MADRID – Many children with juvenile idiopathic arthritis (JIA) who do well on biologics for a prolonged period will stay in remission after the medication is withdrawn, some new real-world data suggest.
A database review found that 70% of those in remission for at least 1.5 years remained in remission after stopping their biologic agent. Patients taking tocilizumab had the best outcomes, with 8 months of sustained, drug-free remission and only a 12% rate of disease flare, Ekaterina Alexeeva, MD, reported at the European Congress of Rheumatology.
Dr. Ekaterina Alexeeva
“Prolonged therapy with biologic agents may cause adverse events which lead to the necessity of discontinuation of therapy in patients once complete disease quiescence has been achieved,” she said. While long-term drug studies do offer some glimpse into the stability of remission after drug discontinuation, these data don’t often reflect real-world experience.
“Clinical trials are made up of highly selected participants in contorted conditions with limited duration. Real-word data, collected under real-life practical circumstances, provide additional characteristics of patient populations, information on the effectiveness and safety of treatment over time, and the outcomes we can achieve under real-world conditions,” Dr. Alexeeva said.
She plumbed a national JIA database to find 83 patients who had achieved longstanding clinical remission on a biologic therapy, then either rapidly discontinued treatment (61) or went through a tapering protocol (22), according to their doctors’ decision. These children were a mean of 11 years old, with mean disease duration of 2 years before the initiation of a biologic treatment. Systemic JIA was present in 40%; 22% had oligoarthritis, and 38% had polyarthritis.
All of the patients with systemic JIA were taking tocilizumab, although only 25% took it as monotherapy. Other medications being used were methotrexate (42%), cyclosporine (15%), glucocorticoids (15%), and leflunomide (3%).
For those with oligo- and polyarthritis, etanercept was the most commonly employed biologic (70%), followed by adalimumab (30%). Most (68%) were on monotherapy with their agent; however, 18% of those taking etanercept and 14% of those taking adalimumab were also taking methotrexate.
Before discontinuing their medication, the systemic JIA patients taking tocilizumab had a mean 43 months of inactive disease and a mean 37 months of remission. Among those taking adalimumab, the mean period of inactive disease was 48 months and the mean remission was 40 months. Among those taking etanercept, the mean period of inactive disease was 40 months and the mean remission was 34 months.
After discontinuing the biologic, the mean overall remission length was 6 months for all patients. However, this varied considerably with diagnosis and medication, Dr. Alexeeva noted. For systemic JIA patients taking tocilizumab, remission ranged from a minimum of 1 month to a maximum of 48 months. For those taking adalimumab, remission ranged from 4 to 38 months. Remission ranged from 1 to 20 months among those taking etanercept.
Disease flare occurred in 12% of those taking tocilizumab, at a mean of 8 months after discontinuation; 31% of those taking etanercept at a mean of 5.5 months; and 60% of those taking adalimumab at a mean of 4 months. Time to flare was longest among those taking tocilizumab (6-18 months), followed by etanercept (1.5-12 months) and adalimumab (1-13 months).
Dr. Alexeeva disclosed research funding and support from numerous pharmaceutical companies.
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