Date: 2015-05-05
Type of information: Presentation of results at a congress
phase: 3
Announcement: presentation of results at the Association for Research in Vision and Ophthalmology (ARVO) 2015 Annual Meeting in Denver
Company: Abbvie (USA - IL)
Product: Humira® (adalimumab)
Action
mechanism: monoclonal antibody. Adalimumab binds specifically to TNF alpha and blocks its interaction with the p55 and p75 cell surface TNF receptors. Adalimumab also lyses surface TNF expressing cells in vitro in the presence of complement. Adalimumab also modulates biological responses that are induced or regulated by TNF, including changes in the levels of adhesion molecules responsible for leukocyte migration (ELAM-1, VCAM-1, and ICAM-1).
Disease: non-infectious intermediate, posterior, or pan-uveitis, or chronic non-infectious anterior uveitis
Therapeutic area: Ophtalmological diseases - Inflammatory diseases - Rare diseases
Country: Argentina, Australia, Austria, Belgium, Canada, Czech Republic, Denmark, France, Germany, Greece, Israel, Italy, Japan, Mexico, Poland, Portugal, Spain, Switzerland, UK, USA
Trial
details: VISUAL-I is a Phase 3, double-masked, randomized, placebo-controlled study designed to investigate the efficacy and safety of HUMIRA in 217 adult patients with active, non-infectious intermediate, posterior, or panuveitis despite corticosteroid therapy. Patients with active uveitis had ≥1 of the following: active, inflammatory chorioretinal or retinal vascular lesion; anterior chamber (AC) cell grade ≥2+; or vitreous haze (VH) grade ≥2+. (NCT01138657)
Latest
news: * On May 5, 2015, AbbVie announced results from VISUAL-I, a Phase 3 study investigating the efficacy and safety of Humira® (adalimumab) in adult patients with active non-infectious intermediate, posterior, or panuveitis who still experienced intraocular inflammation while on systemic corticosteroid therapy. Results showed Humira® significantly lowered their risk of uncontrolled uveitis or vision loss. The results were presented at the Association for Research in Vision and Ophthalmology (ARVO) 2015 Annual Meeting in Denver, Colo. The VISUAL-I study found that compared to placebo, patients on Humira® were less likely to experience treatment failure (TF). The rates of adverse events (AEs) in VISUAL-I were 1,047 events per 100 patient/years (PY) for Humira®-treated patients vs. 965 events per 100PY for placebo patients; rates of serious AEs were 29 events per 100PY for Humira®?treated patients vs. 13 events per 100PY for placebo patients. Of the 217 participating patients, 110 were treated with Humira® and 107 received placebo. The Humira® group received an 80 mg baseline loading dose followed by 40 mg given by subcutaneous injection every other week for up to 80 weeks. At study entry, all subjects received a 60 mg prednisone burst followed by a complete taper over 15 weeks. Starting at week 6 and every visit thereafter, all patients were assessed for treatment failure. The primary endpoint of the study was time to TF, which was defined as having one or more of the following four criteria in at least one eye: New active, inflammatory chorioretinal or vascular lesions AbbVie is also evaluating the safety and efficacy of Humira® in patients with inactive, non-infectious intermediate, posterior, or panuveitis, in the ongoing Phase 3 VISUAL II clinical trial and those results are expected soon. In May 2014, AbbVie received orphan drug designation from the FDA for the investigational treatment of certain forms of non?infectious uveitis with Humira®. U.S. and EU regulatory submissions are expected this year.
Inability to achieve ≤0.5+ AC cell grade at week 6; after week 6, 2-step increase relative to best state achieved
Inability to achieve ≤0.5+ VH grade at week 6; after week 6, 2-step increase relative to best state achieved
Best corrected visual acuity (BCVA) decrease by at least 15 letters relative to best state achieved
