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AB0324 Dose reduction of tocilizumab in rheumatoid arthritis patients with low disease activity: a pilot study
  1. N. van Herwaarden1,
  2. S. Herfkens-Hol1,
  3. A. van der Maas1,
  4. B. van den Bemt2,
  5. R. van Vollenhoven3,
  6. J. Bijlsma4,
  7. A. den Broeder1
  1. 1Rheumatology
  2. 2Pharmacy, Sint Maartenskliniek, Nijmegen, Netherlands
  3. 3ClinTRID, Karolinska Institute, Stockholm, Sweden
  4. 4Rheumatology & Clinical Immunology, University Medical Centre Utrecht, Utrecht, Netherlands

Abstract

Background Tocilizumab, in the registered dose of 8 mg/kg, has proven to be an effective treatment in rheumatoid arthritis (RA) patients. However, RCT data show that a substantial proportion of patients can achieve low disease activity on a lower than registered (4 versus 8mg/kg) starting dose1. A lower dose might reduce dose-dependent side effects and costs. No data, however, are available on the feasibility of dose reduction to 4 mg/kg in RA patients who reached low disease activity on the registered dose of 8 mg/kg.

Objectives To examine the proportion of RA patients with successful dose reduction of tocilizumab after achieving low disease activity, and to asses the frequency of secondary ineffectiveness after re-escalation.

Methods According to the local treatment protocol, RA patients start with tocilizumab 8mg/kg every 4 weeks. After at least 6 months of successful treatment, the dose is reduced to 4 mg/kg if patients have low disease activity(DAS28<3.2 and judgement of rheumatologist). In case of loss of disease control (DAS28>3.2 and judgement of rheumatologist) the dose is increased again to 8mg/kg. In this observational pilot study, patient, disease and treatment characteristics were collected as well as data on disease activity before and after dose reduction and when applicable after dose re-escalation.

Results In 19 patients tocilizumab dose was reduced because of low disease activity. The mean disease duration in those patients was 11 years (SD 8.4), rheumatoid factor positive 68%, anti-CCP positive 81% and erosive disease 58%. The mean DAS28 at time of dose reduction was 2.4 (SD 0.9). After 3 and 6 months follow up, respectively 73% (CI 49-90%) and 53% (CI 31-79%) of the patients still had low disease activity on the dose of 4mg/kg. The DAS28 at respectively 3 and 6 months was somewhat (ns) higher than baseline, 2.9 (SD 1.3) and 2.8 (SD 1.0). Most RA flares (78%) after dose reduction occurred in the first 16 weeks. All patients who experienced worsening of disease activity after dose reduction regained low disease activity after dose re-escalation.

Conclusions Dose reduction of tocilizumab is feasible in a substantial proportion of patients. Dose re-escalation after flare was effective in all patients.

  1. Kremer JM et al, Arthritis&Rheumatism 2011;63(3):609-21

Disclosure of Interest N. van Herwaarden: None Declared, S. Herfkens-Hol: None Declared, A. van der Maas: None Declared, B. van den Bemt: None Declared, R. van Vollenhoven Grant/research support from: Abbott, BMS, GSK, MSD, Pfizer, Roche, UCB, Consultant for: Abbott, BMS, GSK, MSD, Pfizer, Roche, UCB, J. Bijlsma Consultant for: Abbott, Roche, BMS, UCB, Pfizer and Merck, A. den Broeder: None Declared

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