Efficacy and Safety of Adalimumab in Subjects With Inactive Uveitis

Summary

A study comparing the safety and efficacy of adalimumab compared with. placebo in adults with inactive non-infectious intermediate uveitis, posterior uveitis, or panuveitis.

Timeline

Start

2010-08

Primary completion

2015-05

Completion

2015-05

Outcome

Met primary endpoint

registry analysis (unspecified test); Main Study: Placebo vs Main Study: Adalimumab; p = 0.004; Hazard Ratio (HR) 0.57 (95% CI 0.39 to 0.84); Log Rank NCT01124838 ↗

release “In the VISUAL-II study, the median time to TF was 8.3 months for placebo (PBO) and not estimable for adalimumab (ADA)” abbvie.com ↗

Publications

• Background Nguyen QD, Merrill PT, Jaffe GJ, Dick AD, Kurup SK, Sheppard J, Schlaen A, Pavesio C, Cimino L, Van Calster J, Camez AA, Kwatra NV, Song AP, Kron M, Tari S, Brezin AP. Adalimumab for prevention of uveitic flare in patients with inactive non-infectious uveitis controlled by corticosteroids (VISUAL II): a multicentre, double-masked, randomised, placebo-controlled phase 3 trial. Lancet. 2016 Sep 17;388(10050):1183-92. doi: 10.1016/S0140-6736(16)31339-3. Epub 2016 Aug 16.
• Sheppard J, Joshi A, Betts KA, Hudgens S, Tari S, Chen N, Skup M, Dick AD. Effect of Adalimumab on Visual Functioning in Patients With Noninfectious Intermediate Uveitis, Posterior Uveitis, and Panuveitis in the VISUAL-1 and VISUAL-2 Trials. JAMA Ophthalmol. 2017 Jun 1;135(6):511-518. doi: 10.1001/jamaophthalmol.2017.0603.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Adalimumab	Monoclonal antibody	40 mg	Subcutaneous
Background	Prednisone	Other / unclassified	—	Oral

Indications