'Starting biologics early' with DMARDs may boost polyarticular JIA outcomes at 2 years
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Early, aggressive treatment with a biologic alongside a conventional DMARDs for juvenile idiopathic arthritis achieved clinically inactive disease at 24 months more frequently than other strategies, said a presenter at ACR Convergence 2021.
“We know that polyarticular JIA patients are at risk for poor outcomes, and we have begun to understand that initial therapy is critical and may impact outcomes, especially if effective, positively,” Yukiko Kimura, MD, of Hackensack University Medical Center, in New Jersey, told attendees at the virtual meeting. “But there is very little evidence to support when the best time is to start biologics. To address this issue, [the Childhood Arthritis & Rheumatology Research Alliance (CARRA)] developed standardized consensus treatment plans, or CTPs, to reflect the most commonly used strategies for starting biologics to use in comparative-effectiveness research.”
To compare three consensus treatment plans for polyarticular JIA developed by CARRA, specifically to determine whether the timing of biologics is important in overall outcomes, Kimura and colleagues conducted the non-randomized, observational STOP-JIA study.
The three CARRA treatment plans were “step up,” which starts conventional, synthetic DMARDs before adding a biologic after at least 3 months, if necessary; “early combination,” in which biologic and conventional, synthetic DMARDs are started together; and “biologic first,” which begins with biologic monotherapy, with conventional, synthetic DMARDs added if needed after at least 3 months.
The researchers collected data on 291 patients with 2 years of follow-up from the CARRA Registry. Data were collected every 3 months for the first year, and subsequently every 6 months. Among the included patients, 188 received step-up therapy, 76 received the early combination treatment plan, and 27 received biologic first. The primary outcome was the proportion of patients who achieved clinically inactive disease without glucocorticoids at 24 months, with propensity score weighting used to balance baseline differences in confounders between the treatment plans.
Secondary outcomes included clinical Juvenile Arthritis Disease Activity Score based on 10 joints (cJADAS10), Pediatric ACR 70 (pACR70) and patient-reported outcome measures.
According to the researchers, there were significant baseline differences between the treatment plans for several variables, including JIA categories, the number of active joints, Physician Global Assessment of Disease Activity, and cJADAS10. In all, 52% of those who received early combination therapy achieved clinically inactive disease at 24 months, compared with 42% for step-up therapy and 44% for the biologic-first treatment plan. There was a statistically significant difference (P = .006) between the step-up and early-combination groups after propensity score weighting at 24 months, the researchers wrote.
Meanwhile, there were no significant differences between the proportions of patients who achieved cJADAS10 inactive disease or the pACR70 outcome. In addition, patients in all three groups continued to improve at 24 months compared to 12 months.
The proportion of patients in the step-up group who achieved the cJADAS10 outcome was 45% at 12 months and 59% at 24 months. For the early combination group, it was 60% and 66%, respectively, and for those who received the biologic-first plan, it was 48% and 57%, respectively. For the pACR70 outcomes, the figures at 12 and 24 months were 47% and 74%, respectively, in the step-up group, 59% and 83% for early combination, and 44% and 74% for biologic first.
All groups demonstrated improvement in PROMIS pain interference or mobility measures from baseline. The researchers recorded a total of 17 serious adverse events, most commonly infections.
“It is encouraging that outcomes in all three groups improved compared to 12 months,” Kimura said. “The 24-months results support the 12-month primary results, which suggested that the early combination group was superior, and at 24 months more combination CTP patients achieved clinically inactive disease compared to step-up. This suggests that starting biologics early in polyarticular JIA may lead to better long-term outcomes in many patients. However, polyarticular JIA continues to be a challenging disease to treat, with 40% to 60% of patients in our cohort not achieving clinically inactive disease at 24 months.”
“However, the median JDAS was less than or equal to 2.5 in all three groups, which is encouraging,” she added. “Longer-term outcomes like these offer critical information, and more durable information, about the status of these patients. We will be able to continue to assess these and other outcomes over time, fortunately, because registry follow-up will continue for 10 or more years.”
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Kimura Y. Abstract 0960. Presented at: ACR Convergence 2021; November 5-9, 2021 (virtual meeting).
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