Full Length
Arthritis & Rheumatism DOI 10.1002/art.38617
Running Head: Ixekizumab in Biologic-Naïve or TNF-IR Patients With RA
Phase 2 Randomized Study of Subcutaneous Ixekizumab, an Anti-IL-17 Monoclonal Antibody, in Biologic-Naïve or TNF-IR Patients With Rheumatoid Arthritis Mark C. Genovese,1 Maria Greenwald,2 Chul-Soo Cho,3 Alberto Berman,4 Ling Jin,5 Gregory S. Cameron,5 Olivier Benichou,5 Li Xie,5 Daniel Braun,5 Pierre-Yves Berclaz,5 and Subhashis Banerjee5* 1
Stanford University, Palo Alto, California, USA; 2Desert Medical Advances, Palm Desert
California, USA; 3Catholic University of Korea, St. Mary’s Hospital; Seoul, Korea; 4Centro Medico Priv de Reumatol, Tucuman, Argentina; 5Eli Lilly and Company, Indianapolis, Indiana, USA; *formerly, Eli Lilly and Company
This study was funded by Eli Lilly and Company. Corresponding author: Mark C. Genovese, MD Division of Immunology and Rheumatology Stanford University Medical Center 1000 Welch Road, Suite 203 Palo Alto, CA 94304 Phone: 650-498-4528, Fax: 650-723-9656, E-mail: [email protected]
Disclosure of Potential Conflict of Interest: This study was sponsored by Eli Lilly and Company and/or one of its subsidiaries. Mark Genovese receives funding from Eli Lilly and Company for research and consulting. Maria Greenwald and Alberto Berman have received research grants from Eli Lilly and Company. Ling Jin, Gregory Cameron, Li Xie, Daniel Braun, and Pierre-Yves Berclaz are employees of Eli Lilly and Company. Subhashis Banerjee is a former employee of Eli Lilly and Company. This article has been accepted for publication and undergone full peer review but has not been through the copyediting, typesetting, pagination and proofreading process which may lead to differences between this version and the Version of Record. Please cite this article as an ‘Accepted Article’, doi: 10.1002/art.38617 © 2014 American College of Rheumatology Received: Mar 28, 2013; Revised: Jan 21, 2014; Accepted: Feb 27, 2014
Arthritis & Rheumatology
Abstract [currently 250 words] Objective: To evaluate ixekizumab, an anti-IL-17A monoclonal antibody, in 2 rheumatoid arthritis (RA) populations: biologic therapy-naïve or tumor necrosis factor inhibitor inadequate responders (TNF-IRs). Methods: In this Phase 2, randomized, double-blind study, study drug was administered subcutaneously to 260 biologic-naïve (placebo, 3-mg, 10-mg, 30-mg, 80-mg, or 180-mg ixekizumab) and 188 TNF-IR patients (placebo, 80-mg, or 180-mg ixekizumab) at Weeks 0, 1, 2, 4, 6, 8, and 10 with concomitant DMARD therapy. The primary objective was to determine the dose-response relationship of ixekizumab treatment on ACR20 responses in biologic-naïve patients at Week 12. Results: Using an a priori defined logistic regression model, a significant dose-response relationship in biologic-naïve patients was observed (p=0.031) with ACR20 responses at Week 12. For TNF-IR patients, ACR20 responses at Week 12 were significantly better with ixekizumab than placebo (p
Arthritis & Rheumatism DOI 10.1002/art.38617
Running Head: Ixekizumab in Biologic-Naïve or TNF-IR Patients With RA
Phase 2 Randomized Study of Subcutaneous Ixekizumab, an Anti-IL-17 Monoclonal Antibody, in Biologic-Naïve or TNF-IR Patients With Rheumatoid Arthritis Mark C. Genovese,1 Maria Greenwald,2 Chul-Soo Cho,3 Alberto Berman,4 Ling Jin,5 Gregory S. Cameron,5 Olivier Benichou,5 Li Xie,5 Daniel Braun,5 Pierre-Yves Berclaz,5 and Subhashis Banerjee5* 1
Stanford University, Palo Alto, California, USA; 2Desert Medical Advances, Palm Desert
California, USA; 3Catholic University of Korea, St. Mary’s Hospital; Seoul, Korea; 4Centro Medico Priv de Reumatol, Tucuman, Argentina; 5Eli Lilly and Company, Indianapolis, Indiana, USA; *formerly, Eli Lilly and Company
This study was funded by Eli Lilly and Company. Corresponding author: Mark C. Genovese, MD Division of Immunology and Rheumatology Stanford University Medical Center 1000 Welch Road, Suite 203 Palo Alto, CA 94304 Phone: 650-498-4528, Fax: 650-723-9656, E-mail: [email protected]
Disclosure of Potential Conflict of Interest: This study was sponsored by Eli Lilly and Company and/or one of its subsidiaries. Mark Genovese receives funding from Eli Lilly and Company for research and consulting. Maria Greenwald and Alberto Berman have received research grants from Eli Lilly and Company. Ling Jin, Gregory Cameron, Li Xie, Daniel Braun, and Pierre-Yves Berclaz are employees of Eli Lilly and Company. Subhashis Banerjee is a former employee of Eli Lilly and Company. This article has been accepted for publication and undergone full peer review but has not been through the copyediting, typesetting, pagination and proofreading process which may lead to differences between this version and the Version of Record. Please cite this article as an ‘Accepted Article’, doi: 10.1002/art.38617 © 2014 American College of Rheumatology Received: Mar 28, 2013; Revised: Jan 21, 2014; Accepted: Feb 27, 2014
Arthritis & Rheumatology
Abstract [currently 250 words] Objective: To evaluate ixekizumab, an anti-IL-17A monoclonal antibody, in 2 rheumatoid arthritis (RA) populations: biologic therapy-naïve or tumor necrosis factor inhibitor inadequate responders (TNF-IRs). Methods: In this Phase 2, randomized, double-blind study, study drug was administered subcutaneously to 260 biologic-naïve (placebo, 3-mg, 10-mg, 30-mg, 80-mg, or 180-mg ixekizumab) and 188 TNF-IR patients (placebo, 80-mg, or 180-mg ixekizumab) at Weeks 0, 1, 2, 4, 6, 8, and 10 with concomitant DMARD therapy. The primary objective was to determine the dose-response relationship of ixekizumab treatment on ACR20 responses in biologic-naïve patients at Week 12. Results: Using an a priori defined logistic regression model, a significant dose-response relationship in biologic-naïve patients was observed (p=0.031) with ACR20 responses at Week 12. For TNF-IR patients, ACR20 responses at Week 12 were significantly better with ixekizumab than placebo (p
