Long-term efficacy of ustekinumab in patients with moderate-to-severe psoriasis treated for up to 5 years in the PHOENIX 1 study


  • 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.


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.