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Switch to sarilumab from adalimumab is efficacious and safe

Presented By
Dr Gerd Burmester, Free University and Humboldt University of Berlin, Germany
EULAR 2019

Switching from adalimumab to sarilumab improves signs and symptoms in patients with rheumatoid arthritis (RA). The safety profile in the open-label-extension (OLE) study was consistent with that observed in the prior MONARCH study.

In the MONARCH trial, patients who were intolerant or responded inadequately to methotrexate received sarilumab subcutaneously (200 mg twice weekly; n=184) or adalimumab (40 mg twice weekly; n=185) for a total of 24 weeks. The results showed sarilumab monotherapy to be superior compared with adalimumab monotherapy in DAS28-ESR, ACR20/50/70 response, HAQ-DI, and CDAI. Dr Gerd Burmester (Free University and Humboldt University of Berlin, Germany) et al. aimed to assess long-term efficacy and safety in RA patients continuing sarilumab (n=165) or switching from adalimumab to sarilumab monotherapy (n=155) in the OLE follow-up study of MONARCH.

The results showed that, with regard to the primary DAS28-ESR and CDAI endpoints, >40% of switched patients achieved a minimally important difference (MID) improvement from OLE baseline by OLE week 12, increasing to >50% by OLE week 48. Furthermore, >40% of switched patients achieved a MID in DAS28-CRP and a minimally clinically important difference (MCID) in HAQ-DI from OLE baseline to OLE week 48. A sustained response at OLE weeks 36 and 48 was reached by 70.7% (switched group) and 83.5% (continuation group) of patients, indicated by achieving CDAI ≤10 from baseline OLE. Both groups had similar rates of treatment-emergent adverse events (switch: 76.1%, continuation: 70.9%) and infections (switch: 41.9%; continuation: 35.8%). In terms of adverse events, 2 deaths occurred in the switch group (malignancy; cerebrovascular accident) versus 1 in the continuation group (subarachnoid haemorrhage). No gastro-intestinal-related adverse events (ulcerations/perforations/diverticulitis) were observed. These findings support the existing view that IL-6 pathway antagonism is valuable in subjects that are intolerant of methotrexate.

  1.  Burmester GR, et al. Abstract SAT0137. EULAR 2019

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