title: Comparative effectiveness of tocilizumab with either methotrexate or leflunomide in the treatment of rheumatoid arthritis.
abstract: OBJECTIVE
  In agreement with EULAR recommendations, a DMARD in combination with a biotherapy is the reference treatment because of the superior long-term clinical and radiographic outcomes. Methotrexate (MTX) is the cornerstone of combination therapy but is in some cases contra-indicated or poorly tolerated. This observational study aimed to compare the effectiveness and safety of TCZ in combination with either MTX or leflunomide (LEF) in the treatment of patients with active rheumatoid arthritis (RA) and an inadequate response to one or more DMARDs and/or biological agents in a real-world setting.
  
  
  METHODS
  We performed an ambispective review of 91 patients with active RA who were routinely treated with TCZ plus MTX or LEF. A comparative study between the two combinations of treatment was performed at 6 months of follow-up considering 3 outcomes: improvement of RA disease activity, evolution of functional disability, and tolerability and side effect profile.
  
  
  RESULTS
  Of the 91 patients, 62 received TCZ with MTX and 29 received TCZ with LEF. Eighty-one patients were followed for 6 months, and the remaining 10 patients discontinued treatment due to serious adverse events. 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 DMARDs and biological agents used. At 6 months, there were no significant differences between the combinations in terms of disease activity and functional disability. Serious adverse events occurred in 11% and 10% of the patients treated in combination with MTX and LEF, respectively.
  
  
  CONCLUSIONS
  Our preliminary data support the argument that LEF is an effective and safe (equivalent) alternative to MTX for combination treatment with TCZ.
authors.affiliation: Department of Rheumatology, Hospital Universitario de Bellvitge-IDIBELL, Barcelona, Spain.
authors.forename: Javier
authors.initials: J
authors.lastname: Narváez
authors.affiliation: Rheumatology Unit, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.
authors.forename: César
authors.initials: C
authors.lastname: Díaz-Torné
authors.affiliation: Rheumatology Unit, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.
authors.forename: Berta
authors.initials: B
authors.lastname: Magallares
authors.affiliation: Department of Rheumatology, Hospital Clínic de Barcelona-IDIBAPS, Barcelona, Spain.
authors.forename: Maria Victoria
authors.initials: MV
authors.lastname: Hernández
authors.affiliation: Deparment of Rheumatology, Hospital de Sant Joan Despí, Consorci Sanitari Integral, Barcelona, Spain.
authors.forename: Delia
authors.initials: D
authors.lastname: Reina
authors.affiliation: Deparment of Rheumatology, Hospital de Sant Joan Despí, Consorci Sanitari Integral, Barcelona, Spain.
authors.forename: Héctor
authors.initials: H
authors.lastname: Corominas
authors.affiliation: Department of Rheumatology, Hospital Clínic de Barcelona-IDIBAPS, Barcelona, Spain.
authors.forename: Raimon
authors.initials: R
authors.lastname: Sanmartí
authors.affiliation: Rheumatology Unit, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.
authors.forename: Arturo Rodriguez
authors.initials: AR
authors.lastname: de la Serna
authors.affiliation: Rheumatology Unit, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.
authors.forename: Josep Maria
authors.initials: JM
authors.lastname: Llobet
authors.affiliation: Department of Rheumatology, Hospital Universitario de Bellvitge-IDIBELL, Barcelona, Spain.
authors.forename: Joan M
authors.initials: JM
authors.lastname: Nolla
mesh_terms: D000368:Aged; D061067:Antibodies, Monoclonal, Humanized / Q000009:adverse effects / Q000627:therapeutic use*; D018501:Antirheumatic Agents / Q000627:therapeutic use*; D001172:Arthritis, Rheumatoid / Q000188:drug therapy*; D004305:Dose-Response Relationship, Drug; 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; D009503:Neutropenia / Q000139:chemically induced; D012189:Retrospective Studies; D016896:Treatment Outcome
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D018501:Antirheumatic Agents; D007555:Isoxazoles; D000077339:Leflunomide; C502936:tocilizumab; D008727:Methotrexate
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