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

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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.

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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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Authors and Affiliations

  1. Department of Rheumatology, IdiPAZ, Hospital Universitario La Paz, Paseo de la Castellana 261, 28046, Madrid, Spain

    Alejandro Balsa

  2. Department of Rheumatology, Hospital General Universitario de Elche, Cami de L’Almassera, 11, 03203, Elche, Alicante, Spain

    Juan Víctor Tovar Beltrán

  3. Department of Rheumatology, Hospital Universitario Virgen de las Nieves, Avenida de las Fuerzas Armadas, 2, 18014, Granada, Spain

    Rafael Cáliz Cáliz

  4. Department of Rheumatology, Hospital Universitario Doce de Octubre, Avenida de Córdoba, s/n, 28041, Madrid, Spain

    Isabel Mateo Bernardo

  5. Department of Rheumatology, Hospital Universitario La Princesa, Calle de Diego León, 62, 28006, Madrid, Spain

    Rosario García-Vicuña

  6. Department of Rheumatology, Complejo Universitario Hospitalario de Ourense, Calle Ramón Puga Noguerol, 54, 32005, Ourense, Spain

    Manuel Rodríguez-Gómez

  7. Department of Rheumatology, Hospital General Universitario de Castellón, Avinguda de Benicàssim, 12004, Castelló de la Plana, Castelló, Spain

    Miguel Angel Belmonte Serrano

  8. Department of Rheumatology, Hospital Universitario Virgen de la Arrixaca, Ctra. Madrid-Cartagena, s/n, 30120, El Palmar, Murcia, Spain

    Carlos Marras

  9. Department of Rheumatology, Hospital de Navarra, Calle Irunlarrea, 3, 31008, Pamplona, Navarra, Spain

    Eduardo Loza Cortina

  10. Department of Rheumatology, Hospital Clínico Universitario de Santiago, Travesía de Choupana, s/n, 15706, Santiago de Compostela, Spain

    Eva Pérez-Pampin

  11. Department of Rheumatology, Hospital Comarcal de Vinaròs, Avenida Gil de Atrocillo, s/n, 12500, Vinaròs, Castellón, Spain

    Vicente Vila

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  1. Alejandro Balsa
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  2. Juan Víctor Tovar Beltrán
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  3. Rafael Cáliz Cáliz
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  4. Isabel Mateo Bernardo
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  5. Rosario García-Vicuña
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  6. Manuel Rodríguez-Gómez
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  7. Miguel Angel Belmonte Serrano
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  8. Carlos Marras
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  10. Eva Pérez-Pampin
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  11. Vicente Vila
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Correspondence to Alejandro Balsa.

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Balsa, A., Tovar Beltrán, J.V., Cáliz Cáliz, R. et al. Patterns of use and dosing of tocilizumab in the treatment of patients with rheumatoid arthritis in routine clinical practice: the ACT-LIFE study. Rheumatol Int 35, 1525–1534 (2015). https://doi.org/10.1007/s00296-015-3237-x

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