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Long‐term efficacy of ustekinumab in patients with moderate‐to‐severe psoriasis treated for up to 5 years in the PHOENIX 1 study
Author(s) -
Kimball A.B.,
Papp K.A.,
Wasfi Y.,
Chan D.,
Bissonnette R.,
Sofen H.,
Yeilding N.,
Li S.,
Szapary P.,
Gordon K.B.
Publication year - 2013
Publication title -
journal of the european academy of dermatology and venereology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.655
H-Index - 107
eISSN - 1468-3083
pISSN - 0926-9959
DOI - 10.1111/jdv.12046
Subject(s) - medicine , ustekinumab , psoriasis area and severity index , adverse effect , psoriasis , placebo , population , randomized controlled trial , clinical trial , dermatology , disease , adalimumab , alternative medicine , environmental health , pathology
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.