The IL-23 inhibitor from AbbVie indicated for the treatment of moderately to severely active Crohn's disease (CD) in adults.1

Endoscopic and Symptom Control
Endoscopic Response and Clinical Remission Results at Weeks 12 and 52

FIRST and Only IL-23 SPECIFIC inhibitor in Crohn's Disease (CD)1

FIRST Approved Product in CD with Clinical AND Endoscopic Endpoints Aligned to STRIDE-II Guidelines2

FIRST Approved Product in CD with Endoscopic Response as a Co-Primary Endpoint1


Clinical Remission: Defined as a CDAI score of <150 points.

Endoscopic Response: Decrease in SES‑CD >50% from baseline as scored by a central reviewer. The sections evaluated on endoscopy are the: rectum, sigmoid and left colon, transverse colon, right colon and ileum (per SES‑CD assessment).

ENDOSCOPIC AND SYMPTOM CONTROL ACROSS CO-PRIMARY ENDPOINTS1,3,4

Endoscopic response (SES-CD) and Clinical Remission (CDAI) in induction studies at Weeks 12 and 52

Placebo (Induction Responders): Patients who achieved CDAI clinical response (CR‑100) to SKYRIZI induction therapy and were randomized to receive placebo in the maintenance study.

More skyrizi patients saw
endoscopic response vs placebo1

40% of total patients demonstrated endoscopic response with SKYRIZI at Week 12, regardless of biologic experience1,3


Co-Primary Endpoints for ADVANCE:
Endoscopic Response AT WEEK 12:
40% SKYRIZI
vs 12% placebo, p<0.001
Clinical Remission AT WEEK 12:
45% SKYRIZI
vs 25% placebo, p<0.001

More skyrizi patients saw
endoscopic response vs placebo1,5

48% OF TOTAL PATIENTS DEMONSTRATED ENDOSCOPIC RESPONSE WITH SKYRIZI AT WEEK 52, REGARDLESS OF BIOLOGIC EXPERIENCE1,4


Co-Primary Endpoints for FORTIFY:
Endoscopic Response AT WEEK 52:
48% SKYRIZI
vs 22% placebo (induction responders), p<0.05
Clinical Remission AT WEEK 52:
57% SKYRIZI
vs 46% placebo (induction responders), p<0.05

Placebo (Induction Responders): Patients who achieved CDAI clinical response (CR-100) to SKYRIZI induction therapy and were randomized to receive placebo in the maintenance study.

The STRIDE-II recommendations establish MUCOSAL improvement as a long-term treatment target in CD2

More skyrizi patients saw endoscopic REMISSION vs placebo1,6

ADVANCE:  Endoscopic Remission at Week 12

Endoscopic Remission: SES-CD ≤4 and at least a 2-point reduction versus baseline and no subscore greater than 1 in any individual variable, as scored by a central reviewer.

24% of total patients demonstrated endoscopic remission with SKYRIZI at Week 121


Ranked Secondary Endpoint for ADVANCE:
Endoscopic Remission AT WEEK 12
(Total Population):
24% SKYRIZI
vs 9% placebo, p<0.001

Endoscopic Remission: SES-CD ≤4 and at least a 2-point reduction versus baseline and no subscore greater than 1 in any individual variable, as scored by a central reviewer.

ENDOSCOPIC REMISSION DATA: POST HOC DATA OF SUBGROUP ANALYSIS5,7

FORTIFY: Endoscopic Remission at Week 52

Data Limitations: Endoscopic remission sub-group data at Week 52 was not tested for multiplicity control, and cannot demonstrate a statistically significant difference in treatment effect for SKYRIZI vs placebo (induction responders). No statistical or clinical conclusions can be made.

Endoscopic Remission: SES-CD ≤4 and at least a 2-point reduction versus baseline and no subscore greater than 1 in any individual variable, as scored by a central reviewer.

Endoscopic remission was observed at Week 52 in 41% (48/117) of subjects treated with the SKYRIZI 360 mg maintenance regimen and 13% (17/130) of subjects treated with placebo. This endpoint was not statistically significant under the pre-specified multiple testing procedure.

Endoscopic remission was observed at Week 52

Endoscopic remission was observed at Week 52 in 41% (48/117) of subjects treated with the SKYRIZI 360 mg maintenance regimen and 13% (17/130) of subjects treated with placebo. This endpoint was not statistically significant under the pre-specified multiple testing procedure.

Secondary Endpoints for FORTIFY:
Endoscopic Remission AT WEEK 52:
(Total Population):
41% SKYRIZI
vs
13% placebo (induction responders)

This endpoint was not statistically significant under the prespecified multiple testing procedure.

Placebo (Induction Responders): Patients who achieved CDAI clinical response (CR-100) to SKYRIZI induction therapy and were randomized to receive placebo in the maintenance study

Data Limitations: Endoscopic remission and sub-group data at Week 52 could not be tested for multiplicity control, and cannot demonstrate a statistically significant difference in treatment effect for SKYRIZI vs placebo (induction responders). No statistical or clinical conclusions can be made.

Endoscopic Remission: SES-CD ≤4 and at least a 2-point reduction versus baseline and no subscore greater than 1 in any individual variable, as scored by a central reviewer.

CLINICAL REMISSION REGARDLESS OF BIOLOGIC EXPERIENCE1,4,5

Co-Primary Endpoints for FORTIFY:
Endoscopic Response AT WEEK 52:
48% SKYRIZI
vs 22% placebo (induction responders), p<0.05
Clinical Remission AT WEEK 52:
57% SKYRIZI
vs 46% placebo (induction responders), p<0.05

Did you know?

aThe induction-only group consisted of subjects who achieved clinical response (CR-100) to SKYRIZI induction therapy and were randomized to receive placebo in FORTIFY. The mean half-life of SKYRIZI is approximately 21 days for patients with CD which may have contributed to these rates.

Placebo (Induction Responders): Patients who achieved CDAI clinical response (CR-100) to SKYRIZI induction therapy and were randomized to receive placebo in the maintenance study.

Co-Primary Endpoints for ADVANCE:
Endoscopic Response AT WEEK 12:
40% SKYRIZI
vs 12% placebo, p<0.001
Clinical Remission AT WEEK 12:
45% SKYRIZI
vs 25% placebo, p<0.001

SYMPTOM RELIEF AS EARLY AS WEEK 4:
Clinical Response (CDAI CR-100) at Weeks 4, 8, 121,8

ADVANCE: Early clinical response as early as 4 weeks

Data Limitations: Data not labeled as a ranked secondary endpoint were prespecified nonranked endpoints not controlled for multiplicity; therefore, treatment differences could represent chance findings. No conclusions regarding these comparisons can be made.

Clinical Response: Reduction of CDAI score ≥100 points from baseline.

60% of SKYRIZI Patients Responded at Week 12 AFTER INDUCTION

Data Limitations: Data not labeled as a ranked secondary endpoint were prespecified nonranked endpoints not controlled for multiplicity; therefore, treatment differences could represent chance findings. No conclusions regarding these comparisons can be made.

Clinical Response: Reduction of CDAI score ≥100 points from baseline.

Patient Case from the CD Clinical Trials

Patient 1: Failed a Biologic and Presented With Severe CD ON ENDOSCOPY (SES-CD OF 27)9,10

  • Patient Profile:  Age: 34 Years Old
  • Sex: Male
  • Disease Duration: 3.4 years
  • Drug History: Has failed one prior biologic
Patient Case Study Representing Response and/or Remission AT WEEKS 12 AND 52

Patient received 600 mg IV (induction) and 360 mg SC (maintenance)

Patient 1: failed a biologic and presented with a severe CD on endoscopy at Weeks 12 and 52

This image represents an individual patient who was treated with SKYRIZI who had endoscopic remission at Week 52. In the FORTIFY maintenance clinical trial, endoscopic remission data at Week 52 was not statistically significant under the pre-specified multiple testing procedure.

IMAGES ARE FROM A CLINICAL TRIAL PATIENT TREATED WITH SKYRIZI AND REPRESENT AN AVERAGE PATIENT AT BASELINE.

Patient Case from the CD Clinical Trials

Patient 2: Bio-Naïve and Presented With Moderate CD ON ENDOSCOPY (SES-CD OF 11)9,10

  • Patient Profile:  Age: 44 Years Old
  • Sex: Male
  • Disease Duration: 8.6 years
  • Drug History: Bio-naïve
Patient Case Study Representing Response and/or Remission AT WEEKS 12 AND 52

Patient received 600 mg IV (induction) and 360 mg SC (maintenance)

Patient 2: bio-naïve and presented with a moderate CD on endoscopy at weeks 12 and 52

This image represents an individual patient who was treated with SKYRIZI who had endoscopic remission at Week 52. In the FORTIFY maintenance clinical trial, endoscopic remission data at Week 52 was not statistically significant under the pre-specified multiple testing procedure.

IMAGES ARE FROM A CLINICAL TRIAL PATIENT TREATED WITH SKYRIZI AND REPRESENT AN AVERAGE PATIENT AT BASELINE.

Images You Can See

Check out the SKYRIZI CD patient case studies with endoscopy images.

Patient Case Photo Gallery