Elsevier

Joint Bone Spine

Volume 77, Supplement 1, June 2010, Pages S3-S100
Joint Bone Spine

Tocilizumab: Therapy and safety management

https://doi.org/10.1016/S1297-319X(10)70001-4Get rights and content

Abstract

Objectives

:

To develop fact sheets about tocilizumab, in order to assist physicians in the management of patients with inflammatory joint disease.

Methods

:

  • 1.

    selection by a committee of rheumatology experts of the main topics of interest for which fact sheets were desirable;

  • 2.

    identification and review of publications relevant to each topic;

  • 3.

    development of fact sheets based on three levels of evidence: evidencebased medicine, official recommendations, and expert opinion. The 20 experts were rheumatologists and invited specialists in other fields, and they had extensive experience with the management of RA. They were members of the CRI (Club Rhumatismes et Inflammation), a section of the Société Francaise de Rhumatologie. Each fact sheet was revised by several experts and the overall process was coordinated by three experts.

Results

:

Several topics of major interest were selected: contraindications of tocilizumab; the management of adverse effects and concomitant diseases that may develop during tocilizumab therapy; and the management of everyday situations such as pregnancy, surgery, and immunizations. After a review of the literature and discussions among experts, a consensus was developed about the content of the fact sheets presented here. These fact sheets focus on several points:

  • 1.

    in RA, initiation and monitoring of tocilizumab therapy, management of patients with specific past histories, and specific clinical situations such as pregnancy;

  • 2.

    diseases other than RA, such as juvenile idiopathic arthritis;

  • 3.

    models of letters for informing the rheumatologist and general practitioner;

  • 4.

    and patient information.

Conclusion

:

These tocilizumab fact sheets built on evidence-based medicine and expert opinion will serve as a practical tool for assisting physicians who manage patients on tocilizumab therapy. They will be available continuously at www.cri-net.com and updated at appropriate intervals.

References (136)

  • L. Laine et al.

    Serious lower gastrointestinal clinical events with nonselective NSAID or coxib use

    Gastroenterology

    (2003)
  • S. Durieux et al.

    Complications of colonic diverticular disease during rheumatoid polyarthritis: 7 cases

    Rev Med Interne

    (1999)
  • D.C. Tong et al.

    Antibiotic prophylaxis in dentistry: a review and practice recommendations

    JADA

    (2000)
  • A. Ravelli et al.

    Juvenile Idiopathic Arthritis

    Lancet

    (2007)
  • S. Yokota et al.

    Efficacy and safety of tocilizumab in patients with systemic-onset juvenile idiopathic arthritis: a randomised, double-blind, placebo-controlled, withdrawal phase III trial

    Lancet

    (2008)
  • T. Pham et al.

    Rituximab (Mabthera®) therapy and safety management

    Joint Bone Spine

    (2008)
  • T. Pham et al.

    Abatacept therapy and safety management

    Joint Bone Spine

    (2009)
  • Summary of Product Characteristics for tocilizumab. EMA 2009....
  • Prise en charge thérapeutique du patient dyslipidémique. AFSSAPS 2005....
  • Prise en charge des patients adultes atteints d’hypertension artérielle essentielle. HAS 2005....
  • Traitement médicamenteux du diabète de type 2 (actualisation). HAS 2006. http://www.hassante.fr/por-...
  • Méthodes d’évaluation du risque cardio-vasculaire global. ANAES 2004....
  • J. Hippisley-Cox et al.

    Predicting cardiovascular risk in England and Wales: pros- pective derivation and validation of QRISK2

    BMJ

    (2008)
  • R. van Vollenhoven et al.

    Long-term safety and tolerability of tocilizumab treatment in patients with rheumatoid arthritis and mean treatment duration of 2.4 years (Concurrent Abstract Session)

    Arthritis Rheum

    (2009)
  • M. Genovese et al.

    Lipid and Inflammatory Biomarker Profiles in Patients Receiving Tocilizumab for Rheumatoid Arthritis: Analysis of Five Phase 3 Clinical Trials (Abstract)

    Arthritis Rheum

    (2008)
  • M. Genovese et al.

    Concomitant Use of Statins in Tocilizumab-Treated Patients with Rheumatoid Arthritis with Elevated Low Density Lipoprotein Cholesterol: Analysis of Five Phase 3 Clinical Trials (Abstract)

    Arthritis Rheum

    (2008)
  • M.Y. Abeywardena et al.

    Cardiovascular biology of interleukin-6

    Curr Pharm Des

    (2009)
  • J. Danesh et al.

    Long-term interleukin-6 levels and subsequent risk of coronary heart disease: two new prospective studies and a systematic review

    PLoS Med

    (2008)
  • F. Montecucco et al.

    Common inflammatory mediators orchestrate pathophysiological processes in rheu- matoid arthritis and atherosclerosis

    Rheumatology

    (2009)
  • J.A. Aviña-Zubieta et al.

    Risk of cardiovascular mortality in patients with rheumatoid arthritis: a meta-analysis of observational studies

    Arthritis Rheum

    (2008)
  • J.-F. Boyer et al.

    Evaluation de la prévalence des facteurs de risque cardiovasculaire classiques au cours de la polyarthrite rhumatoïde

    Rev Rhum

    (2008)
  • E. Choy et al.

    Interpreting lipid levels in the context of high-grade inflammatory states with a focus on rheumatoid arthritis: a challenge to conventional cardiovascular risk actions

    Ann Rheum Dis

    (2009)
  • B.H. Hahn et al.

    Altered lipoprotein metabolism in chronic inflammatory states: proinflammatory high-density lipoprotein and accelerated atherosclerosis in systemic lupus erythematosus and rheumatoid arthritis

    Arthritis Res Ther

    (2008)
  • V.F. Panoulas et al.

    Prevalence and associations of hypertension and its control in patients with rheumatoid arthritis

    Rheumatology

    (2007)
  • H. John et al.

    Patient education on cardiovascular aspects of rheumatoid disease: an unmet need

    Rheumatology

    (2007)
  • V.P. van Halm et al.

    Rheumatoid arthritis versus diabetes as a risk factor for cardio- vascular disease: a cross-sectional study, the CARRE Investigation

    Ann Rheum Dis

    (2009)
  • J.F. Boyer et al.

    Impact of traditional therapies and biologics on cardiovascular diseases in rheumatoid arthritis

    Curr Vasc Pharmacol

    (2008)
  • S.S. Hamdulay et al.

    Disease-modifying anti-rheumatic drugs: do they reduce cardiac complications of RA?

    Heart

    (2009)
  • C.D. Poole et al.

    An evaluation of the association between C-reactive protein, the change in C-reactive protein over one year, and all-cause mortality in chronic immune-mediated inflammatory disease managed in UK general practice

    Rheumatology

    (2009)
  • Y. Omata et al.

    Neutropenia induced by anti-interleukin-6 receptor antibody, tocilizumab

    Ann Rheum Dis

    (2009)
  • N. Nishimoto et al.

    Treatment of rheumatoid arthritis with humanized anti-interleukin-6 receptor antibody: a multicenter, double-blind, placebocontrolled trial

    Arthritis Rheum

    (2004)
  • N. Nishimoto et al.

    Long-term safety and efficacy of tocilizumab, an anti-inter- leukin-6 receptor monocolonal antibody in monotherapy, in patients with rheumatoid arthritis (the STREAM Study) : evidence of safety and efficacy in a 5-year extension study

    Ann Rheum Dis

    (2009)
  • R.N. Maini et al.

    Double-Blind Randomized Controlled Clinical Trial of the Interleukin-6 Receptor Antagonist. Tocilizumab, in European Patients With Rheumatoid Arthritis Who Had an Incomplete Response to Methotrexate

    Arthritis Rheum

    (2006)
  • N. Nishimoto et al.

    Study of active controlled tocilizumab monotherapy for rheumatoid arthritis patients with an inadequate response to methotrexate (SATORI): significant reduction in disease activity and serum vascular endothelial growth factor by IL-6 receptor inhibition therapy

    Mod Rheumatol

    (2009)
  • N. Nishimoto et al.

    Study of active controlled monotherapy used for rheumatoid arthritis, an IL-6 inhibitor (SAMURAI): evidence of clinical and radiographic benefit from an x ray eader-blinded randomised controlled trial of tocilizumab

    Ann Rheum Dis

    (2007)
  • M.C. Genovese et al.

    Interleukin-6 receptor inhibition with tocilizumab reduces disease activity in rheumatoid arthritis with inadequate response to disease-modifying antirheumatic drugs: the tocilizumab in combination with traditional disease-modifying antirheumatic drug therapy study

    Arthritis Rheum

    (2008)
  • P. Emery et al.

    IL-6 receptor inhibition with tocilizumab improves treatment outcomes in patients with rheumatoid arthritis refractory to anti-TNF biologics : results from a 24-week multicentre randomised placebo controlled trial

    Ann Rheum Dis

    (2008)
  • Jones G, Sebba A, Gu J et al. Comparison of tocilizumab monotherapy versus methotrexate monotherapy in patients with...
  • J. Kremer et al.

    Safety and tolerability of tocilizumab in combination with methotrexate (MTX) in patients with rheumatoid arthritis and inadequate response to MTX : 1-year results of the LITHE study

    EULAR

    (2009)
  • Van Vollenhoven RF, Keystone E, Furie R et al. Gastrointestinal safety in patients with Rheumatoid Arthritis (RA)...
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