SKYRIZI VS OTEZLA® (apremilast)
SKYRIZI VS COSENTYX® (secukinumab)
SKYRIZI VS STELARA® (ustekinumab)
SKYRIZI VS HUMIRA® (adalimumab)

SKYRIZI VS OTEZLA® (apremilast)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)1,4

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=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

VIEW STUDY DESIGN AND BASELINE CHARACTERISTICS
PASI 90 PASI 90
SAFETY & TOLERABILITY SAFETY & TOLERABILITY
DLQI DLQI

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

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

In appropriate patients with moderate plaque psoriasis ready for systemic therapy

OTEZLA is a registered trademark of Amgen Inc. See US Prescribing Information for further information.

SKYRIZI PATIENTS ACHIEVED HIGHER PASI 90 RATES vs OTEZLA PATIENTS
AT WEEK 16 (NRI-MI)2

PERIOD A

SKYRIZI® PASI 90 Rates compared to OTEZLA®. SKYRIZI® PASI 90 Rates compared to OTEZLA®. SKYRIZI® PASI 90 Rates compared to OTEZLA®.

Co-Primary Endpoints: PASI 90 and sPGA 0/1 at Week 16

sPGA 0/1 at Week 16: SKYRIZI: 75% (n=89/118), OTEZLA: 18% (n=43/234)

Ranked Secondary Endpoint: PASI 75 at Week 16

PASI 75 at Week 16: SKYRIZI: 85% (n=100/118), OTEZLA: 19% (n=44/234)

STUDY DESIGN:

IMMpulse was a 52-week, Phase 4, multicenter, randomized, open-label, efficacy assessor-blinded study of SKYRIZI compared to OTEZLA 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 OTEZLA 30 mg orally twice daily, post-titration per label. 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 75 with OTEZLA at Week 16. Patients were eligible for inclusion in this study if they had baseline PASI ≥12, BSA 10%-15%, and sPGA=3.2

VIEW STUDY DESIGN AND BASELINE CHARACTERISTICS

NRI-MI=nonresponder imputation incorporating multiple imputation for missing data due to COVID-19; PASI=Psoriasis Area and Severity Index; PASI 75=≥75% improvement in Psoriasis Area and Severity Index; PASI 90=≥90% improvement in Psoriasis Area and Severity Index; sPGA 0/1=static Physician’s Global Assessment rating of “clear or almost clear.”

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

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

In appropriate patients with moderate plaque psoriasis ready for systemic therapy

OTEZLA is a registered trademark of Amgen Inc. See US Prescribing Information for further information.

OVERVIEW OF TREATMENT-EMERGENT ADVERSE EVENTS AT WEEK 162,3

PERIOD A

Overview of treatment­-emergent adverse events through week 16 for SKYRIZI® and OTEZLA®. 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.

For Period B:

Period B safety rates (E/100 PYs) in the continuous SKYRIZI population (n=118) were consistent with safety rates from Period A, with the exception of: serious AEs (8.9), serious infections (0.8), injection site reactions (5.7), and hypersensitivity (4.1).3

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.

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

STUDY DESIGN:

IMMpulse was a 52-week, Phase 4, multicenter, randomized, open-label, efficacy assessor-blinded study of SKYRIZI compared to OTEZLA 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 OTEZLA 30 mg orally twice daily, post-titration per label. 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 75 with OTEZLA at Week 16. Patients were eligible for inclusion in this study if they had baseline PASI ≥12, BSA 10%-15%, and sPGA=3.2

STUDY DESIGN:

Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat.

VIEW STUDY DESIGN AND BASELINE CHARACTERISTICS

AE=adverse event; IBD=inflammatory bowel disease; MACE=major adverse cardiovascular event;
TEAE=treatment-emergent adverse event.

TOLERABILITY OF SKYRIZI
AND OTEZLA AT WEEK 162

PERCENTAGE OF PATIENTS WHO DISCONTINUED BY WEEK 162

PERIOD A

Discontinuation rates for SKYRIZI® and OTEZLA®. Discontinuation rates for SKYRIZI® and OTEZLA®. Discontinuation rates for SKYRIZI® and OTEZLA®.

PERIOD B DISCONTINUATION RATES2

Continuous SKYRIZI arm: 8% (n=9/116)

Continuous OTEZLA arm: 18% (n=17/97)

DISCONTINUATION RATES IN SKYRIZI PIVOTAL TRIALS4

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:

IMMpulse was a 52-week, Phase 4, multicenter, randomized, open-label, efficacy assessor-blinded study of SKYRIZI compared to OTEZLA 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 OTEZLA 30 mg orally twice daily, post-titration per label. 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 75 with OTEZLA at Week 16. Patients were eligible for inclusion in this study if they had baseline PASI ≥12, BSA 10%-15%, and sPGA=3.2

VIEW STUDY DESIGN AND BASELINE CHARACTERISTICS

IMMpulse: 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

OTEZLA is a registered trademark of Amgen Inc. See US Prescribing Information for further information.

RESPONSE RATES OF DLQI 0/1 AT WEEK 16 (NRI-MI)2

PERIOD A

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

LIMITATIONS:

DLQI 0/1 at Week 16 was a prespecified, nonranked endpoint and was not adjusted for multiplicity; 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.

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:

Achievement of DLQI 0/1 was a prespecified endpoint that was assessed at each postbaseline visit in Period A for SKYRIZI and OTEZLA 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).2,3

STUDY DESIGN:

Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat.

VIEW STUDY DESIGN AND BASELINE CHARACTERISTICS

NRI-MI=nonresponder imputation incorporating multiple imputations to handle missing data due to COVID-19.

Safety Profile Established

in Ps and PsA1

 

Review Safety

4 DOSES PER YEAR

4 doses per year after 2 initiation doses
at Weeks 0 and 4 (150 mg/dose)1

VIEW DOSING SCHEDULE