Long-Term Adalimumab is Safe and Achieves Disease Control in Children with Advanced and Refractory JIA

Jenny Powers

doi:10.1177/155989771417004

Summary

Long-term disease control was observed with adalimumab administered in routine clinical practice to patients with moderately to severely active juvenile idiopathic arthritis (JIA). This article discusses interim findings from an analysis done at 4 years from an ongoing international registry of patients enrolled upon diagnosis of moderately to severely active JIA [NCT00783510].

Arthritis
Rheumatology Clinical Trials
Rheumatological Autoimmune Disorders

Rheumatology

Long-term disease control was observed with adalimumab administered in routine clinical practice to patients with moderately to severely active juvenile idiopathic arthritis (JIA), according to Gerd Horneff, MD, Asklepios Klinik Sankt Augustin, Sankt Augustin, Germany.

Interim findings from an analysis done at 4 years were reported from an ongoing international registry of patients enrolled upon diagnosis of moderately to severely active JIA [NCT00783510]. The multicenter, noninterventional observational study aimed to evaluate long-term safety and effectiveness of adalimumab, which was recently approved for treating patients with severe and refractory JIA from the age of 2 years after failure or intolerance to methotrexate (MTX) treatment. Efficacy and safety were compared with MTX treatment administered in routine clinical practice. Patients aged 2 to 17 years were enrolled in the United States, European Union, and Australia. The planned follow-up was 10 years after enrollment in either treatment arm; crossover to the adalimumab group was allowed.

Patients in the adalimumab cohort had a more advanced disease course compared with those of the MTX cohort. Baseline values for mean disease duration were 1.3 years in the MTX arm and 3.8 years in the adalimumab arm. Patients in the adalimumab arm had a mean age of 12.2 years, a mean weight of 47.8 kg, and a mean height of 150.3 cm compared with patients receiving MTX, who had a mean age of 9.6 years, a mean weight of 37.9 kg, and a mean height of 137.2 cm. Mean baseline active joint count in both groups was 5.8, and disability index of Childhood Health Assessment Questionnaire scores was 0.6 in each arm.

At data cutoff, 306 patients received MTX monotherapy, and 459 received adalimumab with or without MTX. Clinical outcomes based on the 71-joint Juvenile Arthritis Disease Activity Score showed that mean scores improved from 13.1 at baseline to 11.2, 6.4, and 5.1 with MTX and from 12.1 at baseline to 8.5, 5.7, and 5.4 with adalimumab at Months 1, 3, and 6, respectively. In the MTX arm, 131 (42.8%) patients discontinued registry participation, compared with 81 (17.6%) in the adalimumab arm; 34 (25.9%) who discontinued MTX were switched to adalimumab.

Discontinuation due to treatment-related adverse events (AEs) occurred in 23 (7.5%) and 25 (5.4%) patients in the MTX and adalimumab cohorts, respectively. AEs determined by the investigators as possibly drug related were reported in 63 (20.6%) patients. Infectious AEs were reported for 64 (20.9%) and 80 (17.4%) of patients in the MTX and adalimumab arms, respectively. Of these, serious infectious AEs occurred in 7 (2.3%) MTX patients, compared with 12 (2.6%) adalimumab patients (Table 1).

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Table 1.

Overview of Observational Adverse Events, n (%)

In the adalimumab arm, 12 (2.6%) patients had a serious infectious AE: acute tonsillitis, cellulitis, gastroenteritis, mononucleosis, viral meningitis, pneumonia, scarlet fever, subcutaneous abscess, tonsillitis, urinary tract infection, and varicella occurred in 1 patient each. No deaths, malignancies, tuberculosis, or opportunistic infections were reported with either treatment.

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