Golimumab and malignancies: true or false association?

Abstract

Malignancy is one of the comorbidities linked to golimumab, a biological TNF-α blocker. In this systematic review and meta-analysis, we searched different databases and analyzed original publications to elucidate the remaining open question about the real association of malignancies with golimumab therapy. The most frequent cancer in patients treated with golimumab, in association or not with methotrexate, is the lung adenocarcinoma. However, lymphoma is not very commonly represented in these patients. We show that there is no major and evident risk of malignancies associated with golimumab in current scientific literature. An increased risk of malignancies may be associated with golimumab, but this warrants further clinical confirmation. Also, this risk mentioned in different studies must be taken with caution because of number of limits and biases.

Effectiveness of Golimumab in Clinical Management of Patients with Rheumatoid Arthritis

“…An association with the development of malignant tumors has been suggested with GLM, and further clinical confirmation is warranted [20]. However, long-term observation of the patients in our study is needed before any definite conclusions can be made.…”

Antagonistic TNF Receptor One-Specific Antibody (ATROSAB): Receptor Binding and In Vitro Bioactivity

“…Regardless of their successful clinical use, long-term treatment with TNF blockers is accompanied by a higher risk of tuberculosis (TB) reactivation and serious infections, whereas the effect of TNF blockers on incidence and/or manifestation of malignancies is discussed controversially [12], [13], [14], [15], [16]. Counterintuitive were observations that TNF blockade can be associated with development of inflammatory and autoimmune diseases [17], [18], [19], [20], indicating a highly complex regulation of TNF action in vivo.…”

An Open Label Study to Evaluate the Safety and Efficacy of Intratympanic Golimumab Therapy in Patients With Autoimmune Inner Ear Disease

“…However, GLM is a fully human monoclonal antibody preventing interactions with cellular receptors and reducing the negative, inflammatory-related effects associated with TNF-> (26Y28). The side-effect profile of GLM, similar to other TNF-> inhibitors (26,36), includes the potential for increased rate of malignancies (39) and infections (36,40). The current indication for GLM includes the treatment of rheumatoid arthritis (27,29Y34), psoriatic arthritis (35Y37), and active ankylosing spondylitis (38), in adults by monthly injections.…”

“…GLM is available in a prefilled syringe, prepared for subcutaneous injection, whereas infliximab is currently available only in intravenous formulation. However, there seems to be a higher background rate of malignancies in inflammatory diseases, making it difficult to determine whether the association is with the treatment or the disease (39), and other studies have found no increase in risk of malignancies (41). Anti-TNF-> drugs have been on the market for over 10 years, with FDA-mandated registries for patient follow-up, thus, the types of adverse events are well described.…”