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

1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13

 

  1. Division of Rheumatology, University of Pavia, IRCCS Policlinico San Matteo Foundation, Pavia, Italy.
  2. Unit of Rheumatology, University of Verona, Italy.
  3. Rheumatology Unit, University of Pisa, Italy.
  4. Division of Rheumatology, Institute of Rheumatology and Affine Sciences, Catholic University of the Sacred Heart, Rome, Italy.
  5. Rheumatology Unit, Department of Medicine, University of Perugia, Italy.
  6. Department of Medical Sciences, UOC of Rheumatology, Azienda Ospedaliero-Universitaria S. Anna-Ferrara, University of Ferrara, Cona, Italy.
  7. Division of Rheumatology AOUC, Department of Experimental and Clinical Medicine, University of Florence, Italy.
  8. Clinica Medica, Ospedali Riuniti di Ancona, Italy.
  9. Department of Rheumatology, Polytechnic University of the Marche, Ancona, Italy.
  10. Rheumatology Unit, Università della Campania, “Luigi Vanvitelli”, Caserta, Italy.
  11. Division of Rheumatology, University of Pavia, IRCCS Policlinico San Matteo Foundation, Pavia, Italy.
  12. Roche SpA, Italy.
  13. Rheumatology Unit, L. Sacco University Hospital, Milan, Italy.

on behalf of TRUST study investigators.

CER8496
2017 Vol.35, N°6
PI 0919, PF 0928
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PMID: 28516890 [PubMed]

Received: 31/03/2015
Accepted : 08/03/2017
In Press: 08/05/2017
Published: 11/12/2017

Abstract

OBJECTIVES:
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%).
CONCLUSIONS:
This study confirms the good effectiveness and safety profile of TCZ in real life RA patient care.

Rheumatology Article