Baricitinib in juvenile idiopathic arthritis: an international, phase 3, randomised, double-blind, placebo-controlled, withdrawal, efficacy, and safety trial
An erratum to this article was published (Lancet, 12 Aug 2023 ↗)
Primary result · Time to disease flareResult — go to the resultHazard ratio 0.241 95% CI 0.128–0.453Authors' conclusion
Baricitinib was efficacious with an acceptable safety profile in the treatment of polyarticular juvenile idiopathic arthritis, extended oligoarticular juvenile idiopathic arthritis, enthesitis-related arthritis, and juvenile psoriatic arthritis, after inadequate response or intolerance to standard therapy.
Study context
- Population
- Patients aged 2 to <18 years with polyarticular JIA (RF positive or negative), extended oligoarticular JIA, enthesitis-related arthritis or juvenile PsA, with inadequate response (after ≥12 weeks) or intolerance to ≥1 csDMARD or bDMARD163 randomised
- Participants
- 220 patients
- Comparison
- Continued baricitinib vs placebo in JIA-ACR30 responders after 12-week open-label baricitinib lead-in
- Baricitinibn = 82
- Placebon = 81reference
- Primary endpoint
- Time to disease flare during the double-blind withdrawal period
- Follow-up
- Up to week 44
Methodological detailsphase 3, double-blind, placebo-controlled, withdrawal, international, 75 centres in 20 countries, Enrolment Dec 17, 2018 to March 3, 2021
- Phase 3
- Double-blind
- Placebo-controlled
- Withdrawal
- International, 75 centres in 20 countries
- Enrolment Dec 17, 2018 to March 3, 2021
Primary result
Time to disease flare
Hazard ratio
0.241
95% CI 0.128–0.453
P < 0.0001
By group
Placebo
27.14
median · 95% CI 15.29-not estimable · weeks
Baricitinib
not evaluable (<50% had a flare event)
median time to flare
As reported in the abstract
Safety
Serious adverse events, double-blind withdrawal period · exposure-adjusted incidence rates
IR per 100 patient-years at risk (95% CI) Baricitinib 9.7 [95% CI 2.7-24.9] · Placebo 10.2 [2.1-29.7]
Treatment-emergent infections, double-blind withdrawal period · exposure-adjusted incidence rates
IR (95% CI) Baricitinib 102.1 [95% CI 69.3-144.9] · Placebo 59.0 [33.0-97.3]
| Outcome | Baricitinib | Placebo |
|---|---|---|
| PE (serious adverse event), double-blind withdrawal periodJudged to be related to study treatment | 1% | |
| IR (95% CI) | 2.4 [95% CI 0.1-13.3] | — not stated in the abstract |
— not stated in the abstract
Serious adverse events, safety and pharmacokinetic or open-label lead-in period (all patients on baricitinib)
- Patients with serious adverse events, of 220
- Six (3%)
Treatment-emergent infections, safety and pharmacokinetic or open-label lead-in period (all patients on baricitinib)
- Patients with treatment-emergent infections, of 220
- 55 (25%)
Original publication
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