Background/Purpose: Adalimumab (ADA) has been approved for the treatment of polyarticular juvenile idiopathic arthritis (pJIA) with long-term use often required to maintain disease control. The purpose of this analysis was to describe the safety of ADA among children with pJIA treated in current clinical practice with fixed-dosing (F-D, by weight category, in the United States [US] and Australia) or body surface area-dosing (BSA-D, in European countries).

Methods:

This is a year (yr) 8 interim analysis of an ongoing, multicenter, observational registry of patients (pts) with pJIA with up to 10 yr safety follow-up. Pts included in the registry were treated with ADA, alone or in combination with methotrexate (ADA±MTX), or MTX alone as a comparison arm, according to routine clinical care in PRINTO/PRCSG centres in the US, Australia, and Europe. This analysis included only ADA±MTX-treated pts who were sub-grouped according to enrolling site into two groups: F-D (10 – <15 kg, 10 mg every other week [eow]; 15 – <30 kg, 20 mg eow; ≥30 kg, 40 mg eow) or BSA-D (24 mg/m² [maximum of 40 mg] eow). MedDRA observational adverse events (AEs) were recorded from registry entry through last contact, irrespective of duration of registry treatment with ADA±MTX.

Results:

Of the 537 pts enrolled in the ADA±MTX arm, 272 and 263 received F-D and BSA-D, respectively. At registry entry, F-D and BSA-D groups were similar for mean JIA duration (3.5 yrs vs. 3.9 yrs), JADAS27(CRP) (10.8 vs. 12.2), and CHAQ-DI (0.6 for both). Registry follow-up in the F-D and BSA-D groups were comparable [mean (range) in yrs: 3.96 (0.00–8.92) vs. 3.58 (0.00–7.01). Overall, 166 pts (61%) in the F-D and 128 (49%) in the BSA-D group discontinued registry drug. Frequencies and rates of observational AEs per 100 pt years of observation time (from registry entry up to last contact, irrespective of drug treatment duration) were comparable between groups (Table), including rates of serious infection. Two pts from the BSA-D group reported latent TB, although there were no cases of active TB across enrolling sites. One pt (0.2%) from the BSA-D group reported an event of opportunistic infection (fungal oesophagitis). There were no reports of death, malignancy, oral candidiasis, demyelination, or congestive heart failure.

Conclusion:

Overall, ADA±MTX was well-tolerated in pts with pJIA where administration has been with a fixed dose, per weight category, or based on BSA, respectively.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/the-safety-profile-of-adalimumab-across-geographic-regions-and-dosing-administrations-among-patients-with-juvenile-idiopathic-arthritis-enrolled-in-a-registry/