Auranofin therapy in juvenile rheumatoid arthritis: a 48-week phase II study. 1986

T K Kvien, and H M Høyeraal, and B Sandstad, and E Kass

A 48-week phase II open, uncontrolled study of auranofin (AF) in patients juvenile rheumatoid arthritis (JRA) was conducted to assess efficacy, tolerance and serum gold levels, and to consider the feasibility of further controlled studies (phase III) in such patients. The study group included 25 patients (20 F, 5 M) with active pauciarticular (n = 4) or polyarticular (n = 21) JRA. Median age was 100 months (range 62-176); median disease duration was 55 months (range 13-155). AF was given at 0.1 mg/kg/day divided into 2 doses, and increases to maximum of 6 mg/day were permitted if clinical improvement was insufficient. Nonsteroidal anti-inflammatory drugs and physiotherapy also were allowed. Significant improvement (p less than or equal to 0.05) was observed in the various joint counts and articular indices, as well as in the physician's global assessment of health. Some subjective functional measurements also were improved, but the differences were not statistically significant. There were no clinically important trends in the laboratory measurements. No patient was withdrawn because of adverse reactions; 1 was withdrawn because of disease exacerbation and 3 for lack of response. Mild adverse reactions were seen in 9 patients: 6 had abdominal pain, 6 diarrhea/loose stools, 1 nausea, 3 rash, 2 pruritus. Two patients had dosage reduced because of loose stools. Serum gold levels varied greatly; increased dosage usually resulted in increased serum levels. Occurrence of adverse reactions or response to therapy was not related to increases in dose or to serum gold levels.(ABSTRACT TRUNCATED AT 250 WORDS)

UI MeSH Term Description Entries
D008297 Male Males
D002648 Child A person 6 to 12 years of age. An individual 2 to 5 years old is CHILD, PRESCHOOL. Children
D002675 Child, Preschool A child between the ages of 2 and 5. Children, Preschool,Preschool Child,Preschool Children
D004341 Drug Evaluation Any process by which toxicity, metabolism, absorption, elimination, preferred route of administration, safe dosage range, etc., for a drug or group of drugs is determined through clinical assessment in humans or veterinary animals. Evaluation Studies, Drug,Drug Evaluation Studies,Drug Evaluation Study,Drug Evaluations,Evaluation Study, Drug,Evaluation, Drug,Evaluations, Drug,Studies, Drug Evaluation,Study, Drug Evaluation
D005260 Female Females
D006046 Gold A yellow metallic element with the atomic symbol Au, atomic number 79, and atomic weight 197. It is used in jewelry, goldplating of other metals, as currency, and in dental restoration. Many of its clinical applications, such as ANTIRHEUMATIC AGENTS, are in the form of its salts.
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000293 Adolescent A person 13 to 18 years of age. Adolescence,Youth,Adolescents,Adolescents, Female,Adolescents, Male,Teenagers,Teens,Adolescent, Female,Adolescent, Male,Female Adolescent,Female Adolescents,Male Adolescent,Male Adolescents,Teen,Teenager,Youths
D001171 Arthritis, Juvenile Arthritis in children, with onset before 16 years of age. The terms juvenile rheumatoid arthritis (JRA) and juvenile idiopathic arthritis (JIA) refer to classification systems for chronic arthritis in children. Only one subtype of juvenile arthritis (polyarticular-onset, rheumatoid factor-positive) clinically resembles adult rheumatoid arthritis and is considered its childhood equivalent. Arthritis, Juvenile Chronic,Arthritis, Juvenile Idiopathic,Arthritis, Juvenile Rheumatoid,Childhood Arthritis,PCJIA,PJIA Polyarticular Juvenile Idiopathic Arthritis,Polyarticular Juvenile Idiopathic Arthritis,Polyarticular-Course Juvenile Idiopathic Arthritis,Still's Disease, Juvenile-Onset,Enthesitis-Related Arthritis, Juvenile,Juvenile Chronic Arthritis,Juvenile Idiopathic Arthritis,Juvenile Rheumatoid Arthritis,Juvenile-Onset Still Disease,Juvenile-Onset Stills Disease,Oligoarthritis, Juvenile,Polyarthritis, Juvenile, Rheumatoid Factor Negative,Polyarthritis, Juvenile, Rheumatoid Factor Positive,Psoriatic Arthritis, Juvenile,Still Disease, Juvenile-Onset,Systemic Arthritis, Juvenile,Arthritides, Childhood,Arthritis, Childhood,Arthritis, Juvenile Enthesitis-Related,Arthritis, Juvenile Psoriatic,Arthritis, Juvenile Systemic,Childhood Arthritides,Chronic Arthritis, Juvenile,Enthesitis Related Arthritis, Juvenile,Idiopathic Arthritis, Juvenile,Juvenile Arthritis,Juvenile Enthesitis-Related Arthritis,Juvenile Oligoarthritis,Juvenile Onset Still Disease,Juvenile Onset Stills Disease,Juvenile Psoriatic Arthritis,Juvenile Systemic Arthritis,Juvenile-Onset Still's Disease,Rheumatoid Arthritis, Juvenile,Still Disease, Juvenile Onset,Still's Disease, Juvenile Onset,Stills Disease, Juvenile-Onset
D001310 Auranofin An oral chrysotherapeutic agent for the treatment of rheumatoid arthritis. Its exact mechanism of action is unknown, but it is believed to act via immunological mechanisms and alteration of lysosomal enzyme activity. Its efficacy is slightly less than that of injected gold salts, but it is better tolerated, and side effects which occur are potentially less serious. Crisinor,Ridaura,Ridauran,SK&F D 39162,SK&F-39162,SK&F 39162,SK&F39162

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