title: Infectious complications of biologic treatments of rheumatoid arthritis.
abstract: Agents that block the action of tumor necrosis factor-alpha and recombinant interleukin-1 have been shown to be effective biologic treatment modalities in patients with rheumatoid arthritis. Given the immunosuppressive effects of tumor necrosis factor-alpha and interleukin-1 blockers, infections have emerged as possible complications of using these agents, an observation foreshadowed in prelicensure animal studies. At this time, hundreds of thousands of patients have received these drugs, and a wide variety of infectious complications has been reported, among which reactivation tuberculosis is most notable. Case reports alone, however, do not necessarily reflect a causal association between a therapeutic product and an adverse event. The authors review the infectious complications of the use of these agents as reported in the medical literature from November 2001 through October 2002.
authors.affiliation: Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, US Food and Drug Administration, Rockville, Maryland 20852, USA. mohan@cber.fda.gov
authors.forename: Aparna K
authors.initials: AK
authors.lastname: Mohan
authors.forename: Timothy R
authors.initials: TR
authors.lastname: Coté
authors.forename: Jeffrey N
authors.initials: JN
authors.lastname: Siegel
authors.forename: M Miles
authors.initials: MM
authors.lastname: Braun
mesh_terms: D000818:Animals; D001172:Arthritis, Rheumatoid / Q000188:drug therapy*; D001424:Bacterial Infections / Q000453:epidemiology / Q000382:microbiology*; D001688:Biological Products / Q000009:adverse effects* / Q000627:therapeutic use; D001691:Biological Therapy / Q000009:adverse effects* / Q000379:methods; D002986:Clinical Trials as Topic; D004195:Disease Models, Animal; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D015994:Incidence; D007375:Interleukin-1 / Q000009:adverse effects / Q000627:therapeutic use; D008297:Male; D009181:Mycoses / Q000453:epidemiology / Q000209:etiology*; D018570:Risk Assessment; D014409:Tumor Necrosis Factor-alpha / Q000009:adverse effects / Q000627:therapeutic use
chemical_list: D001688:Biological Products; D007375:Interleukin-1; D014409:Tumor Necrosis Factor-alpha