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Real-world experience of tocilizumab in rheumatoid arthritis: sub-analysis of data from the Italian biologics’ register GISEA

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Abstract

To assess the long-term effectiveness and safety of tocilizumab, abatacept, and tumor necrosis factor-α inhibitors (TNFi), in the Italian real-world setting of rheumatoid arthritis (RA). The records of adult RA patients from the Italian biologics’ registry Gruppo Italiano Studio Early Arthritis (GISEA) were analyzed. Demographic and clinical data were obtained at entry. The disease remission rate (28-joint disease activity score calculated using the erythrocyte sedimentation rate [DAS28-ESR] ≤ 2.6) and frequency of adverse events (AEs) were evaluated at 2 years. From 1999 to 2014, 7539 patients were treated with biologics (61.3% in first- and 22.6% in second-line), 68% of cases received TNFi, 9.1% tocilizumab, and 8.6% abatacept. Treatment groups showed a similar DAS28 at entry. As first-line, tocilizumab induced a significantly higher remission rate than abatacept or TNFi at 6 (51 vs 23.3 and 26.2%, respectively; p < 0.0001) and 24 months (52.3 vs 33.3 and 34.4%, respectively; p < 0.01). A similar pattern was observed in later lines. The most common AEs reported were infections, reactions to biologics (more frequent among TNFi-treated patients), increased transaminase (more frequent among TCZ-treated patients), and cardiovascular events. In clinical practice, TCZ induced a rapid and long-lasting remission and in a higher percentage of patients compared to abatacept and TNFi, with a good safety profile.

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Acknowledgements

Medical writing support and editorial assistance was provided by Clara Ricci, PhD (Primula Multimedia S.r.L., Pisa).

Funding

This study was funded by Roche S.p.A., Italy (no grant number).

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Authors and Affiliations

  1. Rheumatology Unit, Department of Emergency Medicine and Transplantation, University of Bari, Bari, Italy

    F. Iannone & G. Lapadula

  2. Institute of Rheumatology and Affine Sciences, Catholic University of the Sacred Heart, Rome, Italy

    G. Ferraccioli & E. Gremese

  3. Department of Rheumatology, Gaetano Pini Institute, Milan, Italy

    L. Sinigaglia & E. G. Favalli

  4. L. Sacco University Hospital, Milan, Italy

    P. Sarzi-Puttini & F. Atzeni

  5. Rheumatology and Clinical Immunology Unit, Spedali Civili di Brescia, Brescia, Italy

    R. Gorla & C. Bazzani

  6. Department of Medical Science, Section of Rheumatology, University of Ferrara and Azienda Ospedaliero Universitaria Sant’Anna di Cona, Ferrara, Italy

    M. Govoni & I. Farina

  7. Rheumatology Unit, University of Verona, Verona, Italy

    A. Carletto & A. Giollo

  8. Rheumatology Unit, University of Siena, Siena, Italy

    M. Galeazzi

  9. Rheumatology Unit, A.O.U. Policlinico Vittorio Emanuele, Catania, Italy

    R. Foti

  10. Roche Spa, Monza, Italy

    L. Bianchino & L. La Grasta

  11. Rheumatology Unit, Interdisciplinary Department of Medicine, University of Bari, P.zza G. Cesare 11, 70124, Bari, Italy

    F. Iannone

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  1. F. Iannone
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  2. G. Ferraccioli
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  3. L. Sinigaglia
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  4. E. G. Favalli
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Correspondence to F. Iannone.

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Disclosures

Laura Bianchino and Lidia La Grasta are employees at Roche S.p.A, Italy. The other authors have nothing to disclose.

Roche S.p.A, Italy supported financially OEG (osservatorio epidemiologico GISEA) to extrapolate clinical data from the GISEA register. The authors maintained their independence in designing the study, interpreting data, and writing the manuscript.

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Iannone, F., Ferraccioli, G., Sinigaglia, L. et al. Real-world experience of tocilizumab in rheumatoid arthritis: sub-analysis of data from the Italian biologics’ register GISEA. Clin Rheumatol 37, 315–321 (2018). https://doi.org/10.1007/s10067-017-3846-8

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