ACR Congress Review 2019

Peficitinib
Peficitinib safety in an Asian population of RA patients
Pooled safety data from four clinical studies of peficitinib in adult patients with active RA were presented
by Takeuchi and colleagues. Two pooled datasets (Phase 3 studies and Phase 2/3 studies) were used
for the analyses. A total of 1052 patients were included in the pooled Phase 2 and 3 studies. Overall
exposure to peficitinib in Phase 2/3 studies was 2336.3 patient-years. Across the 4 studies, there were
3 deaths. In the pooled Phase 3 studies, there were no deaths. The overall incidence of AEs was similar
between the 2 peficitinib groups: 88.5% in the peficitinib 100 mg/day group, 87.7% in the peficitinib
150 mg/day group, and 89.0% in the etanercept group; the incidence of SAEs was 9.4%, 7.6%, and
9.0%, respectively. Among AEs of special interest in the pooled Phase 3 studies, the incidence of
serious infections was 2.9 in patients receiving peficitinib and 2.0 in those receiving etanercept. The
incidence of herpes zoster-related disease was greater in peficitinib groups (5.7) than in placebo (2.3) or
etanercept groups (2.6), and the overall incidence of malignancies (0.6) was similar to that in the
placebo (1.2) and etanercept (0.5) groups. The authors concluded that peficitinib was well tolerated with
no major specific concerns with longer term administration [2403].
JAKi
Short-term risk of MACE or VTE in RA
Results of a meta-analysis of randomised controlled trials (RCTs) to examine the short-term risk of
MACE or VTE in patients with RA initiating a JAKi were presented by Malaurie and colleagues. A total of
30 RCTs were included in the meta-analysis and no statistically significant difference was observed in
MACE or VTE incidences in patients receiving any of the JAKi (baricitinib, decernotinib, filgotinib,
peficitinib, tofacitinib, upadacitinib), compared to the placebo group. A numeric imbalance was observed
in the baricitinib group with 7 VTEs (688 PY) compared with none in the placebo group (452 PY), with
0.01 risk difference, which was not statistically significant. A numeric imbalance was also observed in
the upadacitinib group with 6 VTEs (611 PY) compared to 1 VTE in the placebo group (440 PY), with a
0.01 risk difference, which is not statistically significant. Thus, no statistically significant change was
identified in the short-term risk of MACEs or VTEs in patients with RA initiating a JAKi [2358*].
*Chairman’s Pick