AbbVie's HUMIRA (Adalimumab) Approved by Health Canada to Treat Pediatric Patients with Chronic Non-infectious Anterior Uveitis
- The approval marks HUMIRA as the only approved biologic treatment option in?Canada?for pediatric patients from two years of age with chronic non-infectious anterior uveitis who have had inadequate response to conventional therapy
- The approval is based on results from SYCAMORE, an investigator-initiated clinical trial, which showed that HUMIRA combined with methotrexate significantly delayed the time to treatment failure compared to methotrexate plus placebo in children with active JIA-associated uveitis1
- Juvenile idiopathic arthritis (JIA) is the most common systemic disorder associated with non-infectious uveitis in children, accounting for more than 75 percent of cases of pediatric anterior uveitis2
The SYCAMORE clinical trial was sponsored by the University Hospitals Bristol NHS Foundation Trust and coordinated by the Clinical Trials Research Centre at the?University of Liverpool. The study was supported by grants from the National Institute for Health Research Health Technology Assessment Programme and Arthritis Research UK. In this multicenter, double-masked, randomized, placebo-controlled trial, researchers assessed the efficacy and safety of HUMIRA in children and adolescents two years of age and older who had active JIA-associated uveitis noninfectious anterior uveitis who were refractory to at least 12?weeks of methotrexate treatment. Patients who were taking a stable dose of methotrexate were randomly assigned in a 2:1 ratio to receive either HUMIRA (at a dose of 20 mg or 40 mg, according to body weight) or placebo, administered subcutaneously every two weeks. Patients continued the trial regimen until treatment failure or until 18 months had elapsed. Including a 6 months off-study drug period, they were followed for up to two years after randomization. The primary endpoint was the time to treatment failure, defined as meeting at least one of the following criteria: multiple components of intraocular inflammation, worsening or development of ocular comorbidities, use of concomitant medications that were not allowed or that did not follow pre-specified criteria, and suspension of treatment for an extended period of time. Study results showed that the addition of HUMIRA to methotrexate significantly delayed the time to treatment failure as compared with placebo, and the pre-specified stopping criteria were met after the enrollment of 90 of 114 patients. Researchers observed 16 treatment failures in 60 patients (27 percent) in the HUMIRA group versus 18 treatment failures in 30 patients (60 percent) in the placebo group (hazard ratio, 0.25; 99.9 percent confidence interval [CI], 0.08 to 0.79; P<0.0001 [the pre-specified stopping boundary]). About HUMIRA
HUMIRA resembles antibodies normally found in the body. It works by blocking TNF-a, a protein that, when produced in excess, plays a central role in the inflammatory responses of many immune-mediated diseases. HUMIRA is one of the most comprehensively studied biologics available. The overall clinical database for HUMIRA spans 20 years across 15 indications globally (11 in?Canada), including more than 71 clinical trials with more than 23,000 patients. HUMIRA is approved in 90 countries and used by more than one million patients worldwide. Any medicines can have side effects. Like all medicines that affect the immune system, HUMIRA can cause serious side effects.7?Before initiation of, during and after treatment with HUMIRA, patients should?be evaluated for active or inactive tuberculosis infection with a tuberculin skin test. For further information, please see the HUMIRA Product Monograph1available at?www.abbvie.ca. mportant Safety Information
HUMIRA is a TNF blocker medicine that affects the immune system and can lower the body's 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 before starting HUMIRA. 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 other biologics DMARDS (e.g. anakinra or abatacept) or other TNF antagonists is not recommended. People using HUMIRA should not receive live vaccines. Common side effects of HUMIRA include injection site reactions (redness, swelling, itching, pain or bruising), cough and cold symptoms, headache, rash, nausea, pneumonia, fever and abdominal pain. HUMIRA is given by injection under the skin. The benefits and risks of HUMIRA should be carefully considered before starting therapy. This is not a complete list of the Important Safety Information for HUMIRA. For additional important safety information, please consult the HUMIRA Product Monograph?at?www.abbvie.ca