Efficacy & Remission Data | SKYRIZI® (risankizumab-rzaa)

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 Guidelines^1,2

FIRST Approved Product in CD with Endoscopic Response as a Co-Primary Endpoint^1,3

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

Endoscopic Response: 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).

ENDOSCOPIC AND SYMPTOM CONTROL ACROSS CO-PRIMARY ENDPOINTS^1,3

Co-primary endpoint data: Endoscopic response (SES-CD) and clinical remission (CDAI) at week 12 (ADVANCE and MOTIVATE) and at Week 52 (FORTIFY).

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.

ENDOSCOPIC OUTCOMES

Endoscopic Response: WEEK 12 Endoscopic Response: WEEK 12

Endoscopic Response: WEEK 52 Endoscopic Response: WEEK 52

More skyrizi patients saw
endoscopic response vs placebo^1,3,4

ADVANCE: Endoscopic response at Week 12: Bio-naïve subgroup: 50% in SKYRIZI 600 mg IV (n=141) vs 13% in placebo (n=78). Biologic failure subgroup: 33% in SKYRIZI 600 mg IV (n=195) vs 11% in placebo (n=97)

40% of total patients demonstrated endoscopic response with SKYRIZI at Week 12, regardless of biologic experience^1,3

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 placebo^1,3,5

FORTIFY: Endoscopic response at Week 52: Bio-naïve subgroup: 59% in SKYRIZI 360 mg SC (n=34) vs 23% in placebo (induction responders) (n=31). Biologic failure subgroup: 44% in SKYRIZI 360 mg SC (n=83) vs 21% in placebo (induction responders) (n=99)

48% OF TOTAL PATIENTS DEMONSTRATED ENDOSCOPIC RESPONSE WITH SKYRIZI AT WEEK 52, REGARDLESS OF BIOLOGIC EXPERIENCE^1,3

Co-Primary Endpoints for FORTIFY:
Endoscopic Response AT WEEK 52:
50% SKYRIZI 180mg SC vs 22% placebo (induction responders), p<0.05
48% SKYRIZI 360mg SC vs 22% placebo (induction responders), p<0.05
Clinical Remission AT WEEK 52:
61% SKYRIZI 180mg SC vs 46% placebo (induction responders), p<0.05
57% SKYRIZI 360mg SC 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

ENDOSCOPIC REMISSION DATA

ENDOSCOPIC REMISSION: WEEK 12 ENDOSCOPIC REMISSION: WEEK 12

ENDOSCOPIC REMISSION: WEEK 52 ENDOSCOPIC REMISSION: WEEK 52

More skyrizi patients saw endoscopic REMISSION vs placebo^1,4

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 ANALYSIS^1,5

FORTIFY: Endoscopic Remission at Week 52: 55% in bio-naïve subgroup with Skyrizi 180mg SC (n=40) vs 53% SKYRIZI 360mg SC (n=34) vs 19% placebo (n=31). In Biologic Failure subgroup: 23% in Skyrizi 180mg SC (n=95) vs 36% in SKYRIZI 360mg SC (n=83) vs 11% in placebo (n=99)

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

Secondary Endpoints for FORTIFY:
Endoscopic Remission AT WEEK 52:
(Total Population):

33% SKYRIZI 180 mg SC vs
13% placebo (induction responders)

41% SKYRIZI 360 mg SC 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 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.

CLINICAL REMISSION

CLINICAL REMISSION: WEEK 52 CLINICAL REMISSION: WEEK 52

CLINICAL REMISSION: WEEK 12 CLINICAL REMISSION: WEEK 12

CLINICAL REMISSION REGARDLESS OF BIOLOGIC EXPERIENCE^1,3,5

FORTIFY: Clinical remission at Week 52: Bio-naïve subgroup: 71% in SKYRIZI 360 mg SC (n=34) vs 65% in placebo (induction responders) (n=31). Biologic failure subgroup: 51% in SKYRIZI 360 mg SC (n=83) vs 40% in placebo (induction responders) (n=99)

Did you know?

The 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.

CLINICAL REMISSION REGARDLESS OF BIOLOGIC EXPERIENCE^1,3,4

ADVANCE: Clinical remission at Week 12: Bio-naïve subgroup: 49% in SKYRIZI 600 mg IV (n=141) vs 23% in placebo (n=78). Biologic failure subgroup: 42% in SKYRIZI 600 mg IV (n=195) vs 26% in placebo (n=97)

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

EARLY CLINICAL RESPONSE (AT 4 WEEKS)

SYMPTOM RELIEF AS EARLY AS WEEK 4:
Clinical Response (CDAI CR-100) at Weeks 4, 8, 12^1,6

ADVANCE Clinical response: 41% vs 25% at Week 4 (ranked secondary endpoint) (p≤0.001), 53% vs 32% at Week 8, 60% vs 37% at Week 12 (ranked secondary endpoint) (p<0.001), for SKYRIZI 600 mg IV (n=336) vs placebo (n=175), respectively.

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

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

PATIENT CASES

BIOLOGIC FAILURE PATIENT BIOLOGIC FAILURE PATIENT

BIO-NAÏVE PATIENT BIO-NAÏVE PATIENT

Patient Case from the CD Clinical Trials

Patient 1: Failed a Biologic and Presented With Severe CD ON ENDOSCOPY (SES-CD OF 27)^1,3,7,8

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)

Endoscopy images of a clinical trial patient at baseline, Week 12 and Week 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)^1,3,7,8

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)

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

HAVE YOU SEEN SKYRIZI'S
DOSING SCHEDULE?

REVIEW DOSING

DO YOU KNOW ABOUT SKYRIZI'S
WELL-STUDIED SAFETY PROFILE?

EXPLORE SAFETY

	ADVANCE N=850
CO-PRIMARY ENDPOINTS	Endoscopic Response^a (>50% decrease in SES-CD) and Clinical Remission^b (CDAI <150) at Week 12
DURATION	12-week, randomized, double-blind, placebo-controlled, multi-center study
CONCOMITANT THERAPIES	All patients may have received concomitant conventional therapies that included 5-aminosalicylates, immunomodulators, corticosteroids, and Crohn's-related antibiotics
DOSING	IV infusion of SKYRIZI 600 mg, risankizumab-rzaa 1200 mg^c or placebo, at Weeks 0, 4, and 8
INCLUSION CRITERIA	Moderately to severely active CD: CDAI 220-450 Average daily SF ≥4 or APS ≥2 SES-CD ≥6 (≥4 for isolated ileitis), exluding the narrowing component 16-80 years old Bio-naïve^d or biologic failure^e

	MOTIVATE N=569
CO-PRIMARY ENDPOINTS	Endoscopic Response^a (>50% decrease in SES-CD) and Clinical Remission^b (CDAI <150) at Week 12
DURATION	12-week, randomized, double-blind, placebo-controlled, multi-center study
CONCOMITANT THERAPIES	All patients may have received concomitant conventional therapies that included 5-aminosalicylates, immunomodulators, corticosteroids, and Crohn's-related antibiotics
DOSING	IV infusion of SKYRIZI 600 mg, risankizumab-rzaa 1200 mg^c or placebo, at Weeks 0, 4, and 8
INCLUSION CRITERIA	Moderately to severely active CD: CDAI 220-450 Average daily SF ≥4 or APS ≥2 SES-CD ≥6 (≥4 for isolated ileitis), exluding the narrowing component 16-80 years old Biologic failure^e

	FORTIFY N=382
CO-PRIMARY ENDPOINTS	Endoscopic Response^a (>50% decrease in SES-CD) and Clinical Remission^b (CDAI <150) at Week 52
DURATION	52-week, randomized, double-blind, placebo-controlled, multi-center study
CONCOMITANT THERAPIES	All patients may have received concomitant conventional therapies that included 5-aminosalicylates, immunomodulators, and Crohn's-related antibiotics Patients taking corticosteroids at the start of FORTIFY had their therapy tapered
DOSING	Subcutaneous injection of SKYRIZI 180 mg, SKYRIZI 360 mg or placebo starting at Week 12 and every 8 weeks after
INCLUSION CRITERIA	Moderately to severely active CD: Entry and completion of ADVANCE or MOTIVATE. Completion includes the final endoscopy of ADVANCE or MOTIVATE Achieved Clinical Response^f in ADVANCE or MOTIVATE studies

FORTIFY		Placebo (Induction Responder) N=130	SKYRIZI 180 mg SC N=135	SKYRIZI 360 mg SC N=117
BASELINE OF INDUCTION (ADVANCE, MOTIVATE)
	Male, n (%)	72 (55.4)	62 (45.9)	67 (57.3)
	Age (years), mean (SD)	38.0 (12.8)	39.2 (14.7)	36.2 (12.6)
	Disease duration (years), mean (SD)	9.6 (8.2)	10.6 (10.2)	8.6 (7.1)
	Baseline immunomodulatorimmuno- modulator use, n (%)	33 (25.4)	37 (27.4)	34 (29.1)
	Baseline steroid use, n (%)	40 (30.8)	47 (34.8)	36 (30.8)
	Biologics failure history
	0, n (%)	31 (23.8)	40 (29.6)	34 (29.1)
	1, n (%)	49 (37.7)	34 (25.2)	42 (35.9)
	>1, n (%)	50 (38.5)	61 (45.2)	41 (35.0)
	Baseline CDAI, mean (SD)	314.2 (64.2)	327.6 (68.2)	316.2 (59.6)
	Baseline SES-CD, mean (SD)	14.1 (7.1)	14.9 (7.2)	14.3 (7.0)
	Baseline SF, mean (SD)	5.8 (2.7)	6.2 (3.1)	5.9 (2.7)
	Baseline APS, mean (SD)	1.9 (0.5)	2.0 (0.4)	1.9 (0.5)
	Baseline FCP (mg/kg), median (min,max)	904.0 (30, 11378)	1666.0 (30, 28800)	1622.0 (30, 14649)
	Baseline hs-CRP (mg/L), median (min,max)	7.9 (0.3, 181)	8.7 (0.4, 151)	10.6 (0.3, 129)

Week 0 of Maintenance
	CDAI at Week 0, mean (SD)	111.6 (69.5)	117.6 (66.8)	125.4 (62.7)
	SES-CD at Week 0, mean (SD)	7.9 (6.4)	7.8 (6.4)	8.3 (7.3)
	SF at Week 0, mean (SD)	1.4 (1.7)	2.1 (1.9)	1.9 (1.7)
	APS at Week 0, mean (SD)	0.6 (0.5)	0.6 (0.5)	0.6 (0.5)
	FCP (mg/kg) at Week 0, median (min,max)	300.0 (30, 22912)	361 (30, 28800)	485.5 (30, 14804)
	hs-CRP (mg/L) at Week 0, median (min,max)	3.6 (0, 42)	3.7 (0, 48)	4.0 (0, 258)

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 Guidelines1,2 FIRST Approved Product in CD with Endoscopic Response as a Co-Primary Endpoint1,3

ENDOSCOPIC AND SYMPTOM CONTROL ACROSS CO-PRIMARY ENDPOINTS1,3

More skyrizi patients saw endoscopic response vs placebo1,3,4

More skyrizi patients saw endoscopic response vs placebo1,3,5

More skyrizi patients saw endoscopic REMISSION vs placebo1,4

ENDOSCOPIC REMISSION DATA: POST HOC DATA OF SUBGROUP ANALYSIS1,5

CLINICAL REMISSION REGARDLESS OF BIOLOGIC EXPERIENCE1,3,5

CLINICAL REMISSION REGARDLESS OF BIOLOGIC EXPERIENCE1,3,4

SYMPTOM RELIEF AS EARLY AS WEEK 4: Clinical Response (CDAI CR-100) at Weeks 4, 8, 121,6

Patient Case from the CD Clinical Trials

Patient Case Study Representing Response and/or Remission AT WEEKS 12 AND 52

Patient Case from the CD Clinical Trials

Patient Case Study Representing Response and/or Remission AT WEEKS 12 AND 52

IMPORTANT SAFETY INFORMATION AND INDICATIONS FOR SKYRIZI® (risankizumab-rzaa)1

ADVANCE N=850

MOTIVATE N=569

FORTIFY N=382

ADVANCE

Placebo N=175

SKYRIZI 600 mg IV N=336

MOTIVATE

Placebo N=187

SKYRIZI 600 mg IV N=191

FORTIFY

Placebo (Induction Responder) N=130

SKYRIZI 180 mg SC N=135

SKYRIZI 360 mg SC N=117

FORTIFY

Placebo (Induction Responder) N=164

SKYRIZI 360mg SC N=141

IMPORTANT SAFETY INFORMATION AND INDICATIONS FOR SKYRIZI® (risankizumab-rzaa)1

IMPORTANT SAFETY INFORMATION AND INDICATION FOR SKYRIZI® (risankizumab-rzaa)1

IMPORTANT SAFETY INFORMATION AND INDICATIONS FOR SKYRIZI® (risankizumab-rzaa)1

IMPORTANT SAFETY INFORMATION AND INDICATION FOR SKYRIZI® (risankizumab-rzaa)1

IMPORTANT SAFETY INFORMATION AND INDICATIONS FOR SKYRIZI® (risankizumab-rzaa)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 Guidelines^1,2

FIRST Approved Product in CD with Endoscopic Response as a Co-Primary Endpoint^1,3

ENDOSCOPIC AND SYMPTOM CONTROL ACROSS CO-PRIMARY ENDPOINTS^1,3

More skyrizi patients saw
endoscopic response vs placebo^1,3,4

More skyrizi patients saw
endoscopic response vs placebo^1,3,5

More skyrizi patients saw endoscopic REMISSION vs placebo^1,4

ENDOSCOPIC REMISSION DATA: POST HOC DATA OF SUBGROUP ANALYSIS^1,5

CLINICAL REMISSION REGARDLESS OF BIOLOGIC EXPERIENCE^1,3,5

CLINICAL REMISSION REGARDLESS OF BIOLOGIC EXPERIENCE^1,3,4

SYMPTOM RELIEF AS EARLY AS WEEK 4:
Clinical Response (CDAI CR-100) at Weeks 4, 8, 12^1,6

IMPORTANT SAFETY INFORMATION AND INDICATIONS FOR SKYRIZI® (risankizumab-rzaa)¹

ADVANCE
N=850

MOTIVATE
N=569

FORTIFY
N=382

Placebo
N=175

SKYRIZI 600 mg IV
N=336

Placebo
N=187

SKYRIZI 600 mg IV
N=191

Placebo
(Induction Responder)
N=130

SKYRIZI
180 mg SC
N=135

SKYRIZI
360 mg SC
N=117

Placebo (Induction Responder)
N=164

SKYRIZI 360mg SC
N=141

IMPORTANT SAFETY INFORMATION AND INDICATIONS FOR SKYRIZI® (risankizumab-rzaa)¹

IMPORTANT SAFETY INFORMATION AND INDICATION FOR SKYRIZI® (risankizumab-rzaa)¹

IMPORTANT SAFETY INFORMATION AND INDICATIONS FOR SKYRIZI® (risankizumab-rzaa)¹

IMPORTANT SAFETY INFORMATION AND INDICATION FOR SKYRIZI® (risankizumab-rzaa)¹

IMPORTANT SAFETY INFORMATION AND INDICATIONS FOR SKYRIZI® (risankizumab-rzaa)¹