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Assistant Professor of Clinical Pharmacy, Department of Pharmacy Practice and Pharmacy Administration, University of the Sciences in Philadelphia, Philadelphia, PA
Associate Professor of Clinical Pharmacy, Department of Pharmacy Practice and Pharmacy Administration, University of the Sciences in Philadelphia
Reprints: Dr. McCluggage, 600 S. 43rd St., Philadelphia, PA 19104, fax 215/596-8586, l.mccluggage{at}usp.edu
OBJECTIVE: To review the pharmacologic, pharmacokinetic, efficacy,
and safety data of golimumab, an anti-tumor necrosis factor alpha
(TNF-
) monoclonal antibody.
DATA SOURCES: A search of MEDLINE (1950-September 2009) was
performed to identify any published clinical trials or review articles
pertaining to golimumab. Key search terms included golimumab, rheumatoid
arthritis, CNTO 148, and anti-TNF- inhibitors. Bibliographies of
selected articles were reviewed to identify other relevant citations.
Abstracts from national and international meetings and information from the
manufacturer were also reviewed.
STUDY SELECTION AND DATA EXTRACTION: All available published articles and abstracts describing golimumab's pharmacologic or pharmacokinetic profile, efficacy, and safety were included.
DATA SYNTHESIS: Golimumab is a fully humanized TNF-
monoclonal antibody that is specific for human TNF-. Trials have
investigated the use of golimumab in patients who have rheumatoid arthritis
(RA) and are on methotrexate, are methotrexate-naïve, and have previously
tried TNF- inhibition therapy. When used in combination with
methotrexate or another disease-modifying antirheumatic drug, golimumab
therapy results in improvements of clinical outcomes including the American
College of Rheumatology parameters in all of the aforementioned populations.
Although multiple doses and dosing regimens have been studied, the Food and
Drug Administration-approved dose is 50 mg subcutaneously every 4 weeks. The
most common adverse effects include injection site erythema, headaches, and
nausea. There were a limited number of incidences of serious infection or
malignancy.
CONCLUSIONS: With 4 TNF- monoclonal antibodies currently on
the market, it is unclear what golimumab's place in therapy for RA will be.
Some benefits include monthly injections, proven efficacy after previous
TNF- inhibitor therapy, and limited antibody development during
therapy. However, with a lack of longer-term trials assessing efficacy and
safety compared with other TNF- inhibitors, golimumab should be
reserved for use after other therapies fail.
Key Words: anti-TNF-, CNTO 148, golimumab, rheumatoid arthritis
Published Online, December 29, 2009. www.theannals.com, DOI 10.1345/aph.1M227
THIS ARTICLE IS APPROVED FOR CONTINUING EDUCATION CREDIT
ACPE
UNIVERSAL ACTIVITY NUMBER: 407-000-10-008-H01-P
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