Funding sources This study was funded by Janssen Research & Development, LLC, Spring House, PA, U.S.A.
Long-term efficacy of ustekinumab in patients with moderate-to-severe psoriasis: results from the PHOENIX 1 trial through up to 3 years
Article first published online: 27 MAR 2012
© 2012 The Authors. BJD © 2012 British Association of Dermatologists
British Journal of Dermatology
Volume 166, Issue 4, pages 861–872, April 2012
How to Cite
Kimball, A.B., Gordon, K.B., Fakharzadeh, S., Yeilding, N., Szapary, P.O., Schenkel, B., Guzzo, C., Li, S. and Papp, K.A. (2012), Long-term efficacy of ustekinumab in patients with moderate-to-severe psoriasis: results from the PHOENIX 1 trial through up to 3 years. British Journal of Dermatology, 166: 861–872. doi: 10.1111/j.1365-2133.2012.10901.x
Conflicts of interest Conflicts of interest statements for each author are listed in the Appendix.
- Issue published online: 27 MAR 2012
- Article first published online: 27 MAR 2012
- Accepted manuscript online: 22 FEB 2012 02:08PM EST
- Accepted for publication 13 February 2012
Background An unmet need remains for safe and effective long-term treatments of psoriasis.
Objectives To evaluate ustekinumab efficacy and safety for up to 3 years in the PHOENIX 1 trial.
Methods Patients (n = 766) with moderate-to-severe psoriasis were randomized to ustekinumab 45 mg or 90 mg at weeks 0 and 4, and then every 12 weeks, or placebo at weeks 0 and 4, with crossover to ustekinumab at week 12. Ustekinumab responders [≥ 75% improvement from baseline in the Psoriasis Area and Severity Index (PASI 75) at weeks 28 and 40] were re-randomized at week 40 to continue or withdraw from treatment until psoriasis recurrence. Partial responders (week 28: PASI 50–74; week 40: < PASI 75) switched to dosing every 8 weeks. Clinical efficacy was assessed by PASI, the Physician’s Global Assessment (PGA), and the Dermatology Life Quality Index (DLQI) measures.
Results Overall, 79·8% of the ustekinumab-treated patients remained in the study for 3 years. PASI 75 response rates (45 mg: 61·2%; 90 mg: 72·4%) at week 76 were maintained through year 3 (45 mg: 62·7%; 90 mg: 72·2%); PGA response was similarly durable. At year 3, 80·9% (45 mg) and 82·7% (90 mg) of week 40 responders continuing treatment every 12 weeks achieved a PASI 75 response, while 42·6% (45 mg) and 58·0% (90 mg) achieved a PASI 90 response. Among partial responders adjusted to dosing every 8 weeks, 50·9% (45 mg) and 52·0% (90 mg) had a PASI 75 response at year 3. DLQI responses paralleled the PASI responses. Through year 3, no dose response was observed in rates of adverse events (AEs), overall infections, serious AEs, or AEs leading to discontinuation; nor was there evidence of cumulative organ toxicity.
Conclusions Continuous, stable, maintenance dosing with ustekinumab was generally well tolerated and sustained durable efficacy for up to 3 years of treatment.