Juvenile idiopathic arthritis (JIA)*
HUMIRA is indicated for, in combination with methotrexate (MTX), reducing the signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis (JIA) in patients, 2 years of age and older who have had an inadequate response to one or more disease-modifying antirheumatic drugs (DMARDs). HUMIRA can be used as monotherapy in case of intolerance to MTX or when continued treatment with MTX is not appropriate. HUMIRA has not been studied in pediatric patients with polyarticular JIA aged less than 2 years.
Efficacy data in polyarticular JIA
DISEASE FLARE DATA
Patients with disease flares at the end of 32 weeks: HUMIRA in combination
with MTX and without MTX vs. placebo.1,2*
Adapted from the HUMIRA Product Monograph and Lovell, et al.1,2
† p=0.031
‡ p=0.02
The primary efficacy variable was the proportion of patients treated with HUMIRA without MTX who experienced disease flare in the double-blind phase.1
• Twelve patients were treated for 6 years or longer in an open-label extension phase.1
HUMIRA is recommended for use in combination with MTX, and for use as monotherapy only in case of intolerance to MTX or when continued treatment with MTX is not appropriate.
Disease flare was defined as a worsening of ≥30% from baseline in ≥3 of 6 Pediatric American College of Rheumatology (ACR) core criteria, ≥2 active joints, and improvement of >30% in no more than 1 of the 6 criteria.
HUMIRA IS RECOMMENDED FOR USE IN COMBINATION WITH MTX
USE AS MONOTHERAPY ONLY IN PATIENTS FOR WHOM MTX USE IS NOT APPROPRIATE1
The percentage of patients achieving Pediatric ACR 30 responses was higher (94% vs. 74%), and fewer patients developed antibodies (5.9% vs. 25.6%) when treated with HUMIRA in combination with MTX compared to HUMIRA monotherapy.*
Median time to disease flare in the double-blind phase was >32 weeks for HUMIRA + MTX (n=38) and HUMIRA monotherapy (n=30) vs. respective control groups: 20 weeks for placebo + MTX (n=37) and 14 weeks for placebo alone (n=28).1*
Pediatric ACR 30† response rates
Open-label lead-in phase prior to the randomization to the double-blind
phase: HUMIRA + MTX vs. HUMIRA monotherapy at Week 161
Adapted from the HUMIRA Product Monograph and Lovell, et al.1,2
* Multicentre, randomized, double-blind, parallel-group study in 171 children (4 to 17 years old) with moderate or severe polyarticular JIA. In the open-label lead-in phase (OL LI), patients were stratified into two groups, MTX-treated or non-MTX-treated. Patients who were in the non-MTX stratum were either naïve to or had been withdrawn from MTX at least two weeks prior to study drug administration. Patients remained on stable doses of nonsteroidal anti-inflammatory drugs (NSAIDs) and/or prednisone (≤0.2 mg/kg/day or 10 mg/day maximum). In the OL LI phase, all patients received 24 mg/m2 up to a maximum of 40 mg HUMIRA every other week for 16 weeks. Patients demonstrating a Pediatric ACR 30 response at Week 16 were eligible to be randomized into the double-blind phase and received either HUMIRA 24 mg/m2 up to a maximum of 40 mg, or placebo every other week for an additional 32 weeks or until disease flare. After 32 weeks or at disease flare, patients were eligible to enrol into the OL extension phase.
† Pediatric American College of Rheumatology (ACR) 30: ACR Pediatric response is defined as an improvement of 30% or more in at least 3 of the 6 core criteria for JIA and a worsening of 30% or more in no more than one of the criteria. The criteria are as follows: physician’s global assessment of disease activity and the patient’s or the parent’s global assessment of overall well-being, number of joints with active arthritis, number of joints with limitation of passive motion, physical function (measured by the Disability Index of the Childhood Health Assessment Questionnaire), and a laboratory assessment of inflammation (C-reactive protein concentrations).
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 DMARDs or other 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).
* Polyarticular JIA
References:
1. HUMIRA Product Monograph. AbbVie Corporation.
2. Lovell DJ, et al. Adalimumab with or without methotrexate in juvenile rheumatoid arthritis. NEJM 2008;359:810-20.
CA-HUMR-210015A / OC23