When to stop treatment: new Prevent study

PREVENT study brief outline – Dirk Föll

 

With MTX therapy, remission can be induced in the majority of JIA patients. Those continuing medication can remain symptom-free (also referred to as “remission on medication”) and up to 50% of such patients reach a continuous status of remission after discontinuing medication (also referred to as “remission off medication”). However, this also means that 50% of the patients have flares after withdrawing or tapering therapy. Therefore, in clinical practice many physicians continue MTX therapy because they fear a flare-up of the disease after stopping although half of the patients could potentially do without medication. We have shown that phagocyte-specific S100 proteins are markers of innate immune activation that are elevated in patients with risk of relapse after MTX withdrawal.[1] However, it needs to be demonstrated that these biomarkers allow a reliable stratification of patients for individualized decisions to maintain or stop MTX. We will thus perform a prospective interventional trial in which 100 polyarticular JIA patients are included. Those with subclinical disease activity and high risk of relapse (indicated by elevated S100A12 or hsCRP) will remain on therapy while those with low biomarkers will stop. As a control cohort, 200 matched patients will be followed-up in existing MTX registries after withdrawal of therapy based solely on the physician’s decision. The rate of flares within 1 year and the cumulative dose of MTX in the two cohorts will be compared.

 

Who we are

The Department of Pediatric Rheumatology and Immunology at the University Hospital Münster has a special focus on autoinflammatory and systemic rheumatic diseases of childhood. Our scientific focus is on innate immune mechanisms and biomarker discovery. The department is currently under re-construction as a clinical-translational specialty service with a planned team of 3 Pediatric Rheumatologists, 2 Pediatric Immunologists, 5 Scientists, and a number of Allied Health Professionals.

We are working in several research networks, both on a national and international level. PREVENT is planned as an international multi-center trial involving 5-8 strong Pediatric Rheumatology departments.


[1] Foell D, Wulffraat N, Wedderburn LR, et al. Comparison of 6-month vs 12-month withdrawal of methotrexate in patients with juvenile idiopathic arthritis in clinical remission: a randomized controlled trial. JAMA 2010;303:1266-73

Gerss J,…, Foell D. Phagocyte-specific S100 proteins and high-sensitivity C-reactive protein as biomarkers for a risk-adapted therapy to maintain remission in juvenile idiopathic arthritis: a comparative study. Ann Rheum Dis 2012 Jun 11. [Epub ahead of print]


  
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