title: Comparative effectiveness of rituximab in combination with either methotrexate or leflunomide in the treatment of rheumatoid arthritis.
abstract: OBJECTIVE
  To compare the effectiveness and safety of a combination of rituximab (RTX) with either methotrexate (MTX) or leflunomide (LEF) in the treatment of patients with active rheumatoid arthritis (RA) and inadequate response to anti-tumor necrosis factor agents or traditional disease-modifying antirheumatic drugs (DMARD) in a real-world setting.
  
  
  METHODS
  Data from 77 consecutive unselected patients with active RA and treated with at least 1 cycle of RTX (1 g × 2 weeks) plus MTX or LEF were retrospectively collected. A comparative study between the 2 combinations of treatment (RTX+MTX and RTX+LEF) was performed at 6 months of follow-up considering 3 outcomes: the improvement of RA disease activity, the evolution of functional disability, and the tolerability and side effect profile.
  
  
  RESULTS
  Of the 77 patients, 45 received RTX+MTX and 32 RTX+LEF. At baseline there were no significant differences between the groups in terms of the main clinical and laboratory data, or in the number of previous DMARD and anti-tumor necrosis factor agents used. At 6 months of follow-up, we did not find significant differences between the 2 combinations in the evolution of RA disease activity (DAS28 response, according to the European League Against Rheumatism (EULAR) improvement criteria) and functional disability progression (health assessment questionnaire) over time. Minor adverse events occurred in 9% of RTX+MTX patients and in 9% of RTX+LEF patients. None of the patients had serious adverse events and none discontinued the treatment during the study period.
  
  
  CONCLUSIONS
  Our preliminary data support the view that LEF is a useful alternative if MTX is contraindicated, since its effectiveness and safety seem similar.
authors.affiliation: Department of Rheumatology, Hospital Universitario de Bellvitge-IDIBELL, Barcelona, Spain. 31577edd@comb.cat
authors.forename: Javier
authors.initials: J
authors.lastname: Narváez
authors.forename: César
authors.initials: C
authors.lastname: Díaz-Torné
authors.forename: José Miguel
authors.initials: JM
authors.lastname: Ruiz
authors.forename: Maria Victoria
authors.initials: MV
authors.lastname: Hernández
authors.forename: Vicens
authors.initials: V
authors.lastname: Torrente-Segarra
authors.forename: Sergio
authors.initials: S
authors.lastname: Ros
authors.forename: Arturo
authors.initials: A
authors.lastname: Rodriguez de la Serna
authors.forename: César
authors.initials: C
authors.lastname: Díaz-López
authors.forename: Raimon
authors.initials: R
authors.lastname: Sanmartí
authors.forename: Joan Miquel
authors.initials: JM
authors.lastname: Nolla
mesh_terms: D000328:Adult; D000368:Aged; D058846:Antibodies, Monoclonal, Murine-Derived / Q000009:adverse effects / Q000627:therapeutic use*; D018501:Antirheumatic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001172:Arthritis, Rheumatoid / Q000188:drug therapy*; D018450:Disease Progression; 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; D012189:Retrospective Studies; D000069283:Rituximab; D016896:Treatment Outcome
chemical_list: D058846:Antibodies, Monoclonal, Murine-Derived; D018501:Antirheumatic Agents; D007555:Isoxazoles; D000069283:Rituximab; D000077339:Leflunomide; D008727:Methotrexate