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Golimumab: A Review in Inflammatory Arthritis

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Abstract

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.

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Acknowledgements

During the peer review process, the manufacturer of golimumab was also offered an opportunity to review this article. Changes resulting from comments received were made on the basis of scientific and editorial merit.

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    James E. Frampton

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James Frampton is a salaried employee of Adis/Springer, is responsible for the article content and declares no relevant conflicts of interest.

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The manuscript was reviewed by: D.E. Furst, Division of Rheumatology, David Geffen School of Medicine at University of California Los Angeles, Los Angeles, CA, USA; A. Migliore, Unit of Rheumatology, San Pietro Fatebenefratelli Hospital, Rome, Italy; R.A. Russo, Service of Immunology and Rheumatology, Hospital de Pediatria Prof. Dr. Juan P Garrahan, Buenos Aires, Argentina; R. Sanmarti, Arthritis Unit, Rheumatology Service, Hospital Clínic and Institut d’Investigacions Biomèdiques Agustí Pí I Sunyer, Barcelona, Spain

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Frampton, J.E. Golimumab: A Review in Inflammatory Arthritis. BioDrugs 31, 263–274 (2017). https://doi.org/10.1007/s40259-017-0217-6

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