Peficitinib may be a promising treatment option for RA
medwireNews: Findings from two phase III trials presented at the 2018 ACR/ARHP Annual Meeting in Chicago, Illinois, USA, demonstrate that treatment with the Janus kinase (JAK) inhibitor peficitinib may be beneficial for patients with rheumatoid arthritis (RA).
In the first trial, involving 507 patients from Japan, Korea, or Taiwan with active RA and an inadequate response to at least one conventional DMARD given for 90 days or more, participants who were randomly assigned to receive peficitinib 100 mg/day and those who were given peficitinib 150 mg/day were significantly more likely to achieve an ACR20 response at week 12 than patients given placebo, with corresponding rates of 57.7%, 74.5%, and 30.7%.
ACR50 and ACR70 response rates were also significantly higher among patients treated with peficitinib 100 or 150 mg/day compared with placebo, at 30.8% and 42.2% versus 8.9%, and 13.5% and 27.5% versus 1.0%, respectively.
Yoshiya Tanaka (University of Occupational and Environmental Health, Kitakyushu, Japan) additionally reported that participants given either dose of peficitinib were significantly more likely to achieve remission as defined by a DAS28-CRP or a DAS28-ESR score below 2.6 points than those given placebo, indicating that the JAK inhibitor “was associated with significant clinical improvements.”
The second trial included 519 patients with RA and an inadequate response to at least 90 days of methotrexate treatment, administered at a dose of 8 mg/week or for at least 28 days prior to baseline, and involved the same countries and study design as the first.
In line with the results from the first trial, Tanaka and co-investigators found that ACR20, 50, and 70 response rates at week 12 were significantly higher among patients treated with peficitinib 100 or 150 mg/day than placebo, at 58.6% and 64.4% versus 21.8%, 29.9% and 46.0% versus 7.6%, and 12.1% and 23.6% versus 2.4%, respectively. Patients in the peficitinib groups were also significantly more likely to achieve DAS28 remission at week 12 than those in the placebo group.
Rates of treatment-emergent adverse events (TEAEs) were comparable across the treatment groups at week 12 in both trials, said Tanaka. In the first study, 56.7% of patients given peficitinib 100 mg, 53.9% of those given peficitinib 150 mg, and 53.5% of those in the placebo group experienced TEAEs. The corresponding rates in the second study were 51.1%, 59.8%, and 49.4%.
Tanaka explained that in both studies, patients in the placebo group were switched to one of the peficitinib groups at week 12 (inadequate responders) or week 28 (remainder of patients), and all participants continued to receive the study drug until the 1-year follow-up. At this timepoint, TEAEs were reported in 88.5% of patients given peficitinib 100 mg and 87.3% of those given peficitinib 150 mg in the first trial, and in a corresponding 88.5% and 87.9% in the second trial.
Over the whole study period, serious infections were significantly more common among patients treated with any dose of peficitinib versus placebo, with rates of 2.0 versus 0.0 per 1000 patient–years in the first trial, and 3.4 versus 0.0 per 1000 patient–years in the second trial.
In both studies, “peficitinib was well tolerated [for] up to 52 weeks,” with “no dose-dependent increase in the rate of serious infections, herpes zoster-related disease, or malignancies,” summarized Tanaka.
He said that peficitinib has now been submitted for regulatory approval in Japan.
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