Leflunomide in active rheumatoid arthritis: a prospective study in daily practice

Abstract

AimsWe 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. MethodsIn 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. ResultsDuring 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 followup 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. ConclusionsIn 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.

Efficacy and safety of leflunomide alone and in combination with methotrexate in the treatment of refractory rheumatoid arthritis

“…With combination for three be effective and safe in general practice. [27] resistant RA, provided regular monitoring of months, there was improvement in 9(91%) Weekly use and even omitting the loading liver function and hematological parameters and remission in 1 (9%), respectively. Efficacy dose, has shown comparable efficacy to daily are performed.…”

“…Zero, 7 (8%), 77 (92%) and 0,6 (10%), 54 (90%) patients with mild, moderate and high disease severity respectively, were included in the ITT and PP analysis. Twenty (24%), 45 (54%), 51 (61%) and 12 (20%), 37 (62%), 38 (63%) patients at baseline, 3 and 6 months showed rheumatoid factor negativity by ITT analysis (Chi value=25.91, df=2, P<0.001) and PP 9 (11) 8 (13) 9 (15) 1 (9) 3 (27) (1-6)*** analysis (Chi value=28.97, df=2, P <0.001), respectively. Secondary efficacy parameters also improved from three months [ Table 3].…”

Leflunomide in the treatment of rheumatoid arthritis. An analysis of predictors for treatment continuation

“…Failure rates have been reported between 55.5% and 56.2% per 100 patient years' follow-up [6,7]. Furthermore, Geborek et al [8] and Siva [9] reported withdrawal from leflunomide treatment of 78% of patients after 20 months' and 63% after 6 months' follow-up, respectively.…”

“…Results of an observational study in patients with RA on leflunomide treatment showed that the characteristics of patients treated in a setting of care-as-usual differ from characteristics of the populations in RCTs, suggesting channelling of the application of leflunomide [6]. Compared with the population included in the RCTs on leflunomide, the population in this study had a higher age, had longer disease duration, and was more intensively treated with disease-modifying antirheumatic drugs (DMARDs) before starting leflunomide.…”

Leflunomide in complex treatment for rheumatoid arthritis

“…Это лефлуномид (ЛФ, Арава) и биологические препараты (БП). Поскольку опыт практического исполь-зования новых препаратов был невелик, а стоимость их -довольно высока, они назначались в тех случаях, когда другие противоревматические средства оказались неэф-фективными [2]. Наличие большого количества таких больных и высокая эффективность новых лекарственных средств обеспечили им широкую популярность.…”