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The IL-23 inhibitor from AbbVie indicated for the treatment of moderately to severely active Crohn's disease (CD) in adults.1
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
40% SKYRIZI (600 mg IV)
45% SKYRIZI (600 mg IV)
29% SKYRIZI (600 mg IV)
42% SKYRIZI (600 mg IV)
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
48% SKYRIZI (360 mg SC)
57% SKYRIZI (360 mg SC)
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
WELL-STUDIED Safety Profile AND EXPERIENCE Across Three Indications
Up to ~7 Years of Clinical Experience Starting With Plaque Psoriasis2
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§
Patient-Years of Exposure from CD Clinical Programs to Date9
Nurse Ambassadors* and Insurance Specialists provide 1-to-1 support to help navigate insurance
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.†
No charge for eligible,
commercially insured patients
experiencing initial insurance
denial for up to 24 months‡
STREAMLINED ENROLLMENT PROCESS
Get started with a single
*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.