[Treatment of inflammatory diseases: safety of long-term use of infliximab].
INFLIXIMAB: Is a chimeric antitumour necrosis factor-alpha monoclonal antibody that has been studied for the treatment of Crohn's disease and rheumatoid arthritis. A LONG TERM SAFETY: In several placebo controlled, randomized clinical trials and open trials, 771 patients have been given infliximab (a further 192 received placebo). Follow-up for safety has included the time of study (12 weeks after the last infusion), plus 3 additional years. GENERAL TOLERANCE: Acute infusion reactions (headache, fever, chills, urticaria, chest pain) were seen in 17% of patients receiving infliximab compared with 7% of those receiving placebo. While infections were reported more frequently overall in the patients given infliximab (26% over 27 weeks of follow-up versus 16% of placebo-treated patients over 20 weeks of follow-up), there was no increased risk of serious infections. There was no difference in the overall mortality rate between the groups. AT THE POINT OF VIEW IMMUNOLOGIC: While low titres of autoantibodies developed in less than 10% of patients, drug-induced lupus was seen in less than 1%, with these cases resolving upon discontinuation of the drug. Overall, infliximab showed an acceptable safety profile.
Schaible
T F
TF
Immunology Medical Affairs, Centocor Inc, 200 Great Valley Parkway, Malvern, Pennsylvanie 19355, Etats-Unis. schaible@centocor.com
D000974:Antibodies, Antinuclear / Q000032:analysis; D000911:Antibodies, Monoclonal / Q000008:administration & dosage* / Q000009:adverse effects; D018501:Antirheumatic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D001172:Arthritis, Rheumatoid / Q000188:drug therapy*; D001323:Autoantibodies / Q000032:analysis; D018849:Controlled Clinical Trials as Topic; D003424:Crohn Disease / Q000188:drug therapy*; D005500:Follow-Up Studies; D005765:Gastrointestinal Agents / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D000069285:Infliximab; D008180:Lupus Erythematosus, Systemic / Q000139:chemically induced; D010919:Placebos; D016032:Randomized Controlled Trials as Topic; D013997:Time Factors
D000974:Antibodies, Antinuclear; D000911:Antibodies, Monoclonal; D018501:Antirheumatic Agents; D001323:Autoantibodies; D005765:Gastrointestinal Agents; D010919:Placebos; D000069285:Infliximab