PMID- 18173924
OWN - NLM
STAT- MEDLINE
DCOM- 20080320
LR  - 20181201
IS  - 0392-856X (Print)
IS  - 0392-856X (Linking)
VI  - 25
IP  - 6
DP  - 2007 Nov-Dec
TI  - Leflunomide in psoriatic arthritis: a retrospective study of discontinuation rate 
      in daily clinical practice compared with methotrexate.
PG  - 881-4
AB  - 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). PATIENTS: 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.
FAU - Malesci, D
AU  - Malesci D
AD  - Dipartimento di Internistica Clinica e Sperimentale F. Magrassi e A. Lanzara, 
      Unita di Reumatologia, Seconda Universita degli Studi di Napoli, via S. Pansini 
      5, 80131 Napoli, Italy.
FAU - Tirri, R
AU  - Tirri R
FAU - Buono, R
AU  - Buono R
FAU - La Montagna, G
AU  - La Montagna G
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PL  - Italy
TA  - Clin Exp Rheumatol
JT  - Clinical and experimental rheumatology
JID - 8308521
RN  - 0 (Adjuvants, Immunologic)
RN  - 0 (Immunosuppressive Agents)
RN  - 0 (Isoxazoles)
RN  - G162GK9U4W (Leflunomide)
RN  - YL5FZ2Y5U1 (Methotrexate)
SB  - IM
MH  - Adjuvants, Immunologic/*adverse effects
MH  - Arthritis, Psoriatic/*drug therapy
MH  - Female
MH  - Humans
MH  - Immunosuppressive Agents/*adverse effects
MH  - Isoxazoles/*adverse effects
MH  - Leflunomide
MH  - Male
MH  - Methotrexate/adverse effects
MH  - Middle Aged
MH  - Retrospective Studies
EDAT- 2008/01/05 09:00
MHDA- 2008/03/21 09:00
CRDT- 2008/01/05 09:00
PHST- 2008/01/05 09:00 [pubmed]
PHST- 2008/03/21 09:00 [medline]
PHST- 2008/01/05 09:00 [entrez]
AID - 2220 [pii]
PST - ppublish
SO  - Clin Exp Rheumatol. 2007 Nov-Dec;25(6):881-4.