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Highest clinical effectiveness of rituximab in autoantibody-positive patients with rheumatoid arthritis and in those for whom no more than one previous TNF antagonist has failed: pooled data from 10 European registries
  1. Katerina Chatzidionysiou1,
  2. Elisabeth Lie2,
  3. Evgeny Nasonov3,
  4. Galina Lukina3,
  5. Merete Lund Hetland4,
  6. Ulrik Tarp5,
  7. Cem Gabay6,
  8. Piet L C M van Riel7,
  9. Dan C Nordström8,
  10. Juan Gomez-Reino9,
  11. Karel Pavelka10,
  12. Matija Tomsic11,
  13. Tore K Kvien2,
  14. Ronald F van Vollenhoven1
  1. 1Department of Rheumatology, Karolinska University Hospital, Stockholm, Sweden
  2. 2Department of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway
  3. 3ARBITER, Institute of Rheumatology, Moscow, Russia
  4. 4DANBIO, Department of Rheumatology, Copenhagen University Hospital at Glostrup, Copenhagen, Denmark
  5. 5Department of Rheumatology, Aarhus University Hospital, Aarhus, Denmark
  6. 6University Hospitals of Geneva, Switzerland, for the SCQM registry
  7. 7Department of Rheumatology, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands
  8. 8Department of Rheumatology, ROB-FIN Helsinki University Central Hospital, Helsinki, Finland
  9. 9Department of Rheumatology, Hospital Clinico Univ De Santiago, Santiago, Spain
  10. 10Department of Rheumatology, Charles University, Prague, Czech Republic
  11. 11Department of Rheumatology, University Medical Center, Ljubljana, Slovenia
  1. Correspondence to Katerina Chatzidionysiou, Arbetargatan 28A, 1tr, c/o Gunilla Johansson, 11245 Stockholm, Sweden; aikaterini.chatzidionysiou{at}


Objective To assess the 6-month effectiveness of the first rituximab (RTX) course in rheumatoid arthritis (RA) and to identify possible predictors of response.

Method 10 European registries submitted anonymised datasets (baseline, 3- and 6-month follow-up) from patients with RA who had started RTX, and datasets were pooled and analysed. Heterogeneity between countries was analysed by analysis of variance. Predictors of response were identified by logistic regression.

Results 2019 patients were included (mean age/disease duration 53.8/12.1 years, 80.3% female, 85.6% rheumatoid factor (RF) positive and 76.8% (456/594 patients) anti-cyclic citrullinated peptide antibodies (anti-CCP) positive). For these patients an average of 2.7 disease-modifying antirheumatic drugs (DMARDs) (range 0–10) had failed, and RTX was given as the first biological agent in 36.6% of patients. There was significant heterogeneity between countries for several baseline characteristics, including the number of previous biological agents. Disease Activity Score based on 28 joint counts (DAS28) decreased from 5.8±1.4 at baseline to 4.2±1.4 at 6 months (p<0.0001) and 22.2%/42.5% achieved European League Against Rheumatism (EULAR) good/moderate response. Larger 6-month improvement in DAS28 was observed in RF-positive and anti-CCP-positive versus seronegative patients. The following predictors of EULAR good response at 6 months were identified in a multivariate analysis: anti-CCP positivity (OR=2.86, p=0.003), number of previous DMARDs (OR=0.84, p=0.06), ≤1 previous biological agents (OR=1.89, p=0.04), baseline DAS28 level (OR=0.74, p=0.003).

Conclusion In this large observational cohort of patients with RA treated with RTX, seropositive patients achieved significantly greater reductions in DAS28 at 6 months than seronegative patients. Effectiveness was best when RTX was used as the first biological agent or after failure of no more than one anti-tumour necrosis factor agent.

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  • Ethics approval This study was conducted with the approval of the registry of each country.

  • Provenance and peer review Not commissioned; externally peer reviewed.