Bimekizumab Maintains Improvements in Efficacy Endpoints and has a Consistent Safety Profile Through 52 Weeks in Patients with Non-Radiographic Axial Spondyloarthritis and Ankylosing Spondylitis: Results from Two Parallel Phase 3 Studies.
Bimekizumab Maintains Improvements in Efficacy Endpoints and has a Consistent Safety Profile Through 52 Weeks in Patients with Non-Radiographic Axial Spondyloarthritis and Ankylosing Spondylitis: Results from Two Parallel Phase 3 Studies.
Dr. Atul Deodhar, MD, Author; Désirée van der Heijde, Author
Dr. Atul Deodhar, MD, Author; Désirée van der Heijde, Author
This poster reports key efficacy outcomes such as ASAS40 response at Week 16 and Week 52 for the overall population and in TNFi-naïve and TNFi-experienced patients. The poster also discusses patients treated with BKZ achieving low disease activity (LDA) based on the ASDAS scores, objective signs of inflammation. An overview of safety and patient disposition to Week 52 will also be given.
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Patient Reported Outcomes from a Randomized Controlled Phase 3 Trial of Sarilumab in Polymyalgia Rheumatica
Patient Reported Outcomes from a Randomized Controlled Phase 3 Trial of Sarilumab in Polymyalgia Rheumatica
Jerome Msihid, Author; Vibeke Strand, Author; Jennifer Sloane Lazar, Author; Michael C Nivens, Author; Jingdong Chao, Author; Stefano Fiore, Author; Angeliki Glannelou, Author; Lita Araujo Araujo, Author
Jerome Msihid, Author; Vibeke Strand, Author; Jennifer Sloane Lazar, Author; Michael C Nivens, Author; Jingdong Chao, Author; Stefano Fiore, Author; Angeliki Glannelou, Author; Lita Araujo Araujo, Author
The poster reports the patient reported outcomes from the SAPHYR study. Patients treated with sarilumab 200mg Q2W + 14-week GC had clinically meaningful and robust improvement in patient reported outcomes compared to patients receiving placebo + 52-week GC.
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Sarilumab in Patients with Relapsing Polymyalgia Rheumatica: A Phase 3, Multicenter, Randomized, Double Blind, Placebo Controlled Trial (SAPHYR)
Sarilumab in Patients with Relapsing Polymyalgia Rheumatica: A Phase 3, Multicenter, Randomized, Double Blind, Placebo Controlled Trial (SAPHYR)
Jennifer Sloane Lazar, Author; Dr. Robert Spiera, MD, Author; Sebastian Unizony, Author; Kenneth J. Warrington, Author; Angeliki Glannelou, Author; Michael C Nivens, Author; Bolanie Akinlade, Author; Wanling Wong, Author; Yong Lin, Author; Frank R Buttgereit, MD, Author; Valerie Devauchelle-Pensec, Author; Andrea Rubbert-Roth, Author; Bhaskar Dasgupta, Author
Jennifer Sloane Lazar, Author; Dr. Robert Spiera, MD, Author; Sebastian Unizony, Author; Kenneth J. Warrington, Author; Angeliki Glannelou, Author; Michael C Nivens, Author; Bolanie Akinlade, Author; Wanling Wong, Author; Yong Lin, Author; Frank R Buttgereit, MD, Author; Valerie Devauchelle-Pensec, Author; Andrea Rubbert-Roth, Author; Bhaskar Dasgupta, Author
The poster describes the results of SAPHYR study that assessed the safety and efficacy of sarilumab in PMR patients who flared on tapering glucocorticoid (GC) dose. The study met its primary endpoint with higher number of patients achieving sustained remission with sarilumab 200 mg Q2W + 14-week GC taper when compared with patients receiving placebo + 52-week GC taper.
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Glucocorticoid (GC)-free resolution of polymyalgia rheumatica (PMR) signs and symptoms in patients treated with sarilumab with history of flare: analysis from SAPHYR
Glucocorticoid (GC)-free resolution of polymyalgia rheumatica (PMR) signs and symptoms in patients treated with sarilumab with history of flare: analysis from SAPHYR
Robert Spiera Spiera, Author; Sebastian Unizony, Author; Kenneth J. Warrington, Author; Jennifer Sloane Lazar, Author; Angeliki Glannelou, Author; Michael C Nivens, Author; Bolanie Akinlade, Author; Wanling Wong, Author; Yong Lin, Author; Frank R Buttgereit, MD, Author; Valerie Devauchelle-Pensec, Author; Andrea Rubbert-Roth, Author; Bhaskar Dasgupta, Author
Robert Spiera Spiera, Author; Sebastian Unizony, Author; Kenneth J. Warrington, Author; Jennifer Sloane Lazar, Author; Angeliki Glannelou, Author; Michael C Nivens, Author; Bolanie Akinlade, Author; Wanling Wong, Author; Yong Lin, Author; Frank R Buttgereit, MD, Author; Valerie Devauchelle-Pensec, Author; Andrea Rubbert-Roth, Author; Bhaskar Dasgupta, Author
The poster reports post-hoc results from the SAPHYR study on the resolution of PMR signs and symptoms regardless of glucocorticoid (GC) use and GC-free resolution of PMR signs and symptoms over time. GC-free resolution of PMR signs and symptoms was maintained from week 16 to week 52 in majority of patients treated with sarilumab 200mg Q2W + 14week GC.
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Integrated Safety
This poster reports on data of the safety of avacopan, C5a receptor inhibitor, from two Phase 2 and one Phase 3 studies in 439 patients with ANCA-associated vasculitis. Rates of exposure-adjusted total adverse event (AEs), serious AEs, withdrawal of study medication due to AEs, and pre-specified AEs of interest were calculated based on the integrated data from all three trials.
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