title: Antibody-mediated side effects of recombinant proteins.
abstract: This brief review is focused on the unwanted clinical effects mediated by antibodies against genetechnologically produced drugs. While many antibodies binding biotech-drugs may not be harmful, others may have deleterious clinical effects exposing patients to high risks. These antibodies can cause either lack of efficacy or hypersensitivity reactions. Examples for antibody-mediated lack of efficacy are inhibitors in hemophiliacs treated with Factor VIII, evidence of decreasing therapeutic efficacy of beta-interferons in MS-patients and pure red cell aplasia (PRCA) in patients with chronic renal failure treated with erythropoietin. Antibody-mediated hypersensitivity reactions have to be expected with all recombinant proteins. The mechanisms and causes of antibody production against biotech-drugs in patients are discussed.
authors.affiliation: Division of Biotechnology Medicines, Swiss Agency for Therapeutic Products, Swissmedic, CH-3000 Bern 9, Switzerland. heiner.frost@swissmedic.ch
authors.forename: Heiner
authors.initials: H
authors.lastname: Frost
mesh_terms: D000818:Animals; D000906:Antibodies / Q000276:immunology*; D000911:Antibodies, Monoclonal / Q000009:adverse effects; D064420:Drug-Related Side Effects and Adverse Reactions; D004921:Erythropoietin / Q000009:adverse effects; D006801:Humans; D007328:Insulin / Q000009:adverse effects / Q000276:immunology; D007372:Interferons / Q000009:adverse effects / Q000276:immunology; D011994:Recombinant Proteins / Q000009:adverse effects* / Q000276:immunology*
chemical_list: D000906:Antibodies; D000911:Antibodies, Monoclonal; D007328:Insulin; D011994:Recombinant Proteins; D004921:Erythropoietin; D007372:Interferons