Pediatric rheumatology

Ixekizumab in children with active psoriatic and enthesitis-related juvenile idiopathic arthritis (COSPIRIT-JIA): a multicentre, open-label, 16-week, Bayesian trial including a randomised reference group to adalimumab

Lancet RheumatolPublished Open-label phase 3 trial with a randomised reference group

Authors' conclusion

Ixekizumab was well tolerated and effective for the treatment of children with enthesitis-related arthritis and juvenile psoriatic arthritis who are candidates for biological DMARD therapy.

Study context

Population
Children with enthesitis-related arthritis (aged 6 to <18 years) or juvenile psoriatic arthritis (aged 2 to <18 years) with ≥3 active peripheral joints and bodyweight ≥10 kg40 randomised 1:1
Participants
101 children
Comparison
Ixekizumab vs adalimumab
  • Ixekizumabn = 81
  • Adalimumabn = 20reference
Primary endpoint
Percentage of ixekizumab-treated participants meeting JIA-ACR30 response criteria
Follow-up
Week 16
Methodological detailsmulticentre, Bayesian analysis, randomised adalimumab reference group, ongoing
  • Multicentre
  • Bayesian analysis
  • Randomised adalimumab reference group
  • Ongoing

Primary result

As reported in the abstract

JIA-ACR30 response with ixekizumab

Safety

Treatment-emergent adverse events, ixekizumab
46% · mild · moderate 36% · severe 0

Treatment-emergent adverse events, ixekizumab

Safety profile consistent with adult PsA or SpA and paediatric psoriasis indications

Original publication

Ixekizumab in children with active psoriatic and enthesitis-related juvenile idiopathic arthritis (COSPIRIT-JIA): a multicentre, open-label, 16-week, Bayesian trial including a randomised reference group to adalimumab. Lancet Rheumatol. Published 2 March 2026. doi:10.1016/s2665-9913(25)00346-7

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