NORTH CHICAGO, Ill.—AbbVie has 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 uveitis, posterior uveitis 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.
“AbbVie continues to innovate with Humira in studying potential new indications to help address unmet medical needs,” a company spokesman tells DDNews. “The pivotal VISUAL-I data presented at the ARVO 2015 Annual Meeting reinforce Humira’s well-established safety and efficacy profile, building upon the company’s nearly two decades of experience with Humira.”
“AbbVie continues to drive for innovative solutions in inflammatory disease with a strategic focus on developing new treatment strategies for conditions with high unmet needs,” said Dr. Scott Brun, vice president of pharmaceutical development for AbbVie. “These results from the VISUAL-I study mark our ongoing commitment to patients with a wide range of immune-mediated disorders, and we look forward to further advancing Humira as a potential treatment option for patients living with particular forms of uveitis.”
In May 2014, AbbVie received orphan drug designation from the U.S. Food and Drug Administration for the investigational treatment of certain forms of non-infectious uveitis with Humira. U.S. and EU regulatory submissions are expected this year. Humira is not currently approved to treat any form of uveitis.
Non-infectious uveitis is a group of diseases characterized by inflammation of the eye that is often chronic, can lead to reduced vision or vision loss and are commonly treated by a specialized opthalmologist. Symptoms of non-infectious uveitis may include vision loss, blurred vision, eye pain and redness, as well as sensitivity to light. It is estimated that non-infectious and infectious uveitis together account for 10 to 15 percent of all cases of vision loss in the United States.
“Currently, there are limited treatment options for patients with non-infectious uveitis, a potentially blinding condition,” said Dr. Glenn J. Jaffe of Duke University in Durham, N.C. “These results provide data about the potential clinical benefits of Humira as a treatment option for patients living with particular forms of uveitis.”
Many patients with non-infectious uveitis are managed on systemic corticosteroids, which may lead to treatment failure or loss of disease control over time. In the VISUAL-I study, Humira met the primary endpoint of prolonging time to treatment failure compared to placebo. “These results indicate that Humira is an effective treatment option for controlling inflammation in people with non-infectious uveitis and provide data about the potential clinical benefits of Humira as a treatment option for patients living with particular forms of uveitis,” AbbVie states.
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 uveitis, posterior uveitis or panuveitis despite corticosteroid therapy. Patients with active uveitis had one or more of the following: active, inflammatory chorioretinal or retinal vascular lesion; anterior chamber (AC) cell grade ≥2+ or vitreous haze (VH) grade ≥2+.
The VISUAL-I study found that compared to placebo, patients on Humira were less likely to experience treatment failure (TF). Median time to TF was prolonged by 87 percent, from three months for placebo to 5.6 months for Humira. TF is a multicomponent outcome based on chorioretinal or vascular lesions, best corrected visual acuity (BCVA), AC cell grade and VH grade.
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 trial was conducted in the United States, Argentina, Australia, Austria, Belgium, Canada, Czech Republic, Denmark, France, Germany, Greece, Israel, Italy, Japan, Mexico, Poland, Portugal, Spain, Switzerland and the United Kingdom.
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; inability to achieve ≤0.5+ AC cell grade at week six; after week six, two-step increase relative to best state achieved; inability to achieve ≤0.5+ VH grade at week six; after week six, two-step increase relative to best state achieved; or BCVA decrease by at least 15 letters relative to best state achieved.
Humira is approved for use in moderate to severe rheumatoid arthritis, ankylosing spondylitis, moderate to severe plaque psoriasis, active and progressive psoriatic arthritis, moderate to severely active Crohn’s disease and moderate to severely active ulcerative colitis. Humira is approved in pediatric patients for use in enthesitis-related arthritis, severe plaque psoriasis, severe Crohn’s disease and active juvenile idiopathic arthritis in patients who have had inadequate response to prior therapy.
