Efficacy and Safety of Ixekizumab in the Treatment of Radiographic Axial Spondyloarthritis: Sixteen-Week Results From a Phase III Randomized, Double-Blind, Placebo–Controlled Trial in Patients With Prior Inadequate Response to or Intolerance of Tumor Necrosis Factor Inhibitors

Elisa Gremese, Atul Deodhar, Denis Poddubnyy, Cesar Pacheco-Tena, Carlo Salvarani, Eric Lespessailles, Proton Rahman, Pentti Järvinen, Juan Sanchez-Burson, Karl Gaffney, Eun Bong Lee, Eswar Krishnan, Silvia Santisteban, Xiaoqi Li, Fangyi Zhao, Hilde Carlier, John D. Reveille, Christopher Antolini, Valderilio Azevedo, Magnus BarkhamAaron Alejandro Barrera Rodriguez, Alberto Berman, Tomasz Blicharski, Jan Brzezicki, Gerd Burmester, Judith Carrio, Eduardo Collantes, Bernard Combe, Fidencio Cons-Molina, Gregorio Cortes-Maisonet, Anna Dudek, Sergio Duran Barragan, Ori Elkayam, Kathleen Flint, Mauro Galeazzi, Norman Gaylis, David Goddard, Carlos Gonzalez Fernandez, Philippe Goupille, Jordi Gratacos Masmitja, Maria Greenwald, Seung Jae Hong, Mary Howell, Pawel Hrycaj, Akgun Ince, Ji Hyeon Ju, Jeffrey Kaine, Seong Wook Kang, Mauro Keiserman, Tae-Hwan Kim, Alan Kivitz, Steven Klein, Joel Kremer, Sang Heon Lee, Chang Keun Lee, Sang-Hoon Lee, Roger Lidman, James Loveless, Eleonora Lucero, Jose Maldonado Cocco, Flora Marcolino, Xavier Mariette, Daksha Mehta, Frederic Morin, Yolanda Moscovici, Eric Mueller, Eduardo Mysler, Francisco Navarro Blasco, Minh Nguyen, Carlos Pantojas, Min-Chan Park, Amarilis Perez-De Jesus, Eric Peters, Rafal Plebanski, Roel Querubin, Cesar Ramos Remus, Tatiana Reitblat, Tania Rivera, Juan Cruz Rizo Rodriguez, Michael Sayers, Antonio Scotton, Craig Scoville, David Shaw, Kichul Shin, Atul Singhal, Cassandra Skinner, Oscar Soto-Raices, Martin Soubrier, Malgorzata Szymanska, Christine Thai, Marleen Van De Sande, Alvin Wells, Rafal Wojciechowski, Ricardo Xavier, Antonio Ximenes, Devy Zisman

Risultato della ricerca: Contributo in rivistaArticolo in rivista

64 Citazioni (Scopus)

Abstract

Objective: To investigate the efficacy and safety of ixekizumab in patients with active radiographic axial spondyloarthritis (SpA) and prior inadequate response to or intolerance of 1 or 2 tumor necrosis factor inhibitors (TNFi). Methods: In this phase III randomized, double-blind, placebo-controlled trial, adult patients with an inadequate response to or intolerance of 1 or 2 TNFi and an established diagnosis of axial SpA (according to the Assessment of SpondyloArthritis international Society [ASAS] criteria for radiographic axial SpA, with radiographic sacroiliitis defined according to the modified New York criteria and ≥1 feature of SpA) were recruited and randomized 1:1:1 to receive placebo or 80-mg subcutaneous ixekizumab every 2 weeks (IXEQ2W) or 4 weeks (IXEQ4W), with an 80-mg or 160-mg starting dose. The primary end point was 40% improvement in disease activity according to the ASAS criteria (ASAS40) at week 16. Secondary outcomes and safety were also assessed. Results: A total of 316 patients were randomized to receive placebo (n = 104), IXEQ2W (n = 98), or IXEQ4W (n = 114). At week 16, significantly higher proportions of IXEQ2W patients (n = 30 [30.6%]; P = 0.003) or IXEQ4W patients (n = 29 [25.4%]; P = 0.017) had achieved an ASAS40 response versus the placebo group (n = 13 [12.5%]), with statistically significant differences reported as early as week 1 with ixekizumab treatment. Statistically significant improvements in disease activity, function, quality of life, and spinal magnetic resonance imaging–evident inflammation were observed after 16 weeks of ixekizumab treatment versus placebo. Treatment-emergent adverse events (AEs) with ixekizumab treatment were more frequent than with placebo. Serious AEs were similar across treatment arms. One death was reported (IXEQ2W group). Conclusion: Ixekizumab treatment for 16 weeks in patients with active radiographic axial SpA and previous inadequate response to or intolerance of 1 or 2 TNFi yields rapid and significant improvements in the signs and symptoms of radiographic axial SpA versus placebo.
Lingua originaleEnglish
pagine (da-a)599-611
RivistaARTHRITIS & RHEUMATOLOGY
Volume71
DOI
Stato di pubblicazionePubblicato - 2019

Keywords

  • Immunology
  • Immunology and Allergy
  • Rheumatology

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