The IL-23 inhibitor from AbbVie indicated for the treatment of adults with
active psoriatic arthritis (PsA) and for moderate to severe plaque psoriasis (Ps)
in adults who are candidates for systemic therapy or phototherapy.1

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

SKYRIZI VS OTEZLA® (apremilast)2

SKYRIZI EFFICACY AND SAFETY IN A 2-PART,
OPEN-LABEL, ASSESSOR-BLINDED STUDY
IN PATIENTS WITH MODERATE Ps

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.1,3

VIEW STUDY DESIGN AND BASELINE CHARACTERISTICS
JUMP TO SAFETY RESULTS

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: WEEK 16 (CO-PRIMARY ENDPOINT)

SKYRIZI® has 11 times higher proportion of PASI 90 responses than OTEZLA®.

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

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

 

*P<0.001.

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.2 

The co-primary endpoints of Period A were achievements 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 a baseline PASI ≥12, BSA 10%-15%, and sPGA=3.2

VIEW STUDY DESIGN AND BASELINE CHARACTERISTICS

BSA=body surface area; NRI-Ml=nonresponder imputation incorporating multiple imputation to handle 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 IN PERIOD A2

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 162,4

PERIOD A: WEEK 16

Overview of treatment­ emergent adverse events through week 16 for SKYRIZI® and OTEZLA®. Adverse event, adverse event possibly related to treatment, serious adverse event, serious infections, injection site reaction, hypersensitivity, nausea, diarrhea, tuberculosis, malignancy, diarrhea, headache, depression and candidiasis.

Period B safety rates (E/100 PYs) in the continuous SKYRIZI population (n=118) were consistent with the 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).4

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.2 

The co-primary endpoints of Period A were achievements 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 a baseline PASI ≥12, BSA 10%-15%, and sPGA=3.2

VIEW STUDY DESIGN AND BASELINE CHARACTERISTICS

BSA=body surface area; IBD=inflammatory bowel disease; 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.”

WELL-STUDIED SAFETY PROFILE

Across PsA & Ps1

Review the safety profile

4 DOSES PER YEAR

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

VIEW DOSING SCHEDULE