Day 3 - Top 5 from EULAR 2020 Save
These were my top abstracts from Thursday, 4th of June at EULAR 2020:
- Voclosporin Effective in Lupus Nephritis (OP0277). Voclosporin is a calcineurin inhibitor that has performed well in an earlier phase II trial. The AURORA study was a 357 patient trial wherein with active lupus nephritis (LN) on a background of mycophenolate therapy were randomized to receive voclosporin (VCS) or placebo, with the primary endpoint being a renal response at week 52 (UPCR< 0.5). The renal response was better achieved with VCS 41% compared to PBO 22%. Adverse events were similar with SAEs in 21% of both groups and infection also equally balanced (VCS 10.1% and control 11.2%).
- Emapalumab for Macrophage Activation Syndrome (MAS) in systemic JIA patients (OP0290). This was previously featured at ACR19 but has added a few more patients and the data remain exciting. Emapalumab (Gamifant) has been previously FDA and EMA approved for treatment of primary hemophagocytic lymphohistiocytosis, which, like MAS, can be a deadly complication. De Benedetti and colleagues report on their multinational study of emapalumab in 9 sJIA patients with severe MAS (high D-dimers, ferritin, lymphopenia, etc.) and were given an initial dose of 6 mg/kg followed by 3 mg/kg twice weekly for 4 weeks. All patients normalized their labs and were complete responders who significantly lowered their steroid doses. The drug was well tolerated with a few viral infections and one CMV reactivation.
- Tofacitinib – Effective in Systemic Sclerosis (SSc) (FRI0228). Not much seems to ever work in SSc. This pilot trial enrolled 66 SSc patients and randomized them to receive either methotrexate (MTX) 7.5-10 mg/wk or tofacitinib (TOFA) 5 mg bid. Patients were assessed at baseline and week 26 by modified Rodnan skin score (mRSS) and the ultrasound (US) measured skin thickness. Musculoskeletal assessments by ultrasound scored effects on joints and tendons (US10SSc score). At week 26 there was significant reduction in mRSS – a 50% reduction with TOFA vs 8.7% with MTX. This was supported by skin thickness by US with a 12.9% reduction with TOFA vs. 4.7% with MTX. TOFA was also effective at improving joint and tendon scores by ultrasound (56.2% TOFA vs 12.5% MTX). This encouraging active controlled trial merits further study with JAK inhibitors in SSc.
- H2H – Secukinumab vs Adalimumab as Monotherapy in Psoriatic Arthritis (OP0227). McInnes and colleagues reported the 52 week results from the EXCEED study (SEC vs ADA). This was designed as a superiority trial, but SEC failed to meet its primary endpoint - ACR20 at week 52 (SEC 67.4% vs ADA 61.5%; p=0.07). While SEC was numerically, but not significantly, better in many parameters (ACR20, ACR50, retention rates), SEC was significantly superior with PASI90, DAPSA (skin) outcomes. There were no differences in adverse events between groups.
- Vedolizumab Flares of Arthritis in IBD patients (FRI0294). Inflammatory bowel disease (IBD) patients often switch from TNF inhibitors to alternative therapies, including vedoliziumab (VDZ). This cohort analysis of IBD patients changing from TNFi to VDZ looked at 61 patients, 20% with a history of IBD-related Spondyloarthritis. Of these 25% developed a MSK exacerbation of SpA within 5 mos of starting VDZ therapy. Another 15% (9/49) of the VDZ treated patients developed new MSK complaints, with 3 of them appearing to be a SpA.
The author has received compensation as an advisor or consultant on this subject