ed, double-blind studies [ULTIMMA-1 (NCT02684370),ULTIMMA-2 (NCT02684357), IMMHANCE (NCT02672852), and IMMVENT(NCT02694523)] enrolled 2109 subjects 18 years of age and older with moderate to severeplaque psoriasis who had a body surface area (BSA) involvement of ≥10%, a static Physician’sGlobal Assessment (sPGA) score of ≥3 (“moderate”) in the overall assessment (plaquethickness/induration, erythema, and scaling) of psoriasis on a severity scale of 0 to 4, and aPsoriasis Area and Severity Index (PASI) score ≥12.
Overall, subjects had a median baseline PASI score of 17.8 and a median BSA of 20.0%.
Baseline sPGA score was 4 (“severe”) in 19% of subjects. A total of 10% of study subjects had ahistory of diagnosed psoriatic arthritis.
Across all studies, 38% of subjects had received prior phototherapy, 48% had received prior nonbiologicsystemic therapy, and 42% had received prior biologic therapy for the treatment ofpsoriasis.
ULTIMMA-1 and ULTIMMA-2
In ULTIMMA-1 and ULTIMMA-2, 997 subjects were enrolled (including 598 subjectsrandomized to the SKYRIZI 150 mg group, 200 subjects randomized to the placebo group, and
199 to the biologic active control group). Subjects received treatment at Weeks 0, 4, and every12 weeks thereafter.
Both studies assessed the responses at Week 16 compared to placebo for the two co-primaryendpoints:
• the proportion of subjects who achieved an sPGA score of 0 (“clear”) or 1 (“almost clear”)
• the proportion of subjects who achieved at least a 90% reduction from baseline PASI (PASI90)Secondary endpoints included the proportion of subjects who achieved PASI 100, sPGA 0, andPSS 0 at Week 16.
The results are presented in Table 2.
Table 2. Efficacy Results at Week 16 in Adults with Plaque Psoriasis in ULTIMMA-1 and
ULTIMMA-2
ULTIMMA-1 ULTIMMA-2
SKYRIZI
(N=304)
n (%)
Placebo
(N=102)
n (%)
SKYRIZI
(N=294)
n (%)
Placebo
(N=98)
n (%)
sPGA 0 or 1
(“clear or 267 (88) 8 (8) 246 (84) 5 (5)
almost clear”)a
PASI 90a
229 (75) 5 (5) 220 (75) 2 (2)
sPGA 0
(“clear”) 112 (37) 2 (2) 150 (51) 3 (3)
PASI 100 109 (36) 0 (0) 149 (51) 2 (2)
a Co-primary endpoints
Examination of age, gender, race, body weight, baseline PASI score and previous treatment withsystemic or biologic agents did not identify differences in response to SKYRIZI among thesesubgroups at Week 16.
In ULTIMMA-1 and ULTIMMA-2 at Week 52, subjects receiving SKYRIZI achieved sPGA 0(58% and 60%, respectively), PASI 90 (82% and 81%, respectively), and PASI 100 (56% and60%, respectively).
Patient Reported Outcomes
Improvements in signs and symptoms related to pain, redness, itching and burning at Week 16compared to placebo were observed in both studies as assessed by the Psoriasis Symptom Scale(PSS). In ULTIMMA-1 and ULTIMMA-2, about 30% of the subjects who received SKYRIZIachieved PSS 0 (“none”) at Week 16 compared to 1% of the subjects who received placebo.
IMMHANCE
IMMHANCE enrolled 507 subjects (407 randomized to SKYRIZI 150 mg and 100 to placebo).
Subjects received treatment at Weeks 0, 4, and every 12 weeks thereafter.
At Week 16, SKYRIZI was superior to placebo on the co-primary endpoints of sPGA 0 or 1(84% SKYRIZI and 7% placebo) and PASI 90 (73% SKYRIZI and 2% placebo). The respectiveresponse rates for SKYRIZI and placebo at Week 16 were: sPGA 0 (46% SKYRIZI and 1 |
