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

The IL-23 inhibitor from AbbVie indicated for the treatment of adults with: active psoriatic arthritis (PsA);
moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy; moderately
to severely active Crohn's disease (CD); or moderately to severely active ulcerative colitis (UC)

IN PATIENTS WITH PsA

EFFICACY DATA ACROSS KEY DOMAINS

RESPONSE RATES AT WEEK 24 AND OUT TO ~5 YEARS

IN KEEPsAKE 1 AND KEEPsAKE 2, THE PRIMARY ENDPOINT WAS ACR20 RESPONSE AT WEEK 24.¹

KEEPsAKE 1:
SKYRIZI 57% (n=483), PLACEBO 34% (n=481)

KEEPsAKE 2:
SKYRIZI 51% (n=224), PLACEBO 27% (n=219)

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, open-label extension for up to an additional 292 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

UP TO ~5 YEARS OF EFFICACY DATA ACROSS KEY PsA DOMAINS

MULTIPLE DOMAINS IN ONE VIEW

GET THE FULL PICTURE BELOW

IMPROVEMENTS IN ACR COMPONENTS OF DISEASE ACTIVITY^1,4

KEEPsAKE 1: csDMARD-IR

KEEPsAKE 1 ACR components at 24 weeks and 244 weeks

DATA LIMITATIONS: Data labeled as a ranked secondary endpoint were multiplicity-controlled for comparisons. All other comparisons were not adjusted for multiplicity; statistical significance has not been established.

OLE LIMITATIONS: An OLE may enrich long-term data, as patients intolerant or unresponsive to the drug drop out.

AS OBSERVED (AO) ANALYSIS: Patients with missing data at a specific time are not included, which may enrich the population and increase the response rates.

*Week 24 ranked secondary endpoint.⁵

ACR=American College of Rheumatology; AO=as observed; HAQ-DI=Health Assessment Questionnaire Disability Index; hs-CRP=high sensitivity C-reactive protein; MMRM=mixed-effect model for repeated measures; OLE=open-label extension; RCT=randomized controlled trial; VAS=visual analog scale

RESPONSE RATES AT WEEK 24^5-8

Enthesitis Resolution (LEI=0) (NRI-C)^†a

Ranked key secondary endpoint: Pooled KEEPsAKE 1 and 2 data

48% with SKYRIZI (n=444) & 35% with placebo (n=448)

Dactylitis Resolution (LDI=0) (NRI-C)^†a

Ranked key secondary endpoint: Pooled KEEPsAKE 1 and 2 data

68% with SKYRIZI (n=188) & 51% with placebo (n=204)

SJC ≥50% Improvement (NRI-C)^§c

Post hoc analysis of ACR composite endpoint: KEEPsAKE 1

75% with SKYRIZI (n=483) & 59% with placebo (n=481)

TJC ≥50% Improvement (NRI-C)^§c

Post hoc analysis of ACR composite endpoint: KEEPsAKE 1

65% with SKYRIZI (n=483) & 44% with placebo (n=481)

RADIOGRAPHIC RESULTS IN PsA

MEAN CHANGE IN mTSS (ANCOVA)^‡b

Ranked key secondary endpoint: KEEPsAKE 1

Results were not statistically significant

0.23 with SKYRIZI (n=458) & 0.32 with placebo (n=457)

mTSS ≤0 (ANCOVA)^‡b

Additional nonranked endpoint: KEEPsAKE 1

92% with SKYRIZI (n=458) & 88% with placebo (n=457)

RADIOGRAPHIC LIMITATION: KEEPsAKE 1 results did not establish a treatment effect on radiographic inhibition. The proportion of patients with no radiographic progression (mTSS ≤0.0) at Week 24 was a prespecified, nonranked endpoint; thus, no statistical or clinical conclusions can be drawn.

NAIL PSORIASIS IMPROVEMENT IN PsA

PGA-F: Mean Change from Baseline (MMRM)^†d

Ranked key secondary endpoint: KEEPsAKE 1

-0.8 with SKYRIZI (n=280) & -0.4 with placebo (n=297)

At baseline, 64% of patients with PsA on SKYRIZI (n=309/483) and 71% on placebo (n=338/481) had presence of nail psoriasis.

PGA-F 0/1: PGA-F Score of 'Clear' or  'Minimal' (0/1) (AO)^§‖d

Additional nonranked endpoint: KEEPsAKE 1

40% with SKYRIZI (n=182) & 19% with placebo (n=182)

SKYRIZI is not approved for mild plaque psoriasis.

^§DATA LIMITATIONS: Proportion of patients with ≥50% tender joint count and swollen joint count improvement were post hoc analyses not prespecified or adjusted for multiplicity. PGA-F score 'clear' or 'minimal' was a prespecified nonranked endpoint not adjusted for multiplicity. No statistical or clinical conclusions can be made.

AO ANALYSIS: Patients with missing data at a specific time are not included, which may enrich the population and increase the response rates.

Radiographic Scoring Scale: The maximum possible scores are 320 for erosions, 208 for joint space narrowing, and 528 for the total score.

^†P<0.001.

^‡Radiographic endpoints were analyzed using an analysis of covariance model incorporating linear extrapolation to impute missing data.

^‖PGA-F 0/1 with a ≥2-grade improvement. Among PsA patients with a PGA-F score of ≥2.0 (mild, moderate, or severe) at baseline.

^aIntegrated results from KEEPsAKE 1 and KEEPsAKE 2 in patients with baseline presence of enthesitis (LEI>0) or dactylitis (LDI>0).

^bAt baseline, the mean mTSS score was 13.0 in patients with PsA on SKYRIZI (n=483) and 13.5 in patients on placebo (n=481).

^cTJC/SJC 50% improvement is defined as ≥50% reduction in TJC/SJC.

^dAmong PsA patients with nail psoriasis, the mean baseline PGA-F score was 2.1 for SKYRIZI patients and 2.0 on placebo.

ACR=American College of Rheumatology; ANCOVA=analysis of covariance; AO=as observed; LDI=Leeds Dactylitis Index; LEI=Leeds Enthesitis Index; mTSS=modified total Sharp score; MMRM=mixed-effect model for repeated measures; NRI-C=nonresponder imputation incorporating multiple imputation to handle missing data due to COVID-19; PGA-F=Physician's Global Assessment of Fingernail Psoriasis; PsA=psoriatic arthritis; SJC=swollen joint count; TJC=tender joint count

DATA OUT TO ~5 YEARS WITH SKYRIZI^4,9

KEEPsAKE 1: csDMARD-IR | ALL DATA ARE AS OBSERVED (AO) | OLE

TENDER JOINT COUNT^¶

Post hoc analysis of ACR composite endpoint

93%
(n=354)

OF PATIENTS SAW
TJC improved by ≥50%^#
AT WEEK 244

DACTYLITIS

97%
(n=141)

HAD
NO DACTYLITIS**
AT WEEK 244 (LDI=0)

ENTHESITIS

83%
(n=297)

HAD
NO ENTHESITIS**
AT WEEK 244 (LEI=0)

SWOLLEN JOINT COUNT^¶

Post hoc analysis of ACR composite endpoint

97%
(n=354)

OF PATIENTS SAW
SJC improved by ≥50%^#
AT WEEK 244

NAIL PSORIASIS^¶

82%
(n=147)

OF PATIENTS
OBSERVED ’CLEAR’ or ‘MINIMAL’ PGA-F SCORE
AT WEEK 244 (PGA-F 0/1 with A ≥2 grade improvement)
Among PsA patients with PGA-F score ≥2.0 (mild, moderate, or severe) at baseline.

RADIOGRAPHIC RESULTS

Results were not statistically significant in mean change in mTSS at Week 24

88%
(n=337)

HAD
NO RADIOGRAPHIC PROGRESSION
AT WEEK 244 (CHANGE FROM BASELINE IN mTSS ≤0)

^¶DATA LIMITATIONS: Proportion of patients with ≥50% tender joint count and swollen joint count improvement were post hoc analyses not prespecified or adjusted for multiplicity. PGA-F score 'clear' or 'minimal' was a prespecified nonranked endpoint not adjusted for multiplicity. No statistical or clinical conclusions can be made.

OLE LIMITATIONS: An OLE may enrich long-term data, as patients intolerant or unresponsive to the drug drop out.

AO ANALYSIS: Patients with missing data at a specific time are not included, which may enrich the population and increase the response rates.

SKYRIZI is not approved for mild plaque psoriasis.

^#TJC/SJC 50% improvement is defined as ≥50% reduction in TJC/SJC.

**Integrated results from KEEPsAKE 1 and KEEPsAKE 2 in patients with baseline presence of enthesitis (LEI>0) or dactylitis (LDI>0).

ACR=American College of Rheumatology; AO=as observed; csDMARD=conventional synthetic disease-modifying antirheumatic drug; IR=intolerance or inadequate response; LDI=Leeds Dactylitis Index; LEI=Leeds Enthesitis Index; mTSS=modified total Sharp score; NRI-C=nonresponder imputation incorporating multiple imputation to handle missing data due to COVID-19; OLE=open-label extension; PGA-F=Physician's Global Assessment of Fingernail Psoriasis; PsA=psoriatic arthritis; RCT=randomized controlled trial; SJC=swollen joint count; TJC=tender joint count