SC AND IV
INDUCTION DATA

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Early Disease Control
Early Endoscopic Control

Proven to Give Patients a Chance at Early Disease and Endoscopic Control1,2

In clinical trials Skyrizi helped with: early disease control with clinical remission at Week 12, and early endoscopic control with endoscopic response and endoscopic remission at Week 12.

EARLY DISEASE CONTROL

Patients Achieved Early Disease Control With SC and IV Induction

Clinical Remission* Data at Week 4 SC and IV1-3

Bar chart comparing clinical remission rates. In AFFIRM, remission was achieved by 33% of patients receiving SKYRIZI 720 mg SC versus 23% with placebo and by 40% versus 18% in the advanced therapy-naive subgroup. In ADVANCE, remission was achieved by 18% of patients receiving SKYRIZI 600 mg IV versus 10% with placebo.
In the MOTIVATE study, clinical remission rates were higher with SKYRIZI 600 mg IV than placebo, reaching 21% versus 11% at Week 4

DATA LIMITATIONS: AFFIRM Week 4 data were prespecified nonranked endpoints not controlled for multiplicity; therefore, treatment differences could represent chance findings. No conclusions regarding onset of treatment effect at these timepoints can be made.

Patients experienced early symptom control at Week 12 with both SC and IV Induction

Clinical Remission* Data at Week 12 SC and IV1-3

Bar chart comparing clinical remission rates at Week 12. In AFFIRM, remission was achieved by 56% of patients receiving SKYRIZI 720 mg SC versus 30% with placebo and by 74% versus 27% in the advanced therapy-naive subgroup. In ADVANCE, remission was achieved by 45% of patients receiving SKYRIZI 600 mg IV versus 25% with placebo and by 49% versus 23% in the advanced therapy-naive subgroup.

Cross comparison for efficacy among different trials is not intended.

STUDY DESIGNS

AFFRIM (N=274) was a 12-week, randomized, double-blind, placebo-controlled SC Induction study that evaluated the efficacy and safety of SKYRIZI in adults with moderately to severely active Crohn’s disease who had prior treatment failure with conventional (advanced therapy§-naïve||) and/or an advanced therapy.§ Patients received SC injections of SKYRIZI 720 mg or placebo at Weeks 0, 2, 4, and 8.

ADVANCE (N=850) MOTIVATE (N=569) IV Induction studies were 12-week, randomized, double-blind, placebo-controlled studies that evaluated the efficacy and safety of SKYRIZI in patients with moderately to severely active Crohn’s disease who demonstrated prior treatment failure to conventional (advanced therapy§-naïve||) and/or biological treatment. Patients received an IV infusion of SKYRIZI 600 mg (recommended dose), risankizumab-rzaa 1200 mg, or placebo at Weeks 0, 4, and 8.1

The 1200 mg IV dosage did not demonstrate additional treatment benefit over the 600 mg dosage and is not a recommended regimen.

*Clinical remission was defined as a CDAI score <150 points.1

†Endoscopic response was defined as a decrease in SES-CD >50% from baseline, or a decrease of at least 2 points for subjects with a baseline score of 4 and isolated ileal disease, based on central reading. The sections evaluated on endoscopy are the rectum, sigmoid and left colon, transverse colon, right colon, and ileum (per SES-CD assessment).1

‡Endoscopic remission is defined as SES-CD ≤4 and at least a 2-point reduction versus baseline and no subscore >1 in any individual variable, as scored by a central reviewer.1

§Advanced therapies in Crohn's included biologics (all trials) and JAK inhibitors (AFFIRM only).

||The advanced therapy-naïve subpopulation includes patients who were exposed to an advanced therapy but did not have an inadequate response, loss of response, or intolerance to advanced therapies.4

CDAI=Crohn’s disease activity index; IL-23=interleukin-23; IV=intravenous; RCT=randomized controlled trial; SC=subcutaneous; SES-CD=simple endoscopic score for Crohn’s disease.

STUDY DESIGNS & BASELINE CHARACTERISTICS+

EARLY ENDOSCOPIC CONTROL

Early Endoscopic Control Achieved With SC and IV Induction

Endoscopic Response* at Week 12 SC and IV1,2

Bar chart comparing endoscopic response rates. In AFFIRM, response was achieved by 43% of patients receiving SKYRIZI 720 mg SC versus 15% with placebo and by 60% versus 15% in the advanced therapy-naive subgroup. In ADVANCE, response was achieved by 40% of patients receiving SKYRIZI 600 mg IV versus 12% with placebo and by 50% versus 13% in the advanced therapy-naive subgroup.
In the MOTIVATE induction study, endoscopic response at Week 12 was achieved by 29% of patients treated with SKYRIZI 600 mg IV compared with 11% of patients receiving placebo.

Endoscopic Remission§ at Week 12 SC and IV1,2

Ranked Secondary Endpoint

Bar chart comparing endoscopic remission rates at Week 12. In AFFIRM, remission was achieved by 26% of patients receiving SKYRIZI 720 mg SC versus 11% with placebo and by 43% versus 9% in the advanced therapy- naive subgroup, which is over 40% difference. In ADVANCE, remission was achieved by 24% of patients receiving SKYRIZI 600 mg IV versus 9% with placebo and by 32% versus 14% in the advanced therapy-naive subgroup.
In the MOTIVATE induction study, endoscopic remission was achieved by 19% of patients treated with SKYRIZI 600 mg IV compared with 4% of patients receiving placebo.

Cross comparison for efficacy among different trials is not intended.

The first and only IL-23i to achieve endoscopic remission§ at Week 12 with both SC and IV induction1,2

*Endoscopic response is defined as a decrease in SES-CD >50% from baseline, or a decrease of at least 2 points for subjects with a baseline score of 4 and isolated ileal disease, based on central reading. The sections evaluated on endoscopy are the rectum, sigmoid and left colon, transverse colon, right colon, and ileum (per SES-CD assessment).1

†Advanced therapies in Crohn’s included biologics (all trials) and JAK inhibitors (AFFIRM only).

‡The advanced therapy-naïve subpopulation includes patients who were exposed to an advanced therapy but did not have an inadequate response, loss of response, or intolerance to advanced therapies.4

§Endoscopic remission is defined as SES-CD ≤4 and at least a 2-point reduction versus baseline and no subscore >1 in any individual variable, as scored by a central reviewer.1

IL-23i=interleukin-23 inhibitor; IV=intravenous; RCT=randomized controlled trial; SC=subcutaneous; SES-CD=simple endoscopic score for Crohn's disease.

STUDY DESIGNS & BASELINE CHARACTERISTICS+

See the long-term data for disease and endoscopic control.


VIEW CROHN'S DATA UP TO ~5 YEARS

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