Subset analysis of patients experiencing clinical events of a potentially immunogenic nature in the pivotal clinical trials of tocilizumab for rheumatoid arthritis: Evaluation of an antidrug antibody ELISA using clinical adverse event-driven immunogenicity testing

Clinical Therapeutics

Volumn 32, Issue 9, 2010, Pages 1597-1609

  Stubenrauch, Kay ^a   Wessels, Uwe ^a   Birnboeck, Herbert ^b   Ramirez, Francisco ^c   Jahreis, Angelika ^d   Schleypen, Julia ^a  

^a ROCHE DIAGNOSTICS GMBH   (Germany)

^b F HOFFMANN LA ROCHE LTD   (Switzerland)

^c ROCHE PRODUCTS LTD   (United Kingdom)

^d GENENTECH INC   (United States)

Author keywords

ADA; Adverse event; Antidrug antibody; ELISA; Immunogenicity; Therapeutic antibody

Indexed keywords

DISEASE MODIFYING ANTIRHEUMATIC DRUG; DRUG ANTIBODY; IMMUNOGLOBULIN E; IMMUNOGLOBULIN G4; METHOTREXATE; TOCILIZUMAB;

ADULT; AGED; ANAPHYLAXIS; ANTIBODY BLOOD LEVEL; ANTIBODY DETECTION; ARTICLE; BLISTER; CLINICAL TRIAL; COMBINATION CHEMOTHERAPY; CONTROLLED STUDY; DEPRESSION; DRUG HYPERSENSITIVITY; DRUG INDUCED DISEASE; DRUG WITHDRAWAL; DYSPNEA; ENZYME LINKED IMMUNOSORBENT ASSAY; FEMALE; FEVER; FURUNCULOSIS; HEADACHE; HUMAN; IMMUNOGENICITY; INFLUENZA; MAJOR CLINICAL STUDY; MALE; MENINGIOMA; MOUTH INFECTION; PAIN; PNEUMONIA; RHEUMATOID ARTHRITIS; RHINOPHARYNGITIS; SURFACE PLASMON RESONANCE; SYNCOPE; URINARY TRACT INFECTION; VALIDITY;

ADOLESCENT; ADULT; AGED; AGED, 80 AND OVER; ANTIBODIES; ANTIBODIES, MONOCLONAL; ANTIRHEUMATIC AGENTS; ARTHRITIS, RHEUMATOID; CLINICAL TRIALS AS TOPIC; DOSE-RESPONSE RELATIONSHIP, DRUG; ENZYME-LINKED IMMUNOSORBENT ASSAY; FALSE NEGATIVE REACTIONS; FEMALE; HUMANS; IMMUNOGLOBULIN E; MALE; MIDDLE AGED; RECEPTORS, INTERLEUKIN-6; SURFACE PLASMON RESONANCE; YOUNG ADULT;

EID: 77958165601     PISSN: 01492918     EISSN: 1879114X     Source Type: Journal    
DOI: 10.1016/j.clinthera.2010.07.021     Document Type: Article

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