SKYRIZI HEAD-TO-HEAD TRIAL
Explore data including Clinical Remission and Endoscopic Remission.
SEE TRIAL RESULTSUS-MULT-240253
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 ~9 Years of Clinical Experience Starting in Plaque Psoriasis2
Committed to AbbVie's Legacy of Reliable Access and Patient Support
(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
(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
(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
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
~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.
4,494
Nurse Ambassadors* and Insurance Specialists provide 1-to-1 support to help navigate insurance
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.†
Any eligible, commercially insured
patient who experiences a 5-day
delay‡ in approval or is denied
will be approved for a no-charge shipment of SKYRIZI§
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/.
‡For patients pending insurance approval of their medical benefit for the SKYRIZI IV induction dose.
§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 delay of more than 5 business days or denial of treatment coverage from their insurance 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.
SKYRIZI HEAD-TO-HEAD TRIAL
Explore data including Clinical Remission and Endoscopic Remission.
SEE TRIAL RESULTSINDICATIONS AND IMPORTANT SAFETY INFORMATION FOR SKYRIZI® (risankizumab-rzaa)1 Indications Plaque Psoriasis: SKYRIZI is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. Psoriatic Arthritis: SKYRIZI is indicated for the treatment of active psoriatic arthritis in adults. Crohn's Disease: SKYRIZI is indicated for the treatment of moderately to severely active Crohn's disease in adults. Ulcerative Colitis: SKYRIZI is indicated for the treatment of moderately to severely active ulcerative colitis in adults. |
Important Safety Information
Hypersensitivity Reactions
SKYRIZI® (risankizumab-rzaa) is contraindicated in patients with a history of serious hypersensitivity reaction to risankizumab-rzaa or any of the excipients. Serious hypersensitivity reactions, including anaphylaxis, have been reported with the use of SKYRIZI. If a serious hypersensitivity reaction occurs, discontinue SKYRIZI and initiate appropriate therapy immediately.
Infection
SKYRIZI may increase the risk of infection. Do not initiate treatment with SKYRIZI in patients with a clinically important active infection until it resolves or is adequately treated.
In patients with a chronic infection or a history of recurrent infection, consider the risks and benefits prior to prescribing SKYRIZI. Instruct patients to seek medical advice if signs or symptoms of clinically important infection occur. If a patient develops such an infection or is not responding to standard therapy, closely monitor and discontinue SKYRIZI until the infection resolves.
Tuberculosis (TB)
Prior to initiating treatment with SKYRIZI, evaluate for TB infection and consider treatment in patients with latent or active TB for whom an adequate course of treatment cannot be confirmed. Monitor patients for signs and symptoms of active TB during and after SKYRIZI treatment. Do not administer SKYRIZI to patients with active TB.
Hepatotoxicity in Treatment of Inflammatory Bowel Disease
Drug-induced liver injury was reported in a patient with Crohn’s disease who was hospitalized for a rash during induction dosing of SKYRIZI. For the treatment of Crohn's disease and ulcerative colitis, evaluate liver enzymes and bilirubin at baseline and during induction (12 weeks); monitor thereafter according to routine patient management. Consider an alternate treatment for patients with evidence of liver cirrhosis. Interrupt treatment if drug-induced liver injury is suspected, until this diagnosis is excluded. Instruct your patient to seek immediate medical attention if they experience symptoms suggestive of hepatic dysfunction.
Administration of Vaccines
Avoid use of live vaccines in patients treated with SKYRIZI. Medications that interact with the immune system may increase the risk of infection following administration of live vaccines. Prior to initiating SKYRIZI, complete all age-appropriate vaccinations according to current immunization guidelines.
Adverse Reactions
Most common (≥1%) adverse reactions associated with SKYRIZI in plaque psoriasis and psoriatic arthritis include upper respiratory infections, headache, fatigue, injection site reactions, and tinea infections.
In psoriatic arthritis phase 3 trials, the incidence of hepatic events was higher with SKYRIZI compared to placebo.
Most common (>3%) adverse reactions associated with SKYRIZI in Crohn’s disease are upper respiratory infections, headache, and arthralgia in induction and arthralgia, abdominal pain, injection site reactions, anemia, pyrexia, back pain, arthropathy, and urinary tract infection in maintenance.
Most common (≥3%) adverse reactions associated with SKYRIZI in ulcerative colitis are arthralgia in induction, and arthralgia, pyrexia, injection site reactions, and rash in maintenance.
Lipid Elevations: Increases from baseline and increases relative to placebo were observed at Week 4 and remained stable to Week 12 in patients treated with SKYRIZI in Crohn’s disease. Lipid elevations observed in patients with ulcerative colitis were similar to those in Crohn's disease.
Dosage Forms and Strengths: SKYRIZI (risankizumab-rzaa) is available in a 150 mg/mL prefilled syringe and pen, a 600 mg/10 mL single-dose vial for intravenous infusion, and a 180 mg/1.2 mL or 360 mg/2.4 mL single-dose prefilled cartridge with on-body injector.
INDICATIONS
Plaque Psoriasis: SKYRIZI is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.
Psoriatic Arthritis: SKYRIZI is indicated for the treatment of active psoriatic arthritis in adults.
Crohn's Disease: SKYRIZI is indicated for the treatment of moderately to severely active Crohn's disease in adults.
Ulcerative Colitis: SKYRIZI is indicated for the treatment of moderately to severely active ulcerative colitis in adults.
Please see Full Prescribing Information.
US-SKZG-240258
REFERENCES