@article {van der Heijdejrheum.170429, author = {D{\'e}sir{\'e}e van der Heijde and Dafna D. Gladman and Mitsumasa Kishimoto and Masato Okada and Suchitrita S. Rathmann and Susan R. Moriarty and Catherine L. Shuler and Hilde Carlier and Olivier Benichou and Philip J. Mease}, title = {Efficacy and Safety of Ixekizumab in Patients with Active Psoriatic Arthritis: 52-week Results from a Phase III Study (SPIRIT-P1)}, elocation-id = {jrheum.170429}, year = {2017}, doi = {10.3899/jrheum.170429}, publisher = {The Journal of Rheumatology}, abstract = {Objective To evaluate the efficacy and safety of ixekizumab (IXE), an interleukin 17A antagonist, in patients with psoriatic arthritis (PsA) after 52 weeks in a phase III study. Methods Patients were initially randomly assigned to IXE 80 mg every 2 weeks (IXEQ2W) or every 4 weeks (IXEQ4W) after a 160-mg starting dose, placebo (PBO), or adalimumab (ADA) 40 mg Q2W. At Week 24 (Week 16 for inadequate responders), ADA (8-week washout before starting IXE) and PBO patients were rerandomized to IXEQ2W or IXEQ4W. Six treatment groups were evaluated in the extension period (weeks 24-52): IXEQ2W/IXEQ2W, IXEQ4W/IXEQ4W, ADA/IXEQ2W, ADA/IXEQ4W, PBO/IXEQ2W, and PBO/IXEQ4W. The extension period population (EPP) included patients who received >= 1 dose of study medication during the extension period. Results There were 381/417 (91.4\%) patients who entered the extension period. In the IXEQ4W/IXEQ4W and IXEQ2W/IXEQ2W groups (EPP), respectively, American College of Rheumatology (ACR)20 (69.1\% and 68.8\%), ACR50 (54.6\% and 53.1\%), and ACR70 (39.2\% and 39.6\%) response rates were sustained at Week 52. Patients rerandomized to IXE also demonstrated efficacy measured by ACR response rates at Week 52. A similar pattern was observed for Psoriasis Area and Severity Index outcomes. Radiographic progression in all 6 groups was minimal. The most frequently reported treatment-emergent adverse events (>= 4\%) were nasopharyngitis, injection site reaction, injection site erythema, upper respiratory tract infection, and back pain. No deaths were reported, and serious adverse event frequency was 0{\textendash}4\% with IXE. Conclusion During the extension period, IXEQ4W or IXEQ2W treatment demonstrated sustained efficacy in key PsA domains with a safety profile consistent with other studies investigating IXE. Clinical trial number: NCT01695239; EudraCT 2011-002326-49.}, issn = {0315-162X}, URL = {https://www.jrheum.org/content/early/2017/12/11/jrheum.170429}, eprint = {https://www.jrheum.org/content/early/2017/12/11/jrheum.170429.full.pdf}, journal = {The Journal of Rheumatology} }