@article {Genovese289, author = {Mark C. Genovese and Daniel K. Braun and Janelle S. Erickson and Pierre-Yves Berclaz and Subhashis Banerjee and Michael P. Heffernan and Hilde Carlier}, title = {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}, volume = {43}, number = {2}, pages = {289--297}, year = {2016}, doi = {10.3899/jrheum.140831}, publisher = {The Journal of Rheumatology}, abstract = {Objective. To evaluate ixekizumab, an anti-interleukin 17A monoclonal antibody, for safety and effectiveness through 64 weeks in biologic-naive and tumor necrosis factor{\textendash}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.}, issn = {0315-162X}, URL = {https://www.jrheum.org/content/43/2/289}, eprint = {https://www.jrheum.org/content/43/2/289.full.pdf}, journal = {The Journal of Rheumatology} }