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Below are several of the highlight studies in psoriatic arthritis (PsA) presented at the ACR 2019 annual meeting in Atlanta.
Abstract #807 Guselkumab in Psoriatic Arthritis. Dr. Atul Deodhar presented the results all of the DISCOVER-1 trial) with guselkumab, an IL-23 inhibitor, being studied in patients with active psoriatic arthritis. This study enrolled 381 patients randomize them to receive either placebo or two different dosing regimens of GUS (100 mg given every 4 weeks or every 8 weeks). These psoriatic arthritis patients had relatively low skin scores (PASI = 7.7 to 9.5), but had active synovitis (mean of TJC = 15. SJC = 8) as they entered the trial. The ACR 20 response at 6 months (primary outcome) was significantly higher for those patients on the guselkumab. While nearly a third of the patients had received prior TNF inhibitor therapy, the ACR 20 response rates were roughly 60% regardless of whether you had previously received a TNF inhibitor or not. The ACR 50 responses were roughly 30% and the ACR 70 responses were 11-20%. GUS was not as potent in treating dactylitis and enthesitis, but the results were still significantly better than placebo. There were no new safety signals.
Abstract #2880. MAXIMIZE Study - Secukinumab in Axial Psoriatic Arthritis. This was a phase 3, double blind, placebo (PBO)-controlled, 52-wk trial of 498 pts with active PsA and clinician-diagnosed axial involvements, and spinal pain VAS > 40 and BASDAI > 4 despite prior NSAIDs. The ASAS20 response rates at Week 12 were significantly better with SEC than PBO (63.1%(SEC 300 mg, 66.3% 150 mg vs 31.3% PBO). ASAS20 responses in pts were similar in those patients receiving concomitant methotrexate. The safety profile was similar across groups. MAXIMISE is unique in being the first controlled trial of a biologic in treating the axial manifestations of PsA.
Abstract #2505 Can Biologics Prevent Psoriatic Arthritis. This was a single center, University Hospital, retrospective review of psoriasis patients (n=500) without evidence of PsA, who were treated DMARDs, Methotrexate (MTX), cyclosporine (Cyc), or biologic DMARDs (bDMARDs) (TNFi, IL17i, and IL12-23i). Among 797 patients (10017 patient/years), 75% were treated with topicals/ phototherapy, 13% csDMARDs,, 81% MTX, 19% Cyc, and 11.5% with biologics. A total of 72 patients developed PsA with a global incidence rate of 7.2 per 1000 patient/years. With Cox regression analysis, after adjustments, only biologic therapy was significantly associated with a reduced risk of developing PsA (HR: 0.1; 95%CI - 0.013 – 0.7; p= 0.021). Impressive results that needs to be restudied in a larger dataset.
EXCEED Study. Prior to the ACR Novartis released the preliminary results of the EXCEED study, a double-blinded head-to-head trial comparing secukinumab (SEC) against adalimumab (ADA). Over 850 patients were enrolled. Top line results of this 52-week, Phase IIIb trial showed that while SEC and ADA ACR20 response rates were equivalent, the trial was designed to be a superiority trial and thus SEC failed to meet its primary endpoint at week 52. No new safety signals generated for either agent in this study. The details and numeric results of this trial are expected to be presented at a major medical meeting in the near future.