Reason for request

Extension of indication

Insufficient actual benefit in the treatment of rheumatoid arthritis in adults previously untreated with methotrexate or other disease-modifying treatments.

  • CIMZIA, in combination with methotrexate (MTX), now has Marketing Authorisation in the treatment of severe, active and progressive rheumatoid arthritis (RA) in adults previously untreated with MTX or other disease-modifying treatments.
  • It is preferable, at an early stage, to await a response to the first line treatment with methotrexate with a dynamic therapeutic adaptation strategy and, if need be, to introduce a targeted treatment in the event of inadequate response to methotrexate or methotrexate intolerance.
  • CIMZIA has no place in the treatment strategy of patients previously untreated with a conventional disease-modifying treatment, in particular MTX.

 

 

 

 


Clinical Benefit

Insufficient

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Clinical Added Value

Not applicable

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Therapeutic use

-

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