Baricitinib bij patiënten met reumatoïde artritis

Outcomes of patients with rheumatoid arthritis (RA) have improved markedly over the last decades, mainly due to the availability of novel biological therapies and the practice of adjusting treatment to ensure that predefined disease activity targets are met and maintained over time, i.e. treat to target (T2T). Despite these developments, sustained disease control still cannot be achieved in a substantial subpopulation of patients in clinical practice. Recently, a new class of so called targeted synthetic disease modifying drugs (tsDAMRD) has become available as a potential additional second line treatment option for patients with RA. However, not much is currently known about the real-world benefits these medications provide when applied within contemporary T2T based management strategies. The study objective is to demonstrate non-inferiority of a T2T strategy in which conventional synthetic disease modifying drugs (csDMARDs) refractory RA patients are initially treated with tsDMARD baricitinib versus the comparable T2T strategy in which patients are initially treated with a biological tumor necrosis factor inhibitor (TNFi) in a pragmatic randomized trial.

Non-inferiority of tsDAMRD first versus TNFi first in terms of ACR50 response at 12 weeks

Data collection and follow-up will take place at baseline, and 12-weekly thereafter until final follow up at 48 weeks.

Patients will be randomized (1:1) to a treatment strategy starting with tsDMARD or a treatment strategy starting with TNFi. Patients will be followed up over the course of 48 weeks with scheduled clinic visits at 0, 12, 24, 36, and 48 weeks, and will also be encouraged to schedule visits if they experience a disease flare or adverse events in between scheduled visits. At each visit, disease activity guided therapeutic adjustments will be made as necessary, with the aim of achieving clinical remission. In both groups, therapeutic adjustments include the option to taper or switch medication, depending on the clinical status of the patient.