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Highlights from Sunday, Day 1 of the ACR Annual meeting in Chicago, included:
Abstract 898 Tocilizumab (TCZ) in Systemic Sclerosis (SSc) – a phase 3 study.
This is a follow-up study to the previous Fasscinate trial which showed encouraging results for TCZ in the SSc, meriting “breakthrough” status with the FDA. This new trial phase 3 (labed FocuSSed) trial enrolled 212 patients who were randomized to either TCZ or placebo (PBO) for 48 weeks. The primary endpoint of the study was modification in modified Rodnan skin scores, but unfortunately those on TCZ failed to do any better than PBO patients for this primary endpoint.
However, there was a significant reduction in the change in forced vital capacity (FVC) with better preserved lung function for those on TCZ. There was no difference and safety signals and there was slightly better time to treatment failure favoring TCZ.
The question is - how will this data be viewed by the FDA, given the significant lung function benefit yet not meeting his primary endpoint. It appears that more work is needed to get this drug approved by the FDA.
Abstract 837 - High vs. Standard Dose Influenza Vaccination in Rheumatoid Arthritis.
This novel study from McGill University, assessed the impact of influenza vaccination in rheumatoid arthritis patients on DMARD and biologic therapies. In general, Rheumatoid arthritis patients have a two to three fold increase risk of influenza, yet less than one-third of our patients are routinely vaccinated - therefor putting them at high risk. The study was done over 2 years during the 2016-17 and 2017-2018 flu seasons. A total of 279 patients were randomized to receive either standard dose or high-dose quadrivalent flu vaccine. The primary endpoint was seroconversion and seroprotection rates. Data was presented according whether patients were receiving methotrexate, other DMARDs or biologics.
The results were impressive in that patients receiving the high dose vaccine showed seroconversion rates that were two to three times that seen with standard dose flu vaccine. This was seen for all treatment groups lthough lower responses were seen in those on rituximab. Most of the questins and discussion centered around the cost and availability of the vaccine. The quadrivalent vaccine is 4 to 10 times the cost of the standard influenza vaccine. This trial included RA patients with a mean age of 59-62 years. Thus our RA patients can be treated with and benefit from this high-dose vaccine which is usually reserved for use elderly patients.
JAK Studies in RA - Abstracts 886, 889, 890
Abstract 889 - Updataciinib (UPA) monotherapy in MTX-IR RA patients. A total of 648 pts were randomized, to receive UPA 15 mg vs UPA 30 mg qd vs PBO (stayed on MTX) for 14 wks of blinded therapy. UPA monotherapy at 15mg and 30mg QD showed significant improvements over continuing MTX alone for RA measures ACR 20/50/70 and DAS28 remission. ACR 20 results - 41% PBO, UPA 15 68% and UPA 30 71%.
Abstract 890 - The SELECT–COMPARE study looked at 1629 active RA, who were MTX- IR and then randomized once-daily UPA 15mg, PBO, or adalimumab (ADA 40mg EOW. At 26 weeks ACR 20 responses were significantly better for UPA (68%) compared to ADA (58%) and PBO (36%). There were no deaths but there were more AE discontinuations and Herpes Zoster events in UPA patients compared to ADA and PBO. Six venous thromboembolic events (VTEs) were reported (1 on PBO, 2 on UPA and 3 on ADA).
Abstract 886 - Switching from ADA to Baricitinib. The BEAM trial included 1305 active RA, MTX-IR patients who were treated with Baricitinib (Bari), ADA or PBO. At the end fo the trial, patients were continued into a long term extension study (without washout) on Bari. Bari patients who continued on Bari did well and even improve. ADA patients who switched to Bari also maintained disease control through 48 wks, with some nonresponders being able to achieve LDA as well. There was no increase in serious AEs or infections.