspapers in several parts of Canada, he was the science writer for the Toronto Star before becoming a freelancer in 1994. His byline has appeared in New Scientist, Science, the Globe and Mail, United Press International, Toronto Life, Canadian Business, the Toronto Star, Marketing Computers, and many others. He is based in Toronto, and when not transforming dense science into compelling prose he can usually be found sailing.
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