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 ENDPOINTS MET AT WEEKS 12 AND 52 WITH DATA OBSERVED AT WEEK 152^1-3

First-line advanced therapy option for moderate to severe crohn’s disease

*Advanced therapy in Crohn's is defined as biologics.

FIRST IL-23 SPECIFIC INHIBITOR IN CROHN'S DISEASE¹

IL-23=interleukin-23

ENDOSCOPIC AND SYMPTOM CONTROL ACROSS CO-PRIMARY ENDPOINTS¹

SKYRIZI treatment efficacy data for Crohn's disease patients displaying response rates in induction and maintenance studies compared to placebo. Includes co-primary endpoint data: Endoscopic response (SES-CD) and clinical remission (CDAI) at week 12 (ADVANCE and MOTIVATE) and at Week 52 (FORTIFY)

^†Advanced therapy in Crohn's is defined as biologics.

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.

STUDY DESIGNS

ADVANCE (N=850) and MOTIVATE (N=569) 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 and/or biologic treatment.³ Patients received an IV infusion of SKYRIZI 600 mg (recommended dose), risankizumab-rzaa 1200 mg^|| or placebo at Weeks 0, 4, and 8.¹

FORTIFY (N=382) Maintenance study was a 52-week study that evaluated the efficacy and safety of SKYRIZI in patients who achieved clinical response (decrease in CDAI ≥100)^‡ from SKYRIZI induction in the ADVANCE and MOTIVATE studies. Patients were randomized to SKYRIZI 180 mg SC, SKYRIZI 360 mg SC, or placebo at Week 12 and every 8 weeks thereafter.¹

REVIEW THE DATA

SKYRIZI vs STELARA^® (ustekinumab)

See Trial Results

®STELARA is a registered trademark of Johnson & Johnson.

FORTIFY OPEN-LABEL EXTENSION (OLE) STUDY DESIGN

FORTIFY-OLE is an ongoing, multicenter, open-label extension study that evaluated long-term efficacy and safety of SKYRIZI that included patients from the FORTIFY maintenance study. Patients in the FORTIFY maintenance study achieved clinical response with SKYRIZI in the ADVANCE and MOTIVATE induction studies. This study population for FORTIFY-OLE is a sub analysis that includes all randomized subjects who had a baseline eligibility SES-CD of ≥6 (≥4 for isolated ileal disease), received 600 mg IV SKYRIZI for 12 weeks in the induction studies, have received at least one dose of SKYRIZI 180 mg or 360 mg SC in the Phase 3 maintenance study FORTIFY, and at least one dose of SKYRIZI 180 mg SC in the FORTIFY OLE study.

ENDOSCOPIC OUTCOMES

ENDOSCOPIC CONTROL: VISIBLE MUCOSAL IMPROVEMENT

SKYRIZI Achieved its Co-Primary Endpoint of Endoscopic Response at Week 12 and Week 52^1,3

Endoscopic response rates for SKYRIZI (risankizumab) in clinical trials. Results from the ADVANCE double-blind RCT at week 12 reveal a 40% response with SKYRIZI 600 mg IV versus 12% with placebo (p<0.001). FORTIFY double-blind RCT at week 52 shows a 48% response with SKYRIZI 360 mg SC versus 22% with placebo (p<0.05). Open-label extension (OLE) at week 152 indicates a 78% response with SKYRIZI 180/360 mg SC (pooled)

Results at 52 weeks are among 382 patients who achieved clinical response^‡ after 12 weeks of treatment with SKYRIZI in induction trials.¹

^aContinuous placebo data not intended for direct comparison.

^*OLE Limitations: 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.

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

ENDOSCOPIC REMISSION

IMPROVE PATIENTS’ POSSIBILITY OF ENDOSCOPIC REMISSION

SKYRIZI SECONDARY ENDPOINT OF ENDOSCOPIC REMISSION RATES AT WEEK 12 AND 52^1,3

Endoscopic remission rates for SKYRIZI (risankizumab) in clinical studies. ADVANCE double-blind RCT at week 12 shows a 24% remission rate with SKYRIZI 600 mg IV versus 9% with placebo (p<0.001). FORTIFY double-blind RCT at week 52 indicates a 41% remission with SKYRIZI 360 mg SC and a 33% remission with SKYRIZI 180 mg SC compared to 13% on Continuous Placebo, all vs 13% on placebo (induction responders). Open-label extension (OLE) at week 152 shows a 64% remission with SKYRIZI 180/360 mg SC (pooled).

DATA LIMITATIONS: Endoscopic remission at Week 52 was not statistically significant under the pre‑specified multiple testing procedure.

Results at 52 weeks are among 382 patients who achieved clinical response^‡ after 12 weeks of treatment with SKYRIZI in induction trials.

^aContinuous placebo data not intended for direct comparison.

CLINICAL REMISSION

EARLY AND DURABLE SYMPTOM CONTROL

SKYRIZI ACHIEVED ITS CO-PRIMARY ENDPOINT OF CLINICAL REMISSION AT WEEK 12 AND WEEK 52^1-3

Clinical remission rates for SKYRIZI (risankizumab) in clinical trials. ADVANCE double-blind RCT at week 12 shows a 45% remission rate with SKYRIZI 600 mg IV versus 25% with placebo (p<0.001). FORTIFY double blind RCT at week 52 shows a 57% remission with SKYRIZI 360 mg SC (p<0.05) compared to 46% on placebo (induction responders), all vs 23% on continuous placebo.Open-label extension (OLE) at week 152 indicates an 86% clinical remission with SKYRIZI 180/360 mg SC (pooled)

^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 Crohn's which may have contributed to these rates.

Results at 52 weeks are among 382 patients who achieved clinical response^‡ after 12 weeks of treatment with SKYRIZI in induction trials.

^bContinuous placebo data not intended for direct comparison.

EARLY CLINICAL RESPONSE (AT 4 WEEKS)

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

ADVANCE Clinical response: 41% on SKYRIZI 600mg IV (n=336) vs 25% placebo (n=175) at Week 4 (ranked secondary endpoint) (p≤0.001), approximately 50% SKYRIZI vs 32% placebo at Week 8, 60% SKYRIZI vs 37% placebo at Week 12 (ranked secondary endpoint) (p<0.001)

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 patients responded
at week 12 in induction studies^1,4

Clinical Response is defined as a reduction of CDAI score ≥100 points from baseline.

PATIENT CASE

WHAT DID IMPROVEMENT LOOK LIKE IN A REAL BIO-NAÏVE PATIENT?

SEE THESE RESULTS IN AN ACTUAL PATIENT CASE WITH SKYRIZI⁵

Clinical Trial Patient Profile: Age: 40's
Sex: Female
Disease Duration: 2.1 Years
Disease Severity: Moderate to Severe

Drug history: Bio-Naïve Patient received SKYRIZI 600 mg IV (Induction) and 180 mg SC (Maintenance)

Corticosteroid use at baseline^*

*Corticosteriods were tapered starting at Week 0 of FORTIFY.

Actual Patient Presenting With Remission at Weeks 12 and 52

THIS IMAGE REPRESENTS AN INDIVIDUAL PATIENT 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. INDIVIDUAL RESULTS MAY VARY.

GET YOUR PATIENTS
STARTED ON SKYRIZI

LEARN ABOUT SKYRIZI COMPLETE

LEARN 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 Crohn's disease: 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 Advanced therapy naïve^d or advanced therapy 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 Crohn's disease: 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 Advanced therapy 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 Crohn's disease: 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)
	Disease location
	lleal only, n (%)	18 (14)	12 (9)	13 (11)
	Colonic only, n (%)	49 (38)	63 (47)	52 (44)
	lleal-colonic, n (%)	63 (49)	60 (44)	52 (44)
	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)
	Advanced therapy*-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)	7.3 (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 ENDPOINTS MET AT WEEKS 12 AND 52 WITH DATA OBSERVED AT WEEK 1521-3

ENDOSCOPIC AND SYMPTOM CONTROL ACROSS CO-PRIMARY ENDPOINTS1

STUDY DESIGNS

REVIEW THE DATA

FORTIFY OPEN-LABEL EXTENSION (OLE) STUDY DESIGN

ENDOSCOPIC CONTROL: VISIBLE MUCOSAL IMPROVEMENT

SKYRIZI Achieved its Co-Primary Endpoint of Endoscopic Response at Week 12 and Week 521,3

IMPROVE PATIENTS’ POSSIBILITY OF ENDOSCOPIC REMISSION

SKYRIZI SECONDARY ENDPOINT OF ENDOSCOPIC REMISSION RATES AT WEEK 12 AND 521,3

EARLY AND DURABLE SYMPTOM CONTROL

SKYRIZI ACHIEVED ITS CO-PRIMARY ENDPOINT OF CLINICAL REMISSION AT WEEK 12 AND WEEK 521-3

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

WHAT DID IMPROVEMENT LOOK LIKE IN A REAL BIO-NAÏVE PATIENT?

SEE THESE RESULTS IN AN ACTUAL PATIENT CASE WITH SKYRIZI5

ADVANCE N=850

MOTIVATE N=569

FORTIFY N=382

ADVANCE

Placebo

SKYRIZI 600 mg IV

MOTIVATE

Placebo

SKYRIZI 600 mg IV

FORTIFY

Placebo (Induction Responder)

SKYRIZI 180 mg SC

SKYRIZI 360 mg SC

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

ENDOSCOPIC RESPONSE AND CLINICAL REMISSION ENDPOINTS MET AT WEEKS 12 AND 52 WITH DATA OBSERVED AT WEEK 152^1-3

ENDOSCOPIC AND SYMPTOM CONTROL ACROSS CO-PRIMARY ENDPOINTS¹

SKYRIZI Achieved its Co-Primary Endpoint of Endoscopic Response at Week 12 and Week 52^1,3

SKYRIZI SECONDARY ENDPOINT OF ENDOSCOPIC REMISSION RATES AT WEEK 12 AND 52^1,3

SKYRIZI ACHIEVED ITS CO-PRIMARY ENDPOINT OF CLINICAL REMISSION AT WEEK 12 AND WEEK 52^1-3

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

SEE THESE RESULTS IN AN ACTUAL PATIENT CASE WITH SKYRIZI⁵

ADVANCE
N=850

MOTIVATE
N=569

FORTIFY
N=382

Placebo
(Induction Responder)

SKYRIZI
180 mg SC

SKYRIZI
360 mg SC

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