Regulatory Decision Summary for HUMIRA

Assessment of the efficacy and safety of HUMIRA (adalimumab) for the treatment of non-infectious uveitis was based on two phase 3, double-blinded placebo-controlled clinical trials in a total of 500 adult patients with non-infectious uveitis (intermediate, posterior and pan uveitis) and one ongoing open-label extension study.

Benefit: Results from the two double-blinded trials show that in comparison with placebo, treatment with HUMIRA at an initial loading dose of 80 mg administered subcutaneously (SC), followed by 40 milligram (mg) every other week SC starting one week after the initial dose, reduced the risk of treatment failure in (1) adult patients with active non-infectious uveitis despite previous systemic corticosteroid treatment, when initiated at the same time as a systemic corticosteroid burst; and (2) adult patients with inactive steroid-dependent non-infectious uveitis, when initiated with systemic corticosteroids at the prior dose. In both studies, the systemic corticosteroids were tapered to zero, but patients could continue prior treatment with one systemic immunosuppressant. Patients were considered treatment failures if they developed new inflammatory ocular lesions and/or had increased anterior chamber cell grade or vitreous haze and/or had worsened best corrected visual acuity. The long-term durability of response and the efficacy of adalimumab treatment in severe disease are unknown.

Risk: The safety profile of HUMIRA in non-infectious uveitis was consistent overall with the known safety profile in other patient populations for which HUMIRA is authorized in Canada. No new safety signals were identified; however, long term safety data were limited in the non-infectious uveitis population.

To ensure that the benefit continues to outweigh any risk after authorization, Health Canada has required standard post-approval activities to monitor long-term safety.