title: Leflunomide treatment in elderly patients with rheumatoid or psoriatic arthritis: retrospective analysis of safety and adherence to treatment.
abstract: BACKGROUND
  Disease-modifying antirheumatic drugs (DMARDs) play a crucial role in the treatment of persistent chronic synovitis, such as active rheumatoid arthritis (RA) and spondyloarthritis, by inducing or maintaining disease remission, reducing the frequency of flares or relapses, and allowing corticosteroids to be tapered while maintaining disease control.
  
  
  OBJECTIVE
  The aim of this retrospective study was to evaluate the safety of, and adherence to treatment with, leflunomide in elderly RA and psoriatic arthritis patients compared with younger patients.
  
  
  METHODS
  A total of 90 Italian patients (80 with active RA and 10 with psoriatic arthritis) were retrospectively examined at entry and after 24 months' follow-up. Patients were divided into two groups according to age: those aged <or=65 years (n = 50) and those aged >65 years (n = 40). Each patient was analysed for clinical, demographic and laboratory parameters in order to evaluate liver, renal and haematological toxicity. Disease Activity Score including a 28-joint count (DAS28) and physician global assessment of disease activity (MD global) were measured to define disease activity.
  
  
  RESULTS
  During the 24-month follow-up period, 30 patients (33.3%) discontinued leflunomide: 17 patients (34.0%) in the group of patients aged <or=65 years and 13 patients (32.5%) in those aged >65 years. There were no differences in treatment withdrawal between the two groups. Overall, 10 patients (11.1%) in the entire study population discontinued leflunomide for lack of efficacy, while 21 (23.3%) discontinued the drug because of adverse effects (one patient withdrew because of both inefficacy and adverse effects). There were no significant differences in efficacy or adverse effects between patients aged <or=65 years and patients aged >65 years. There was also no significant difference in survival rates of leflunomide treatment when patients aged <or=65 years were compared with patients aged >65 years (p = 0.94). There were no significant differences in withdrawal rates in the overall population when leflunomide monotherapy was compared with leflunomide combination therapy. There were also no significant differences in the types of adverse effects associated with monotherapy or combination therapy when the two age groups were compared.
  
  
  CONCLUSIONS
  Leflunomide is a useful and well tolerated DMARD for the treatment of RA and psoriatic arthritis in the elderly. The safety profile of, and adherence to, leflunomide is not different in older patients with chronic inflammatory joint diseases such as RA or psoriatic arthritis to that observed in younger patients.
authors: Division of Rheumatology UCSC-Catholic University of Rome, Rome, Italy.
authors: Stefano
authors: S
authors: Alivernini
authors: Daniela
authors: D
authors: Mazzotta
authors: Angelo
authors: A
authors: Zoli
authors: Gianfranco
authors: G
authors: Ferraccioli
mesh_terms: D000328:Adult; D000367:Age Factors; D000368:Aged; D018501:Antirheumatic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D015535:Arthritis, Psoriatic / Q000188:drug therapy*; D001172:Arthritis, Rheumatoid / Q000188:drug therapy*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007555:Isoxazoles / Q000009:adverse effects / Q000627:therapeutic use*; D007558:Italy / Q000453:epidemiology; D000077339:Leflunomide; D008297:Male; D055118:Medication Adherence; D008875:Middle Aged; D012189:Retrospective Studies; D012720:Severity of Illness Index; D015996:Survival Rate; D016896:Treatment Outcome
chemical_list: D018501:Antirheumatic Agents; D007555:Isoxazoles; D000077339:Leflunomide