Spondyloarthritis & psoriatic arthritis
Etanercept Withdrawal and Retreatment in Nonradiographic Axial Spondyloarthritis: Results of RE-EMBARK, an Open-Label Phase IV Trial
Authors' conclusion
Approximately 25% of patients maintained inactive disease for 40 weeks after discontinuing ETN. Absence of both MRI sacroiliitis and high hs-CRP at baseline predicted response maintenance after ETN withdrawal.
Study context
- Population
- Patients with nonradiographic axial spondyloarthritis (nr-axSpA) achieving inactive disease on etanercept (ETN)
- Comparison
- ETN withdrawal after inactive disease, with ETN retreatment on flare
- ETN retreatmentn = 87
- Primary endpoint
- Proportion of patients with inactive disease who flared within 40 weeks of ETN withdrawal
- Follow-up
- 40 weeks
Methodological detailswithdrawal and retreatment, post hoc predictor analysis
- Withdrawal and retreatment
- Post hoc predictor analysis
Primary result
As reported in the abstract
Flare after ETN withdrawal (P2)
ETN withdrawal
67%
77 events
Further findings
Flare after ETN withdrawal (P2) · 4 weeks
- Proportion experiencing flare after 4 weeks
- 22.3% (25/112)
Flare at any time during P2 after ETN withdrawal
- Proportion experiencing flare at any time during P2
- 74.8% (86/115)
Time to flare after ETN withdrawal
- Median time to flare
- 16.1 weeks
Reachieved inactive disease with ETN retreatment in P3 · 12 weeks
- Patients retreated with ETN in P3 who reachieved inactive disease
- 54/87, 62.1%
Baseline predictors of inactive disease maintenance in P2 and regaining in P3
- Absence of both magnetic resonance imaging (MRI) sacroiliitis and high-sensitivity CRP (hs-CRP) > 3 mg/L at baseline predicted inactive disease maintenance in P2 after ETN withdrawal (multivariable analysis)
- Male sex and age younger than 40 years predicted regaining of inactive disease in P3 after flare/retreatment
- Post hoc analysis
Safety
- No unexpected safety signals
Original publication
Etanercept Withdrawal and Retreatment in Nonradiographic Axial Spondyloarthritis: Results of RE-EMBARK, an Open-Label Phase IV Trial. J Rheumatol. Published 15 November 2022. doi:10.
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