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

Control is everything
SKYRIZI provides the opportunity for endoscopic and symptom control | For your patients that's everything. The first & only IL-23 inhibitor in Crohn's Disease

Visible Mucosal Improvement: Endoscopic Response at Weeks 12 and 521

Durable Disease Control: Clinical Remission at Week 52 and as Early as Week 121

Safety Profile Established Across Three Indications With up to ~7 Years of Clinical Experience Starting in Plaque Psoriasis2

Committed to AbbVie's Legacy of Reliable Access and Patient Support

FIRST APPROVED PRODUCT IN Crohn’s Disease WITH ENDOSCOPIC RESPONSE AND CLINICAL REMISSION AS CO-PRIMARY ENDPOINTS1,3

At Week 12 in the ADVANCE trial

(Mixed Population of Bio-Naïve and Biologic Failure, n=511)

ENDOSCOPIC
RESPONSE
}

40% SKYRIZI (600 mg IV)

12% Placebo,p<0.001


CLINICAL
REMISSION
}

45% SKYRIZI (600 mg IV)

25% Placebo,p<0.001


At Week 12 in the MOTIVATE trial

(Biologic Failure Population, n=378)

ENDOSCOPIC
RESPONSE
}

29% SKYRIZI (600 mg IV)

11% Placebo,p<0.001


CLINICAL
REMISSION
}

42% SKYRIZI (600 mg IV)

20% Placebo,p<0.001

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).

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

ADVANCE Study Design:
12-week, randomized, double-blind, placebo-controlled study that evaluated the efficacy and safety of SKYRIZI in 850 patients with moderately to severely active Crohn's disease* who demonstrated prior treatment failure to conventional and/or biologic treatment. Patients received an IV infusion of SKYRIZI 600 mg (recommended dose), risankizumab-rzaa 1200 mg or placebo at Weeks 0, 4, and 8. The co-primary endpoints were endoscopic response and clinical remission at Week 12.1

MOTIVATE Study Design:
12-week, randomized, double-blind, placebo-controlled study that evaluated the efficacy and safety of SKYRIZI in 569 patients with moderately to severely active Crohn's disease* who demonstrated failure to biologic treatment. Patients received an IV infusion of SKYRIZI 600 mg (recommended dose), risankizumab-rzaa 1200 mg or placebo at Weeks 0, 4, and 8. The co-primary endpoints were endoscopic response and clinical remission at Week 12.1


Going Beyond Week 12: Endoscopic and Durable Symptom Control1,4

At Week 52 in the FORTIFY trial

(Mixed Population of Bio-Naïve and Biologic Failure, n=247)

ENDOSCOPIC
RESPONSE
}

48% SKYRIZI (360 mg SC)

22% Placebo
(Induction Responders),p<0.05


CLINICAL
REMISSION
}

57% SKYRIZI (360 mg SC)

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.

FORTIFY Study Design:
52-week study that evaluated the efficacy and safety of SKYRIZI in 247 patients who achieved clinical response (decrease in CDAI ≥100) from SKYRIZI induction in the ADVANCE and MOTIVATE studies. Patients were randomized to SKYRIZI 360 mg SC or placebo at Week 12 and every 8 weeks thereafter. The co-primary endpoints were endoscopic response and clinical remission at Week 52.1

76% (343/450) of SKYRIZI Patients Experienced a Clinical Response (CR-100) at Week 12 or a Delayed Clinical Response at Week 24 in a Post Hoc Analysis1,5

  • In the ADVANCE clinical trial, 60% of SKYRIZI (600 mg n=336) patients achieved clinical response (CR-100) vs 37% placebo (n=175) at Week 12; p<0.001. In the MOTIVATE clinical trial, 60% of SKYRIZI (600 mg n=191) patients achieved clinical response (CR-100) vs 30% placebo (n=187) at Week 12; p<0.001
  • In a pooled analysis of ADVANCE and MOTIVATE, 313/527 patients who received SKYRIZI 600 mg IV induction achieved a clinical response (CR-100) at Week 12
  • In a post hoc analysis, 30/47 patients who were delayed responders (those who were non-responders at Week 12 and continued on SKYRIZI 360 mg SC to Week 24) had a clinical response (CR-100) at Week 24
  • The population of 450 included in this post hoc analysis represents those who received on-label dosing for SKYRIZI CD (600 mg IV and/or 360 mg SC). All patients with insufficient data were counted as non-responders for CR-100 delayed response at Week 24. Patients were excluded if they were assigned to non-labeled doses during this extended induction period

DATA LIMITATIONS: Post-hoc analysis of pooled data of clinical response (CR-100) from induction trials. Analysis is not multiplicity or placebo controlled, subjects were not restratified at Week 12 for Week 24 assessment and are not counted in the efficacy or safety analysis at Week 52. No clinical or statistical inferences can be made due to the exploratory nature of the assessment and should be interpreted with caution.

Induction period for SKYRIZI is 12 weeks.

Patients who were delayed clinical responders (CR-100) continued into maintenance but were not included in the primary efficacy analysis.

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

CDAI=Crohn's disease activity index

EFFICACY DATA BASED ON BIOLOGIC EXPERIENCE

WELL-STUDIED Safety Profile AND EXPERIENCE Across Three Indications

~7  

Up to ~7 Years of Clinical Experience Starting With Plaque Psoriasis2

26

Clinical Trials
Across Indications2-4,6,7*

107,000

Patients Prescribed Worldwide Since 2019 in Plaque Psoriasis8‡

~7

Up to ~7 Years of Clinical Experience Starting With Plaque Psoriasis2

26

Clinical Trials
Across Indications2-4,6,7*

107,000

Patients Prescribed
Worldwide Since 2019
in Plaque Psoriasis8‡

*Safety data were evaluated for all patients receiving ≥1 dose of SKYRIZI from Phase 1-3 trials, including open-label extension and dose-ranging studies.


Safety Data Derived from the Largest Phase 3 Clinical Program in CD to Date§


2,059

Patient-Years of Exposure from CD Clinical Programs to Date9


ENCOURAGE YOUR PATIENTS TO ENROLL IN

1-TO-1 SUPPORT

Nurse Ambassadorsand Insurance Specialists provide 1-to-1 support to help navigate insurance

as little as $5 per dose
AFFORDABILITY

Eligible commercially-insured patients may pay as little as $5 per dose on their prescription and can also be reimbursed for certain out-of-pocket costs related to IV administration, lab tests, and monitoring related to their SKYRIZI treatment.

ACCESS

No charge for eligible,
commercially insured patients
experiencing initial insurance
denial for up to 24 months

STREAMLINED ENROLLMENT PROCESS

Get started with a single
enrollment form


*Nurse Ambassadors are provided by AbbVie and do not provide medical advice or work under the direction of the prescribing health care professional (HCP). They are trained to direct patients to speak with their HCP about any treatment-related questions, including further referrals.

Eligibility: Available to patients with commercial insurance coverage for SKYRIZI® (risankizumab-rzaa) who meet eligibility criteria. This co-pay assistance program is not available to patients receiving prescription reimbursement under any federal, state, or government-funded insurance programs (for example, Medicare [including Part D], Medicare Advantage, Medigap, Medicaid, TRICARE, Department of Defense, or Veterans Affairs programs) or where prohibited by law. Offer subject to change or termination without notice. Restrictions, including monthly maximums, may apply. This is not health insurance. For full Terms and Conditions, visit www.SKYRIZICDSavingsCard.com. To learn about AbbVie's privacy practices and your privacy choices, visit www.abbvie.com/privacy.html

Eligibility criteria: Available to patients aged 63 or younger with commercial insurance coverage. Patients must have a valid prescription for SKYRIZI® (risankizumab-rzaa) for an FDA approved indication and a denial of insurance coverage based on a prior authorization request on file along with a confirmation of appeal. For medical coverage, a pre-certification submission will be required. Continued eligibility for the program requires the submission of an appeal of the coverage denial every 180 days. Program provides for SKYRIZI® (risankizumab-rzaa) at no charge to patients for up to two years or until they receive insurance coverage approval, whichever occurs earlier, and is not contingent on purchase requirements of any kind. Program is not available to patients whose medications are reimbursed in whole or in part by Medicare, Medicaid, TRICARE, or any other federal or state program. Offer subject to change or discontinuance without notice. This is not health insurance and program does not guarantee insurance coverage. No claims for payment may be submitted to any third party for product dispensed by program. Limitations may apply.

Images You Can See

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

Patient Case Photo Gallery