EULAR 2018 Review

Poster Sessions
Poster Tour: Novel insights on non-biologics in RA
Efficacy and safety of baricitinib at 52 weeks in the Phase 3 RA-BALANCE trial
Li and colleagues presented 52-week efficacy and safety results from the Phase 3 RA-
BALANCE trial. The study enrolled patients from China, Argentina and Brazil with
moderately to severely active RA despite a stable background of MTX; patients received
baricitinib 4 mg QD or PBO for 24 weeks, when patients receiving placebo were switched
to receive baricitinib 4 mg QD until end of study. The primary endpoint, ACR20 at Week
12, was significantly greater with baricitinib compared with placebo (58.6% versus 28.3%,
P≤0.001). The ACR20 response observed at 12 weeks was maintained through 52 weeks
in patients receiving baricitinib (Week 24: 64.1%; Week 52, 62.8%). Significant
improvements in HAQ-DI physical function (PF), duration and severity of morning joint
stiffness, and worst tiredness were observed at Week 12 with baricitinib versus placebo.
Treatment-emergent adverse events (TEAEs) and serious infections during Weeks 0–24
were reported in 74.5% and 42.1% of baricitinib patients (respectively) compared with
62.1% and 28.3% of patients receiving placebo. No major adverse cardiovascular events
(MACE), deaths, TB, venous thromboembolisms or malignancies were reported through
Week 52 with baricitinib, and no unexpected safety signals were observed [#0218].
Upadacitinib Phase 3 study results
A poster by Genovese, et al. presented the results of a Phase 3, randomised, placebocontrolled
trial of upadacitinib in patients with active RA and an inadequate response or
intolerance to bDMARDs. In this study, patients received upadacitinib 15 mg or 30 mg QD,
or placebo, followed by upadacitinib 15 mg or 30 mg QD starting at Week 12. Compared
with placebo, more patients receiving upadacitinib achieved the primary endpoints of
ACR20 and proportion achieving DAS28CRP≤3.2 (both at Week 12). Among patients with
an inadequate response to multiple bDMARDs/MOAs, and those with lack of efficacy for
alpha-IL-6, the proportions achieving ACR20 on upadacitinib versus placebo were
comparable to the overall treated population. Overall rates of AEs were slightly higher for
upadacitinib 30 mg QD versus upadacitinib 15 mg QD, and there were more serious
infections and HZ cases in patients receiving upadacitinib 30 mg. PE was reported in two
patients through Week 12, and four more patients through Week 24; all had risk factors for
DVT/PE. One death in each upadacitinib dose group was reported. The overall safety
profile was considered consistent with Phase 2 and other Phase 3 studies of upadacitinib
[#0219].
Tofacitinib and the effect of live zoster vaccine on herpes zoster events in RA
Calabrese, et al. presented an evaluation of LZV in a subset of 1146 patients with RA
treated with tofacitinib with or without MTX, and adalimumab plus MTX in ORAL Strategy.
A total of 216 patients received vaccination with LZV. No patients had zoster-like lesions
within 42 days of vaccination; one had vaccination-site erythema. In the overall study
population, the incidence rate of HZ was similar between tofacitinib monotherapy and
adalimumab plus MTX, and numerically higher with tofacitinib plus MTX. Overall, 18
patients had HZ; only three vaccinated patients had HZ. No events were serious, and only