The Committee for Medicinal Products for Human Use ( CHMP ) of the European Medicines Agency ( EMA ) has granted a positive opinion for Humira ( Adalimumab ) for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids or in whom corticosteroid treatment is inappropriate.
Humira can also decrease corticosteroid use in corticosteroid-dependent patients.
Non-infectious uveitis is a group of diseases characterized by inflammation of the uvea, the middle layer of the eye. It can lead to reduced vision or vision loss and is the third-leading cause of preventable blindness worldwide.
Non-infectious uveitis can be complicated to diagnose and treat and there are no universally accepted guidelines for the treatment of the condition.
At this time, corticosteroids are the current mainstay of treatment after underlying conditions, such as infection, are ruled out.
However, they may not be effective in all patients, and can have serious ocular long-term side effects including glaucoma and cataracts. Some patients have underlying diseases that preclude the use of corticosteroids.
Adalimumab targets and helps block TNF-alpha, a specific source of inflammation that can have a role in uveitis.
The CHMP opinion is based on results from two double-masked, randomized and placebo-controlled pivotal phase 3 studies, VISUAL-I and VISUAL-II, which have demonstrated that patients with active and controlled non-infectious intermediate, posterior and panuveitis treated with Adalimumab had a significantly lower risk for uveitic flare or decrease in visual acuity, compared to placebo.
The safety profile for patients with uveitis treated with Adalimumab every other week was consistent with the known safety profile of Adalimumab.
VISUAL-I and VISUAL-II clinical trials were randomized 1:1 and patients treated with Adalimumab received an 80 mg baseline loading dose followed by 40 mg given by subcutaneous injection every other week for up to 80 weeks.
The primary endpoint in the VISUAL-I and VISUAL-II studies was time to treatment failure ( TF ).
To be considered a TF, any 1 of these 4 criteria needed to be present in at least one eye: new lesions, anterior chamber cell grade, vitreous haze and visual acuity.
The VISUAL-I study found that compared to placebo, patients on Adalimumab were less likely to experience treatment failure ( hazard ratio, HR=0.5; 95% CI, 0.36–0.70; P less than 0.001 ).
Median time to treatment failure was prolonged by 87%, from 3 months for placebo ( PBO ) to 5.6 months for Adalimumab.
In the VISUAL-II study, the median time to treatment failure was 8.3 months for placebo ( PBO ) and not estimable for Adalimumab, as more than half of the Adalimumab-treated patients did not experience treatment failure ( HR=0.57; 95% Cl, 0.39-0.84; P=0.004 ).
No significant differences were observed between serious adverse events, serious infections and the overall rate of adverse events between Adalimumab and placebo. ( Xagena )
Source: Abbvie, 2016