title: Leflunomide in psoriatic arthritis: a retrospective study of discontinuation rate in daily clinical practice compared with methotrexate.
abstract: OBJECTIVE
  To assess the safety profile of leflunomide (LEF) in a two-year retrospective analysis of psoriatic arthritis (PsA) patients (pts) treated in daily clinical practice compared with methotrexate (MTX).
  
  
  METHODS
  Fourty-two PsA patients with polyarticular involvement or asymmetrical oligoarticular arthritis, satisfying ESSG criteria for the spondyloarthropathies, treated with LEF monotherapy (10-20mg/die without loading dose) between September, 2004 and August, 2006 were reviewed. They were compared with MTX (7.5-15mg/week) users (44 cases). The adverse events (AEs) and the causes of withdrawal were evaluated.
  
  
  RESULTS
  At 24 months, cumulative survival rate of pts remaining on drugs was 54.9% in LEF users and 57.0% in MTX users (p > 0.05). The discontinuation rate (DR) for toxicity was higher in LEF group (29.2%) than in MTX group (10.8%) (p = 0.07). The occurrence of AEs was more frequently registered in the first year in both groups. LEF monotherapy showed a significant higher crude incidence for any AEs (38.7 events x100 person-years) compared to MTX (14.3 events x100 person-years) (p < 0.001). The cumulative DR for inefficacy was greater but not statistically significant in MTX group than LEF (28.6% vs. 12.6% respectively; p = 0.056). Finally, DR for other causes accounted for 8.7% vs. 11.0% respectively (p > 0.05).
  
  
  CONCLUSIONS
  Our data showed, in a setting of clinical practice, that the rate of PsA pts remaining on drug was comparable between LEF and MTX, and a manageable LEF safety profile during a 24 months of follow-up, even if a greater incidence of DR for AEs was registered than in MTX users.
authors.affiliation: Dipartimento di Internistica Clinica e Sperimentale F. Magrassi e A. Lanzara, Unità di Reumatologia, Seconda Università degli Studi di Napoli, via S. Pansini 5, 80131 Napoli, Italy.
authors.forename: D
authors.initials: D
authors.lastname: Malesci
authors.forename: R
authors.initials: R
authors.lastname: Tirri
authors.forename: R
authors.initials: R
authors.lastname: Buono
authors.forename: G
authors.initials: G
authors.lastname: La Montagna
mesh_terms: D000276:Adjuvants, Immunologic / Q000009:adverse effects*; D015535:Arthritis, Psoriatic / Q000188:drug therapy*; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000009:adverse effects*; D007555:Isoxazoles / Q000009:adverse effects*; D000077339:Leflunomide; D008297:Male; D008727:Methotrexate / Q000009:adverse effects; D008875:Middle Aged; D012189:Retrospective Studies
chemical_list: D000276:Adjuvants, Immunologic; D007166:Immunosuppressive Agents; D007555:Isoxazoles; D000077339:Leflunomide; D008727:Methotrexate