Biologic therapies made clinical remission an achievable goal for most juvenile idiopathic arthritis (JIA) patients. Nevertheless, antirheumatic drugs have side effects and are costly. Currently, no guidelines exist for withdrawing drugs in JIA patients with clinical inactive disease (CID). Relapses following the withdrawal of antirheumatic drugs are common. To establish an optimal timeline for treatment discontinuation is a major unmet need in pediatric rheumatology.
It is hypothesized that biomarkers-guided early withdrawal of antirheumatic drugs in patients achieving clinical, imaging and biological remission is safe and more effective compared to the standard practice of maintenance of stable treatment over 12 months.
- Children with a diagnosis of JIA according to the ILAR classification criteria
JIA patients who satisfy criteria for inactive disease for a minimum of 6 continuous months while still taking medication.
Patients who have been treated with cs/b/bs/ts DMARDs according to the label indication
Ability to comply with the entire study procedures, ability to communicate meaningfully with the investigational staff, competence to give written informed consent; to be applied to the parents and/or patients, as appropriate
- Patients with systemic JIA according to ILAR criteria
Patients with undifferentiated arthritis according to ILAR criteria
Patients with severe disease-related ocular damage and who need systemic treatment for uveitis
Patients who received glucocorticoid treatment 3 months prior to baseline visit
Parallel
Treatment medication withdrawal strategy
Other interventionThe study aims to compare early biomarkers-guided versus conventional unguided drugs withdrawal strategy.
Effectiveness of early biomarker-guided withdrawal of antirheumatic agents
At each timepoint the following procedures will be performed: joint assessment, Physician's Global Assessment of Overall Disease Activity, JAMAR, Uveitis assessment (in ANA positive patients), Hematology, chemistry, CRP, ESR, urine analysis according to drug specific schedule and Good Clinical Practice (GCP). Drug Adverse Events will be collected (MedDRA), to measure safety and efficacy of early biomarker-guided withdrawal of antirheumatic agents in JIA patients achieving 6 months clinical inactive disease (CID) who do not have subclinical inflammation when compared to the standard practice of maintenance of stable treatment intensity over 12 months.
Rate of flare
To compare rate and time to flare in the randomized arms. Disease flare is defined as any patient who will loose the status of inactive disease or has a clinical Juvenile Arthritis Disease Activity Score (cJADAS)10 \>1.5 or 2.5 for oligoarticular or polyarticular disease, respectively and prompt the caring physician to make a major therapeutic intervention that could include an intrarticular glucocorticoid injection, the start of systemic glucocorticoid therapy, the restart of cs/b/ts-DMARDs at the conventional regimen. Frequencies of flares will be analyzed in both study arms and will be compared by means of the Chi-square test or the Fisher's exact test whenever appropriate. Bionomial exact 95% confidence interval will be also computed and reported.
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