ACR Congress Review 2019

non-melanoma skin cancer) incidence rates were 0.8 (2 mg) and 1.0 (4 mg; as-randomised analysis). In
summary, baricitinib maintained a safety profile similar to that previously reported and acceptable in the
context of demonstrated efficacy [847*].
Filgotinib
Filgotinib safety in the FINCH programme
Pooled safety data from the double-blind, active and placebo-controlled periods of FINCH 1–3 up to 24
weeks were presented by Winthrop and colleagues. The FINCH studies enrolled patients who had a
diagnosis of RA (2010 ACR/EULAR criteria) and had ≥ 6 swollen joints and ≥ 6 tender joints at both
screening and Day 1. The pooled safety analyses included 3,452 patients across FINCH 1–3, including
2,088 patients who received filgotinib. At Week 24, the frequency of TEAEs was similar between
patients who received filgotinib and those in the control arms. The proportions of patients with TEAEs of
interest were also similar across groups. Overall, the frequency of MACE, herpes zoster virus, DVT and
PE was low, and similar across groups. The incidences of MACE were 0.2% for filgotinib, 0.3% for
adalimumab, and 0.5% for placebo/csDMARD. Additionally, the incidences of DVT/PE were