SKYRIZI VS SOTYKTU® (deucravacitinib)² SUPERIOR RATES OF PASI 90 AT WEEK 16 IN A 2-PART,
OPEN-LABEL, ASSESSOR-BLINDED STUDY  
IN MODERATE PLAQUE PSORIASIS PATIENTS

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=nonresponder 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

PASI 90 PASI 90

SAFETY & DISCONTINUATION SAFETY & DISCONTINUATION

DLQI DLQI

IMMpactful: a Phase 4, 2-part, open-label, assessor-blinded study

SUPERIOR RATES OF PASI 90 WITH SKYRIZI VS SOTYKTU AT WEEK 16 (PERIOD A)²

In appropriate patients with moderate plaque psoriasis ready for systemic therapy

SOTYKTU is a registered trademark of the Bristol-Myers Squibb Company. See US Prescribing Information for further information.

SKYRIZI ACHIEVED HIGHER PASI 90 RATES AT WEEK 16²

PERIOD A

SKYRIZI® PASI 90 Rates compared to SOTYKTU®.

Co-primary endpoints: PASI 90 and sPGA 0/1 at Week 16

sPGA 0/1 at Week 16: SKYRIZI: 80% (n=105/131), SOTYKTU: 40% (n=104/262)

STUDY DESIGN:

IMMpactful is a 52-week, Phase 4, randomized, open-label, efficacy assessor-blinded study of SKYRIZI compared to SOTYKTU for the treatment of bio-naive adults with moderate plaque psoriasis who are candidates for systemic therapy. Patients were randomly assigned (1:2) to either SKYRIZI 150 mg as a single subcutaneous injection at Week 0, Week 4, and every 12 weeks thereafter or SOTYKTU 6 mg daily per label.²

NRI-MI=nonresponder imputation incorporating multiple imputation for missing data due to COVID-19; PASI 90=≥90% improvement in Psoriasis Area and Severity Index; sPGA 0/1=static Physician’s Global Assessment rating of “clear or almost clear.”

IMMpactful: a Phase 4, 2-part, open-label, assessor-blinded study

OVERALL RATES OF AEs AND TEAEs WITH SKYRIZI AND SOTYKTU AT WEEK 16 (PERIOD A)²

In appropriate patients with moderate plaque psoriasis ready for systemic therapy

SOTYKTU is a registered trademark of the Bristol-Myers Squibb Company. See US Prescribing Information for further information.

OVERVIEW OF TREATMENT-EMERGENT ADVERSE EVENTS AT WEEK 16²

PERIOD A

Overview of treatment-emergent adverse events through week 16 for SKYRIZI® and SOTYKTU®. Adverse event, serious adverse event, any infection, serious infections, tuberculosis, hypersensitivity, malignancy, injection site reaction, nausea, diarrhea, headache, depression, IBD and oral candidiasis were considered.

STUDY DESIGN:

IMMpactful was a 52-week, Phase 4, randomized, open-label, efficacy assessor-blinded study of SKYRIZI compared to SOTYKTU for the treatment of adults with moderate plaque psoriasis who are candidates for systemic therapy. Patients were randomly assigned (1:2) to either SKYRIZI 150 mg as a single subcutaneous injection at Week 0, Week 4, and every 12 weeks thereafter or SOTYKTU 6 mg daily per label.²

These data only represent available safety data from Period A (Week 16).

The co-primary endpoints of Period A were achievement of PASI 90 and sPGA 0/1 at Week 16. The primary endpoint of Period B was achievement of PASI 90 at Week 52 among patients who failed to achieve PASI 90 with SOTYKTU at Week 16. Patients were eligible for inclusion in the study if they had a baseline PASI ≥12, BSA 10%-15%, and sPGA=3.²

Adverse reaction rates observed in clinical trials may not predict rates observed in clinical practice.

Safety A population includes all those randomized at baseline who received at least 1 dose of study drug.

STUDY DESIGN:

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AE=adverse event; PASI=Psoriasis Area and Severity Index; PASI 90=≥90% improvement in Psoriasis Area and Severity Index; sPGA=static Physician's Global Assessment; sPGA 0/1=static Physician’s Global Assessment rating of “clear or almost clear"; TEAE=treatment-emergent adverse event.

DISCONTINUATION OF SKYRIZI AND
SOTYKTU AT WEEK 16²

PERCENTAGE OF PATIENTS WHO DISCONTINUED BY WEEK 16²

Discontinuation rates for SKYRIZI® and SOTYKTU®.

DISCONTINUATION RATES IN SKYRIZI PIVOTAL TRIALS³:

UltlMMa-1	UltlMMa-2
Week 16: 2% (n=5/304)	Week 16: 1% (n=2/294)
Week 52: 3% (n=8/297)	Week 52: 4% (n=13/291)

STUDY DESIGN:

The co-primary endpoints of Period A were achievement of PASI 90 and sPGA 0/1 at Week 16. The primary endpoint of Period B was achievement of PASI 90 at Week 52 among patients who failed to achieve PASI 90 with SOTYKTU at Week 16. Patients were eligible for inclusion in this study if they had baseline PASI ≥12, BSA 10%-15%, and sPGA=3.²

IMMpactful: a Phase 4, 2-part, open-label, assessor-blinded study

PATIENT-REPORTED OUTCOMES BASED ON THE DERMATOLOGY LIFE QUALITY INDEX (DLQI)²

In appropriate patients with moderate plaque psoriasis ready for systemic therapy

SOTYKTU is a registered trademark of the Bristol-Myers Squibb Company. See US Prescribing Information for further information.

RESPONSE RATES OF DLQI 0/1 AT WEEK 16²

PERIOD A

SKYRIZI AND SOTYKTU® (deucravacitinib) (NRI-MI^†)²

DLQI 0/1 rates for SKYRIZI® and SOTYKTU®.

LIMITATIONS:

DLQI 0/1 at Week 16 was a prespecified, nonranked endpoint and was not adjusted for multiplicity²; thus, treatment differences cannot be regarded as statistically significant. Additionally, due to the open-label study design, patients knew which drug they were taking, which may have introduced bias.

Achievement of DLQI 0/1 was a prespecified endpoint that was assessed at each postbaseline visit in Period A for SKYRIZI and SOTYKTU patients. DLQI consists of 10 self-administered questions covering 6 domains: symptoms and feelings, daily activities, leisure, work and school, personal relationships, and bother with Ps treatment. Total composite scores can range from 0 (no effect on patient’s life) to 30 (extremely large effect on patient’s life).²

SKYRIZI safety in Period A

No patients taking SKYRIZI experienced adjudicated MACE, any infection, serious infections, hepatic events, serious hypersensitivity, IBD, or malignancy.

There were no deaths or cases of tuberculosis reported in the study.

In the IMMpulse study, most frequent adverse events (≥5%) in risankizumab-treated patients were COVID-19  and nasopharyngitis and among apremilast-treated patients were diarrhea, nausea, and headache.

Most common adverse reactions (≥1%) associated with SKYRIZI include upper respiratory infections, headache, fatigue, injection site reactions, and tinea infections.

STUDY DESIGN:

IMMpactful was a 52-week, Phase 4, multicenter, randomized, open-label, efficacy assessor-blinded study of SKYRIZI compared to SOTYKTU for the treatment of bio-naive adults with moderate plaque psoriasis who are candidates for systemic therapy. Patients were randomly assigned (1:2) to either SKYRIZI 150 mg as a single subcutaneous injection at Week 0, Week 4, and every 12 weeks thereafter or SOTYKTU 6 mg daily per label.²

STUDY DESIGN:

^†IMMpactful NRI-MI=nonresponder imputations (NRI) incorporating multiple imputations (MI) for missing data that can be reasonably assumed to be missing at random.