Gobivaz is an anti\-inflammatory medicine. It is used to treat the following diseases: * active rheumatoid arthritis (a disease causing inflammation of the joints). Gobivaz is used in combination with methotrexate (a medicine that acts on the immune system). It can be used in adults who have not responded adequately to other treatments including methotrexate whose disease is moderate to severe, and in adults who have not previously been treated with methotrexate whose disease is severe and progressive; * active and progressive psoriatic arthritis (a disease causing red, scaly patches on the skin and inflammation of the joints). Gobivaz is used in adults who have not responded adequately to other treatments. It can be used alone or in combination with methotrexate; * axial spondyloarthritis (a disease causing inflammation and pain in the joints of the spine), including: + adults with severe active ankylosing spondylitis who have not responded adequately to other treatments; + adults with severe non\-radiographic axial spondyloarthritis (when there are objective signs of inflammation but no abnormalities seen on x\-ray) who have not responded adequately or are intolerant to anti\-inflammatory medicines called non\-steroidal anti\-inflammatory drugs (NSAIDs); * moderately to severely active ulcerative colitis (a disease causing inflammation and ulcers in the lining of the gut). Gobivaz is used in adults who have not responded adequately to, or cannot use, conventional treatment; * polyarticular juvenile idiopathic arthritis (a rare childhood disease causing inflammation of many joints). Gobivaz is used in combination with methotrexate. It is used in children from 2 years of age who have not responded adequately to treatment with methotrexate. Gobivaz contains the active substance golimumab and is a biological medicine. It is a ‘biosimilar medicine’; this means that Gobivaz is highly similar to another biological medicine (the ‘reference medicine’) that is already authorised in the EU. The reference medicine for Gobivaz is Simponi.
Therapeutic Indication
**Rheumatoid arthritis (RA)** Gobivaz, in combination with methotrexate (MTX), is indicated for: * the treatment of moderate to severe, active rheumatoid arthritis in adults when the response to disease\-modifying anti\-rheumatic drug (DMARD) therapy including MTX has been inadequate. * the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with MTX. Golimumab, in combination with MTX, has been shown to reduce the rate of progression of joint damage as measured by X\-ray and to improve physical function. **Juvenile idiopathic arthritis** *Polyarticular juvenile idiopathic arthritis (pJIA)* Gobivaz in combination with MTX is indicated for the treatment of polyarticular juvenile idiopathic arthritis in children 2 years of age and older, who have responded inadequately to previous therapy with MTX. **Psoriatic arthritis (PsA)** Gobivaz, alone or in combination with MTX, is indicated for the treatment of active and progressive psoriatic arthritis in adult patients when the response to previous DMARD therapy has been inadequate. Golimumab has been shown to reduce the rate of progression of peripheral joint damage as measured by X\-ray in patients with polyarticular symmetrical subtypes of the disease and to improve physical function. **Axial spondyloarthritis** *Ankylosing spondylitis (AS)* Gobivaz 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)* Gobivaz 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). **Ulcerative colitis (UC)** Gobivaz is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6\-mercaptopurine (6\-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies. **Paediatric ulcerative colitis (pUC)** Gobivaz is indicated for the treatment of moderately to severely active ulcerative colitis in paediatric patients 2 years of age and older with a body weight of at least 15 kg, who have had an inadequate response to conventional therapy, including corticosteroids and 6\-mercaptopurine (6\-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.
Therapeutic Area (MeSH)
ATC Code
L04AB06
ATC Item
N/A
Pharmacotherapeutic Group
Immunosuppressants
Active Substance (Summary)
INN / Common Names
EMA Name
Gobivaz
Medicine Name
Gobivaz
Aliases
N/ANo risk management plan link.
