Investigators are listed at the end of the report.
Long-term efficacy of ustekinumab in patients with moderate-to-severe psoriasis treated for up to 5 years in the PHOENIX 1 study
Article first published online: 20 DEC 2012
© 2012 The Authors. Journal of the European Academy of Dermatology and Venereology © 2012 European Academy of Dermatology and Venereology
Journal of the European Academy of Dermatology and Venereology
Volume 27, Issue 12, pages 1535–1545, December 2013
How to Cite
Kimball, A.B., Papp, K.A., Wasfi, Y., Chan, D., Bissonnette, R., Sofen, H., Yeilding, N., Li, S., Szapary, P., Gordon, K.B. and on behalf of the PHOENIX 1 investigators (2013), Long-term efficacy of ustekinumab in patients with moderate-to-severe psoriasis treated for up to 5 years in the PHOENIX 1 study. Journal of the European Academy of Dermatology and Venereology, 27: 1535–1545. doi: 10.1111/jdv.12046
Conflict of interest A.B. Kimball is an investigator and consultant for Amgen, Abbott and Janssen; she also has fellowship funding from Janssen; K.A. Papp has received grants and/or honoraria as a consultant, speaker and/or advisory board member from Abbott, Amgen, Anacor, Astellas, Celgene, Celtic Pharma, Dow Pharma, Eli Lilly, Galderma, J&J, Merck, Novartis, Pfizer and/or UCB; R. Bissonnette has been a consultant, speaker and/or investigator and has received honoraria and/or grants from Janssen, Abbott, Amgen, Astellas Pharma, Isotecknika Pharma, Celgene, Pfizer, Novartis and Tribute Pharmaceuticals; H. Sofen has been a paid consultant and investigator for Janssen; and K.B. Gordon has served as a consultant/investigator for Abbott, Amgen, Centocor and Merck and as a consultant for Eli Lilly and Pfizer. Y. Wasfi, D. Chan, N. Yeilding, S. Li, and P. Szapary are employees of Janssen Research & Development, LLC, Spring House, PA and own stock in Johnson and Johnson.
Funding This study was funded by Janssen Research & Development, LLC, Spring House, PA, USA.
- Issue published online: 21 NOV 2013
- Article first published online: 20 DEC 2012
- Received: 24 May 2012; Accepted: 18 October 2012
Background Ongoing evaluation of biological agents in patients with moderate-to-severe psoriasis is needed to support their long-term use.
Objective To evaluate long-term efficacy and safety of ustekinumab through 5 years in the PHOENIX 1 study.
Methods Patients were randomized to placebo or ustekinumab (45 mg or 90 mg) at Weeks 0, 4 and every-12-weeks thereafter; placebo patients crossed-over to ustekinumab at Week 12. Clinical response through Week 244 was evaluated using the Psoriasis Area and Severity Index (PASI) in the Overall Population (i.e. patients receiving ≥1 dose of ustekinumab), Initial Responders (i.e. PASI 75 responders [Weeks 28/40] re-randomized at Week 40 to continue every-12-week maintenance) and Partial Responders (i.e. <PASI 75 responders adjusted to every-8-week maintenance at Weeks 28 or 40). Safety endpoints were evaluated through Week 264 for the Overall Population.
Results Overall, 68.7% (517/753) of ustekinumab-treated patients completed treatment through Week 244. Initial clinical responses were generally maintained through Week 244 (PASI 75: 63.4% and 72.0%; PASI 90: 39.7% and 49.0%; PASI 100: 21.6% and 26.4%) for patients receiving 45 mg and 90 mg, respectively. Similarly, PASI 75 responses were generally maintained among Initial Responders [79.1% (45 mg) and 80.8% (90 mg)] and Partial Responders [57.6% (45 mg) and 55.1% (90 mg)]. With 3104 patient-years of follow-up, rates of overall adverse events (AEs), serious AEs, serious infections, malignancies and major adverse cardiovascular events were generally consistent over time and comparable between doses.
Conclusions Through 5 years of continuous treatment, ustekinumab demonstrated stable clinical response and a safety profile consistent with previous reports.