Adalimumab effective but not a cure for uveitis
All patients received 60 mg prednisone at the start of the trial, after which the dose was gradually tapered to discontinuation at week 15.
Patients in the adalimumab group received 80 mg at baseline followed by a 40 mg dose every 2 weeks starting at week 1 and continuing for the duration of the trial.
The trial continued until 138 treatment failures occurred after 6 weeks, or until the patients had been treated for 80 weeks, which ever occurred first.
The researchers considered the treatment to have failed after week 6 if at least one eye had new inflammatory lesions, anterior chamber cell, or vitreous haze grade that did not decrease to 0.5+ or lower, or worsening of best-corrected visual acuity by 15 or more letters. At week 6, the criteria for treatment failure was the same except that it did not include haze.
Overall, treatment failed less often in patients who received adalimumab than in patients who received the placebo (hazard ratio [HR] 0.50; 95% confidence interval [CI] 0.36–0.70; p<0.001).
Likewise, treatment failure occurred less often in the adalimumab group from vitreous haze (HR 0.32; 95% CI 0.18 to 0.58; p<0.001), new active inflammatory lesions (HR 0.38; 95% CI 0.21–0.69; p=0.001), anterior chamber cell grade (HR 0.51; 95% CI 0.30–0.86; p=0.01), or a worsening of best corrected visual acuity (HR 0.56; 95% CI 0.32–0.98; p=0.04).
In the placebo group, the most common reason for treatment failure was vitreous haze (36%), followed by anterior chamber cells (32%), chorioretinal or retinal vascular lesions (27%), and worsening visual acuity (25%).
In the adalimumab group, the most common reason for treatment failure was anterior chamber cells (22%), followed by worsening visual acuity (21%), and chorioretinal or retinal vascular lesions (15%) and vitreous haze (15%).
Looking at diagnoses within uveitis, the researchers found that adalimumab was significantly more effective than the placebo among patients with idiopathic uveitis (HR 0.50; 95% CI 0.31– 0.80; p=0.003), but it was not more effective than placebo in patients with birdshot choroidopathy (HR 0.49; 95% CI 0.21–1.15; p=0.09).
Adalimumab worked better than the placebo in patients who were not using immunomodulatory therapies at baseline (HR 0.49; 95% CI 0.33–0.73; p<0.001), but not among those patients who were using immunomodulatory therapies (HR 0.44; 95% CI, 0.30–1.01 p=0.05).
Among patients with no macular oedema, macular holes, or retinal detachment at baseline, the risk of developing new retinal thickening was 67% lower in the adalimumab group than in the placebo group.
The adalimumab group also fared better in percent change in central retinal thickness and in changes in the Visual Functioning Questionnaire-25 composite, distance vision, near vision, and ocular pain scores.