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Safety and efficacy of zilucoplan in patients with generalised myasthenia gravis (RAISE): a randomised, double-blind, placebo-controlled, phase 3 study by James F Howard; Saskia Bresch; Angela Genge; Channa Hewamadduma; John Hinton; Yessar Hussain; Raul Juntas-Morales; Henry J Kaminski; Angelina Maniaol; Renato Mantegazza; Masayuki Masuda; Kumaraswamy Sivakumar; Marek Śmiłowski; Kimiaki Utsugisawa; Tuan Vu; Michael D Weiss; Małgorzata Zajda; Babak Boroojerdi; Melissa Brock; Guillemette de la Borderie; Petra W Duda; Romana Lowcock; Mark Vanderkelen; M Isabel Leite; Dylan Sembinelli; Jeanne Teitelbaum; Michael Nicolle; Emilien Bernard; Juliette Svahn; Marco Spinazzi; Tanya Stojkovic; Sophie Demeret; Nicolas Weiss; Loïc Le Guennec; Sihame Messai; Christine Tranchant; Aleksandra Nadaj-Pakleza; Jean-Baptiste Chanson; Muhtadi Suliman; Leila Zaidi; Celine Tard; Peggy Lecointe; Jana Zschüntzsch; Jens Schmidt; Stefanie Glaubitz; Rachel Zeng; Matthias Scholl; Markus Kowarik; Ulf Ziemann; Markus Krumbholz; Pascal Martin; Christoph Ruschil; Jutta Dünschede; Roswitha Kemmner; Natalie Rumpel; Benjamin Berger; Andreas Totzeck; Tim Hagenacker; Benjamin Stolte; Raffaele Iorio; Amelia Evoli; Silvia Falso; Carlo Antozzi; Rita Frangiamore; Fiammetta Vanoli; Elena Rinaldi; Kazushi Deguchi; Naoya Minami; Yuriko Nagane; Yasushi Suzuki; Sayaka Ishida; Shigeaki Suzuki; Jin Nakahara; Astushi Nagaoka; Shunsuke Yoshimura; Shingo Konno; Youko Tsuya; Akiyuki Uzawa; Tomoya Kubota; Masanori Takahashi; Tatsusada Okuno; Hiroyuki Murai; Nils Erik Gilhus; Marion Boldingh; Tone Hakvåg Rønning; Urszula Chyrchel-Paszkiewicz; Klaudiusz Kumor; Tomasz Zielinski; Krzysztof Banaszkiewicz; Michał Błaż; Agata Kłósek; Mariola Świderek-Matysiak; Andrzej Szczudlik; Aneta Paśko; Lech Szczechowski; Marta Banach; Jan Ilkowski; Solange Kapetanovic Garcia; Patricia Ortiz Bagan; Ana Belén Cánovas Segura; Joana Turon Sans; Nuria Vidal Fernandez; Elena Cortes Vicente; Patricia Rodrigo Armenteros; Mohammad Ashraghi; Ana Cavey; Liam Haslam; Anna Emery; Kore Liow; Sharon Yegiaian; Alexandru Barboi; Rosa Maria Vazquez; Joshua Lennon; Robert M Pascuzzi; Cynthia Bodkin; Sandra Guingrich; Adam Comer; Mark Bromberg; Teresa Janecki; Sami Saba; Marco Tellez; Bakri Elsheikh; Miriam Freimer; Sarah Heintzman; Raghav Govindarajan; Jeffrey Guptill; Janice M Massey; Vern Juel; Natalia Gonzalez; Ali A Habib; Tahseen Mozaffar; Manisha Korb; Namita Goyal; Hannah Machemehl; Georgios Manousakis; Jeffrey Allen; Emily Harper; Constantine Farmakidis; Lilli Saavedra; Mazen Dimachkie; Mamatha Pasnoor; Salma Akhter; Said Beydoun; Courtney McIlduff; Joan Nye; Bhaskar Roy; Bailey Munro Sheldon; Richard Nowak; Benjamin Barnes; Michael Rivner; Niraja Suresh; Jessica Shaw; Brittany Harvey; Lucy Lam; Nikki Thomas; Manisha Chopra; Rebecca E Traub; Sarah Jones; Mary Wagoner; Sejla Smajic; Radwa Aly; Jonathan Katz; Henry Chen; Robert G Miller; Liberty Jenkins; Shaida Khan; Bhupendra Khatri; Lisa Sershon; Pantelis Pavlakis; Shara Holzberg; Yuebing Li; Irys B Caristo; Robert Marquardt; Debbie Hastings; Jacob Rube; Robert P Lisak; Aparna Choudhury; Katherine Ruzhansky; Amit Sachdev; Susan Shin; Joan Bratton; Mary Fetter; Naya McKinnon; Jonathan McKinnon; Laura Sissons-Ross; Amos Sahu; B Jane Distad is a nonfiction available to read on EtoBox.
What is Safety and efficacy of zilucoplan in patients with generalised myasthenia gravis (RAISE): a randomised, double-blind, placebo-controlled, phase 3 study about?
Background Generalised myasthenia gravis is a chronic, unpredictable, and debilitating rare disease, often accompanied by high treatment burden and with an unmet need for more efficacious and well tolerated treatments. Zilucoplan is a subcutaneous, self-administered macrocyclic peptide complement C5 inhibitor. We aimed to assess safety, efficacy, and tolerability of zilucoplan in patients with acetylcholine receptor autoantibody (AChR)-positive generalised myasthenia gravis. Methods RAISE was a randomised, double-blind, placebo-controlled, phase 3 trial that was done at 75 sites in Europe, Japan, and North America. We enrolled patients (aged 18–74 years) with AChR-positive generalised myasthenia gravis (Myasthenia Gravis Foundation of America disease class II–IV), a myasthenia gravis activities of daily living (MG-ADL) score of least 6, and a quantitative myasthenia gravis score of at least 12. Participants were randomly assigned (1:1) to receive subcutaneous zilucoplan 0·3 mg/kg once daily by self-injection, or matched placebo, for 12 weeks. The primary efficacy endpoint was change from baseline to week 12 in MG-ADL score in the modified intention-to-treat population (all randomly
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- Author
- James F Howard; Saskia Bresch; Angela Genge; Channa Hewamadduma; John Hinton; Yessar Hussain; Raul Juntas-Morales; Henry J Kaminski; Angelina Maniaol; Renato Mantegazza; Masayuki Masuda; Kumaraswamy Sivakumar; Marek Śmiłowski; Kimiaki Utsugisawa; Tuan Vu; Michael D Weiss; Małgorzata Zajda; Babak Boroojerdi; Melissa Brock; Guillemette de la Borderie; Petra W Duda; Romana Lowcock; Mark Vanderkelen; M Isabel Leite; Dylan Sembinelli; Jeanne Teitelbaum; Michael Nicolle; Emilien Bernard; Juliette Svahn; Marco Spinazzi; Tanya Stojkovic; Sophie Demeret; Nicolas Weiss; Loïc Le Guennec; Sihame Messai; Christine Tranchant; Aleksandra Nadaj-Pakleza; Jean-Baptiste Chanson; Muhtadi Suliman; Leila Zaidi; Celine Tard; Peggy Lecointe; Jana Zschüntzsch; Jens Schmidt; Stefanie Glaubitz; Rachel Zeng; Matthias Scholl; Markus Kowarik; Ulf Ziemann; Markus Krumbholz; Pascal Martin; Christoph Ruschil; Jutta Dünschede; Roswitha Kemmner; Natalie Rumpel; Benjamin Berger; Andreas Totzeck; Tim Hagenacker; Benjamin Stolte; Raffaele Iorio; Amelia Evoli; Silvia Falso; Carlo Antozzi; Rita Frangiamore; Fiammetta Vanoli; Elena Rinaldi; Kazushi Deguchi; Naoya Minami; Yuriko Nagane; Yasushi Suzuki; Sayaka Ishida; Shigeaki Suzuki; Jin Nakahara; Astushi Nagaoka; Shunsuke Yoshimura; Shingo Konno; Youko Tsuya; Akiyuki Uzawa; Tomoya Kubota; Masanori Takahashi; Tatsusada Okuno; Hiroyuki Murai; Nils Erik Gilhus; Marion Boldingh; Tone Hakvåg Rønning; Urszula Chyrchel-Paszkiewicz; Klaudiusz Kumor; Tomasz Zielinski; Krzysztof Banaszkiewicz; Michał Błaż; Agata Kłósek; Mariola Świderek-Matysiak; Andrzej Szczudlik; Aneta Paśko; Lech Szczechowski; Marta Banach; Jan Ilkowski; Solange Kapetanovic Garcia; Patricia Ortiz Bagan; Ana Belén Cánovas Segura; Joana Turon Sans; Nuria Vidal Fernandez; Elena Cortes Vicente; Patricia Rodrigo Armenteros; Mohammad Ashraghi; Ana Cavey; Liam Haslam; Anna Emery; Kore Liow; Sharon Yegiaian; Alexandru Barboi; Rosa Maria Vazquez; Joshua Lennon; Robert M Pascuzzi; Cynthia Bodkin; Sandra Guingrich; Adam Comer; Mark Bromberg; Teresa Janecki; Sami Saba; Marco Tellez; Bakri Elsheikh; Miriam Freimer; Sarah Heintzman; Raghav Govindarajan; Jeffrey Guptill; Janice M Massey; Vern Juel; Natalia Gonzalez; Ali A Habib; Tahseen Mozaffar; Manisha Korb; Namita Goyal; Hannah Machemehl; Georgios Manousakis; Jeffrey Allen; Emily Harper; Constantine Farmakidis; Lilli Saavedra; Mazen Dimachkie; Mamatha Pasnoor; Salma Akhter; Said Beydoun; Courtney McIlduff; Joan Nye; Bhaskar Roy; Bailey Munro Sheldon; Richard Nowak; Benjamin Barnes; Michael Rivner; Niraja Suresh; Jessica Shaw; Brittany Harvey; Lucy Lam; Nikki Thomas; Manisha Chopra; Rebecca E Traub; Sarah Jones; Mary Wagoner; Sejla Smajic; Radwa Aly; Jonathan Katz; Henry Chen; Robert G Miller; Liberty Jenkins; Shaida Khan; Bhupendra Khatri; Lisa Sershon; Pantelis Pavlakis; Shara Holzberg; Yuebing Li; Irys B Caristo; Robert Marquardt; Debbie Hastings; Jacob Rube; Robert P Lisak; Aparna Choudhury; Katherine Ruzhansky; Amit Sachdev; Susan Shin; Joan Bratton; Mary Fetter; Naya McKinnon; Jonathan McKinnon; Laura Sissons-Ross; Amos Sahu; B Jane Distad
- Publisher
- Elsevier BV
- Published
- 2023
- Language
- EN
- Category
- nonfiction
More by James F Howard; Saskia Bresch; Angela Genge; Channa Hewamadduma; John Hinton; Yessar Hussain; Raul Juntas-Morales; Henry J Kaminski; Angelina Maniaol; Renato Mantegazza; Masayuki Masuda; Kumaraswamy Sivakumar; Marek Śmiłowski; Kimiaki Utsugisawa; Tuan Vu; Michael D Weiss; Małgorzata Zajda; Babak Boroojerdi; Melissa Brock; Guillemette de la Borderie; Petra W Duda; Romana Lowcock; Mark Vanderkelen; M Isabel Leite; Dylan Sembinelli; Jeanne Teitelbaum; Michael Nicolle; Emilien Bernard; Juliette Svahn; Marco Spinazzi; Tanya Stojkovic; Sophie Demeret; Nicolas Weiss; Loïc Le Guennec; Sihame Messai; Christine Tranchant; Aleksandra Nadaj-Pakleza; Jean-Baptiste Chanson; Muhtadi Suliman; Leila Zaidi; Celine Tard; Peggy Lecointe; Jana Zschüntzsch; Jens Schmidt; Stefanie Glaubitz; Rachel Zeng; Matthias Scholl; Markus Kowarik; Ulf Ziemann; Markus Krumbholz; Pascal Martin; Christoph Ruschil; Jutta Dünschede; Roswitha Kemmner; Natalie Rumpel; Benjamin Berger; Andreas Totzeck; Tim Hagenacker; Benjamin Stolte; Raffaele Iorio; Amelia Evoli; Silvia Falso; Carlo Antozzi; Rita Frangiamore; Fiammetta Vanoli; Elena Rinaldi; Kazushi Deguchi; Naoya Minami; Yuriko Nagane; Yasushi Suzuki; Sayaka Ishida; Shigeaki Suzuki; Jin Nakahara; Astushi Nagaoka; Shunsuke Yoshimura; Shingo Konno; Youko Tsuya; Akiyuki Uzawa; Tomoya Kubota; Masanori Takahashi; Tatsusada Okuno; Hiroyuki Murai; Nils Erik Gilhus; Marion Boldingh; Tone Hakvåg Rønning; Urszula Chyrchel-Paszkiewicz; Klaudiusz Kumor; Tomasz Zielinski; Krzysztof Banaszkiewicz; Michał Błaż; Agata Kłósek; Mariola Świderek-Matysiak; Andrzej Szczudlik; Aneta Paśko; Lech Szczechowski; Marta Banach; Jan Ilkowski; Solange Kapetanovic Garcia; Patricia Ortiz Bagan; Ana Belén Cánovas Segura; Joana Turon Sans; Nuria Vidal Fernandez; Elena Cortes Vicente; Patricia Rodrigo Armenteros; Mohammad Ashraghi; Ana Cavey; Liam Haslam; Anna Emery; Kore Liow; Sharon Yegiaian; Alexandru Barboi; Rosa Maria Vazquez; Joshua Lennon; Robert M Pascuzzi; Cynthia Bodkin; Sandra Guingrich; Adam Comer; Mark Bromberg; Teresa Janecki; Sami Saba; Marco Tellez; Bakri Elsheikh; Miriam Freimer; Sarah Heintzman; Raghav Govindarajan; Jeffrey Guptill; Janice M Massey; Vern Juel; Natalia Gonzalez; Ali A Habib; Tahseen Mozaffar; Manisha Korb; Namita Goyal; Hannah Machemehl; Georgios Manousakis; Jeffrey Allen; Emily Harper; Constantine Farmakidis; Lilli Saavedra; Mazen Dimachkie; Mamatha Pasnoor; Salma Akhter; Said Beydoun; Courtney McIlduff; Joan Nye; Bhaskar Roy; Bailey Munro Sheldon; Richard Nowak; Benjamin Barnes; Michael Rivner; Niraja Suresh; Jessica Shaw; Brittany Harvey; Lucy Lam; Nikki Thomas; Manisha Chopra; Rebecca E Traub; Sarah Jones; Mary Wagoner; Sejla Smajic; Radwa Aly; Jonathan Katz; Henry Chen; Robert G Miller; Liberty Jenkins; Shaida Khan; Bhupendra Khatri; Lisa Sershon; Pantelis Pavlakis; Shara Holzberg; Yuebing Li; Irys B Caristo; Robert Marquardt; Debbie Hastings; Jacob Rube; Robert P Lisak; Aparna Choudhury; Katherine Ruzhansky; Amit Sachdev; Susan Shin; Joan Bratton; Mary Fetter; Naya McKinnon; Jonathan McKinnon; Laura Sissons-Ross; Amos Sahu; B Jane Distad
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