Background/Purpose: We aimed to study the outcomes (remission, flare, and adverse events) of biological disease-modifying anti-rheumatic drugs (bDMARD) in children with JIA from a low-middle-income country setting, and explore the factors associated with these outcomes.

Methods: The Pediatric Rheumatology Clinic bDMARD register (2009 to August 2024) was screened to enrol children with JIA and at least 3 months of follow-up whilst on bDMARDs. Participant characteristics and clinical responses were collected in a pre-designed proforma to evaluate the primary objective i.e. studying outcomes among children with JIA on bDMARDs. The secondary objective was to study factors associated with time-to-remission (TTR) and flare-after-stopping-bDMARDs.The study was approved by the Institute Ethics Committee (IECPG-596/20/09.2023, RT-02/21.02.2024). Consent was waived for this retrospective study.

Results: One-hundred-fifteen children (59.1% boys) with 168 patient-years of bDMARD use were enrolled for this study. Enthesitis-related-arthritis was the commonest subtype of JIA (n=44, 38.3%). The most commonly used bDMARD was adalimumab (n=43, 37.3%). The median (IQR) delay to initiation of bDMARD from the perceived need was 2 (0-6) months, primarily due to financial impediments (n=81, 70.4%). Fifteen (13%) children screened positive for tuberculosis infection. One hundred ten (95.6%) children achieved remission on bDMARD, after a median (IQR) of 7.5 (4-12) weeks. Macrophage activation syndrome at initiation was significantly associated (HR 3.1 (1.1-8.8), p=0.03) with a longer time-to-remission. bDMARDs were stopped in n=68/115 (59.1%) after a median (IQR) 15 (9.6-26.5) months, of whom n=33/68 (48.5%) flared during the next 6 (3.5-12) months. Longer time-to-remission (OR 1.12 (1-1.2), p=0.02) was significantly associated with flare after stopping bDMARDs. Forty-two (36.5%) patients experienced adverse events. The most striking adverse events were serious infections requiring hospitalisation (n=13, 11.3%) and tuberculosis (n=4, 3.4%). All children who developed tuberculosis were on TNFi (Adalimumab).

Conclusion: : Though children on bDMARDs showed comparable remission rates, we noted a higher frequency of serious infections and tuberculosis, compared to the experience described from high-income countries. These observations highlight the need for further surveillance of outcomes of bDMARD use in JIA in an LMIC setting.

Key characteristics

Analyses for factors associated with time-to-remission (A), flare after stopping (B)

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/outcomes-of-children-with-juvenile-idiopathic-arthritis-receiving-biological-disease-modifying-anti-rheumatic-drugs-retrospective-analysis-of-a-real-world-experience-from-a-resource-limited-setting/