SAN FRANCISCO — Ustekinumab outperformed etanercept for treatment of psoriasis in the first-ever large head-to-head comparison of the two biologics.
The 12-week phase III multicenter trial involved 903 patients with moderate to severe plaque psoriasis who were randomized to two doses of the interleukin-12/-23-blocker ustekinumab (Stelara) at either 45 mg or 90 mg or to the tumor necrosis factor-inhibitor etanercept (Enbrel) at 50 mg twice weekly.
Ustekinumab is marketed in Europe and Canada and is under review by the U.S. Food and Drug Administration.
The primary study end point was at least a 75% improvement compared with baseline in Psoriasis Area and Severity Index (PASI 75). This was achieved in 68% of patients on ustekinumab 45 mg and 74% on 90 mg, both significantly better than the 57% rate with etanercept, Dr. Kim A. Papp said at the annual meeting of the American Academy of Dermatology.
A PASI 90 was achieved in 45% of patients who received high-dose ustekinumab, in 36% of those on low-dose ustekinumab, and in 23% on etanercept. Again, the outcome difference was significant, noted Dr. Papp of Probity Medical Research, Waterloo, Ont.
Of patients in the ustekinumab 90 mg group, 71% were rated clear or having only minimal skin involvement at 12 weeks by Physician Global Assessment. This was the case in 65% of patients in the low-dose ustekinumab group and in 49% of those on etanercept, he reported.
The trial was supported by Centocor Inc., which discovered ustekinumab and will market it in the United States. Dr. Papp serves as a consultant to and advisory board member for Centocor.
A PASI 90 was achieved in 45% of patients on high-dose ustekinumab and in 23% of those on etanercept. DR. PAPP