Efficacy data in pediatric uveitis
SYCAMORE TRIAL
Time to treatment failure in children and adolescents (≥2 years of age) with JIA-associated UV 1,2*
Adapted from the HUMIRA Product Monograph and Ramanan, et al.1,2
* SYCAMORE: 2-year, randomized, double-blind, placebo-controlled, multicentre trial of 90 children and adolescents
2 years of age or older who had active JIA-associated uveitis taking a stable weekly dose of methotrexate for at least
12 weeks. All patients received a stable dose of weekly oral or subcutaneous MTX (10 to 20 mg per square meter of
body surface area, maximum dose of 25 mg). Patients were randomized to receive either HUMIRA (20 mg in
patients weighing <30 kg or 40 mg in patients weighing ≥30 kg) or placebo.
Safety information
Click here for additional information and for a link to the Product Monograph discussing:
• Contraindications in patients with severe infections such as sepsis, tuberculosis (TB) and opportunistic infections, and moderate to severe heart failure (NYHA class III/IV).
• The most serious warnings and precautions regarding hepatosplenic T-cell lymphoma (HSTCL), serious infections and pediatric malignancy.
• Other relevant warnings and precautions regarding concurrent administration with other biologic disease-modifying antirheumatic drugs (DMARDs) or other tumour necrosis factor (TNF) antagonists not recommended, switching between biological DMARDs, surgery, patients with congestive heart failure, hematologic events, hypersensitivity reactions, autoimmunity, immunosuppression, immunizations, infections including TB, opportunistic infections and hepatitis B virus reactivation, malignancies including malignancies in pediatric patients and young adults, lymphoma and non-lymphoma malignancy, neurologic events, uveitis and central demyelinating disorders, pregnant or nursing women, and geriatrics.
• Conditions of clinical use, adverse reactions, drug interactions, and dosing instructions.
The Product Monograph is also available by calling us at 1-866-8HUMIRA (1-866-848-6472).
References:
1. HUMIRA Product Monograph. AbbVie Corporation.
2. Ramanan A, et al. Adalimumab plus methotrexate for uveitis in juvenile idiopathic arthritis. N Engl J Med 2017;376(17):1637-46.
CA-HUMR-220011A / OC23