Abbott Study Examines Rates of Uveitis (Inflammation of the Eye) in Ankylosing Spondylitis Patients Treated with HUMIRA

13/11/07 A study of ankylosing spondylitis (AS) patients treated with Abbott’s HUMIRA showed a decrease in the rate of uveitis flares by approximately half compared to patients treated with placebo. Ankylosing spondylitis is an inflammatory disease of the spine, and may also be associated with other inflammatory diseases of the skin, eyes, and intestines. Uveitis, or inflammation of the eye, occurs in up to 40 percent of people with AS, and can lead to severe and painful symptoms, including eye damage and blindness. These data were presented today at the American College of Rheumatology Annual Scientific Meeting in Boston.

The RHAPSODY (Review of safety and effectiveness witH Adalimumab in Patients with active ankylosing SpOnDYlitis) trial was designed to examine the effectiveness of HUMIRA in treating the signs and symptoms of AS in patients with active disease despite previous standard treatment. The 1,250 patient trial also included a subset of patients (n=274) with uveitis. Results of the trial suggested that the number of uveitis flares was reduced in patients with active AS treated with HUMIRA.

In the prospective, multi-national, open-label trial, adult patients with active AS who had insufficient responses to prior non-steroidal anti-inflammatory drug (NSAID) therapy received open-label HUMIRA 40 mg subcutaneously every other week for 12 weeks. Patients with symptomatic uveitis at baseline and/or in the previous year received the same regimen for a total of 20 weeks. Evaluations of treatment effects were measured at weeks 2, 6, 12 and week 20, if applicable.

This analysis measured the number of acute flares during treatment with HUMIRA both for all patients in the trial and for patients with pre-known history of uveitis. The rate was calculated as flares per 100-patient-years (100-PYs), which represent the number of flares that would occur in 100 patients observed or treated for one year. The rate of uveitis flares was reduced by approximately half during treatment with HUMIRA compared with the rate prior to the trial (15 flares/100-PY to 7.4 flares/100-PY in the entire trial population, 68.4 flares/100-PY to 28.9 flares/100-PY in the subset with a history of uveitis).

Overall, 27 adverse events of uveitis were reported for 25/1,250 patients. Two of the 25 patients experienced an attack of uveitis for the first time. In both patients, the general AS disease activity was high at time of the anterior uveitis episode.

"Uveitis is a fairly common and potentially serious complication of ankylosing spondylitis," said Martin Rudwaleit, M.D., of the Charité University Hospital in Germany and lead author of the trial. "This study is an example of the research needed to better understand this condition and the impact it has on these patients."