ACR 2019 – Best of the Plenary Sessions Save

The ACR Plenary Sessions featured some of the best research presented on Sunday, Monday, and Tuesday. Below are my selections of notable highlights from the Plenaries.

Abstract 805. High Mortality in Blacks with SLE.  Garg and colleagues presented their analysis of the Georgia lupus registry (75% AA/black), that included 336 lupus patients who were followed for an average of 14 years. They showed that Lupus patients have a higher rate of cardiovascular (CV) disease when compared to whites, an 8-fold higher rate of CV events than did whites.

Abstract 806. RITAZERAM Study in AAV. Smith et al presented the results of the RITAZERAM trial that compared the outcomes ANCA-associated vasculitis (AAV) after a standard 4-month rituximab and steroid induction regimen. The 170 patients who achieved remission were randomized to receive either azathioprine (AZA) or RTX. These AAV patients were 72% PR3+ ANCA and the remainder were MPO positive.

After 24 months those on RTX had a 70% lower rate of AAV relapse. Thus the relapse rates were 13% relapse in the RTX group and 38% in the AZA group. There were no differences in adverse events when comparing the groups. These data support the long-term maintenance effect of RTX.

Abstract 807. Guselkumab in Psoriatic Arthritis. Dr. Atul Deodhar presented the results of the DISCOVER-1 trial that tested the efficacy of guselkumab (GUS), the il-23p19 monoclonal antibody, in patients with active psoriatic arthritis (PsA) who were either biologic naive or TNF inhibitor experienced. A total of 381 patients were randomized to receive either placebo or GUS every 4 weeks or every 8 weeks. The results at week 16 and 24 showed that GUS had significantly higher ACR20/50/70 scores and remission rates than did placebo patients. The PASI75 response was significant by week 52.  Serious adverse events were seen a 2.4%, serious infections and 0.5% of patients and there was only one death in the trial.

Abstract 1759. Methotrexate Fails in Erosive Hand OA.  Roux presented an interesting study testing the efficacy of methotrexate vs. placebo in patients with erosive hand osteoarthritis (EHOA). This was a single center, 6 month, placebo controlled trial in 64 EHOA patients where pain reduction at week 12 was the primary outcome.  Overall there was no significant difference between groups in pain reduction on a 100 mm scale (MTX -17.8,  PBO -8.4). Thus MTX did not demonstrate superior efficacy over placebo on pain or function; but MTX did show some benefits regarding the progression of joint damage. These results suggest MTX should not be used in EHOA.

Abstract 1763. TULIP-1 Anifrolumab in SLE.   Dr. Richard Furie presented the results of the TULIP-1 study, a phase two, 6 month trial in active SLE patients, that tested the efficacy of IV anifrolumab (ANI) 300 or 150 mg vs. placebo every 4 months. All patents remained on background standard of care therapy. To be enrolled patients had to have a SLEDAI-2k score > 6. Unfortunately, at 52 weeks the ANI patients were no better than PBO patients as far as the primary endpoint, the SRI-4 (36% vs 40%).  The results were the same in those patients expressing a higher type I interferon signature.  ANI was numerically better in some secondary measures and in lowering steroid use.  There were more cases of H. Zoster in the ANI patients (5.6% vs. 1.6%). (Editor’s note: we also reported the results of the TULIP-2 trial that did show a small but significant for ANI using a BICLA primary endpoint response).

Abstract 2728. Upadacitinib in AS.  Efficacy and Safety of Upadacitinib in Active Ankylosing Spondylitis was presented by Dr. Désirée van der Heijde.  The SELECT-AXIS study enrolled biologic-naïve active AS patients were given either placebo or UPA 15 or 30 mg qd.  By week 14 UPA was significantly superior to PBO in changes in ASDAS and MRI spine SPARCC scores, BASDAI50, ASAS PR, and ∆ BASFI. There were very few discontinuations from AE (2.2% vs 3.2%); serious AEs were few (1.1% vs 1.1%), and there were no serious infections, herpes zoster, malignancy, venous thromboembolic events, or deaths were reported.  This study is novel in that it is one of the first JaK inhibitors shown to be effective in AS.  

Abstract 2729. Ixekizumab in Non-Radiographic Axial Spondyloarthritis (nrAxSpA). Dr. Deodhar presented the results of this Phase 3 trial assessing the efficacy of ixekizumab (IXE) against placebo. The COAST X trial enrolled 303 active nrAxSpA patients to receive either PBO or IXE (every 2 or 4 weeks; on top of background NSAIDs, etc.) for a total of 52 weeks.  At 16 weeks, IXE was significantly better than PBP for - ASAS40 (35-40% vs 19%; p< 0.01) at week 16 and week 52 (30-31% vs. 13%, p< 0.01). IXE also had significantly effects disease activity, functional status, and SIJ SPARCC scores. There were few serious adverse events or adverse events that led to discontinuation. There were no unexpected safety findings.