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Treatment pause leads to high rate of relapse in children with a type of autoimmune eye inflammation
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<span>Treatment pause leads to high rate of relapse in children with a type of autoimmune eye inflammation</span>
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NIH-supported findings suggest stopping treatments should be approached with caution
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February 12, 2025
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<p>According to a National Institutes of Health (NIH)-funded clinical study, children with a type of autoimmune arthritis and associated eye inflammation are likely to experience disease recurrence when discontinuing a biologic therapy called adalimumab. Adalimumab effectively controls the condition, known as juvenile idiopathic arthritis with uveitis. However, many patients seek to stop or pause therapy due to high cost, the burden of injections, and potential, serious side effects. For those who wish to try stopping treatment, careful monitoring to prevent permanent vision loss is important. The findings, funded by NIH’s National Eye Institute (NEI), were published in The Lancet on January 25, 2025.</p><p>“Children with juvenile arthritis often need medications to control ocular inflammation for many years,” said Nisha Acharya, M.D., University of California, San Francisco, lead author of the study. “Ideally, we can find ways to reduce the burden of these treatments, which carry a risk of side effects and are very costly. Self-administered injections can also be difficult for patients and families. While some children may benefit from stopping treatment, the high risk of relapse suggests this process should be approached with caution by clinicians.”</p><p>Juvenile idiopathic arthritis is a chronic autoimmune disease that causes rashes, joint pain, swelling, and stiffness, as well as eye inflammation that can lead to blindness if untreated. Several drugs are commonly used to treat the condition, including anti-inflammatories, corticosteroids, methotrexate, and biologics such as adalimumab. However, because many of these drugs are expensive and have serious side effects—including increased susceptibility to infection—many patients seek to safely reduce their drug treatments. For those taking adalimumab, clinicians have worried that the drug might not work as well if patients need to resume treatment after a pause.</p><p>To investigate whether patients can safely pause adalimumab treatment, NEI funded the Adalimumab in Juvenile Idiopathic Arthritis-associated Uveitis Stopping Trial (ADJUST), which enrolled 87 children with juvenile arthritis and associated uveitis at clinical sites across the United States, the United Kingdom, and Australia. All the participants were already taking adalimumab and had achieved control of their arthritis and uveitis for at least one year. Half the participants were randomly assigned to receive a placebo, while the remainder continued taking adalimumab. </p><p>Over the following 48 weeks, 68% of the participants in the placebo group experienced recurrence of inflammation, compared to 14% of those in the adalimumab group. All the participants in the placebo group who experienced recurrence were able to successfully control their uveitis by restarting adalimumab. Participants in the placebo group mostly experienced recurrence within the first six months of the study, and all regained control of their uveitis prior to the end of the 48-week trial. The remaining 32% of participants in the placebo group remained in remission for the duration of the study.</p><p>The study found that while most children needed to restart treatment, a subset of children in the study did not see a recurrence of uveitis or arthritis after stopping, suggesting stopping could potentially be beneficial for some children. But because the type of uveitis that occurs with juvenile arthritis rarely causes pain, redness, or visual symptoms until quite advanced, the authors emphasized that if children want to try stopping adalimumab, they should be carefully monitored by an eye doctor to ensure that any eye inflammation is caught before damage occurs.</p><p>Guidelines in the <a href="https://rheumatology.org/juvenile-idiopathic-arthritis-guideline#2019-jia-uveitis-guideline">United States</a> and <a href="https://ard.bmj.com/content/77/8/1107">Europe</a> recommend that patients have controlled inflammation for at least two years before trying to stop adalimumab treatment. However, these guidelines were created without supporting clinical trial data. This study is the first randomized, controlled trial to provide actionable information about stopping adalimumab treatment in children with juvenile arthritis-associated uveitis.</p><p>“Seventy percent of the participants in this study had controlled uveitis for over two years on adalimumab, but they still had a high risk of recurrence, even if they were taking another drug such as methotrexate,” said Acharya. “The data indicates that time in remission while on medication is not a good indicator of whether disease will recur.”</p><p>Moving forward, the study team plans to explore additional strategies that could help patients, including reducing the frequency of adalimumab treatments. They also will look for ways to predict which children will stay in remission and which will experience disease recurrence after stopping treatment, which may help clinicians better understand who may be at lower risk of relapse.</p><p>The ADJUST study, clinicaltrials.gov number <a href="https://www.clinicaltrials.gov/study/NCT03816397">NCT03816397</a>, was funded by NEI. AbbVie Inc. provided the study drug and placebo. </p><p> </p><p>Reference: Acharya NR, Ramanan AV, et al, for the ADJUST Study Group. “Adalimumab in Juvenile Idiopathic Arthritis (JIA)-associated Uveitis Stopping Trial (ADJUST): a multicentre, double-masked, randomised, placebo-controlled trial.” The Lancet. Jan 25, 2025. <a href="https://doi.org/10.1016/s0140-6736(24)02468-1">https://doi.org/10.1016/s0140-6736(24)02468-1</a></p><hr><p>NEI leads the federal government’s research on the visual system and eye diseases. NEI supports basic and clinical science programs to develop sight-saving treatments and address special needs of people with vision loss. For more information, visit <a href="/">https://www.nei.nih.gov</a>. </p><p>About the National Institutes of Health (NIH): NIH, the nation’s medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit <a href="https://www.nih.gov/">https://www.nih.gov/</a>. </p><p>NIH…Turning Discovery Into Health® </p>
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