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

Abstract

(2016). 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, 388(10050) Link to publication record in Explore Bristol Research PDF-document This is the author accepted manuscript (AAM). The final published version (version of record) is available online via Elsevier at http://www.sciencedirect.com/science/article/pii/S0140673616313393. Please refer to any applicable terms of use of the publisher., University of Bristol -Explore Bristol Research General rightsThis document is made available in accordance with publisher policies. Please cite only the published version using the reference above. Full terms of use are available: http://www.bristol.ac.uk/pure/about/ebr-terms

Adalimumab in Active and Inactive, Non-Infectious Uveitis: Global Results from the VISUAL I and VISUAL II Trials

“…23 Most recently, the main study data from VISUAL I and VISUAL II studies also demonstrated the efficacy and safety of adalimumab (anti-TNFα) to treat uveitis. 13,14 Low adalimumab immunogenicity was observed in both VISUAL I and VISUAL II studies and was in the range of rates observed in other disease states. 13,14 The safety profile of adalimumab was similar to the established safety profile for approved adalimumab indications, 24 and the rates of AEs were similar compared with placebo.…”

“…13,14 Low adalimumab immunogenicity was observed in both VISUAL I and VISUAL II studies and was in the range of rates observed in other disease states. 13,14 The safety profile of adalimumab was similar to the established safety profile for approved adalimumab indications, 24 and the rates of AEs were similar compared with placebo. In participants with active uveitis (VISUAL I), the overall rates of adalimumab-associated AEs were higher than the placebo group, as were serious AEs and AEs leading to discontinuation.…”

“…In participants with inactive uveitis (VISUAL II), injection-site reactions were the most frequently reported AEs with adalimumab, consistent with other reports.- 21,25 The strengths and the limitations of the VISUAL I and VISUAL II studies have been described and published. 13,14 Additionally, in the Japan substudies, the sample sizes of 16 participants (VISUAL I) and 32 participants (VISUAL II) were very low and no clear differences were expected. Furthermore, to receive 60 mg of prednisone per the VISUAL I protocol, participants needed to be hospitalized, which was one of the reasons for low enrollment in the VISUAL I study in Japan.…”

“…The VISUAL I and VISUAL II studies were randomized, doublemasked, placebo-controlled clinical trials designed to assess the efficacy and safety of adalimumab in inducing quiescence along with CS and maintaining the achieved quiescence in participants with active uveitis (VISUAL I) and as a steroid-sparing agent preventing relapse in participants dependent on CS to maintain inactivity (VISUAL II). The VISUAL program demonstrated adalimumab's ability to lower the risk of uveitic recurrence and visual acuity loss in participants with active (VISUAL I) and an inactive disease state (VISUAL II) uveitis.- 13,14 The VISUAL program is the first successful program where the treatment effect of a non-CS medication could be demonstrated in two separate randomized controlled trials in non-infectious uveitis populations.…”

A systematic review and economic evaluation of adalimumab and dexamethasone for treating non-infectious intermediate uveitis, posterior uveitis or panuveitis in adults

“…Patients with bilateral uveitis but no active systemic disease could be treated using either a local or a systemic approach. Although the inclusion criteria for the clinical trials of these drugs [46][47][48] were not limited by these factors, our clinical experts suggest that clinicians may have selected patients for the trials accordingly.…”