Rheumatology International

, Volume 35, Issue 9, pp 1525–1534 | Cite as

Patterns of use and dosing of tocilizumab in the treatment of patients with rheumatoid arthritis in routine clinical practice: the ACT-LIFE study

  • Alejandro Balsa
  • Juan Víctor Tovar Beltrán
  • Rafael Cáliz Cáliz
  • Isabel Mateo Bernardo
  • Rosario García-Vicuña
  • Manuel Rodríguez-Gómez
  • Miguel Angel Belmonte Serrano
  • Carlos Marras
  • Eduardo Loza Cortina
  • Eva Pérez-Pampin
  • Vicente Vila
Original Article - Observational Research

Abstract

The aim of the study was to identify and describe the patterns of use of tocilizumab in clinical practice to ensure safety and optimal management of rheumatoid arthritis (RA). This is a 12-month prospective observational study in patients with moderate or severe RA of ≥6 months’ duration who have started tocilizumab after failure of at least one previous disease-modifying antirheumatic drug (DMARD) including TNF inhibitors. For some analyses, patients were categorized by the use of tocilizumab as monotherapy or in combination, and by previous use of biological therapy. Overall, 379 were evaluable (84.4 % received tocilizumab after prior biologics and 78.4 % in combination with classic DMARDs). Tocilizumab was discontinued in 68/379 (17.9 %) patients after a median of 6.7 (3.7–10.4) months, mainly due to a lack of efficacy (24/379, 6.3 %) and adverse events (23/379, 6.1 %). Of 131 temporary interruptions of tocilizumab required in 101/379 (26.6 %) patients, 81/131 (61.8 %) were related to adverse events, and in 120/131 (91.6 %) cases, tocilizumab was reintroduced at 8 mg/kg. Thirty-six tocilizumab dose reductions occurred in 34/379 (9 %) patients due to abnormal laboratory values in 20/34 (55.6 %) cases. DAS28-ESR scores decreased from baseline (5.6 ± 1.0) to week 24 (3.0 ± 1.4) and week 52 (2.7 ± 1.3). DAS28 response differed between biologics-naive and biologics-experienced patients, both at weeks 24 and 52. In clinical practice, tocilizumab is effective in RA while retaining the expected safety and tolerability profile. Tocilizumab seems to be more effective for biologics-naive patients than for biologics-experienced patients, while it proves to be similarly effective when used in combination or monotherapy.

Keywords

Rheumatoid arthritis Clinical practice Biological therapy Disease-modifying antirheumatic drugs 

Notes

Acknowledgments

The authors thank the patients and investigators who participated in the study.

Funding

This work was supported by Roche Farma S.A., Spain.

Conflict of interest

AB has received unrestricted grants from Pfizer and Abbvie and speaker fees from Pfizer, Janssen, Abbvie, MSD, BMS, UCB and Roche; RCC has received speaker fees and honoraria for participating in advisory boards from Roche, MSD, Abbvie and Pfizer; RGV has received research support from Pfizer, UCB, BMS, MSD, Abbvie and FER (Spanish Rheumatologist Foundation). She has received honoraria for participating in advisory boards and congress from UCB, BMS, Hospira and Roche, as well as speaker fees from UCB, BMS, Roche and SER (Spanish Rheumatologist Society); MABS has received speaker fees from MSD, UCB, Roche, Abbvie and BMS; ELC has received speakers fees and research support from MSD, BMS and Roche. EPP has received speaker fees and honoraria for participating in advisory boards Roche, MSD, Pfizer, Abbvie, UCB and BMS. The rest of authors have declared no competing interests.

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Copyright information

© Springer-Verlag Berlin Heidelberg 2015

Authors and Affiliations

  • Alejandro Balsa
    • 1
  • Juan Víctor Tovar Beltrán
    • 2
  • Rafael Cáliz Cáliz
    • 3
  • Isabel Mateo Bernardo
    • 4
  • Rosario García-Vicuña
    • 5
  • Manuel Rodríguez-Gómez
    • 6
  • Miguel Angel Belmonte Serrano
    • 7
  • Carlos Marras
    • 8
  • Eduardo Loza Cortina
    • 9
  • Eva Pérez-Pampin
    • 10
  • Vicente Vila
    • 11
  1. 1.Department of Rheumatology, IdiPAZHospital Universitario La PazMadridSpain
  2. 2.Department of RheumatologyHospital General Universitario de ElcheElcheSpain
  3. 3.Department of RheumatologyHospital Universitario Virgen de las NievesGranadaSpain
  4. 4.Department of RheumatologyHospital Universitario Doce de OctubreMadridSpain
  5. 5.Department of RheumatologyHospital Universitario La PrincesaMadridSpain
  6. 6.Department of RheumatologyComplejo Universitario Hospitalario de OurenseOurenseSpain
  7. 7.Department of RheumatologyHospital General Universitario de CastellónCastelló de la PlanaSpain
  8. 8.Department of RheumatologyHospital Universitario Virgen de la ArrixacaEl PalmarSpain
  9. 9.Department of RheumatologyHospital de NavarraPamplonaSpain
  10. 10.Department of RheumatologyHospital Clínico Universitario de SantiagoSantiago de CompostelaSpain
  11. 11.Department of RheumatologyHospital Comarcal de VinaròsVinaròsSpain

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