medwireNews: Tofacitinib is effective for reducing the risk for disease flare in patients with polyarticular juvenile idiopathic arthritis (pJIA), results of a randomized phase III study show.
Among 72 patients randomly assigned to receive the oral Janus kinase (JAK) inhibitor for 26 weeks following an open-label 18-week run-in phase, 29.2% experienced flares, which was significantly less than the 52.9% of 70 patients assigned to placebo.
The study, presented at the 2019 ACR/ARP Annual Meeting in Atlanta, Georgia, USA, involved patients aged an average of 13 years with very active pJIA, at least five active joints, an average disease duration of 2.5 years, and an inadequate response or intolerance to at least one DMARD. Most patients had prior conventional synthetic DMARD use and about 40% had prior biologic DMARD use.
They were treated with tofacitinib 5 mg twice a day, or equivalent dosing adjusted for weight in those weighing less than 40 kg. A total of 173 patients achieved the required JIA ACR30 response at the end of the open-label run-in phase and 72 of those with pJIA were randomly assigned to continue taking the drug, while 70 newly started placebo.
Presenter Hermine Brunner, from Cincinnati Children’s Hospital Medical Center in Ohio, USA, commented that during the course of the trial “the most common reason for discontinuation was insufficient clinical response rather than adverse events.”
Among the patients taking placebo, the median time to disease flare was 155 days, whereas it could not be calculated for the patients taking tofacitinib because less than 50% had flared by the end of the 44 weeks.
Brunner reported that the risk for flare for the tofacitinib group was 54.1% lower than that for the placebo group, which she said was “highly statistically significant.”
Observed data also showed a good response to the drug, with significantly greater JIA ACR30, 50, and 70 response rates in the active treatment group compared with placebo, at 70.8% versus 47.1%, 66.7% versus 47.1%, and 54.2% versus 37.1%.
And CHAQ-DI, which is comparable to the HAQ-DI in adults, improved slightly during the randomization part of the study for those given tofacitinib, whereas it remained stable in those given placebo.
With regard to disease activity observed over time, based on JADAJS27-CRP, Brunner said that it was very high to start with in the pJIA participants on tofacitinib and then “decreased rapidly until about week 14,” at which point it remained at a moderate level on average around week 18, reaching low disease activity levels by the end of the 44 weeks.
Tofacitinib was generally well tolerated. Brunner noted that “serious infections and serious adverse events were very rare and well balanced in placebo as compared to tofacitinib in the double-blinded part of the study.”
There were two cases of herpes zoster in the tofacitinib group, but they were mild cases that resolved and they did not fulfill the criteria for opportunistic infection.
By Lucy Piper
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Arthritis Rheumatol. 2019; 71 (suppl 10)
ACR/ARP 2019; Atlanta, Georgia, USA: 8–13 November