[Side effects and contraindications for biological therapy in inflammatory bowel disease]

TNF-alpha blockers side effects vary according to the frequency and severity and mainly include immunogenicity (ability to cause immune reactions), infections, malignancies, heart failure, demyelinating disease and others. Treatment with TNF-alpha blockers may result in the formation of autoantibodies and, rarely, in the development of a lupus-like syndrome. They should not be administered to patients who have experienced a severe hypersensitivity reaction. Urticaria, dyspnea and hypotension can occur after TNF-alpha inhibitors administration. Serious infusion reactions including anaphylaxis are infrequent. Patients treated with TNF-alpha blockers are at increased risk for developing serious infections (active tuberculosis, including reactivation of latent TB, invasive fungal infections, bacterial, viral, and also infections due to opportunistic pathogens). Therefore, all patients should be screened for systemic or localized infection before starting therapy. Patients with a positive screening for TB should be treated with isoniazid for at least 4 weeks, before starting TNF-alpha blocker therapy. TNF-alpha blockers may be associated with non-Hodgkin lymphoma or other cancers especially if combined with other immunosuppressive drugs. Monotherapy showed no such effect in patients, who cited a personal history of malignant disease, therefore caution is needed. TNF-alpha blockers are contraindicated in patients with moderate to severe congestive heart failure (NYHA Class III/IV). TNF-alpha blockers have been associated with reactivation of hepatitis B virus (HBV) infection in patients who are chronic carriers. Patients should be tested for HBV infection before treatment. Patients who test positive should be monitored closely for reactivation of HBV infection during and following termination of therapy. Patients with negative serology should be vaccinated. Severe hepatic reactions, including acute liver failure, jaundice, hepatitis, and cholestasis have been reported. Patients with symptoms or signs of liver dysfunction should be evaluated for evidence of liver injury. Cases of leucopenia, neutropenia, thrombocytopenia, and pancytopenia have been reported. TNF-alpha blockers have been associated in rare cases with CNS manifestation of systemic vasculitis, new onset or exacerbation of CNS and peripheral demyelinating disorders, including multiple sclerosis and Guillain-Barré syndrome.