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Tofacitinib in juvenile idiopathic arthritis: A double-blind, placebo-controlled, withdrawal phase 3 randomised trial

The Lancet Dec 02, 2021

Ruperto N, Brunner HI, Synoverska O, et al. - Findings demonstrate effectiveness of tofacitinib, an oral Janus kinase inhibitor, as a treatment choice for polyarticular course juvenile idiopathic arthritis (JIA). For children and adolescents, who might wish to avoid injections, new oral therapies are especially relevant.

  • In this double-blind, withdrawal phase 3 trial, a total of 225 patients (aged 2 years to younger than 18 years), including 184 (82%) with polyarticular course JIA, 20 (9%) with psoriatic arthritis, and 21 (9%) with enthesitis-related arthritis were included.

  • A total of 147 (65%) patients received concomitant methotrexate, and in part 2 of the study, a total of 142 patients with polyarticular course JIA were treated with tofacitinib (n=72) or placebo (n=70).

  • Tofacitinib vs placebo was associated with significantly lower flare rate by week 44 (29% vs 53%) with hazard ratio 0·46.

  • In part 2, 77% of the patients receiving tofacitinib and 74% in the placebo group suffered adverse events; serious adverse events occurred in one (1%) and two (2%), respectively.

  • In the entire tofacitinib exposure period, 48% of patients developed infections or infestations.

  • During study span, no deaths occurred.

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