Nothing less than the opportunity for

POWERFUL JOINT SYMPTOM RELIEF IN ACTIVE PsA¹

KEEPsAKE-1 KEEPsAKE-1

KEEPsAKE-2 KEEPsAKE-2

After 3 doses of SKYRIZI

57% OF PATIENTS ACHIEVED ACR20 RESPONSE AT WEEK 24 VS PLACEBO^1,2

NRI ANALYSIS

After 3 doses of SKYRIZI

51% OF PATIENTS ACHIEVED ACR20 RESPONSE AT WEEK 24 VS PLACEBO^1,6

NRI ANALYSIS

After 3 doses of SKYRIZI, 51% of patients achieved ACR20 response at week 24 VS placebo.

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

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

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 316 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.^1,3,4

NRI=nonresponder imputation; RCT=randomized, controlled trial.

KEEPsAKE-1 KEEPsAKE-1

KEEPsAKE-2 KEEPsAKE-2

ACR20/50/70 Response Rates OUT TO WEEK 148 (OLE)^3,5

ALL DATA ARE AS OBSERVED

KEEPsAKE-1 Study: ACR20/50/70 Response Rates compared to placebo up to week 148(OLE).

ACR20/50/70 Response Rates OUT TO WEEK 148 (OLE)^4,5

ALL DATA ARE AS OBSERVED

KEEPsAKE-2 Study: ACR20/50/70 response rates compared to placebo up to week 148(OLE).

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

AO DISCLOSURE:

In an as observed analysis (AO), missing visit data were excluded from calculations for that visit, which may increase the percent of responders. All observed data were used regardless of premature discontinuation of study drug, initiation of concomitant medication, or rescue medication. The same patient may not have a response at each timepoint.

OLE LIMITATIONS:

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

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 316 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.^1,3,4

POWERFUL JOINT SYMPTOM RELIEF¹

SIGNIFICANTLY HIGHER ACR20 RESPONSE RATES VS PLACEBO AT WEEK 24 (PRIMARY ENDPOINT)

MEAN CHANGE FROM BASELINE IN ALL ACR COMPONENTS OUT TO WEEK 148^1,5

ALL DATA OBSERVED

KEEPsAKE 1 and KEEPsAKE 2: SKYRIZI® mean change from baseline in all acr components out to week 148.

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

AO DISCLOSURE:

OLE LIMITATION:

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

To achieve ACR20, 50, 70, a patient must have at least a 20%, 50%, or 70%, respectively, improvement in tender and swollen joint counts and 3 of 5 scores of individual elements⁷:

Patient-reported pain
Physician Global Assessment
Patient's Global Assessment
Physical function (HAQ-DI)
Acute phase reactant (hs-CRP)

^aAssessment based on Visual Analog Scale (100 mm) with the left end indicating “no pain” (for patient’s assessment of pain), “very well” (for patient global assessment), or “no arthritis activity” (for physician global assessment) and the right end indicating “the worst possible pain” (for patient assessment of pain), “poor” (for patient global assessment), or “extremely active arthritis” (for physician global assessment).¹

^bDisability Index of the Health Assessment Questionnaire: 0=no difficulty to 3=inability to perform, measures the patient’s ability to perform the following: dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living.¹

KEEPsAKE-1 KEEPsAKE-1

KEEPsAKE-2 KEEPsAKE-2

SKYRIZI PATIENTS REPORTED A REDUCTION IN PAIN OUT TO WEEK 52 (OLE)⁸

BASED ON A POST HOC ANALYSIS OF MCID RESPONSE

Mean baseline score of Patient's Assessment of Pain: 57.1 (SKYRIZI) and 57.1 (placebo). Mean score at Week 24: 35.7 (SKYRIZI) and 46.2 (placebo).¹

KEEPsAKE Study-1: Nearly 61% of patients reported experiencing less pain.

ACHIEVEMENT OF MCID RESPONSE (≥10-POINT DECREASE OF PAIN VAS ON 100-POINT SCALE) FROM BASELINE.

MCID=minimal clinically important difference;

NRI-C=nonresponder imputation incorporating multiple imputation to handle missing data due to COVID-19; VAS=visual analog scale.

DATA LIMITATIONS:

Change from baseline in ACR components, including pain, at Week 24 was a prespecified, nonranked endpoint. Post hoc analysis of MCID for pain VAS at Week 24 was not included as a prespecified endpoint. No statistical or clinical conclusions can be drawn.

OLE LIMITATIONS:

STUDY DESIGN:

KEEPsAKE-1 (N=964) was a randomized, double-blind, placebo-controlled study that evaluated SKYRIZI 150 mg vs placebo over 24 weeks in adult patients with active PsA who have an inadequate response or intolerance to at least 1 conventional synthetic disease-modifying anitrheumatic drug (csDMARD). At Week 24 patients entered the open-label extension on SKYRIZI 150 mg for up to an additional 316 weeks.^1,3

Patient's overall assessment of pain due to their psoriatic arthritis during the last 24 hours was measured using a 100-mm horizontal visual analog scale (VAS), ranging from 0 (no pain) to 100 (severe pain).

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

56% OF PATIENTS REPORTED A REDUCTION IN PAIN AT WEEK 52 (OLE)⁸

BASED ON A POST HOC ANALYSIS OF PATIENT’S ASSESSMENT OF PAIN

Mean baseline score of Patient's Assessment of Pain: 55.0 (SKYRIZI) and 57.0 (placebo). Mean score at Week 24: 39.7 (SKYRIZI) and 48.3 (placebo).¹

KEEPsAKE Study-2: Over 50% of patients reported experiencing less pain.

ACHIEVEMENT OF MCID RESPONSE (≥10-POINT DECREASE OF PAIN VAS ON 100-POINT SCALE) FROM BASELINE.

MCID=minimal clinically important difference;

NRI-C=nonresponder imputation incorporating multiple imputation to handle missing data due to COVID-19; VAS=visual analog scale.

DATA LIMITATIONS:

OLE LIMITATIONS:

STUDY DESIGN:

KEEPsAKE-2 (N=443) was a randomized, double-blind, placebo-controlled study that evaluated SKYRIZI 150 mg vs placebo over 24 weeks in a mixed population of adult patients with active PsA who have demonstrated inadequate response or intolerance to biological (bDMARD) therapy or lack of response to at least 1 conventional synthetic disease-modifying anti-rheumatic drug (csDMARD). At Week 24 patients entered the open-label extension on SKYRIZI 150 mg for up to an additional 316 weeks.^1,4

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