Autoinflammatory & rare systemic diseases
Long-term safety and efficacy of tocilizumab in adult-onset Still’s disease: open-label, long-term extension of the phase III trial
Authors' conclusion
During the observation period, no new safety findings were observed with the long-term use of tocilizumab. Response to tocilizumab was sustained even with an extended dosing interval, with substantial glucocorticoid dose reduction or discontinuation.
Study context
- Population
- Patients with AOSD who completed the precedent phase III trial of tocilizumab16 completed
- Participants
- 22 patients
- Outcome
- Safety and tolerability
Methodological detailssingle-group, Mean observation period 168.9 ± 10.8 weeks, Efficacy assessed every 12 weeks
- Single-group
- Mean observation period 168.9 ± 10.8 weeks
- Efficacy assessed every 12 weeks
Main finding
As reported in the abstract
Patients with serious AEs: 3
13.6%
Secondary outcomes
ACR70 response rate · last visit
- ACR70 response rate
- 68.2%
GC dose reduction from start of phase III trial · last visit
- Reduction in GC doses
- 95.2%
GC-free remission · last visit
- GC-free remission
- 40.9%
Tocilizumab dosing interval · final visit
- Dosing interval successfully extended
- 63.6%
- Overall mean tocilizumab interval (weeks)
- 3.4
Laboratory markers (CRP, ferritin)
- CRP and ferritin remained well controlled
Safety
- Patients with serious AEs: 3
- 13.6%
- Withdrawn from the trial due to serious AEs: 2 patients
- No new safety signal detected
Original publication
Long-term safety and efficacy of tocilizumab in adult-onset Still’s disease: open-label, long-term extension of the phase III trial. Rheumatology (Oxford). Published 29 January 2026. doi:10. 1093/ rheumatology/ keag054
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