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  • Humoral immune response to vaccines in patients with rheumatoid arthritis treated with tocilizumab: results of a randomised controlled trial (VISARA)

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Clinical and epidemiological research
Extended Report
Humoral immune response to vaccines in patients with rheumatoid arthritis treated with tocilizumab: results of a randomised controlled trial (VISARA)
  1. Clifton O Bingham III1,
  2. Warren Rizzo2,
  3. Alan Kivitz3,
  4. Azra Hassanali4,
  5. Ruchi Upmanyu5,
  6. Micki Klearman4
  1. 1Department of Medicine, Johns Hopkins University, Baltimore, Maryland, USA
  2. 2Advanced Arthritis Care, Scottsdale, Arizona, USA
  3. 3Altoona Center for Clinical Research, Duncansville, Pennsylvania, USA
  4. 4Genentech, South San Francisco, California, USA
  5. 5Roche, Welwyn Garden City, UK
  1. Correspondence to Dr Clifton O Bingham III, Divisions of Rheumatology and Allergy and Clinical Immunology, Department of Medicine, Johns Hopkins University, 5200 Eastern Avenue, Mason F Lord Center Tower, Baltimore, MD 21224, USA; Clifton.bingham{at}jhmi.edu

Abstract

Objective To evaluate the effect of tocilizumab (TCZ), an interleukin 6 receptor inhibitor, on humoral immune responses to immunisations in patients with rheumatoid arthritis (RA).

Methods Patients with RA with inadequate response/intolerance to one or more anti-tumour necrosis factor-α agents were randomly assigned (2:1) to TCZ 8 mg/kg intravenously every 4 weeks plus methotrexate (MTX) or MTX alone up until week 8. Serum was collected before vaccination at week 3, antibody titres were evaluated at week 8, and then all patients received TCZ+MTX through week 20. End points included proportion of patients responding to ≥6/12 pneumococcal polysaccharide vaccine (PPV23) serotypes (primary) and proportions responding to tetanus toxoid vaccine (TTV; secondary) at week 8.

Results 91 patients were randomised. At week 8, 60.0% of TCZ+MTX and 70.8% of MTX patients responded to ≥6/12 PPV23 serotypes, with insufficient evidence for any difference in treatments (10.8% (95% CI −33.7 to 12.0)), and 42.0% and 39.1%, respectively, responded to TTV. Two of three TCZ+MTX patients with non-protective baseline TTV antibody titres achieved protective levels by week 8. The safety profile of TCZ was consistent with previous reports.

Conclusions Short-term TCZ treatment does not significantly attenuate humoral responses to PPV23 or TTV. To maximise vaccine response, patients should be up to date with immunisations before starting TCZ treatment.

ClinicalTrials.gov identifier NCT01163747.

  • Methotrexate
  • Rheumatoid Arthritis
  • Vaccination

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 3.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/3.0/

https://doi.org/10.1136/annrheumdis-2013-204427

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