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THU0535 Safety and Efficacy of Tocilizumab in Patients with Polyarticular Course Juvenile Idiopathic Arthritis: Result from Long-Term, Interventional, Open Label Extension Study in Patients from Poland and Russia Who Completed the Global, Multinational Trial (Cherish Study)
  1. V. Opoka-Winiarska1,
  2. E. Smolewska2,
  3. Z. Żuber3,
  4. G. Dębowska4
  1. 1Department of Pediatric Pulmonology and Rheumatology, Medical University of Lublin, Lublin
  2. 2Department of Pediatric Cardiology and Rheumatology, Medical University of Łόdź, Łόdź
  3. 3Department of Pediatric Neurology and Rheumatology, St. Louis Children's Hospital, Cracow
  4. 4Medical Department, Roche Polska Sp. z o.o., Warsaw, Poland

Abstract

Background Efficacy and safety of tocilizumab (TCZ), an interleukin-6 receptor inhibitor, were previously demonstrated at week 104 of CHERISH, a phase 3 trial in patients with polyarticular course juvenile idiopathic arthritis (pcJIA).1

Objectives The purpose of this analysis was to evaluate the long term safety and efficacy of tocilizumab (TCZ) treatment with pcJIA in patients from Poland and Russia who entered this extension study.

Methods 41 patients with pcJlA from Poland (18) and Russia (23), who had completed CHERISH1 (104 weeks) with at least juvenile idiopathic arthritis (JIA) American College of Rheumatology (ACR30) clinical response to TCZ relative to baseline in core study with no adverse events (AEs), serious adverse events (SAEs) or conditions that could lead to unacceptable risk of continued treatment were enrolled. Patients received TCZ therapy 8 mg/kg in intravenous infusion every 4 weeks. As a result of early study termination patients had varying durations of time in the study ranging from 27 to 89 weeks.

Results The safety population comprised 41 patients with 46.41 patient-years (PY). It should be emphasized that at the start of the study, each patient received the drug for 104 weeks. Rates/100 PY of adverse events (AEs) and serious AEs (SAEs) were 181.0 and 6.46, respectively. Pharyngitis and upper respiratory tract infection were the most common AE (14,6% and 12,2% respectively). With the exception of 1 patient who had severe neutropenia that led to withdrawal from the study, all other AEs were mild (24.4%) or moderate (29.3%) in intensity and did not lead to withdrawal. There were no deaths, life-threatening AEs, or AEs of special interest during this study. The incidence of SAEs was low (3 patients – 7,3%): mild proteinuria, severe neutropenia and moderate multiple injuries. The majority of AEs were unrelated to TCZ and were consistent with a pediatric and pcJIA population. There were no new safety findings of note for laboratory and vital sign parameters.

All patients in this study achieved ACR70 at Baseline (Week 104 of the core study) and continued to achieve at least ACR50 response up to Week 24 of this long-term extension study. Other efficacy parameters showed similar patterns of continued response across the first 24 weeks of this long-term extension study.

Conclusions The long-term use of TCZ was well tolerated in population of pcJIA patients. The safety profile of TCZ treatment consistent with reported previously.1 Efficacy of TCZ was maintained over 2,5 years of treatment. The continued efficacy response and the consistent safety profile currently support a positive benefit-risk ratio for the use of TCZ in pcJIA.

References

  1. Brunner HI et al. Ann Rheum Dis doi:10.1136/annrheumdis-2014-205351

Disclosure of Interest V. Opoka-Winiarska: None declared, E. Smolewska: None declared, Z. Żuber: None declared, G. Dębowska Employee of: Roche Polska Sp. z o.o.

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