Adalimumab in Patients With Active Noninfectious Uveitis
New England Journal of Medicine
Jaffe et al. designed a trial to assess the efficacy and safety of adalimumab as a steroid-sparing agent for the treatment of active noninfectious uveitis. They found that adalimumab was effective in controlling the disease after steroids were discontinued.
The multinational phase 3 trial included adults with noninfectious intermediate uveitis, posterior uveitis, or panuveitis that remained active despite their having received prednisone treatment for 2 or more weeks. Patients were randomly assigned in a 1:1 ratio to receive subcutaneous (SC) adalimumab (loading dose of 80 mg followed by a dose of 40 mg every 2 weeks) or a matched SC placebo. Each patient received a mandatory prednisone burst followed by tapering of prednisone over a course of 15 weeks.
The primary efficacy end point was the time to treatment failure occurring at or after week 6. Treatment failure was a multicomponent outcome based on assessment of new inflammatory lesions, best-corrected visual acuity (BCVA), anterior chamber cell grade, and vitreous haze grade.
The median time to treatment failure was 24 weeks in the adalimumab group and 13 weeks in the placebo group. Among the 217 patients in the intention- to-treat population, those who received adalimumab were significantly less likely to experience treatment failure (hazard ratio, 0.50) than the placebo group. The outcomes related to anterior chamber cell grade, vitreous haze grade, and BCVA were also significantly better in the adalimumab group. However, adverse events and serious adverse events were reported more often among patients who received adalimumab compared with placebo (respectively, 1,052.4 vs. 971.7 for adverse events and 28.8 vs. 13.6 serious adverse events per 100 person-years).
The researchers concluded that treatment with adalimumab achieved early and sustained disease control after discontinuation of corticosteroid treatment. Treated patients had reduced inflammation and visual impairment compared with the placebo group. However, they experienced more adverse events and serious adverse events than the placebo patients did.
The original article can be found here.