Spondyloarthritis & psoriatic arthritis
Efficacy and safety of jaktinib hydrochloride tablets in active axial spondyloarthritis: a multicentre, randomised, double-blind, placebo-controlled phase II clinical trial
An erratum to this article was published (RMD Open, 27 Jan 2025 ↗)
Authors' conclusion
Jaktinib showed good efficacy and tolerability in the treatment of active r-axSpA, with the 100 mg two times per day showing a trend towards better efficacy.
Study context
- Population
- Adults with active radiographic axial spondyloarthritis (r-axSpA) meeting modified New York criteria with inadequate response to NSAIDsrandomised 1:1:1
- Participants
- 107 adults
- Comparison
- Jaktinib 75 mg twice daily or 100 mg twice daily vs placebo
- Jaktinib 75 mg two times per dayn = 35
- Jaktinib 100 mg two times per dayn = 36
- Placebon = 36reference
- Primary endpoint
- ASAS20 response
- Follow-up
- Week 16
Methodological detailsphase II, multicentre, double-blind, placebo-controlled
- Phase II
- Multicentre
- Double-blind
- Placebo-controlled
Primary result
As reported in the abstract
ASAS20 response rate
Secondary outcomes
- ASAS40 response rate (key secondary) · week 16 — placebo
- 13.9%
- ASAS40 response rate (key secondary): Jaktinib 75 mg bid 37.1%
- ASAS40 response rate (key secondary): Jaktinib 100 mg bid 47.2%
ASAS40 response rate (key secondary) · week 16
- Significantly higher with jaktinib vs placebo
Safety
- Treatment-emergent adverse events — placebo
- 86.1%
- Treatment-emergent adverse events: Jaktinib 75 mg bid 88.6%
- Treatment-emergent adverse events: Jaktinib 100 mg bid 94.4%
Treatment-emergent adverse events
- No statistically significant difference among the three groups
MACE, malignancy, thromboembolism or deaths
- None reported
Original publication
Efficacy and safety of jaktinib hydrochloride tablets in active axial spondyloarthritis: a multicentre, randomised, double-blind, placebo-controlled phase II clinical trial. RMD Open. Published 2 January 2025. doi:10.
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