Golimumab associated with risk of serious fungal infections

June 15, 2009

Centocor Ortho Biotech has issued a Dear Healthcare Professionals letter to remind healthcare providers that golimumab (Simponi), a tumor necrosis factor (TNF)-alpha blocker, is associated with a risk of serious fungal infections.

Centocor Ortho Biotech has issued a Dear Healthcare Professionals letter to remind healthcare providers that golimumab (Simponi), a tumor necrosis factor (TNF)-alpha blocker, is associated with a risk of serious fungal infections. FDA has stated that histoplasmosis and other invasive fungal infections are not consistently recognized in patients being treated with other TNF-alpha blockers, including certolizumab pegol (Cimzia, UCB), etanercept (Enbrel, Amgen/Wyeth), adalimumab (Humira, Abbott), and infliximab (Remicade, Centocor Ortho Biotech). This lack of recognition has led to delays in treatment, sometimes resulting in death.

Golimumab was recently approved for the treatment of moderate-to-severe rheumatoid arthritis (in combination with methotrexate), psoriatic arthritis (with or without methotrexate), and ankylosing spondylitis.

Healthcare professionals should carefully weigh the potential risks and benefits of treatment in individual patients before initiating golimumab therapy.