AbbVie, a global, research-based biopharmaceutical company, 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.

"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 US 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.1 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 per cent 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 per cent CI, 0.36–0.70; P<0.001). Median time to TF was prolonged by 87 per cent, 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, randomised, 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 US, Argentina, Australia, Austria, Belgium, Canada, Czech Republic, Denmark, France, Germany, Greece, Israel, Italy, Japan, Mexico, Poland, Portugal, Spain, Switzerland and the UK.

The primary endpoint of the study was time to TF, which was defined as having one or more of the four criteria in at least one eye---- new active, inflammatory chorioretinal or vascular lesions, 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.

Humira is a prescription medicine used to reduce the signs and symptoms of moderate to severe rheumatoid arthritis (RA) in adults. Humira can be used alone, with methotrexate, or with certain other medicines. Humira may prevent further damage to bones and joints and may help the ability to perform daily activities.

Humira can be used alone, with methotrexate, or with certain other medicines to reduce the signs and symptoms of moderate to severe polyarticular juvenile idiopathic arthritis (JIA) in children 2 years of age and older.

Humira can be used alone or with certain other medicines to reduce the signs and symptoms of psoriatic arthritis (PsA) in adults. Humira may prevent further damage to bones and joints and may help the ability to perform daily activities.

Humira can be used to reduce the signs and symptoms of ankylosing spondylitis (AS) in adults, moderate to severe Crohn's disease (CD) and to achieve and maintain clinical remission in adults who have not responded well to conventional treatments. Humira is also used to reduce signs and symptoms and achieve clinical remission in these adults who have also lost response to or are unable to tolerate infliximab.

Humira can be used to reduce the signs and symptoms of moderate to severe Crohn's disease (CD) and to achieve and maintain clinical remission in children 6 years of age and older when certain other treatments have not worked well enough and in adults, to help get moderate to severe ulcerative colitis (UC) under control (induce remission) and keep it under control (sustain remission) when certain other medicines have not worked well enough.

It is not known if Humira is effective in people who stopped responding to or could not tolerate anti-TNF medicines.

It is also used to treat moderate to severe chronic plaque psoriasis (Ps) in adults who are ready for systemic therapy or phototherapy, and are under the care of a doctor who will decide if other systemic therapies are less appropriate.

Humira is a TNF blocker medicine that affects the immune system and can lower the ability to fight infections. Serious infections have happened in people taking Humira. These serious infections include tuberculosis (TB) and infections caused by viruses, fungi, or bacteria that have spread throughout the body. Some people have died from these infections.

For people taking TNF blockers, including Humira, the chance of getting lymphoma or other cancers may increase. Some people have developed a rare type of cancer called hepatosplenic T-cell lymphoma. This type of cancer often results in death. If using TNF blockers including Humira, the chance of getting two types of skin cancer (basal cell and squamous cell) may increase. These types are generally not life- threatening if treated.

Other possible serious side effects with Humira include hepatitis B infection in carriers of the virus; allergic reactions; nervous system problems; blood problems; certain immune reactions, including a lupus-like syndrome; liver problems; and new or worsening heart failure or psoriasis.

Common side effects of Humira include injection site reactions (redness, rash, swelling, itching, or bruising), upper respiratory infections (including sinus infections), headaches, rash, and nausea. Humira is given by injection under the skin.