Efficacy and Safety of Upadacitinib in Patients with Giant Cell Arteritis (SELECT-GCA): A Double-Blind, Randomized Controlled Phase 3 Trial
Abstract format and assignment number: Oral presentation 0770
Presenting author: P. Merkel (USA)
Date: Saturday, 16th November 2024
The SELECT-GCA trial is the first randomized controlled trial evaluating the efficacy of upadacitinib (7.5 mg/d or 15 mg/d), versus placebo, in patients with newly diagnosed or relapsing giant cell arteritis. The rate of sustained remission was superior to placebo only in the group receiving 15 mg/d. Another abstract describing the results in subgroup analysis confirmed these results in most subgroups.
A Multicenter, Randomized, Controlled Trial to Evaluate the Effects of Low-dose Glucocorticoids Compared to Stopping Glucocorticoids to Maintain Remission of Granulomatosis with Polyangiitis: The TAPIR Trial
Abstract format and assignment number: Oral presentation 0774
Presenting author: P. Merkel (USA)
Date: Saturday, 16th November 2024
In the TAPIR study, the authors compared two strategies of glucocorticoid treatment in patients with granulomatosis with polyangiitis in remission. Patients who stopped glucocorticoids had more relapses than patients maintaining 5 mg/d of prednisone. But interestingly, there was no difference between the two strategies in patients receiving rituximab.
Plasma Exchange for Severe Alveolar Hemorrhage in ANCA-Associated Vasculitis: Emulation of a Target Trial
Abstract format and assignment number: Oral presentation 0826
Presenting author: AC. Sanna (France)
Date: Saturday, 16th November 2024
The PEXIVAS study did not show any decrease of mortality with the use of plasma exchange in alveolar hemorrhage during ANCA associated vasculitis. In this emulated trial, the authors wanted to evaluate the potential benefits of plasma exchanges in patient with severe diffuse alveolar hemorrhage. But, even in severe patients, plasma exchanges did not improve early mortality.
Results of a One Year Randomized Double-Blind Placebo-Controlled Trial with Methotrexate 25mg Per Week for Recently Diagnosed Polymyalgia Rheumatica
Abstract format and assignment number: Oral presentation 1697
Presenting author: T. Bolhuis (The Netherlands)
Date: Sunday, 17th November 2024
Methotrexate is the most commonly used glucocorticoid sparing agent in PMR, despite contradictory studies. In this randomized controlled trial, methotrexate 25 mg/week was not superior to placebo, in association to glucocorticoids, for the remission at 52 weeks. Moreover, no glucocorticoid sparing effect was observed during the first year.
Efficacy and Safety of Nipocalimab, an Anti-FcRn Monoclonal Antibody, in Primary Sjogren’s Disease: Results from a Phase 2, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study (DAHLIAS)
Abstract format and assignment number: Oral presentation 2527
Presenting author: P. Ruscitti (Italy)
Date: Monday, 18th November 2024
So far, there is no drug approved for Sjögren’s disease. Nipocalimab is a monoclonal targeting the FcRN and accelerating the clearance of antibodies, including autoantibodies. In this phase 2 trials, some clinical outcomes were assessed and the decrease in ESSDAI was significantly higher in patients receiving the nipocalimab. Results of a phase 3 trial are now expected to confirm these interesting data.
Guillermo Carvajal Alegria
Guillermo is an associate professor of rheumatology at the University of Tours and in the rheumatology department of the Tours University Hospital, France. His research interest are polymyalgia rheumatica and giant cell arteritis, ultrasonography and procedures for clinical research and administration of biopharmaceuticals for scientific research. He is part of the board of directors of the French Rheumatology Society and of steering committee of the French College of Teaching Rheumatologists. He is a member of the EMEUNET Visibility & Global Affairs sub-committee.