Challenging areas of the body

SCALP, PALMOPLANTAR, AND NAIL PSORIASIS

CO-PRIMARY ENDPOINTS IN ULTIMMA-1 AND ULTIMMA-2 (NRI)1,3

PASI 90 at Week 16
UltIMMa-1:
SKYRIZI 75% (229/304), placebo 5% (5/102)
UltIMMa-2:
SKYRIZI 75% (220/294), placebo 2% (2/98)

P<0.0001.

sPGA 0/1 at Week 16
UltIMMa-1:
SKYRIZI 88% (267/304), placebo 8% (8/102)
UltIMMa-2:
SKYRIZI 84% (246/294), placebo 5% (5/98)

NRI=Non-responder imputation.

Study Design:

UltIMMa-1 (N=506) and UltIMMa-2 (N=491) were replicate phase 3, randomized, double-blind, placebo- and active-controlled studies to evaluate the efficacy and safety of SKYRIZI (150 mg) vs placebo over 16 weeks and biologic active control (45 mg or 90 mg, based on screening weight) over 52 weeks in adult patients with moderate to severe plaque psoriasis. Patients received SKYRIZI 150 mg at Week 0, Week 4, and every 12 weeks thereafter.1,3

AT WEEK 52, ON AVERAGE, PATIENTS EXPERIENCED IMPROVEMENT IN CHALLENGING BODY AREAS: SCALP, PALMOPLANTAR, AND NAIL PSORIASIS2

In integrated analyses of UltIMMa-1 & -2 patients at WEEk 52 (LOCF)2

94%

IMPROVEMENT
IN SCALP PSORIASIS

(MEAN CHANGE IN PSSI FROM BASELINE)

n=528

91%

IMPROVEMENT IN
PALMOPLANTAR PSORIASIS

(MEAN CHANGE IN PPASI FROM BASELINE)

n=184

66%

IMPROVEMENT IN
NAIL PSORIASIS

(MEAN CHANGE IN NAPSI FROM BASELINE)

n=361

MEAN PATIENT SCORES AT BASELINE (SD)

PSSI

18.2 (14.7)

PPASI

2.42 (6.0)

NAPSI

13.6 (18.4)

LIMITATIONS:

Mean changes in NAPSI, PSSI, and PPASI were all pre-specified, non-ranked endpoints and were not adjusted for multiplicity. Therefore, treatment differences cannot be regarded as statistically significant.

LOCF=Last Observation Carried Forward; NAPSI=Nail Psoriasis Severity Index; PPASI=Palmoplantar Psoriasis Area and Severity Index; PSSI=Psoriasis Scalp Severity Index; SD=Standard Deviation.

Based on analyses of integrated data from UltIMMa-1 and UltIMMa-2 at Week 52 of patients receiving SKYRIZI who had a baseline score of >0 on NAPSI, PSSI, and PPASI, respectively. Missing NAPSI, PSSI, and PPASI data were imputed as LOCF.2

STUDY DESIGN:

UltIMMa-1 (N=506) and UltIMMa-2 (N=491) were replicate phase 3, randomized, double-blind, placebo- and active-controlled studies to evaluate the efficacy and safety of SKYRIZI (150 mg) vs placebo over 16 weeks and biologic active control (45 mg or 90 mg, based on screening weight) over 52 weeks in adult patients with moderate to severe plaque psoriasis.1,3


Well-Studied Safety Profile

across 4 pivotal trials1

4 doses per year

3-month dosing after 2 initiation doses at
Weeks 0 and 4 (150 mg/dose)1