Spondyloarthritis & psoriatic arthritis
Recapture and retreatment rates with ixekizumab after withdrawal of therapy in patients with axial spondyloarthritis: results at week 104 from a randomised placebo-controlled withdrawal study
Authors' conclusion
Ninety-six per cent of patients withdrawn to placebo recaptured at least ASDAS LDA and 71% recaptured ASDAS ID with IXE retreatment at week 104.
Study context
- Population
- Patients with axial spondyloarthritis in remission (Ankylosing Spondylitis Disease Activity Score (ASDAS) <1.3 at least once at week 16 or 20 and <2.1 at both visits) on ixekizumab (IXE)138 (89%) completed week 104
- Participants
- 155 patients
- Comparison
- Continued IXE vs withdrawal to placebo, with open-label (OL) IXE retreatment after flare
- Placebon = 53reference
- IXE Q4Wn = 48
- IXE Q2Wn = 54
- Primary endpoint
- Recapture of ASDAS LDA and ID with OL IXE retreatment in patients who flared
- Follow-up
- Week 104
Methodological detailsphase III extension study, double-blind, placebo-controlled, randomised withdrawal-retreatment period
- Phase III extension study
- Double-blind
- Placebo-controlled
- Randomised withdrawal-retreatment period
Primary result
As reported in the abstract
Recapture after flare (weeks 24-104)
- Placebo: flare
- 28 (53%)
- Placebo: recaptured ASDAS LDA before retreatment
- 4 (14%)
- Placebo: recaptured ASDAS LDA after retreatment
- 23 (82%)
- Placebo: met ASDAS ID after retreatment
- 19 (68%)
- Continuous IXE (n=102): flare
- 13
- Continuous IXE: recaptured ASDAS LDA before switching to OL IXE
- 7 of 13 (54%)
- Continuous IXE: recaptured ASDAS LDA after switching
- 5 of 13 (38%)
- Continuous IXE: met ID after switching
- 4 of 13 (31%)
Original publication
Recapture and retreatment rates with ixekizumab after withdrawal of therapy in patients with axial spondyloarthritis: results at week 104 from a randomised placebo-controlled withdrawal study. Ann Rheum Dis. Published 13 September 2022. doi:10.
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