Dear Faria,

They conducted two large multicentric trials with ustekinumab.

The summary of those multicentric trials are as follows.

Two multicenter, randomized, double-blind, placebo-controlled studies (STUDY 1 and STUDY 2) enrolled a total of 1996 subjects 18 years of age and older with plaque psoriasis who had a minimum body surface area involvement of 10%, and Psoriasis Area and Severity Index (PASI) score >12, and who were candidates for phototherapy or systemic therapy. Subjects with guttate, erythrodermic, or pustular psoriasis were excluded from the studies.

STUDY 1 enrolled 766 subjects and STUDY 2 enrolled 1230 subjects. The studies had the same design through Week 28. In both studies, subjects were randomized in equal proportion to placebo, 45 mg or 90 mg of ustekinumab. Subjects randomized to ustekinumab received 45 mg or 90 mg doses, regardless of weight, at Weeks 0, 4, and 16. Subjects randomized to receive placebo at Weeks 0 and 4 crossed over to receive ustekinumab (either 45 mg or 90 mg) at Weeks 12 and 16.

In both studies, the endpoints were the proportion of subjects who achieved at least a 75% reduction in PASI score (PASI 75) from baseline to Week 12 and treatment success (cleared or minimal) on the Physician’s Global Assessment (PGA). The PGA is a 6-category scale ranging from 0 (cleared) to 5 (severe) that indicates the physician’s overall assessment of psoriasis focusing on plaque thickness/induration, erythema, and scaling.

In both studies, subjects in all treatment groups had a median baseline PASI score ranging from approximately 17 to 18. Baseline PGA score was marked or severe in 44% of subjects in STUDY 1 and 40% of subjects in STUDY 2. Approximately two-thirds of all subjects had received prior phototherapy, 69% had received either prior conventional systemic or biologic therapy for the treatment of psoriasis, with 56% receiving prior conventional systemic therapy and 43% receiving prior biologic therapy. A total of 28% of study subjects had a history of psoriatic arthritis.

Clinical Response
The results of STUDY 1 and STUDY 2 are presented in Table below.

STUDY 1 STUDY 2
Placebo 45 mg ustekinumab 90 mg ustekinumab Placebo 45 mg ustekinumab 90 mg ustekinumab
Subjects randomized 255 255 256 410 409 411
PASI 75 response 8 (3%) 171 (67%) 170 (66%) 15 (4%) 273 (67%) 311 (76%)
PGA of cleared or minimal 10 (4%) 151 (59%) 156 (61%) 18 (4%) 277 (68%) 300 (70%).

The product reached the market by 1st of october in US.