SKYRIZI HEAD-TO-HEAD TRIAL
Explore data including Clinical Remission and Endoscopic Remission.
SEE TRIAL RESULTSThe 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 ~9 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 ENDPOINTS1,3,4
At Week 12 in the ADVANCE trial
(Mixed Population of Bio-Naïve and Biologic Failure, n=511)
ENDOSCOPIC
RESPONSE}
40% SKYRIZI (600 mg IV),p<0.001
12% Placebo
CLINICAL
REMISSION}
45% SKYRIZI (600 mg IV),p<0.001
25% Placebo
At Week 12 in the MOTIVATE trial
(Biologic Failure Population, n=378)
ENDOSCOPIC
RESPONSE}
29% SKYRIZI (600 mg IV),p<0.001
11% Placebo
CLINICAL
REMISSION}
42% SKYRIZI (600 mg IV),p<0.001
20% Placebo
All p-values are SKYRIZI treatment arms vs. placebo
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).
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
At Week 52 in the FORTIFY trial
(Mixed Population of Bio-Naïve and Biologic Failure, n=382)
ENDOSCOPIC
RESPONSE}
50% SKYRIZI (180 mg SC),p<0.05
48% SKYRIZI (360 mg SC),p<0.05
22% Placebo
(Induction Responders)
CLINICAL
REMISSION}
61% SKYRIZI (180 mg SC),p<0.05
57% SKYRIZI (360 mg SC),p<0.05
46% Placebo
(Induction Responders)
All p-values are SKYRIZI treatment arms vs. placebo
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 382 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. The co‑primary endpoints were endoscopic response and clinical remission at Week 52.1
EFFICACY DATA BASED ON BIOLOGIC EXPERIENCE
Combined Clinical Response Data (CR-100) for Initial and Delayed Responders
~3 out of 4 (343/450) 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
The population of 450 included in this post hoc analysis represents those who received SKYRIZI 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.
*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.
Clinical Response: Reduction of CDAI score ≥100 points from baseline.
CDAI=Crohn's disease activity index
WELL-STUDIED Safety Profile AND EXPERIENCE Across Three Indications
~9
Up to ~9 Years of Clinical Experience Starting With Plaque Psoriasis (Ps)2
29
Clinical Trials
Across Indications2,4,6-8*†
221,413
US Patients Prescribed Since 2019 Starting with Ps9‡
~9
Up to ~9 Years of Clinical Experience Starting With Plaque Psoriasis (Ps)2
29
Clinical Trials
Across Indications2,4,6-8*†
221,413
US Patients Prescribed Since 2019 Starting with Ps9‡
*Safety data were evaluated for all patients receiving ≥1 dose of SKYRIZI from Phase 1-4 trials, including open-label extension and dose-ranging studies.
Safety Data Derived from the Largest Phase 3 Clinical Program in CROHN'S to Date Across Indication Approval Trials§
4,494
Patient-Years of Exposure from CROHN'S Clinical Programs to Date10
ENCOURAGE YOUR PATIENTS TO ENROLL IN 
1-TO-1 SUPPORT
Nurse Ambassadors* and Insurance Specialists provide 1-to-1 support to help navigate insurance
AFFORDABILITY
Eligible commercially-insured patients may pay as little as $0 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
Utilize a single enrollment
form to enroll your patients
into Skyrizi Complete
*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 or call 1.866.SKYRIZI for additional information. To learn about AbbVie's privacy practices and your privacy choices, visit https://privacy.abbvie/.
‡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.
