Efficacy, Safety, Pharmacokinetics of Anti-CD40 Antibody Abiprubart in Patients with Rheumatoid Arthritis: A Phase 2, Randomized, Placebo-Controlled 12-week-treatment Proof-of-Concept Study
Abstract format and assignment number: Oral presentation 1678
Presenting author: E. Jenkins (United States)
Date: Sunday, 17th November 2024
Abiprubart, an anti-CD40 monoclonal antibody, was evaluated in a phase 2 trial for RA patients refractory to b/tsDMARDs. The 5 mg/kg weekly dose achieved a statistically significant reduction in DAS28-CRP (-2.17 vs. -1.61, p=0.0470) at 12 weeks compared to placebo. A pooled analysis also showed significant efficacy (-2.04 vs. -1.52, p=0.010). Rheumatoid factor levels decreased by >40%, indicating robust target engagement. Safety was favorable, with mild/moderate adverse events. Further studies, including phase 2B in Sjögren’s syndrome, are planned.
Safe Switching from Originator Tocilizumab to MSB11456 Tocilizumab Biosimilar in Subjects with Moderate-to-Severe Rheumatoid Arthritis: Efficacy, Safety and Immunogenicity Data Following Treatment Transition in a Pivotal, Randomized, Double-blind, Phase III Study
Abstract format and assignment number: Oral presentation 1681
Presenting author: A. Illes (Switzerland)
Date: Sunday, 17th November 2024
The Phase III APTURA I study demonstrated that MSB11456, the first tocilizumab biosimilar approved by FDA and EMA, achieved clinical biosimilarity to reference tocilizumab in moderate-to-severe RA patients. Transitioning from reference to MSB11456 at Week 24 showed sustained efficacy, safety, and immunogenicity up to Week 52. Improvements in DAS28-ESR/CRP and other disease activity measures were maintained, with no notable safety differences. This supports MSB11456 as a cost-effective, accessible alternative for RA.
Subcutaneous Abatacept vs Adalimumab Head-to-Head Comparison in Adults with Early, Dual Seropositive Rheumatoid Arthritis, Positive for the Shared Epitope HLA Class II Risk Alleles, and an Inadequate Response to Methotrexate: Results from a Phase 3 Trial
Abstract format and assignment number: Oral presentation 2671
Presenting author: M. Weinblatt (United States)
Date: Tuesday, 19th November 2024
The AMPLIFIED trial assessed abatacept (ABA) versus adalimumab (ADA) in early RA patients with high anti-CCP2 titers and shared epitope (SE) positivity. At 24 weeks, ACR50 rates, DAS28, and PROs were similar between groups. ABA showed greater reductions in autoantibodies, but SE and autoantibody levels did not predict superior treatment response. Both treatments were well-tolerated, with comparable adverse event rates. The trial did not confirm the prior hypothesis that SE and autoantibodies could predict ABA efficacy over ADA.
Prevention of the Development of Rheumatoid Arthritis by a 1-year Course of Methotrexate in ACPA-negative Arthralgia Patients at Increased Risk for Rheumatoid Arthritis: 4 Year Results of the TREAT EARLIER Trial
Abstract format and assignment number: Oral presentation 2672
Presenting author: Q. Dumoulin (Netherlands)
Date: Tuesday, 19th November 2024
The TREAT EARLIER trial investigated the effectiveness of methotrexate in preventing ACPA-negative rheumatoid arthritis (RA) in clinically suspect arthralgia (CSA). After 4 years, methotrexate reduced RA development in ACPA-negative participants with increased risk (8.6% vs 29.0%, HR 0.27), but had no effect in low-risk participants. Additionally, physical function and grip strength improved in the increased-risk group. These findings suggest methotrexate could prevent ACPA-negative RA in CSA patients with increased risk.
Timeframe for Initiating Methotrexate and Vaccine Response Against Pneumococcus in Rheumatoid Arthritis: The VACIMRA Study
Abstract format and assignment number: Oral presentation 2676
Presenting author: J. Morel (France)
Date: Tuesday, 19th November 2024
Rheumatoid arthritis (RA) patients vaccinated with PCV13 one month prior to methotrexate (MTX) initiation showed significantly higher immunological response rates at one month (88% vs. 75% by ELISA, p < 0.01) compared to simultaneous vaccination with MTX. These higher responses persisted at one year, with similar RA control and no differences in glucocorticoid or targeted DMARD use between groups. The findings emphasize the importance of completing pneumococcal vaccination before starting MTX therapy in RA patients.
Roba Ghossan
Roba is a rheumatologist at the Department of Rheumatology of Cochin Hospital APHP in Paris, France. Her main clinical and research interests include Inflammatory Rheumatic Diseases, MSK Ultrasound and Epidemiology.
Roba is a member of the French Society of Rheumatology and the society’s young rheumatologists section (REF). She is a member of the EMEUNET Social Media Sub-Committee.
E-mail: roba.ghossan@gmail.com