Abbvie reports positive results from Phase III trial of Humira

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.

"Backed by 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 Scott Brun, M.D., vice president, pharmaceutical development, 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. US 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 Glenn J. Jaffe, M.D., Duke University, 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."

The VISUAL-I study found that compared to placebo, patients on HUMIRA were less likely to experience treatment failure (TF) (hazard ratio=0.5; 95 percent CI, 0.36-0.70; P<0.001).

Median time to TF was prolonged by 87 percent, from 3 months for placebo to 5.6 months for HUMIRA. TF is a multi-component outcome based on chorioretinal or vascular lesions, best corrected visual acuity (BCVA), anterior chamber (AC) cell grade, and vitreous haze (VH) grade.

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.

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+.

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 (TF).

The trial was conducted in the U.S., Argentina, Australia, Austria, Belgium, Canada, Czech Republic, Denmark, France, Germany, Greece, Israel, Italy, Japan, Mexico, Poland, Portugal, Spain, Switzerland and the U.K.