EULAR 2019- Day 4 Report Save

Saturday June 15th was the last half-day at EULAR 2019 but was highlighted by the “late-breaking” (LB) presentations that were presented from the podium and by poster.

Below are the top “LB” presentations from EULAR this year:

• FINCH3 Trial: Dr. Rene Westhovens presented the results of a phas3 trial of the JAK inhibitor filgotinib in MTX-naïve rheumatoid arthritis (RA) patients.  Patients were either given MTX alone, FIL 200 mg qd (alone) or MTX plus one of 2 does of filgotinib (100 or 200 mg qd).At 24 weeks FIL 200 + MTX (81%) was significantly better than MTX alone (71.4%). Remission was more likely with Combo MTX + FIL 200 (54.1% vs 29.1%) compared to MTX alone. The safety profile of  FIL appears to be good with no unexpected or excessive serious adverse events.  There were no deaths, malignancies, thrombotic events and serious infections were seen in roughly 1% of patients.  These data add to the portfolio of FIL – from all data suggests this would be an “approvable” drug in the future.  (LB003)
• ORAL Shift Study:  answers the question of what to do when someone does well on MTX plus tofacitinib (Tofa) and what to withdraw if anything.  Dr. Stanley Cohen presented the trial which enrolled moderate to severe RA patients who were put on MTX plus Tofa ER 11 mg qd.  Patients were followed for 6 mos. and 76% of them achieved low disease activity (LDA) state with a CDAI < 10; this cohort entered into a blinded phase were half continued on MTX + Tofa ER and the other half had MTX withdrawn and were maintained on Tofa ER for 6 mos.  The results showed that withdrawing MTX made very little difference as both cohorts continued to do well from Weeks 24 to 48.  This study doesn’t answer whether it’s better to start Tofa monotherapy vs MTX + Tofa combination therapy.  It does suggest that it is reasonable to stop MTX once patients have done well on the combination of MTX and Tofa ER. (LB004)
• SPIRIT-H2H trial in PsA:  Philip Mease MD presented a novel trial design wherein psoriatic arthritis (PsA) patients were given either adalimumab or ixekizumab (+/- DMARDs) and the primary endpoint was the combination of an ACR50 (a big joint) and PASI (big skin) responses. After 24 weeks, the primary endpoint (Big skin + big joint response) was seen in 35% of IXE and 28% of ADA patients (P < 0.05).  This was largely driven by differences in the PASI100 responses (60% vs 47%) as the joint responses were equivalent (51% vs 47%). Comparing IXE to ADA, there were more injection site reactions with IXE (9.5 vs 3.2%), more cytopenias with ADA 91.8 vs 3.9%), and more candida infections with IXE (2.5 vs 0.7%) (LB005)
• Early AMPLE study: This small trial examined the impact of seropositivity and the shared epitope (SE) on responses to either adalimumab (ADA) or abatacept (ABA) in 80 patients with early RA. But to be in the trial patients had to be doubly positive for (higher titer) ACPA.   All patients were put on MTX and either ABA or ADA. By week 16 and 24 it appeared that ABA was superior to ADA but when you examined the outcomes according to SE status (hetero- or homozygous), there were no differences between ADA and ABA in patients who were SE negative. However, SE positive patients showed significantly greater ACR20/50/70 responses to ABA over ADA at week 24.  At baseline, SE+ patients tended to have much higher ACPA levels and a propensity to respond to ABA. (LB008)
• Vagal Nerve Stimulation in RA: Dr. Mark Genovese presented the novel approach of using and implanted vagal nerve neurostimulator to manage inflammatory RA. The device is about the size of a large capsule and takes ~45 minutes to be surgically implanted.  The rationale is that vagal nerve stimulation can induce a cholinergic reflex that down regulates inflammatory cytokine (eg, TNF) production for 24-48 hrs. post stimulation.  After 3 patients were tested, another 11 RA patients were treated with efficacy.  Patients either received a sham stimulator, once daily or 4 times daily vagal stimulation.  The results showed no response with sham or qid stimulation but a good decline in clinical parameters with daily vagal stimulation. Cytokine studies showed a reduction in IL-1, IL-6, IL-17, IL-23 and TNF levels with daily stimulation.   .  Safety was the main priority in this early phase 2 trial and there was one vocal cord paralysis and one Horner’s syndrome.  (LB009)