Leflunomide in active rheumatoid arthritis
| Autor: | van Eric Roon, Pieternella M. Houtman, Jacobus R. B. J. Brouwers, Bob Wilffert, Hilde Tobi, G. A. W. Bruyn, T.L.Th.A. Jansen, L Mourad, EN Griep |
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| Přispěvatelé: | Groningen University Institute for Drug Exploration (GUIDE), Faculty of Science and Engineering, Methods in Medicines evaluation & Outcomes research (M2O), Reproductive Origins of Adult Health and Disease (ROAHD) |
| Jazyk: | angličtina |
| Rok vydání: | 2004 |
| Předmět: |
Male
rheumatoid arthritis demography vomiting drug safety diarrhea gastrointestinal symptom thrombocytopenia THERAPY Etanercept Arthritis Rheumatoid dry eye DOUBLE-BLIND mouth ulcer CRITERIA Pharmacology (medical) Prospective Studies xerostomia nocturnal enuresis Leflunomide Aged 80 and over education.field_of_study PLACEBO Anti-Inflammatory Agents Non-Steroidal article clinical trial Middle Aged anxiety nausea METHOTREXATE Treatment Outcome priority journal sweating anorexia Rheumatoid arthritis drug withdrawal Antirheumatic Agents SAFETY Female cerebrovascular accident hoarseness headache medicine.drug Adult medicine.medical_specialty hydroxychloroquine hypertension Population muscle cramp salazosulfapyridine ischemia Therapeutics medical record CONTROLLED-TRIAL Drug withdrawal Internal medicine medicine ETANERCEPT follow up Humans controlled study human tinnitus education coughing dizziness Aged Pharmacology leflunomide skin disease controlled clinical trial business.industry Hydroxychloroquine constipation Isoxazoles pruritus medicine.disease alopecia EFFICACY major clinical study tremor Infliximab Surgery drug efficacy Withholding Treatment heart palpitation EXPERIENCE fatigue polyuria weight reduction business infliximab disease activity Adverse drug reaction Follow-Up Studies |
| Zdroj: | British Journal of Clinical Pharmacology, 58(6), 790-797. Wiley British Journal of Clinical Pharmacology, 58(2), 201-208. Wiley |
| ISSN: | 0306-5251 |
| DOI: | 10.1111/j.1365-2125.2004.02075.x |
| Popis: | Aims We prospectively studied the efficacy, incidence of adverse drug reactions and withdrawal from leflunomide in an outpatient population with rheumatoid arthritis in a setting of care-as-usual. Methods In this prospective case series study, from outpatient medical records a standard dataset was collected including patient and disease characteristics, data on leflunomide use and adverse drug reactions. Results During the study period 136 rheumatoid arthritis patients started leflunomide. Median (range) follow-up duration was 317 (11–911) days. Sixty-five percent of patients experienced at least one adverse drug reaction related to leflunomide. During follow-up 76 patients (56%) withdrew from leflunomide treatment, mainly because of adverse drug reactions (29%) or lack of efficacy (13%). The overall incidence density for withdrawal from leflunomide was 56.2 per 100 patient-years. Complete data for calculating efficacy using a validated disease activity score on 28 joints (DAS28) was available for 48, 36, and 35% of patients at 2, 6, and 12 months follow-up, respectively. Within a 12-month period after start of leflunomide treatment 76% of the evaluable patients were classified as moderate or good responders according to the DAS28 response criteria. Conclusions In the setting of care-as-usual, rheumatoid arthritis patients starting leflunomide frequently experienced adverse drug reactions. More than half of the patients withdrew from leflunomide treatment within a year after start of leflunomide treatment, mainly because of adverse drug reactions. |
| Databáze: | OpenAIRE |
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