Biomaterial Database

The safety of biologic agents in early rheumatoid arthritis. 2003

A Kavanaugh, and E C Keystone

Division of Rheumatology, Allergy, and Immunology, University of California, San Diego, California, USA.

Accompanying the excitement surrounding the prominent efficacy of biologic agents in rheumatoid arthritis (RA) has been concern regarding potential adverse effects. Data from clinical trials and pharmacovigilance has provided an assessment of their safety in patients with established RA. As biologic agents are utilized in patients with earlier disease, optimal determination of the risk/benefit will depend on continued careful monitoring, collection, reporting and analysis of safety information.

UI	MeSH Term	Description	Entries
D007074	Immunoglobulin G	The major immunoglobulin isotype class in normal human serum. There are several isotype subclasses of IgG, for example, IgG1, IgG2A, and IgG2B.	Gamma Globulin, 7S,IgG,IgG Antibody,Allerglobuline,IgG(T),IgG1,IgG2,IgG2A,IgG2B,IgG3,IgG4,Immunoglobulin GT,Polyglobin,7S Gamma Globulin,Antibody, IgG,GT, Immunoglobulin
D008297	Male		Males
D002986	Clinical Trials as Topic	Works about pre-planned studies of the safety, efficacy, or optimum dosage schedule (if appropriate) of one or more diagnostic, therapeutic, or prophylactic drugs, devices, or techniques selected according to predetermined criteria of eligibility and observed for predefined evidence of favorable and unfavorable effects. This concept includes clinical trials conducted both in the U.S. and in other countries.	Clinical Trial as Topic
D004305	Dose-Response Relationship, Drug	The relationship between the dose of an administered drug and the response of the organism to the drug.	Dose Response Relationship, Drug,Dose-Response Relationships, Drug,Drug Dose-Response Relationship,Drug Dose-Response Relationships,Relationship, Drug Dose-Response,Relationships, Drug Dose-Response
D004334	Drug Administration Schedule	Time schedule for administration of a drug in order to achieve optimum effectiveness and convenience.	Administration Schedule, Drug,Administration Schedules, Drug,Drug Administration Schedules,Schedule, Drug Administration,Schedules, Drug Administration
D005260	Female		Females
D005500	Follow-Up Studies	Studies in which individuals or populations are followed to assess the outcome of exposures, procedures, or effects of a characteristic, e.g., occurrence of disease.	Followup Studies,Follow Up Studies,Follow-Up Study,Followup Study,Studies, Follow-Up,Studies, Followup,Study, Follow-Up,Study, Followup
D006801	Humans	Members of the species Homo sapiens.	Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000068800	Etanercept	A recombinant version of soluble human TNF receptor fused to an IgG FC fragment that binds specifically to TUMOR NECROSIS FACTOR and inhibits its binding with endogenous TNF receptors. It prevents the inflammatory effect of TNF and is used to treat RHEUMATOID ARTHRITIS; PSORIATIC ARTHRITIS and ANKYLOSING SPONDYLITIS.	Enbrel,Erelzi,Etanercept-szzs,Recombinant Human Dimeric TNF Receptor Type II-IgG Fusion Protein,TNF Receptor Type II-IgG Fusion Protein,TNFR-Fc Fusion Protein,TNR 001,TNR-001,TNT Receptor Fusion Protein,TNTR-Fc,Fusion Protein, TNFR-Fc,Recombinant Human Dimeric TNF Receptor Type II IgG Fusion Protein,TNF Receptor Type II IgG Fusion Protein,TNFR Fc Fusion Protein,TNR001
D000068879	Adalimumab	A humanized monoclonal antibody that binds specifically to TNF-ALPHA and blocks its interaction with endogenous TNF RECEPTORS to modulate INFLAMMATION. It is used in the treatment of RHEUMATOID ARTHRITIS; PSORIATIC ARTHRITIS; CROHN'S DISEASE and ULCERATIVE COLITIS.	Adalimumab-adbm,Adalimumab-atto,Amjevita,Cyltezo,D2E7 Antibody,Humira,Antibody, D2E7