AbbVie Announces Pivotal Phase 3 Data Evaluating Efficacy and Safety of HUMIRA® (adalimumab) in Patients with Non-Infectious Intermediate, Posterior, or Panuveitis

-- Results of the VISUAL-I study show HUMIRA meets primary endpoint of prolonging time to treatment failure in patients with non?infectious intermediate, posterior, or panuveitis

-- Non?infectious and infectious uveitis together account for 10 to 15 percent of all cases of vision loss in the United States(1)

News provided by

AbbVie

May 05, 2015, 12:20 ET

NORTH CHICAGO, Ill., May 5, 2015 /PRNewswire/ -- AbbVie (NYSE: ABBV) 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 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.¹ Symptoms of non‑infectious uveitis may include vision loss, blurred vision, eye pain and redness, as well as sensitivity to light.²It 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.¹

"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.

About the VISUAL-I Study
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.

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 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

About HUMIRA in the U.S.³Uses
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.
- Moderate to severe polyarticular juvenile idiopathic arthritis (JIA) in children 2 years of age and older. HUMIRA can be used alone, with methotrexate, or with certain other medicines.
- Psoriatic arthritis (PsA) in adults. HUMIRA can be used alone or with certain other medicines. HUMIRA may prevent further damage to bones and joints and may help the ability to perform daily activities.
- 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.
- 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.
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.
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.

Important Safety Information
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. People should be tested for TB before HUMIRA use and monitored for signs and symptoms of TB during therapy. People at risk of TB may be treated with medicine for TB. Treatment with HUMIRA should not be started in a person with an active infection, unless approved by a doctor. HUMIRA should be stopped if a person develops a serious infection. People should tell their doctor if they live in or have been to a region where certain fungal infections are common, have had TB or hepatitis B, are prone to infections, or have symptoms such as fever, fatigue, cough, or sores.

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. The use of HUMIRA with anakinra or abatacept is not recommended. People using HUMIRA should not receive live vaccines.

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.

The benefits and risks of HUMIRA should be carefully considered before starting therapy.

Please click here for the Full U.S. Prescribing Information and Medication Guide.

HUMIRA EU Therapeutic Indications⁴HUMIRA 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. See SmPC for full indication.

Important EU Safety Information⁴HUMIRA is contraindicated in patients with active tuberculosis or other severe infections and in patients with moderate to severe heart failure. The use of HUMIRA increases the risk of developing serious infections which may, in rare cases, be life threatening. Rare cases of lymphoma and leukemia have been reported in patients treated with a TNF-antagonist. On rare occasions, a severe type of cancer called hepatosplenic T-cell lymphoma has been observed and often results in death. A risk for the development of malignancies in patients treated with TNF-antagonists cannot be excluded. The most frequently reported adverse events across all indications included respiratory infections, injection site reactions, headache, abdominal pain, nausea, rash and musculoskeletal pain.

(see SmPC for full details at http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000481/WC500050870.pdf)

Globally, prescribing information varies; refer to the individual country product label for complete information.

About AbbVie
AbbVie is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott Laboratories. The company's mission is to use its expertise, dedicated people and unique approach to innovation to develop and market advanced therapies that address some of the world's most complex and serious diseases. AbbVie employs more than 26,000 people worldwide and markets medicines in more than 170 countries. For further information on the company and its people, portfolio and commitments, please visit www.abbvie.com. Follow @abbvie on Twitter or view careers on our Facebook or LinkedIn page.

Forward-Looking Statements
Some statements in this news release may be forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements.

Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry.

Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," in AbbVie's 2013 Annual Report on Form 10-K/A, which has been filed with the Securities and Exchange Commission. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

References

Durrani OM, Tehrani NN, Marr JE, Moradi P, Stavrou P, Murray PI. Degree, duration, and causes of visual loss in uveitis. Br J of Ophthalmol. 2004;88(9):1159-1162.
National Eye Institute, National Institutes of Health. Facts about Uveitis. https://www.nei.nih.gov/health/uveitis/uveitis. Accessed April 2, 2015.
HUMIRA Injection [package insert]. North Chicago, IL: AbbVie Inc. http://www.rxabbvie.com/pdf/humira.pdf. Accessed April 2, 2015.
HUMIRA Summary of Product Characteristics. Updated March 2015. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000481/WC500050870.pdf. Accessed April 2, 2015.