title: Effectiveness of disease-modifying antirheumatic drug co-therapy with methotrexate and leflunomide in rituximab-treated rheumatoid arthritis patients: results of a 1-year follow-up study from the CERERRA collaboration.
abstract: OBJECTIVE
  To compare the effectiveness and safety of rituximab alone or in combination with either methotrexate or leflunomide.
  
  
  METHODS
  10 European registries submitted anonymised datasets with baseline, 3, 6, 9 and 12-month clinical data from patients who started rituximab.
  
  
  RESULTS
  1195 patients were treated with rituximab plus methotrexate, 177 with rituximab plus leflunomide and 505 with rituximab alone. Significantly more patients achieved a European League Against Rheumatism good response at 6 months when treated with rituximab plus leflunomide (29.1%) compared with rituximab plus methotrexate (21.1%) and rituximab alone (19.3%; p=0.02 and p=0.01, respectively). Similar results were observed at 12 months. Adverse events occurred in 10.2%, 13.2% and 13.9% of patients on rituximab plus leflunomide, rituximab plus methotrexate and rituximab alone, respectively.
  
  
  CONCLUSIONS
  Leflunomide is an effective and safe alternative to methotrexate as concomitant treatment with rituximab. Slightly better results were obtained by the combination of rituximab and leflunomide than rituximab and methotrexate, raising the possibility of a synergistic effect of leflunomide and rituximab.
authors.affiliation: Department of Rheumatology, Karolinska University Hospital, Stockholm, Sweden.
authors.forename: Katerina
authors.initials: K
authors.lastname: Chatzidionysiou
authors.forename: Elisabeth
authors.initials: E
authors.lastname: Lie
authors.forename: Evgeny
authors.initials: E
authors.lastname: Nasonov
authors.forename: Galina
authors.initials: G
authors.lastname: Lukina
authors.forename: Merete Lund
authors.initials: ML
authors.lastname: Hetland
authors.forename: Ulrik
authors.initials: U
authors.lastname: Tarp
authors.forename: Piet L C M
authors.initials: PL
authors.lastname: van Riel
authors.forename: Dan C
authors.initials: DC
authors.lastname: Nordström
authors.forename: Juan
authors.initials: J
authors.lastname: Gomez-Reino
authors.forename: Karel
authors.initials: K
authors.lastname: Pavelka
authors.forename: Matija
authors.initials: M
authors.lastname: Tomsic
authors.forename: Tore K
authors.initials: TK
authors.lastname: Kvien
authors.forename: Ronald F
authors.initials: RF
authors.lastname: van Vollenhoven
authors.forename: Cem
authors.initials: C
authors.lastname: Gabay
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*; D004359:Drug Therapy, Combination; D004812:Epidemiologic Methods; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000009:adverse effects / Q000627:therapeutic use; D007555:Isoxazoles / Q000008:administration & dosage / Q000009:adverse effects; D000077339:Leflunomide; D008297:Male; D008727:Methotrexate / Q000008:administration & dosage / Q000009:adverse effects; D008875:Middle Aged; D011358:Product Surveillance, Postmarketing / Q000379:methods; D000069283:Rituximab; D016896:Treatment Outcome
chemical_list: D058846:Antibodies, Monoclonal, Murine-Derived; D018501:Antirheumatic Agents; D007166:Immunosuppressive Agents; D007555:Isoxazoles; D000069283:Rituximab; D000077339:Leflunomide; D008727:Methotrexate