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A head‐to‐head comparison of ixekizumab vs. guselkumab in patients with moderate‐to‐severe plaque psoriasis: 12‐week efficacy, safety and speed of response from a randomized, double‐blinded trial

2019; Oxford University Press; Volume: 182; Issue: 6 Linguagem: Inglês

10.1111/bjd.18851

1365-2133

Andrew Blauvelt, Kim Papp, Alice B. Gottlieb, Abel Jarell, Kristian Reich, Catherine Maari, Kenneth B. Gordon, Laura K. Ferris, Richard Langley, Yayoi Tada, Renata Gontijo Lima, Hany Elmaraghy, Gaia Gallo, L. Renda, S‐M. Park, Russel Burge, Jerry Bagel, Ronald Vender, Mark Lomaga, Isabelle Delorme, Chih-ho Hong, Richard Langley, Lorne Albrecht, Lyn Guenther, Catherine Maari, Kim Papp, Kamal Ohson, Kirk Barber, Charles Lynde, Aditya Gupta, Leslie Rosoph, Jean‐Sébastien Gauthier, Melinda Gooderham, Norman Wasel, Mani Raman, Marni Wiseman, David Greenstein, Abel Jarell, C. A. L. Moon, Lani Clark, S. Jazayeri, Michael Bukhalo, Angela Moore, Tiffani K. Hamilton, Aron Gewirtzman, Lydie Hazan, Jeffrey Crowley, Craig Teller, Matthew Zirwas, Stacy Smith, Mark Lee, Stephen K. Tyring, Patricia Lee, Sunil Dhawan, Craig L. Leonardi, Amarilis Perez‐De Jesus, Wendy McFalda, Ellen Frankel, Paul S. Yamauchi, Scott Fretzin, Rocco Serrao, Todd Schlesinger, Scott Gottlieb, Peter Jenkin, Rola Gharib, Steven A. Davis, Navid Nami, Zoe Diana Draelos, Lloyd Godwin, Cindy E. Owen, Megan N. Landis, William Abramovits, Samuel Sanchez‐Rivera, Abby Van Voorhees, David Fivenson, Francisco A. Kerdel, Seth Forman, Jeffrey S. Weinberg, José González-Chávez, Brent Boyce, Linda Stein‐Gold, Charles P. Hudson, Constance Brown, James Coggi, Christina Feser, Rion Forconi, Sandra Johnson, M. Mccune, Lawrence Green, Vandana Madkan, Dana Maxwell Shipp, Kenneth B. Gordon, Jill Waibel, Oscar Soto‐Raices, Jennifer Cather, Scott Miller, John P. Scott, Douglas Young, Jessica Kaffenberger, Kelley Yokum, Matthew Zook, Andrew Blauvelt, Artis Truett, George Schmieder, Gary McCracken, Patrick McElgunn, James Herrmann, J.M. Suchniak, James Z. Appel, Elizabeth Barranco, Mark Lee, Jerry Bagel, Lawrence Osman, Ashley Cauthen, Neil S. Sadick, Eneida De La Torre, Kelly Taylor, David J. Cohen, Holly Hake Harris, Jennifer Soung, Vassilios Dimitropoulos, Stephen E. Miller, Cathy Barnes, Rawan Jumean‐Haddad, Suzanne Bruce, Lawrence Cheung, Scott Guenthner, Anthony A. Gaspari, Vivian Laquer, James Krell, Shahram Jacobs, Walter K. Nahm, Neil J. Korman, Boni E. Elewski, Laura K. Ferris, Kristina Callis Duffin, David M. Pariser, B. Johnson, Paul Wallace, Jeffrey B. Travers, Richard G. Fried,

Autoimmune Bullous Skin Diseases

Patients with psoriasis value rapid and complete skin clearance. No head‐to‐head studies have focused on early responses to interleukin (IL)‐17 vs. IL‐23 inhibitors. To compare early and complete skin clearance by the IL‐17A inhibitor ixekizumab vs. the IL‐23p19 inhibitor guselkumab. IXORA‐R, a 24‐week, randomized, double‐blinded study, enrolled adults with moderate‐to‐severe plaque psoriasis [static Physician's Global Assessment of Disease (sPGA) score of ≥ 3, Psoriasis Area and Severity Index (PASI) ≥ 12, and ≥ 10% body surface area]. Patients were randomized (1 : 1) to receive the approved dose of subcutaneous ixekizumab or guselkumab. Primary end point was 100% improvement in PASI (PASI 100) at week 12. Major secondary end points included other levels of improved PASI and sPGA at different time points. Comparisons were made using the Cochran–Mantel–Haenszel test with a multiple testing strategy. Nonresponder imputation was used for missing data. After the completion of the study, the final secondary end point (PASI 100 at 24 weeks) and safety data through week 24 will be reported. In total, 1027 patients were randomized. The primary end point PASI 100 at week 12 was met [215/520 ixekizumab (41%); 126/507 guselkumab (25%); P < 0·001]. All major secondary end points measured up to week 12 were met, including PASI 50 at week 1 and PASI 75 at week 2. Serious adverse event frequency was 3% for each group; no new safety signals were identified. Ixekizumab was superior to guselkumab for rapidly improving signs and symptoms in patients with moderate‐to‐severe plaque psoriasis by week 12. Adverse events were similar to previous ixekizumab and guselkumab studies. Compared with the IL‐23 inhibitor guselkumab, ixekizumab can offer complete skin clearance more rapidly to patients with moderate‐to‐severe plaque psoriasis. What's already known about this topic? Patients with plaque psoriasis desire both high levels of clearance and rapid onset of treatment effects. Ixekizumab, a high‐affinity monoclonal antibody that selectively targets interleukin (IL)‐17A, has demonstrated greater and faster skin clearance than etanercept and ustekinumab, with consistent long‐term efficacy, safety and durability of response. Clinical trial data and systematic reviews have suggested that IL‐17 inhibitors can improve a patient's psoriasis more rapidly than IL‐23 inhibitors. What does this study add? The head‐to‐head study design directly compares the efficacy and speed of response of ixekizumab and the IL‐23 inhibitor guselkumab in moderate‐to‐severe plaque psoriasis. The primary end point was met, showing superiority of ixekizumab over guselkumab for achieving complete skin clearance at week 12. The safety profile of ixekizumab was consistent with previous studies. Ixekizumab can deliver patients complete skin clearance and improved quality of life more rapidly than guselkumab.