Safety and Efficacy of Open-label Subcutaneous Ixekizumab Treatment for 48 Weeks in a Phase II Study in Biologic-naive and TNF-IR Patients with Rheumatoid Arthritis.

Mark C Genovese Daniel K Braun Janelle S Erickson Pierre-Yves Berclaz Subhashis Banerjee Michael P Heffernan Hilde Carlier

J Rheumatol

From the Division of Immunology and Rheumatology, Stanford University Medical Center, Palo Alto, California; Eli Lilly and Company, Indianapolis, Indiana; Bristol-Myers Squibb, Princeton, New Jersey, USA.M.C. Genovese, MD, James W. Raitt Professor of Medicine, Co-Chief of Division of Immunology and Rheumatology, Stanford University School of Medicine; D.K. Braun, MD, Medical Fellow; Eli Lilly and Company; J.S. Erickson, PhD, Statistician, Eli Lilly and Company; P.Y. Berclaz, MD, Senior Medical Director, Eli Lilly and Company; M.P. Heffernan, MD, Senior Medical Director, Eli Lilly and Company; H. Carlier, MD, Senior Medical Advisor, Eli Lilly and Company, Indianapolis; S. Banerjee, MD, Bristol-Myers Squibb.

Published: February 2016

The study aimed to assess the safety and effectiveness of ixekizumab, an anti-interleukin 17A monoclonal antibody, over 64 weeks in patients with rheumatoid arthritis who had never received biologic treatment or did not respond to TNF therapy.
Following a 16-week double-blind phase, 390 eligible patients entered an open-label extension, receiving ixekizumab every 4 weeks after an initial loading dose.
The majority of patients reported mild to moderate side effects, with serious adverse events occurring in a small percentage; importantly, clinical improvements seen at 16 weeks were sustained or enhanced until week 64.

Objective: To evaluate ixekizumab, an anti-interleukin 17A monoclonal antibody, for safety and effectiveness through 64 weeks in biologic-naive and tumor necrosis factor-inadequate responder (TNF-IR) patients with rheumatoid arthritis.

Methods: Patients completing the 16-week double-blind period of a phase II study were eligible to enter the open-label extension (OLE) for an additional 48 weeks of ixekizumab treatment. After a treatment hiatus between weeks 10 to 16, 232 biologic-naive and 158 TNF-IR patients entered the OLE with all patients receiving 160 mg ixekizumab at weeks 16, 18, and 20, and then every 4 weeks through Week 64.

Results: A total of 201 (87%) biologic-naive and 99 (62%) TNF-IR patients completed the OLE. Treatment-emergent adverse events (AE) occurred in 168 (72%) biologic-naive and 115 (73%) TNF-IR patients during the OLE. Most AE were mild to moderate in severity and did not lead to study discontinuation. Serious AE (SAE) occurred in 17 (7%) biologic-naive patients, including 5 (2%) serious infections and 2 (1%) deaths. SAE occurred in 18 (11%) TNF-IR patients, including 4 (3%) serious infections and 1 (1%) death. No mycobacterial or invasive fungal infections were reported. Clinical responses [American College of Rheumatology (ACR) 20, ACR50, ACR70, and 28-joint Disease Activity Score with C-reactive protein] observed at Week 16 were maintained or improved through Week 64.

Conclusion: Ixekizumab was well tolerated, and safety findings in the OLE were consistent overall with those in the double-blind period of this study. Clinical improvements observed with ixekizumab through Week 16 were maintained or improved in patients participating in the OLE through Week 64.

Trial Registration Number: NCT00966875.

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http://dx.doi.org/10.3899/jrheum.140831	DOI Listing

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