EULAR 2019 updates
Updated: Dec 14, 2019
Pfizer has presented ORAL shift study of Xeljanz XR in patients who have rheumatoid arthritis. In the trail, Xeljanz XR was evaluated as monotherapy after the withdrawal of methotrexate treatment.
About ORAL SHIFT study: (phase 2b/4)
The study intended to evaluate the safety and efficacy of Xeljanz XR 11mg as monotherapy in patients who have rheumatoid arthritis.
Primary endpoint: Change in Disease Activity Score (DAS28-4[ESR]) at week 24 to end of the study (week 48)
Results: Xeljanz XR 11 mg as monotherapy was non-inferior to the combination of Xeljanz plus methotrexate combination.
DAS-28 change from 24 week to week 48 was0.33 in Xeljanz XR monotherapy s. 0.03 in Xeljanz XR + methotrexate combination
AbbVie has presented long term data of upadacitinib at EULAR 2019. The data was presented from the Phase 3 trials indicating the long term safety and efficacy of upadacitinib. SELECT EARLY and SELECT COMPARE were intended to demonstrate safety and efficacy and is indicated in the patients suffering from moderate to severe rheumatoid arthritis. Upadacitinib is a JAK 1 inhibitor.
ABOUT SELECT EARLY study (Phase 3):
Treatment arms: Methotrexate (MTX) vs. Upadaticitinib (upa) 15 mg vs. Upadaticitinib (upa) 30 mg
Endpoints: ACR 20, ACR 50 and DAS 28
ACR 20 at week 12: MTX - 54% vs. upa (15 mg) 76% vs upa (30 mg) 77%
ACT 20 at week 24: MTX - 59% vs. upa (15 mg) 79 % vs. upa (30 mg) 78%
ACT 50 at week 12: MTX - 28% vs. upa (15 mg) 52 % vs. upa (30 mg) 56%
ACT 50 at week 24: MTX - 33% vs. upa (15 mg) 60 % vs. upa (30 mg) 66%
UCB Pharma’s bimekizumab showed improved outcomes in patients with ankylosing spondylitis.
UCB Pharma has presented the Phase 2b results of bimekizumab in the Annual European Congress of Rheumatology, 2019 in Madrid. Bimekizumab is a novel humanized monoclonal IgG1 antibody selectively inhibiting IL-17A and IL-17F cytokines. The product has shown better disease activity and other factors like pain, fatigue, morning stiffness, and QoL.
Bimekizumab is the Phase 3 trials evaluating its safety and efficacy in the patients suffering from AS, non-radiographic axial spondyloarthritis, psoriatic arthritis (PsA) and psoriasis.
About the Phase 2b trial:
Endpoint: Symptoms of ankylosing spondylitis like pain, fatigue, morning stiffness and function
Results: 50% improvement than placebo in symptoms related to disease
BMS presents the data showing the relation between genetic marker and Orencia (abatacept) or adalimumab in patients with moderate to severe RA
BMS has presented the Phase IV trials of abatacept comparing with adalimumab in patients suffering from moderate to severe rheumatoid arthritis and are seropositive to certain patients. Patients who are positive to anti-citrullinated protein antibody (ACPA) and rheumatoid factor (RF) were more responsive to Orencia than adalimumab. Shared Epitope positive patients were more reactive to Orencia than adalimumab. Rheumatoid factor and ACPA are expressed in severe disease.