title: Therapeutic efficacy and safety of methotrexate + leflunomide in Colombian patients with active rheumatoid arthritis refractory to conventional treatment.
abstract: BACKGROUND
  The combination of methotrexate (MTX) + leflunomide (LFN) has been shown to be effective in the treatment of RA. Its safety has been questioned.
  
  
  OBJECTIVE
  To evaluate the effectiveness and safety of the combination of MTX + LFN in patients with active RA.
  
  
  METHODS
  This was a 24-week multicenter study, which included 88 patients with active disease despite consistent treatment with methotrexate and prednisolone.
  
  
  RESULTS
  We included 78 women (88%) and 10 men. The age was 51.3 ± 12.4 years, and the evolution of disease was 8 ± 6.8 years. Patients had active disease, which was indicated by a median of IQR of 10.0 (7.0-13.0) for swollen and of 14.0 (18.0-10.0) for tender joints for the whole group. The ACR responses achieved at week 24 were: ACR20: 76.0%; ACR50: 67.1%; ACR70: 23.9%. There was improvement in the activity of disease: DAS-28 score: 5.8 ± 1.2 at baseline vs. 3.8 ± 1.6 at week 24 (P = 0.000). The most significant adverse event was elevation of transaminases in eight patients (26%). Eight patients were withdrawn due to adverse events: four due to the elevation of transaminases, and one each due to diabetes insipidus, rash, diabetes mellitus and osteomuscular pain.
  
  
  CONCLUSIONS
  The combination of MTX + LFN is effective for treating RA in patients for whom conventional treatment has failed. Strict medical and laboratory control is to be enforced for safety.
authors.affiliation: Universidad de La Sabana, Campus Universitario del Puente del Comun, Km. 7 Autopista Norte de Bogota D.C., Chia, Colombia. john.londono@unisabana.edu.co
authors.forename: John
authors.initials: J
authors.lastname: Londono
authors.forename: Ana Maria
authors.initials: AM
authors.lastname: Santos
authors.forename: Pedro Ivan
authors.initials: PI
authors.lastname: Santos
authors.forename: Maria Fernanda
authors.initials: MF
authors.lastname: Cubidez
authors.forename: Claudia
authors.initials: C
authors.lastname: Guzman
authors.forename: Rafael
authors.initials: R
authors.lastname: Valle-Oñate
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001172:Arthritis, Rheumatoid / Q000188:drug therapy*; D002648:Child; D003105:Colombia; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D007555:Isoxazoles / Q000009:adverse effects / Q000627:therapeutic use*; D000077339:Leflunomide; D008297:Male; D008727:Methotrexate / Q000009:adverse effects / Q000627:therapeutic use*; D008875:Middle Aged; D055815:Young Adult
chemical_list: D007555:Isoxazoles; D000077339:Leflunomide; D008727:Methotrexate