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|Summary of Clinical Use|
|Sarilumab was granted FDA approval as a treatment for moderate to severe active RA in May 2017 (with EMA approval granted in June 2017), following evaluation in several clinical trials, either as a monotherapy (eg NCT02121210) or in combination with other drugs such as etanercept, methotrexate, tocilizumab and adalimumab.
Click here to link to ClinicalTrials.gov's listing of Phase III sarilumab trials. A Phase II study for non-infectious uveitis (NCT01900431) has been completed, whereas a Phase II extension study (NCT01118728) for ankylosing spondylitis was terminated.
|Mechanism Of Action and Pharmacodynamic Effects|
|Interleukin 6 (IL6) is a potent pleiotropic cytokine that regulates cell growth and differentiation and plays an important role in the immune response. Dysregulated production of IL6 and its receptor are implicated in the pathogenesis of autoimmune diseases such as RA. Sarilumab blocks the abberant IL6R signalling associated with RA, thereby modulating pathological symptoms.|
For extended ADME data see the following:
Electronic Medicines Compendium (eMC)
European Medicines Agency (EMA)