Golimumab (Simponi®), a fully human
monoclonal antibody against tumour
necrosis factor-alpha (TNFα), is given once monthly by
subcutaneous injection. In the EU,
golimumab is approved as monotherapy and/or in combination with
methotrexate for the treatment of inflammatory
arthritis, including
rheumatoid arthritis (RA),
psoriatic arthritis (PsA) and
axial spondyloarthritis [comprising
ankylosing spondylitis (AS) and
non-radiographic axial spondyloarthritis (
nr-axSpA)] in adults, and
polyarticular juvenile idiopathic arthritis (pJIA) in children. These approvals were based on the observations that
golimumab was generally well tolerated and conferred some or all of the following benefits in pivotal studies in these settings: reduced signs and symptoms of
arthritis; improved physical functioning and health-related quality of life; and slowed radiographic progression. Of note, data from long-term extensions (LTEs) of pivotal studies in RA, PsA and AS have confirmed that the safety and efficacy of
golimumab are sustained through 5 years of treatment; the long-term tolerability profile of the
drug is similar to that of other TNFα inhibitors (TNFis). Like other subcutaneous TNFis,
golimumab offers patients the convenience and flexibility of home-based self-injection, although it has the added potential advantage of requiring less frequent administration, in particular compared with older, first generation agents, such as
etanercept and
adalimumab. Thus,
golimumab is an effective, generally well tolerated and potentially convenient option for the treatment of RA, PsA, AS and
nr-axSpA in adults, and pJIA in children.