TAKT Longterm
(2020)Objective
To investigate the long-term efficacy and safety of tocilizumab in patients with refractory Takayasu arteritis
Study Summary
• Most patients (85.7%) had improved or stable disease on imaging evaluation after 96 weeks
• Patient quality of life improved and was maintained throughout treatment with no new safety concerns
Intervention
Tocilizumab 162 mg subcutaneous weekly
Inclusion Criteria
Patients aged ≥12 years with confirmed Takayasu arteritis who experienced relapse within 12 weeks despite glucocorticoid treatment at ≥0.2 mg/kg/day prednisolone-equivalent dose
Study Design
Arms: Open-label extension where all patients received tocilizumab 162 mg/week subcutaneously
Patients per Arm: 36 patients total (all received tocilizumab in extension phase)
Outcome
• 17.9% showed improved and 67.9% showed stable disease on imaging at 96 weeks
• SF-36 quality of life scores clinically improved and maintained over 96 weeks
Bottom Line
Tocilizumab 162 mg weekly for up to 96 weeks demonstrated significant steroid-sparing effects, with nearly half of patients achieving very low glucocorticoid doses, improved quality of life, and stable or improved vascular imaging with acceptable safety profile.
Major Points
- Open-label extension study of 36 patients with refractory Takayasu arteritis treated with tocilizumab 162 mg subcutaneously weekly
- Median glucocorticoid dose reduced from 0.223 mg/kg/day at baseline relapse to 0.105 mg/kg/day at 96 weeks
- 46.4% of patients achieved glucocorticoid dose reduction to <0.1 mg/kg/day by week 96
- 85.7% of patients had improved (17.9%) or stable (67.9%) disease on imaging evaluation at 96 weeks
- SF-36 quality of life scores showed clinically meaningful improvements that were sustained over 96 weeks
- 18 relapses occurred in 14 patients during the extension period (29.4 events per 100 patient-years)
- Safety profile consistent with known tocilizumab adverse events, with infections being most common
Study Design
- Study Type
- Open-label extension of randomized controlled phase 3 trial
- Randomization
- Yes
- Blinding
- Open-label extension
- Sample Size
- 36
- Follow-up
- 96 weeks
- Countries
- Japan
Primary Outcome
Definition: Glucocorticoid dose reduction at 96 weeks
| Control | Intervention | HR/OR | P-value |
|---|---|---|---|
| 0.223 mg/kg/day (baseline relapse dose) | 0.105 mg/kg/day at 96 weeks; 46.4% achieved <0.1 mg/kg/day | - |
Limitations & Criticisms
- Data collected at randomization were used as baseline rather than first tocilizumab dose for patients who received placebo during double-blind period
- Small sample size of 36 patients limits generalizability
- Open-label design introduces potential bias
- No control group during extension period
- Four patients showed worsened imaging at 96 weeks, highlighting need for regular monitoring
- Limited frequency of imaging examinations due to safety and cost considerations
- Need for biomarkers to facilitate early detection of patients requiring therapy modifications