Re-treatment with etanercept effective in juvenile idiopathic arthritis
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Approximately 70% of patients with juvenile idiopathic arthritis who are re-treated with etanercept achieve inactive disease status 12 months after receiving the second course, according to data published in Arthritis Research & Therapy.
“Randomized clinical trials have shown that biologics are an effective treatment option when first used in patients with JIA,” Jens Klotsche, PhD, of the German Rheumatism Research Centre at the Leibniz Institute, in Berlin, told Healio Rheumatology. “We know little about how successfully these agents can be discontinued and used again, including in adulthood, after a disease flare.
“This information can be obtained from data from the biologics registry BIKER, and its follow-up registry JUMBO,” he added. “In the meantime, both registries have such a long follow-up in a large number of patients that it is possible to analyze the second biologic [disease-modifying antirheumatic drug] course in detail after discontinuation of first-line biologic DMARD in a large patient population with sufficient observation time. To date, there have been no prospective data of a large cohort published showing the effectiveness of retreatment with etanercept.”
To analyze the factors that correlate with etanercept (Enbrel, Amgen) discontinuation due to achieving inactive disease status and the subsequent risk for flare, as well as examine the effectiveness of the drug in re-treatment following said flare, Klotsche and colleagues studied data from two ongoing registries. The first registry, called Biologika in der Kinderrheumatologie/Biologics in Paediatric Rheumatology, or BIKER, launched in 2001 to examine the safety and effectiveness of biologic and conventional synthetic DMARDs in children and adolescents with JIA.
The second registry, called Juvenile arthritis Methotrexate/Biologics long-term Observation, or JUMBO, is the follow-up to BIKER and follows participants into adulthood. Both registries include individual trajectories of clinical and outcome data, from childhood to adulthood, in patients with JIA treated with biologic and conventional synthetic DMARDs.
For their study, Klotsche and colleagues analyzed data from 1,779 BIKER participants who were older than 18 years — to include those potentially eligible for JUMBO enrollment — who had received at least one dose of etanercept. Among these participants, 1,724 received a first treatment with etanercept, while 338 received the drug as a second-line course and 54 as a third. The observation period for each patient covered the total follow-up period from BIKER enrollment until the last available follow-up in JUMBO.
According to the researchers, there were similar rates of discontinuation due to ineffectiveness and adverse events in the first — 19.4% and 6.2%, respectively — second — 18.6% and 5.9% — and third — 14.8% and 5.6% — etanercept courses. In all, 332 patients discontinued the drug after achieving remission with the first course. Younger age (P<.001), persistent oligoarthritis (P=0.004), shorter duration between JIA onset and etanercept start (P<0.001), and a good response to therapy within the first 6months (P<0.001) significantly correlated to discontinuation with inactive disease.
Active disease returned for 77% of patients who discontinued, with a mean time to flare of 12.1months. The researchers reported that they could not identify any factor correlating to flare risk.
A total of 117, out of the 161 with reported flare, were re-treated with etanercept following the return of active disease. Subsequently, 19.7% of these patients discontinued the drug again after achieving an inactive disease, while about 70% achieved an inactive disease 12months after restarting etanercept.
“About one in five patients could discontinue etanercept after achieving an inactive disease,” Klotsche said. “An early biologic DMARD treatment start in the JIA disease course was associated with a higher likelihood to achieve inactive disease state and to discontinue etanercept. That can be used as an indication for a window of opportunity in JIA. Subsequently, patients who discontinued etanercept due to an inactive disease showed a high risk for a disease flare — about 50%. Patients who were re-treated responded well to etanercept in the second treatment course, with a rate of inactive disease of about 70% after 12 months.
“Physicians should start early treatment according to the treat-to-target principle to achieve the therapy goal of an inactive disease or even remission in patients with JIA,” he added. “Etanercept provides an effective treatment for JIA patients on a severe polyarticular disease course. If there is a primary good response to etanercept in the first treatment course, physicians can continue to use etanercept in subsequent treatment cycles because there appears to be no loss of effectiveness.”
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