SKYRIZI VS COSENTYX® (secukinumab)2

SUPERIOR RATES OF PASI 90 AT WEEK 52 IN AN
OPEN-LABEL, ASSESSOR-BLINDED, HEAD-TO-HEAD STUDY

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

In an open-label, assessor-blinded
study, IMMerge

SKYRIZI DEMONSTRATED SUPERIOR RATES OF PASI 90 AT WEEK 522

SOURCING:

In this study, 46 patients outside of the US received non–US-licensed secukinumab. Data regarding comparability between US and non-US secukinumab is not publicly available.3

The adverse events observed in this study were consistent with those observed in previously reported studies and as described in the full Prescribing Information for SKYRIZI and COSENTYX.*

*COSENTYX is a registered trademark of Novartis AG. See US Prescribing Information for further information.

87% OF SKYRIZI PATIENTS ACHIEVED PASI 90 AT WEEK 52 VS 57% OF COSENTYX® (secukinumab) PATIENTS (NRI)2

SKYRIZI® demonstrated superior rates of PASI 90 at Week 52. SKYRIZI® demonstrated superior rates of PASI 90 at Week 52. SKYRIZI® demonstrated superior rates of PASI 90 at Week 52.

SKYRIZI 5 doses in year one

and COSENTYX 16 doses in year one

SOURCING:

In this study, 46 patients outside of the US received non–US-licensed secukinumab. Data regarding comparability between US and non-US secukinumab is not publicly available.3

The adverse events observed in this study were consistent with those observed in previously reported studies and as described in the full Prescribing Information for SKYRIZI and COSENTYX.*

*COSENTYX is a registered trademark of Novartis AG. See US Prescribing Information for further information.

STUDY DESIGN:

The head-to-head study was an open-label, assessor-blinded, 52-week study where patients were randomized 1:1 to receive either SKYRIZI 150 mg (two 75 mg injections) at Weeks 0, 4, and every 12 weeks until the last dose at Week 40; or COSENTYX* 300 mg (two 150 mg injections) at Weeks 0, 1, 2, 3, 4, and every 4 weeks until the last dose at Week 48.2

NRI=Non-responder imputation; ITT=Intent-to-treat.

In an open-label, assessor-blinded
study, IMMerge

SKYRIZI DEMONSTRATED SUPERIOR RATES OF PASI 100 AND sPGA 0/1 AT WEEK 522

SOURCING:

In this study, 46 patients outside of the US received non–US-licensed secukinumab. Data regarding comparability between US and non-US secukinumab is not publicly available.3

The adverse events observed in this study were consistent with those observed in previously reported studies and as described in the full Prescribing Information for SKYRIZI and COSENTYX.* No new safety signals were observed through Week 52.1,2

SECONDARY ENDPOINT DATA2

SKYRIZI® demonstrated superior rates of PASI 100 and sPGA 0/1 at Week 52. SKYRIZI® demonstrated superior rates of PASI 100 and sPGA 0/1 at Week 52. SKYRIZI® demonstrated superior rates of PASI 100 and sPGA 0/1 at Week 52.

SKYRIZI 5 doses in year one

and COSENTYX 16 doses in year one

SOURCING:

In this study, 46 patients outside of the US received non–US-licensed secukinumab. Data regarding comparability between US and non-US secukinumab is not publicly available.3

The adverse events observed in this study were consistent with those observed in previously reported studies and as described in the full Prescribing Information for SKYRIZI and COSENTYX.* No new safety signals were observed through Week 52.1,2

 

STUDY DESIGN:

The head-to-head study was an open-label assessor-blinded, 52-week study where patients were randomized 1:1 to receive either SKYRIZI 150 mg (two 75 mg injections) at Weeks 0, 4, and every 12 weeks until the last dose at Week 40, or COSENTYX* 300 mg (two 150 injections); at Weeks 0, 1, 2, 3, 4, and every 4 weeks until the last dose at Week 48.2

NRI=Non-responder imputation;

ITT=Intent-to-treat.


Safety Profile Established

in Ps and PsA1