Long‐term efficacy of ustekinumab in patients with moderate‐to‐severe psoriasis treated for up to 5 years in the PHOENIX 1 study. (20th December 2012)

• Record Type: Journal Article
• Authors: Kimball, A.B.; Papp, K.A.; Wasfi, Y.; Chan, D.; Bissonnette, R.; Sofen, H.; Yeilding, N.; Li, S.; Szapary, P.; Gordon, K.B.
• Is Part Of: Journal of the European Academy of Dermatology and Venereology. Volume 27:Number 12(2013:Dec.)
• Page Start: 1535
• Page End: 1545
• Publication Date: 2012-12-20
• Subjects: Dermatology -- Periodicals; Sexually transmitted diseases -- Periodicals; 616.5
• DOI: 10.1111/jdv.12046
• Languages: English
• ISSNs: 0926-9959

Abstract

<abstract abstract-type="main" xml:lang="en"> <title>Abstract</title> <p> <bold>Background </bold> Ongoing evaluation of biological agents in patients with moderate‐to‐severe psoriasis is needed to support their long‐term use.</p> <p> <bold>Objective </bold> To evaluate long‐term efficacy and safety of ustekinumab through 5 years in the PHOENIX 1 study.</p> <p> <bold>Methods </bold> Patients were randomized to placebo <italic>or</italic> 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.</p> <p> <bold>Results </bold> 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.</p> <p> <bold>Conclusions </bold> Through 5 years of continuous treatment, ustekinumab demonstrated stable clinical response and a safety profile consistent with previous reports.</p> </abstract>