Golimumab for the Treatment of Rheumatoid Arthritis: A Narrative Review of Pivotal Randomized Trials and Real-World Studies.

Rheumatoid arthritis (RA) is a chronic, inflammatory autoimmune disease characterized by progressive joint involvement. The disease is associated with reduced health-related quality of life, functional ability, work productivity, and daily activity, in addition to pain, fatigue, and inflammation-induced structural damage. RA emerges through a complex interplay of multiple factors, including the release of inflammatory cytokines. One such cytokine is tumor necrosis factor (TNF), which is inhibited by golimumab, an approved treatment for the disease. Golimumab is produced using a recombinant cell line that originated from genetically modified mice immunized with human TNF. This narrative review presents the efficacy and safety outcomes from the golimumab pivotal randomized controlled trials (RCTs) that evaluated the subcutaneous and intravenous formulations. Across the RCTs, treatment was associated with an American College of Rheumatology ≥ 20% improvement. A majority of participants reported at least one AE and the most frequent were upper respiratory infection, nasopharyngitis, and bronchitis. The review also presents data from post hoc analyses and real-world studies, which demonstrated benefits that included improvements in health-related quality of life and daily productivity, prolonged drug survival, and reduced fatigue, pain, disease activity, and structural damage. Lastly, data from meta-analyses, including RCTs and real-world studies, demonstrated that golimumab had an adverse event pattern similar to other TNF inhibitors. Collectively, these studies demonstrated that golimumab is an effective and safe treatment for RA when used according to the approved indication.