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Orencia may improve symptoms for patients with JIA
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Long-term treatment of patients with juvenile idiopathic arthritis with Orencia for up to 7 years may be beneficial, according to recently published research.
Researchers studied 190 patients with juvenile idiopathic arthritis (JIA) aged 6 to 17 years in Europe, Latin America and the U.S. enrolled in either the Pediatric Rheumatology Collaborative Study Group or the Paediatric Rheumatology International Trials Organisation phase 3 trial. The study design had a 4-month open-label lead-in phase in which all participants received IV Orencia (abatacept, Bristol-Meyers Squibb) at 10 mg/kg followed by a 6-month, double-blind withdrawal phase. Upon enrollment, included patients had active disease in at least two joints with a history of involvement in at least five joints, while the average number of active joints in patients was 16.
Patients who reached an American College of Rheumatology (ACR) Pedi 30 response after 4 months were randomized to abatacept or placebo, and patients who did not respond to treatment were able to enter the long-term extension (LTE) treatment group (n = 153). Concomitant use of up to 10 mg per day of prednisone equivalent dose, methotrexate or other nonbiologic disease-modifying antirheumatic drugs (DMARDs) was permitted.
At study entry, 75.2% of patients received methotrexate, 72.5% received folic acid, 41.2% received oral corticosteroids and 12.4% added a nonbiologic DMARD during the study.
Safety was comparable across all three groups of patients. Adverse events included nonserious urticaria and bronchospasm, skin lesions, temporal lobe epilepsy, multiple sclerosis and appendicitis considered possibly linked to treatment. The IR for infections was 83.8 over 683.4 patient-years, including an IR of 8.85 for nasopharyngitis, 6.81 for upper respiratory tract infection and 1.65 for a serious infection.
At the time of entry into the LTE, 84.5% of patients met the ACR Pedi 30, 79.3% met ACR Pedi 50, 55.2% met ACR Pedi 70 and 41.4% met the ACR Pedi 90. Eighteen patients (31%) had inactive disease. Two patients developed antibodies to the whole abatacept molecule during the second year of treatment, neither of whom had infusion reactions.
Freedom from pain based on a pain score of 0 was reached by 20.4% of patients in the double-blind abatacept group compared to 15.7% of patients in the placebo group on day 169 and in 17.9% vs. 16%, respectively, on day 1,765. Participation in daily activities was improved on day 1,765 in all groups with a reduction in patient or caregiver missed activity days by between 2.43 and 5.52 standard deviations per month. – by Shirley Pulawski
Disclosure: Lovell reports the receipt of consulting fees from AstraZeneca, Janssen, Bristol-Myers Squibb, Abbott, Pfizer, Hoffman-La Roche, Novartis, UBC and Horizon; speaking fees from Abbott and Amgen; and honoraria from Forest Research for Data and Safety Monitoring Board service. Please see the full study for a list of all other authors’ relevant financial disclosures.
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