Challenging areas of the body

SCALP, PALMOPLANTAR, AND NAIL PSORIASIS

CO-PRIMARY ENDPOINTS IN UltIMMa-1 AND UltIMMa-2 (NRI)1,4

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.1,4

VIEW STUDY DESIGN AND BASELINE CHARACTERISTICS

IMMprint, a randomized, double-blind,
placebo-controlled, Phase 3b study

 

SKYRIZI EFFICACY IN
PLAQUE Ps PATIENTS WITH PALMOPLANTAR INVOLVEMENT2

 

Evaluating SKYRIZI in moderate to severe Ps
patients with palmoplantar involvement

pplGA 0/1 pplGA 0/1
PPASI PPASI

SKYRIZI met the primary endpoint of ppIGA 0/1 at Week 16 with RESPONSE RATES observed at Week 522

PROPORTION OF PATIENTS ACHIEVING ppIGA 0/1 (NRI-C)

  • SKYRIZI 150 mg
    (n=87)
  • PLACEBO
    (n=87)
33% of SKYRIZI® patients achieved ppIGA 0/1 AT WEEK 16 vs placebo.

The primary endpoint was ppIGA 0/1 at Week 16.

LIMITATIONS:

All endpoints at Week 52 were pre-specified, non-ranked endpoints and were not controlled for multiple comparisons. Therefore, no statistical or clinical conclusions can be drawn.

Open-Label Limitation:

In an open-label study or period, there is potential for enrichment; awareness of active treatment may cause bias to overall treatment effect.

The ppIGA scale ranges from clear (0) to severe (4) and is based on the modified IGA but specifically applied to the palms and soles.

STUDY DESIGN:

IMMprint was a Phase 3b, multicenter, randomized, double-blind, parallel-group, placebo-controlled, 52-week study that assessed the safety and efficacy of SKYRIZI (150 mg) vs placebo for the treatment of moderate to severe plaque psoriasis in patients with palmoplantar (non-pustular) involvement. The primary endpoint evaluated the proportion achieving ppIGA of 0 or 1 with ≥2-point reduction from baseline at Week 16. Additional ranked secondary endpoints included PPASI 75, PPASI 90, sPGA 0/1, and PPASI 100 at Week 16.2

VIEW SAFETY, STUDY DESIGN, AND BASELINE CHARACTERISTICS

NRI-C=non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19; PPASI=Palmoplantar Psoriasis Area and Severity Index; ppIGA=Palmoplantar Psoriasis Investigator's Global Assessment; sPGA=static Physician's Global Assessment.

EFFICACY IN PALMOPLANTAR PSORIASIS2

SKYRIZI® PPASI 75 and 90 rates at week 16 and 52.

*Ranked secondary endpoints.

MEAN CHANGE IN PPASI FROM BASELINE (AO)5

52%

(n=86)

AT WEEK 16

Placebo 30% (n=81)

76%

(n=75)

AT WEEK 52 (OL)

MEAN PPASI SCORES AT BASELINE (SD)2

SKYRIZI (n=87): 22.5 (13.6) PLACEBO (n=87): 22.5 (12.1)

LIMITATIONS:

PPASI 75 and 90 at Week 52 and mean change in PPASI were non-ranked endpoints and not adjusted for multiplicity. Therefore, treatment differences cannot be regarded as statistically significant.

OPEN-LABEL (OL) LIMITATION:

In an open-label study or period, there is potential for enrichment; awareness of active treatment may cause bias to overall treatment effect.

AO DISCLOSURE:

In an as observed analysis (AO) missing visit data were excluded from calculations for that visit, which may increase the percent of responders. All observed data were used regardless of premature discontinuation of study drug, initiation of concomitant medication, or rescue medication. The same patient may not have a response at each timepoint.

STUDY DESIGN:

IMMprint was a Phase 3b, multicenter, randomized, double-blind, parallel-group, placebo-controlled, 52-week study that assessed the safety and efficacy of SKYRIZI (150 mg) vs placebo for the treatment of moderate to severe plaque psoriasis in patients with palmoplantar (non-pustular) involvement. The primary endpoint evaluated the proportion achieving ppIGA of 0 or 1 with ≥2-point reduction from baseline at Week 16. Additional ranked secondary endpoints included PPASI 75, PPASI 90, sPGA 0/1, and PPASI 100 at Week 16.2

VIEW SAFETY, STUDY DESIGN, AND BASELINE CHARACTERISTICS

PPASI=Palmoplantar Psoriasis Area and Severity Index; ppIGA=Palmoplantar Psoriasis Investigator's Global Assessment; SD=Standard Deviation; sPGA=static Physician's Global Assessment.

SEE ADDITIONAL Ps DATA IN CHALLENGING AREAS
FROM A SUBGROUP ANALYSIS OF UltlMMa-1 AND UltlMMa-2 BELOW

In a subgroup analysis of UltlMMa-1 and UltlMMa-2

ON AVERAGE, PATIENTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS EXPERIENCED IMPROVEMENT IN CHALLENGING BODY AREAS: SCALP, PALMOPLANTAR, AND NAIL PSORIASIS3

IN AN INTEGRATED SUBANALYSIS OF UltIMMa-1 & -2 PATIENTS
AT WEEK 52 (LOCF)3

94%

IMPROVEMENT
IN SCALP PSORIASIS

(MEAN CHANGE IN PSSI FROM BASELINE)

n=528

66%

IMPROVEMENT IN
NAIL PSORIASIS

(MEAN CHANGE IN NAPSI FROM BASELINE)

n=361

91% IMPROVEMENT IN PALMOPLANTAR PSORIASIS

(MEAN CHANGE IN PPASI FROM BASELINE) n=184

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

Based on analysis 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 last observation carried forward (LOCF).3

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.1,4

VIEW STUDY DESIGN AND BASELINE CHARACTERISTICS

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

Well-Studied Safety Profile

across 4 pivotal trials1

Review Safety

4 doses per year

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

View dosing schedule