STOP-JIA: 'Early combination' DMARD, biologic may improve key outcomes in polyarticular JIA
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Three strategies aimed at starting patients with polyarticular juvenile idiopathic arthritis on different combinations of DMARDs and biologics resulted in similar rates of clinically inactive disease without glucocorticoids at 12 months, according to data.
However, a strategy that employed an early combination of DMARDs and biologics demonstrated some potential improvement in disease activity scores and earlier discontinuation of glucocorticoids.
The three treatment plans, which were developed by the Childhood Arthritis and Rheumatology Research Alliance (CARRA), included initial non-biologic DMARD monotherapy, with a biologic added if necessary; DMARD and biologic started together; and biologic monotherapy. The researchers published their findings in Arthritis & Rheumatology.
“This was one of the largest prospective studies of untreated polyarticular JIA that has been successfully completed,” Yukiko Kimura, MD, of the Joseph M. Sanzari Children's Hospital, Hackensack Meridian School of Medicine, in New Jersey, told Healio Rheumatology. “Although we have many new treatments for JIA that are very effective, providers and families do not know which type of medication should be started first for a patient with polyarticular JIA to have the best outcomes. CARRA developed a concept called consensus treatment plans (CTPs) to help address being able to do comparative effectiveness research in pediatric rheumatic diseases.”
To compare CARRA’s three consensus treatment plans, Kimura and colleagues conducted the prospective, observational Start Time Optimization of biologics in the PJIA (STOP-JIA) study. Participants included 400 patients, aged 19 years or younger, with untreated polyarticular JIA who had presented to one of 56 CARRA Registry sites. Enrollment stretched from December 2015 to August 2018, with follow-up completed in September 2019.
Among the participants, 257 were assigned the “step up” strategy, or an initial non-biologic DMARD monotherapy, with a biologic added if necessary. Meanwhile, 100 patients received the “early combination” strategy, which saw a DMARD and biologic started together, and 43 were assigned to “biologic first,” where they received biologic monotherapy. The primary outcome was clinically inactive disease without glucocorticoids at 12 months. Secondary outcomes included PROMIS pain interference and mobility, inactive disease — based on a clinical Juvenile Arthritis Disease Activity Score (cJADAS10 ID) of 2.5 or less — and pediatric ACR70 response.
According to the researchers, after propensity score weighting and multiple imputation, clinically inactive disease at 12 months without glucocorticoids was achieved in 32% of those in the “step up” group, 37% of those in the “early combination” group, and 24% of those who received the “biologic first” strategy (P = .17).
Results for the secondary outcome also favored the “early combination” strategy over “step up,” with 59% and 43% meeting the cJADAS10 ID endpoint, respectively (P = .03), and 80% versus 64% achieving the pediatric ACR70 response (P = .008). However, generalizability was limited because of missing data, the researchers wrote.
PROMIS measures improved across all groups, but without significant differences, they added. There were 17 total serious adverse events reported, with most being infections.
“While the primary outcome did not show a significant difference, these results support that idea that earlier use of biologic DMARDs and the early combination strategy may be best for some patients,” Kimura said. “This needs further confirmation.”
“Although there are certainly some patients that will respond well to conventional synthetic DMARDs such as methotrexate alone, and may not need to start a biologic DMARD, if a patient isn't responding quickly, clinicians and families should probably not wait too long to start biologic DMARDs,” she added. “Longer-term outcomes of the patients enrolled in STOP-JIA will be available and will be informative, since many of these patients will continue to be followed for at least 10 years in the CARRA Registry.”
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