Aikaterini Thanou1, Joan T Merrill2. 1. Arthritis and Clinical Immunology Research Program, Oklahoma Medical Research Foundation, 825 NE 13th Street, MS 22, Oklahoma City, OK, 73104, USA. aikaterini-thanou@omrf.org. 2. Arthritis and Clinical Immunology Research Program, Oklahoma Medical Research Foundation, 825 NE 13th Street, MS 22, Oklahoma City, OK, 73104, USA.
Abstract
PURPOSE OF REVIEW: To review progress in the field of clinical trials for SLE. RECENT FINDINGS: Treatment development for SLE has been marked by failures of many later phase studies, representing billions of dollars of lost research and development funding. Recently, more successful Phase II trials have tested reductions in background medications, novel stringent endpoints, and identification of informative immunologic subsets to achieve greater treatment effects. A large number of agents with promising novel biologic mechanisms have continued to enter clinical development, and momentum is building to capitalize on newer strategies for trial designs. Widespread SLE drug development is proceeding despite setbacks and controversies. Approaches focusing on patients with high disease activity, reduction of background polypharmacy, or increased endpoint stringency provide strategies that might improve interpretation of trial results. Pharmacodynamics of immune-modulation is a field in its infancy, but ripe for development.
PURPOSE OF REVIEW: To review progress in the field of clinical trials for SLE. RECENT FINDINGS: Treatment development for SLE has been marked by failures of many later phase studies, representing billions of dollars of lost research and development funding. Recently, more successful Phase II trials have tested reductions in background medications, novel stringent endpoints, and identification of informative immunologic subsets to achieve greater treatment effects. A large number of agents with promising novel biologic mechanisms have continued to enter clinical development, and momentum is building to capitalize on newer strategies for trial designs. Widespread SLE drug development is proceeding despite setbacks and controversies. Approaches focusing on patients with high disease activity, reduction of background polypharmacy, or increased endpoint stringency provide strategies that might improve interpretation of trial results. Pharmacodynamics of immune-modulation is a field in its infancy, but ripe for development.
Authors: L Kahl; J Patel; M Layton; M Binks; K Hicks; G Leon; E Hachulla; D Machado; D Staumont-Sallé; M Dickson; L Condreay; L Schifano; S Zamuner; R F van Vollenhoven Journal: Lupus Date: 2016-07-11 Impact factor: 2.911
Authors: Jason S Weinstein; Sarah A Bertino; Sairy G Hernandez; Amanda C Poholek; Taylor B Teplitzky; Heba N Nowyhed; Joe Craft Journal: J Immunol Date: 2014-03-07 Impact factor: 5.422
Authors: D A Isenberg; M Petri; K Kalunian; Y Tanaka; M B Urowitz; R W Hoffman; M Morgan-Cox; N Iikuni; M Silk; D J Wallace Journal: Ann Rheum Dis Date: 2015-09-03 Impact factor: 19.103
Authors: Susan Manzi; Jorge Sánchez-Guerrero; Joan T Merrill; Richard Furie; Dafna Gladman; Sandra V Navarra; Ellen M Ginzler; David P D'Cruz; Andrea Doria; Simon Cooper; Z John Zhong; Douglas Hough; William Freimuth; Michelle A Petri Journal: Ann Rheum Dis Date: 2012-05-01 Impact factor: 19.103
Authors: Karina A de Groot; Michel Tsang A Sjoe; Denise Niewerth; Jacqueline Cloos; Jonathan L Blank; Hans W M Niessen; Sonja Zweegman; Alexandre E Voskuyl; Gerrit Jansen; Joost W van der Heijden Journal: Lupus Sci Med Date: 2015-12-18
Authors: Megan E B Clowse; Daniel J Wallace; Richard A Furie; Michelle A Petri; Marilyn C Pike; Piotr Leszczyński; C Michael Neuwelt; Kathryn Hobbs; Mauro Keiserman; Liliana Duca; Kenneth C Kalunian; Catrinel Galateanu; Sabine Bongardt; Christian Stach; Carolyn Beaudot; Brian Kilgallen; Caroline Gordon Journal: Arthritis Rheumatol Date: 2017-02 Impact factor: 10.995
Authors: Kevin L Winthrop; Michael E Weinblatt; Joan Bathon; Gerd R Burmester; Philip J Mease; Leslie Crofford; Vivian Bykerk; Maxime Dougados; James Todd Rosenbaum; Xavier Mariette; Joachim Sieper; Fritz Melchers; Bruce N Cronstein; Ferry C Breedveld; Joachim Kalden; Josef S Smolen; Daniel Furst Journal: Ann Rheum Dis Date: 2019-10-29 Impact factor: 19.103