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Leflunomide in active rheumatoid arthritis: a prospective study in daily practice
Author(s) -
Van Roon E. N.,
Jansen T. L. TH. A.,
Mourad L.,
Houtman P. M.,
Bruyn G. A. W.,
Griep E. N.,
Wilffert B.,
Tobi H.,
Brouwers J. R. B. J.
Publication year - 2004
Publication title -
british journal of clinical pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.216
H-Index - 146
eISSN - 1365-2125
pISSN - 0306-5251
DOI - 10.1111/j.1365-2125.2004.02075.x
Subject(s) - leflunomide , medicine , rheumatoid arthritis , adverse effect , adverse drug reaction , prospective cohort study , incidence (geometry) , medical record , outpatient clinic , arthritis , drug , surgery , pharmacology , physics , optics
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 (DAS 28 ) 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 DAS 28 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.