Benepali™ in combination with methotrexate, is indicated for:

• the treatment of moderate to severe active rheumatoid arthritis in adults when the response to disease-modifying antirheumatic drugs, including methotrexate (unless contraindicated), has been inadequate;
• the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate.

Benepali™ can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.

Benepali™, alone or in combination with methotrexate, has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function (see Section 5.1 of the Summary of Product Characteristics).

Ankylosing spondylitis (AS)

Benepali™ is indicated for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy.

Non-radiographic axial spondyloarthritis

Benepali™ is indicated for the treatment of adults with severe non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and / or magnetic resonance imaging (MRI), who have had an inadequate response to nonsteroidal anti-inflammatory drugs (NSAIDs).

Benepali™ is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying antirheumatic drug therapy has been inadequate.

Etanercept has been shown to improve physical function in patients with psoriatic arthritis, and to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease (see Section 5.1 of the Summary of Product Characteristics).

Benepali™ is indicated for the treatment of adults with moderate to severe plaque psoriasis who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy, including ciclosporin, methotrexate or psoralen and ultraviolet-A light (PUVA) (see Section 5.1 of the Summary of Product Characteristics).

Benepali™ is also indicated for the treatment of psoriatic arthritis in adolescents from the age of 12 years who have had an inadequate response to, or who have proved intolerant of, methotrexate.

Etanercept has not been studied in patients aged less than 2 years.

Polyarthritis (rheumatoid factor positive or negative) and extended oligoarthritis

Benepali™ is indicated for the treatment of polyarthritis (rheumatoid factor positive or negative) and extended oligoarthritis in children and adolescents from the age of 2 years who have had an inadequate response to, or who have proved intolerant of, methotrexate.

Etanercept has not been studied in patients aged less than 2 years.

Enthesitis-related arthritis

Benepali™ is indicated for the treatment of enthesitis-related arthritis in adolescents from the age of 12 years who have had an inadequate response to, or who have proved intolerant of, conventional therapy.

Etanercept has not been studied in patients aged less than 2 years.

Benepali™ is indicated for the treatment of chronic severe plaque psoriasis in children and adolescents from the age of 6 years who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.