Reason for request

Re-assessment of the actual benefit

Insufficient actual benefit in the treatment of active, severe and progressive rheumatoid arthritis in adults not previously treated with methotrexate or another conventional disease-modifying drug.

 

  • ENBREL, HUMIRA, REMICADE have Marketing Authorisation in first-line treatment of active, severe and progressive rheumatoid arthritis, in patients not previously treated with methotrexate (MTX) or for REMICADE, with another conventional disease-modifying drug.
  •  It is preferable, at an early stage, to expect a response to first-line treatment with methotrexate, with a treatment adjustment strategy, and to introduce, where applicable, a targeted treatment in case of insufficient response or intolerance of methotrexate.
  • ENBREL, HUMIRA, REMICADE have no role in the treatment strategy for patients who have not been previously treated with MTX or with other conventional treatments.

Clinical Benefit

Insufficient

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Therapeutic use

-

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