Nothing less than the opportunity for

POWERFUL JOINT SYMPTOM RELIEF IN ACTIVE PsA1

JOINT SYMPTOM RELIEF WITH SIGNIFICANTLY HIGHER ACR RESPONSE RATES VS PLACEBO AT WEEK 241,2

ACR20
PRIMARY ENDPOINT

ACR50*

ACR70*

KEEPsAKE-1 Study: Joint symptom relief with significantly higher ACR response rates vs placebo at week 24. KEEPsAKE-1 Study: Joint symptom relief with significantly higher ACR response rates vs placebo at week 24. KEEPsAKE-1 Study: Joint symptom relief with significantly higher ACR response rates vs placebo at week 24.

Analysis conducted using NRI-C method.

A patient was considered as a non-responder after initiation of rescue medication or concomitant medications for PsA that could meaningfully impact efficacy assessment.

*Non-ranked secondary endpoints.

Multiplicity-controlled p≤0.001 SKYRIZI vs placebo comparison.

p<0.001.

*Non-ranked secondary endpoints.

Joint symptom relief beyond ACR20 at week 241,3

ACR20
PRIMARY ENDPOINT

ACR50*

ACR70*

KEEPsAKE-2 Study: Joint symptom relief beyond ACR20 at week 24. KEEPsAKE-2 Study: Joint symptom relief beyond ACR20 at week 24. KEEPsAKE-2 Study: Joint symptom relief beyond ACR20 at week 24.

Analysis conducted using NRI-C method.

A patient was considered as a non-responder after initiation of rescue medication or concomitant medications for PsA that could meaningfully impact efficacy assessment.

*Non-ranked secondary endpoints.

Multiplicity-controlled p≤0.001 SKYRIZI vs placebo comparison.

p<0.001.

§p<0.05.

*Non-ranked secondary endpoints.

VIEW MORE ABOUT PsA-RELATED MEASURES INCLUDING ACR, HAQ-DI, AND hs-CRP

STUDY DESIGN:

KEEPsAKE-1 (N=964) and KEEPsAKE-2 (N=443) were 2 randomized, double-blind, placebo-controlled studies that evaluated the efficacy and safety of SKYRIZI 150 mg vs placebo over 24 weeks with a long-term extension for up to an additional 204 weeks. Both studies enrolled adult patients with active psoriatic arthritis. In KEEPsAKE-1, the study population had an inadequate response or intolerance to at least 1 csDMARD while in KEEPsAKE-2 patients had an inadequate response or intolerance to at least 1 biologic therapy OR to at least 1 csDMARD.1-3

Durable response rate of ACR20 observed at Week 52 (OLE)1,2,4

  • SKYRIZI 150 mg (n=483)
  • PLACEBO (n=481)
KEEPsAKE-1 Study: Durable response rate with 70% of Skyrizi patients reaching ACR20 at week 52 in the OLE. KEEPsAKE-1 Study: Durable response rate with 70% of Skyrizi patients reaching ACR20 at week 52 in the OLE. KEEPsAKE-1 Study: Durable response rate with 70% of Skyrizi patients reaching ACR20 at week 52 in the OLE.

DURABLE RESPONSE RATE AT WEEK 52 (OLE)1,3,5

  • SKYRIZI 150 mg (n=224)
  • PLACEBO (n=219)
KEEPsAKE-2 Study: Durable response rate with 59% of SKYRIZI® patients reaching ACR20 at week 52 in the OLE. KEEPsAKE-2 Study: Durable response rate with 59% of SKYRIZI® patients reaching ACR20 at week 52 in the OLE. KEEPsAKE-2 Study: Durable response rate with 59% of SKYRIZI® patients reaching ACR20 at week 52 in the OLE.

STUDY WEEK

llp≤0.001 for ranked endpoints.

Analysis conducted using NRI-C method through Week 24; NRI method used through Week 52.

VIEW MORE ABOUT PsA-RELATED MEASURES INCLUDING ACR, HAQ-DI, AND hs-CRP

STUDY DESIGN:

KEEPsAKE-1 (N=964) and KEEPsAKE-2 (N=443) were 2 randomized, double-blind, placebo-controlled studies that evaluated the efficacy and safety of SKYRIZI 150 mg vs placebo over 24 weeks with a long-term extension for up to an additional 204 weeks. Both studies enrolled adult patients with active psoriatic arthritis. In KEEPsAKE-1, the study population had an inadequate response or intolerance to at least 1 csDMARD while in KEEPsAKE-2 patients had an inadequate response or intolerance to at least 1 biologic therapy OR to at least 1 csDMARD.1-3

OLE LIMITATIONS:

In an OLE, there is a potential for enrichment of the long-term data in remaining patient populations since patients who are unable to tolerate or do not respond to the drug often drop out.

NRI=non-responder imputation; NRI-C=non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19.

COMPLETE RESOLUTION OF
ENTHESITIS & DACTYLITIS

COMPLETE RESOLUTION OF ENTHESITIS & DACTYLITIS AT 24 WEEKS4

RESPONSE RATE AT WEEK 24 POOLED FROM KEEPsAKE-1 AND KEEPsAKE-2

48%

(n=444)

VS 35% with PLACEBO
(n=448)

COMPLETE
RESOLUTION
OF ENTHESITIS
(LEI score=0)

Baseline enthesitis presence: (LEI >0) SKYRIZI n=444; PLACEBO n=448.

68%

(n=188)

VS 51% with PLACEBO
(n=204)

COMPLETE
RESOLUTION
OF DACTYLITIS
(LDI score=0)

Baseline dactylitis presence: (LDI >0) SKYRIZI n=188; PLACEBO n=204.

p<0.001

These measures were only evaluated in patients with involvement at baseline and were not criteria for stratification.4,5

RESPONSE RATES AT WEEK 52 (OLE DATA)4,5

POOLED FROM KEEPsAKE-1 AND KEEPsAKE-2

55%

(n=444)

COMPLETE
RESOLUTION
OF ENTHESITIS
(LEI score=0)

Baseline enthesitis presence: SKYRIZI n=444.

76%

(n=188)

COMPLETE
RESOLUTION
OF DACTYLITIS
(LDI score=0)

Baseline dactylitis presence: SKYRIZI n=188.

These measures were only evaluated in patients with involvement at baseline and were not criteria for stratification.

At Week 28, patients who completed the double-blind period had the option to enter the open-label extension
and receive SKYRIZI  (150 mg/dose) every 12 weeks. 

OLE LIMITATIONS:

In an OLE, there is potential for enrichment of the long-term data in the remaining patient population since patients who are unable to tolerate or do not respond to the drug often drop out.

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