Tocilizumab in the treatment of patients with rheumatoid arthritis in real clinical practice: Results of an Italian observational study

Roberto Caporali, Luca Idolazzi, Stefano Bombardieri, Gianfranco Ferraccioli, Roberto Gerli, Marcello Govoni, M. Matucci-Cerinic, Giovanni Pomponio, Fausto Salaffi, Rosella Tirri, Francesca Benaglio, Laura Bianchino, P. Sarzi-Puttini, Roberto Caporali, S. Adami, A. Afeltra, L. Altomonte, E. Arrigoni, G. Bagnato, G. BianchiS. Bombardieri, R. N. Bucci, M. Caminiti, F. Cantini, D. Caputo, G. Carlino, P. Clerico, P. Colombelli, S. M. Corsaro, G. D'Alessandro, L. De Riso, S. De Silva, T. D'Errico, L. Di Matteo, G. Ferraccioli, C. Ferri, R. Foti, E. Fusaro, A. Gabrielli, R. Gerli, R. Giacomelli, M. Govoni, C. Lunardi, M. S. Massarotti, A. Mazzone, G. Monti, N. Pappone, M. R. Pozzi, R. Russo, G. Saviola, on behalf of TRUST study investigators

Research output: Contribution to journalArticlepeer-review


Objective To describe the effectiveness and safety of tocilizumab (TCZ), an interleukin-6 receptor inhibitor, in a cohort of patients with rheumatoid arthritis (RA) recruited in clinical practice. Methods TRUST was an observational study in RA patients who started treatment with TCZ in the 6 months prior to site activation and were still on treatment at start of study; patients were followed up to 12 months after the first TCZ infusion. Results 322 RA patients were enrolled in 59 Italian centres (mean age: 55.8 years; mean disease duration: 120.5 months; baseline DAS28: 5.3). After 6 months of TCZ treatment, patients achieving low disease activity (DAS28 ≤3.2; 57.52%) or disease remission (DAS28 < 2.6; 38.05%) were 216 out of 226 patients with available DAS28 (p < 0.001). No statistically significant differences were found in mean DAS28 and HAQ score changes from baseline (start of TCZ treatment) to study end between patients previously inadequately responding to disease-modifyinganti-rheumatic drugs (DMARD-IR) or to DMARDs plus tumour necrosis factor inhibitors (DMARD +TNFi-IR): both patient populations responded to TCZ. A statistically significant decrease in mean VAS Fatigue score (48.4 vs. 34.7; p=0.0025) at month 6 was observed. In patients treated with TCZ as monotherapy (32.61%), DAS28, VAS fatigue and HAQ scores decreased from baseline to any post-baseline time point. Overall, 62 patients (19.3%) prematurely discontinued TCZ treatment, 24 (7.5%) for safety reasons. Drug-related adverse events occurred in 92 patients (28.6%) (mostly 3 hypercholesterolaemia and leucopenia) and drug-related serious adverse events in 11 patients (3.4%). Conclusion This study confirms the good effectiveness and safety profile of TCZ in real life RA patient care.

Original languageEnglish
Pages (from-to)919-928
Number of pages10
JournalClinical and Experimental Rheumatology
Issue number6
Publication statusPublished - Nov 1 2017


  • Interleukin-6
  • Monotherapy
  • Rheumatoid arthritis
  • Tocilizumab

ASJC Scopus subject areas

  • Rheumatology
  • Immunology and Allergy
  • Immunology


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