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1. Improved physical functioning, sleep, work productivity and overall health-related quality of life with bimekizumab in patients with axial spondyloarthritis: results from two phase 3 studies

Author

Annelies Boonen, Atul Deodhar, Martin Rudwaleit, Lianne S Gensler, Karl Gaffney, Maureen Dubreuil, Victoria Navarro-Compán, Vanessa Taieb, Carmen Fleurinck, Ute Massow, Thomas Vaux, Michael F Mørup, and Christine de la Loge

Subjects
Medicine
Abstract

Objective To assess the impact of bimekizumab on physical functioning, sleep, work productivity and overall health-related quality of life (HRQoL) in patients with non-radiographic (nr-) and radiographic (r-) axial spondyloarthritis (axSpA) in the phase 3 studies BE MOBILE 1 and 2.Methods Patients were randomised to subcutaneous bimekizumab 160 mg or placebo every 4 weeks; from Week 16, all patients received bimekizumab 160 mg every 4 weeks. We report the following outcomes to Week 52: Bath Ankylosing Spondylitis Functional Index (BASFI), Medical Outcomes Study Sleep Scale Revised (MOS-Sleep-R) Index II, Work Productivity and Activity Impairment: axSpA (WPAI:axSpA), Short Form-36 Physical and Mental Component Summary (SF-36 PCS/MCS) and Ankylosing Spondylitis Quality of Life (ASQoL).Results At Week 16, bimekizumab-randomised patients demonstrated significantly greater improvement from baseline versus placebo in BASFI, SF-36 PCS and ASQoL (p

Published
2024
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2. Minimal Impact of the COVID‐19 Pandemic on Disease Activity and Health‐Related Quality of Life in Patients With Ankylosing Spondylitis Receiving Bimekizumab: Exploratory Analyses From a Phase 2b Open‐Label Extension Study

Author

Philip C. Robinson, Pedro M. Machado, Nigil Haroon, Lianne S. Gensler, John D. Reveille, Vanessa Taieb, Thomas Vaux, Carmen Fleurinck, Marga Oortgiesen, Natasha dePeyrecave, and Atul Deodhar

Subjects
Diseases of the musculoskeletal system, RC925-935
Abstract

Objective The impact of the COVID‐19 pandemic on patients with inflammatory rheumatic diseases, such as ankylosing spondylitis (AS), has been variable. Here, we assess disease activity and health‐related quality of life (HRQoL) through the pandemic in patients with AS. Methods In the open‐label extension (OLE) of the phase 2b BE AGILE study, patients with AS received 160 mg of subcutaneous bimekizumab every 4 weeks. We assessed Ankylosing Spondylitis Disease Activity Score with C‐reactive protein (ASDAS‐CRP), Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and Ankylosing Spondylitis Quality of Life (ASQoL) scores in the OLE immediately before and during the COVID‐19 pandemic (September 2019 to April 2021). Results A total of 232 patients remained in the BE AGILE OLE and were included in this post hoc study at the start of the analysis period (September 1, 2019); 12 patients had a COVID‐19 treatment‐emergent adverse event, and no cases resulted in death. The number of missed bimekizumab doses due to COVID‐19 (11 doses) was minimal, and missed assessments remained low (≤5%) compared with the prepandemic period. Mean ASDAS‐CRP (1.8), BASDAI (2.4), and ASQoL scores (2.8) in the OLE were low at pre‐pandemic baseline and remained stable at 1.7 to 1.8, 2.2 to 2.4, and 2.0 to 2.8, respectively, across successive 3‐month periods immediately before and during the pandemic. ASDAS‐CRP, BASDAI, and ASQoL stability was consistent across major study countries. Conclusion Disease activity and HRQoL remained stable during the COVID‐19 pandemic in patients with AS receiving bimekizumab in the BE AGILE OLE, with no indication of negative effects on these outcomes.

Published
2022
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3. Safety and Efficacy of Bimekizumab in Patients With Active Ankylosing Spondylitis: <scp>Three‐Year</scp> Results From a Phase <scp>IIb</scp> Randomized Controlled Trial and Its <scp>Open‐Label</scp> Extension Study

Author

Xenofon Baraliakos, Atul Deodhar, Maxime Dougados, Lianne S. Gensler, Anna Molto, Sofia Ramiro, Alan J. Kivitz, Denis Poddubnyy, Marga Oortgiesen, Thomas Vaux, Carmen Fleurinck, Julie Shepherd‐Smith, Christine de la Loge, Natasha de Peyrecave, and Désirée van der Heijde

Subjects
Rheumatology, Immunology, Immunology and Allergy
Published
2022
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4. Efficacy and safety of bimekizumab in axial spondyloarthritis

Author

Désirée van der Heijde, Atul Deodhar, Xenofon Baraliakos, Matthew A Brown, Hiroaki Dobashi, Maxime Dougados, Dirk Elewaut, Alicia M Ellis, Carmen Fleurinck, Karl Gaffney, Lianne S Gensler, Nigil Haroon, Marina Magrey, Walter P Maksymowych, Alexander Marten, Ute Massow, Marga Oortgiesen, Denis Poddubnyy, Martin Rudwaleit, Julie Shepherd-Smith, Tetsuya Tomita, Filip Van den Bosch, Thomas Vaux, and Huji Xu

Subjects
Biological Therapy, Inflammation, Ankylosing, Rheumatology, Immunology, Immunology and Allergy, Cytokines, General Biochemistry, Genetics and Molecular Biology, Spondylitis, Autoimmune Diseases
Abstract

ObjectivesAxial spondyloarthritis (axSpA) is a complex disease with diverse manifestations, for which new treatment options are warranted. BE MOBILE 1 (non-radiographic (nr)-axSpA) and BE MOBILE 2 (radiographic axSpA (r-axSpA)) are double-blind, phase 3 trials designed to evaluate efficacy and safety of bimekizumab, a novel dual interleukin (IL)-17A and IL-17F inhibitor, across the axSpA spectrum.MethodsIn parallel 52-week trials, patients with active disease were randomised 1:1 (nr-axSpA) or 2:1 (r-axSpA) to bimekizumab 160 mg every 4 weeks:placebo. From week 16, all patients received bimekizumab 160 mg every 4 weeks. Primary (Assessment of SpondyloArthritis international Society ≥40% improvement (ASAS40)) and secondary endpoints were assessed at week 16. Here, efficacy and treatment-emergent adverse events (TEAEs) are reported up to week 24.Results254 patients with nr-axSpA and 332 with r-axSpA were randomised. At week 16, primary (ASAS40, nr-axSpA: 47.7% bimekizumab vs 21.4% placebo; r-axSpA: 44.8% vs 22.5%; p3%) included nasopharyngitis, upper respiratory tract infection, pharyngitis, diarrhoea, headache and oral candidiasis. More fungal infections (all localised) were observed with bimekizumab vs placebo; no major adverse cardiovascular events (MACE) or active tuberculosis were reported. Incidence of uveitis and adjudicated inflammatory bowel disease was low.ConclusionsDual inhibition of IL-17A and IL-17F with bimekizumab resulted in significant and rapid improvements in efficacy outcomes vs placebo and was well tolerated in patients with nr-axSpA and r-axSpA.

Published
2023

6. Calendar of the Correspondence of Richard Baxter, Vol. 1: 1638–1660

Author

Thomas Smith, Bruno Ryves, Richardus Morton, Francis Garbett, James Nayler, George Hopkins, Edward Burton, Francis Rous, John Greenbrough, Matthew Meade, Anthony Burgess, John Wilson, John Griggs, Thomas Willes, John Dolphin, John Humfrey, Thomas Seale, Richard Fford, Edward Baines, John Milner, William Taylor, Samuel Jones, Francis Youell, John Brodnax, Mathew Poole, Edmund Alderne, James Stansfielde, George Nichols, Henry Hammond, Timothy Garthwait, Thomas Jackman, Morgan Llwyd, Barbara Lambe, Michael Edge, Matthew Poole, Thomas Underhill, Henry Bartlett, Thomas Gataker, Raymond Gaches, William Hicks, Henry Stubbs, John Tombes, John Corbyn, John Warren, John Howe, Thomas Greaves, Richard Swayne, Wroth Rogers, John Davis, William White, Peter Ince, Robert Abbott, John Jackson, Francis Tallents, Edmund Elis, William Bates, Henry Newcome, Robert Beake, Simon Ford, Thomas Good, Edward Harley, Samuel Woodward, Giles Firmin, Anthony Tuckney, Thomas Brooks, Thomas Vaux, John Watson, Richard Green, Geoffrey F. Nuttall, Thomas Doughtey, William Duncumbe, John Warner, William Pynchon, Samuel Whittell, Francis Full Wood, Samuel Foley, John Dury, George Ashwell, George Lawson, Nathaniel Brokesby, James Berry, Charles Gataker, Stephen Streete, Francis Fullwood, Samuel Corbyn, Edward Hughes, Thomas Doelittle, Clement Writer, Peter Heylyn, Thomas Manton, William Allen, Michael Stephens, Edward Lawrence, Peter Du Moulin, Thomas Blake, John Bryan, John Taylor, Edward Jeffreys, Richard Beresford, Thomas Gouldstone, William Robertson, Oliver Bromskel, John Brand, Robert West, Humphrey Burton, George Maynard, William Mewe, Giles Collier, Henry Pearsall, John Beale, Henry Smith, Thomas Grove, Richard Vines, Silvanus Taylor, Thomas Hone, William Stephens, Abel Warren, Ralph Brownrig, Mary Rogers, Thomas Hotchkis, Richard Baxter, Adam Hough, Cornelius Burges, Abraham Pinchbecke, Abraham Garington, Thomas Lambe, John Bolt, Katherine Gell, Thomas Hill, Richard Eedes, John Arrowsmith, Joseph Baker, Robert Morton, Ludiomaeus Colvinus, Richard Pyke, John Eliot, Tristram Dimond, Martin Johnson, John Lewis, Thomas Bedford, John Horne, Henry Hickman, Viscount Conway, Thomas Wadsworth, Nathaniell Stephens, Henry Osland, Benjamin Woodbridge, John Wallis, John Durie, N. H. Keeble, Thomas Bampfielde, William Johnson, Thomas White, and Benjamin Nicholson

Subjects
Psychoanalysis, History, Art history
Published
1991
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7. The paradise of daintie deuises containyng sundrie pithie preceptes, learned counsailes and excellent inuentions : right pleasant and profitable for all ages / deuised and written for the most parte by M. Edwardes, sometime of her Maiesties chappell, the rest by sundrie learned gentlemen both of honor and worship, whose names hereafter followe.

Author

Edwards, Richard, 1523?-1566., Edwards, Richard, 1523?-1566., Bernard, of Cluny, 12th cent. De contemptu mundi. English & Latin. Selections., Vaux, Thomas Vaux, Baron, 1510-1556., Hunnis, William, d. 1597., Heywood, Jasper, 1535-1598., E. O., Kinwelmersh, Francis, d. 1580?, Sande, D., Yloop, M., Edwards, Richard, 1523?-1566., Edwards, Richard, 1523?-1566., Bernard, of Cluny, 12th cent. De contemptu mundi. English & Latin. Selections., Vaux, Thomas Vaux, Baron, 1510-1556., Hunnis, William, d. 1597., Heywood, Jasper, 1535-1598., E. O., Kinwelmersh, Francis, d. 1580?, Sande, D., and Yloop, M.

Abstract

[96] p., In verse., "The names of those who wrote these deuises: Sainct Barnard, E.O., Lorde Vaux, the elder, W. Hunis, Iasper Heiwood, F. Kindlemarsh, D. Sande, M. Yloop" -- t.p. verso., Signatures: A-M⁴., Reproductions of original in: Henry E. Huntington Library and Art Gallery., (DLPS) A21166.0001.001, (stc) STC 7520, http://quod.lib.umich.edu/t/text/accesspolicy.html, To the extent possible under law, the Text Creation Partnership has waived all copyright and related or neighboring rights to this keyboarded and encoded edition of the work described above, according to the terms of the CC0 1.0 Public Domain Dedication (http://creativecommons.org/publicdomain/zero/1.0/). This waiver does not extend to any page images or other supplementary files associated with this work, which may be protected by copyright or other license restrictions. Please go to http://www.textcreationpartnership.org/ for more information.

8. The paradise of daintie deuises containyng sundrie pithie preceptes, learned counsailes and excellent inuentions : right pleasant and profitable for all ages / deuised and written for the most parte by M. Edwardes, sometime of her Maiesties chappell, the rest by sundrie learned gentlemen both of honor and worship, whose names hereafter followe.

Author

Edwards, Richard, 1523?-1566., Edwards, Richard, 1523?-1566., Bernard, of Cluny, 12th cent. De contemptu mundi. English & Latin. Selections., Vaux, Thomas Vaux, Baron, 1510-1556., Hunnis, William, d. 1597., Heywood, Jasper, 1535-1598., E. O., Kinwelmersh, Francis, d. 1580?, Sande, D., Yloop, M., Edwards, Richard, 1523?-1566., Edwards, Richard, 1523?-1566., Bernard, of Cluny, 12th cent. De contemptu mundi. English & Latin. Selections., Vaux, Thomas Vaux, Baron, 1510-1556., Hunnis, William, d. 1597., Heywood, Jasper, 1535-1598., E. O., Kinwelmersh, Francis, d. 1580?, Sande, D., and Yloop, M.

Abstract

[96] p., In verse., "The names of those who wrote these deuises: Sainct Barnard, E.O., Lorde Vaux, the elder, W. Hunis, Iasper Heiwood, F. Kindlemarsh, D. Sande, M. Yloop" -- t.p. verso., Signatures: A-M⁴., Reproductions of original in: Henry E. Huntington Library and Art Gallery., (DLPS) A21166.0001.001, (stc) STC 7520, http://quod.lib.umich.edu/t/text/accesspolicy.html, To the extent possible under law, the Text Creation Partnership has waived all copyright and related or neighboring rights to this keyboarded and encoded edition of the work described above, according to the terms of the CC0 1.0 Public Domain Dedication (http://creativecommons.org/publicdomain/zero/1.0/). This waiver does not extend to any page images or other supplementary files associated with this work, which may be protected by copyright or other license restrictions. Please go to http://www.textcreationpartnership.org/ for more information.

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