Axial spondyloarthritis

Active Ingredient: Golimumab

Indication for Golimumab

Population group: only adults (18 years old or older)

Ankylosing spondylitis (AS)

Golimumab is indicated for the treatment of severe, active ankylosing spondylitis in adults who have responded inadequately to conventional therapy.

Non-radiographic axial spondyloarthritis (nr-Axial SpA)

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

For this indication, competent medicine agencies globally authorize below treatments:

50 mg once a month

Route of admnistration

Subcutaneous

Defined daily dose

50 - 50 mg

Dosage regimen

From 50 To 50 mg once every 30 day(s)

Detailed description

Golimumab 50 mg given once a month, on the same date each month. Golimumab should be given concomitantly with MTX.

For all of the above indications, available data suggest that clinical response is usually achieved within 12 to 14 weeks of treatment (after 3-4 doses). Continued therapy should be reconsidered in patients who show no evidence of therapeutic benefit within this time period.

Patients with body weight greater than 100 kg

For all of the above indications, in patients with RA, PsA, AS, or nr-Axial SpA with a body weight of more than 100 kg who do not achieve an adequate clinical response after 3 or 4 doses, increasing the dose of golimumab to 100 mg once a month may be considered, taking into account the increased risk of certain serious adverse reactions with the 100 mg dose compared with the 50 mg dose. Continued therapy should be reconsidered in patients who show no evidence of therapeutic benefit after receiving 3 to 4 additional doses of 100 mg.

Active ingredient

Golimumab

Golimumab is a human monoclonal antibody that forms high affinity, stable complexes with both the soluble and transmembrane bioactive forms of human TNF-α, which prevents the binding of TNF-α to its receptors.

Read more about Golimumab

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