Abstract | OBJECTIVE: For reasons of insufficient quality of the raw material, aurothioglucose was withdrawn from the Dutch market at the end of 2001. Aurothiomalate became available as an alternative preparation. We followed a cohort of patients during the first year after switching from aurothioglucose to aurothiomalate to study efficacy and tolerability. METHODS: Patients were observed at baseline and at 3 and 12 months after switching. At each visit, data on adverse drug reactions (ADR), withdrawal, and disease activity were collected. RESULTS: In total 120 patients were included [age 63(SD 15) yrs, 68% female, 93% with rheumatoid arthritis, duration of disease 15 (SD 9) years, 82% IgM rheumatoid factor-positive, with 9 (SD 9, range 0.1-45) yrs of previous aurothioglucose therapy]. Nineteen patients (16%) reported an ADR taking aurothiomalate not previously experienced with aurothioglucose, the most frequently reported being pruritus, dermatitis/ stomatitis, and chrysiasis/ hyperpigmentation. Twenty-nine patients (24%) withdrew from aurothiomalate within 12 months of followup for reasons of inefficacy (14%), ADR (7%), or disease in state of remission (3%). Kaplan-Meier estimates show aurothiomalate survival rates of 78.5% after 12 months. No statistically significant differences between the disease activity indicators during followup visits compared with the baseline visit were detected for the patients continuing aurothiomalate. CONCLUSION: Within the first 12 months after switching from aurothioglucose, 24% of patients withdrew from aurothiomalate. Sixteen percent of patients reported novel ADR. For the population continuing to take aurothiomalate no clinically relevant changes in disease activity were recorded after switching.
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Authors | Eric N van Roon, Mart A F J van de Laar, Matthijs Janssen, Marijn W M Kruijsen, Tim L T A Jansen, Jacobus R B J Brouwers |
Journal | The Journal of rheumatology
(J Rheumatol)
Vol. 32
Issue 6
Pg. 1026-30
(Jun 2005)
ISSN: 0315-162X [Print] Canada |
PMID | 15940762
(Publication Type: Clinical Trial, Journal Article, Multicenter Study)
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Chemical References |
- Antirheumatic Agents
- Gold Sodium Thiomalate
- Aurothioglucose
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Topics |
- Adverse Drug Reaction Reporting Systems
- Antirheumatic Agents
(adverse effects)
- Arthritis, Rheumatoid
(drug therapy, physiopathology)
- Aurothioglucose
(adverse effects)
- Dose-Response Relationship, Drug
- Female
- Gold Sodium Thiomalate
(adverse effects)
- Health Status
- Humans
- Male
- Middle Aged
- Severity of Illness Index
- Skin Diseases
(chemically induced, pathology)
- Treatment Outcome
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