For moderate to severe Crohn's disease (CD) in adult TNFi-IR patients.1
For moderate to severe ulcerative colitis (UC) in adult TNFi-IR patients.1
RAPID SYMPTOM RELIEF.1 DURABLE CLINICAL
REMISSION.1 SIGNIFICANT ENDOSCOPIC CONTROL.1
Results were measured at Weeks 12 and 52
IR=intolerance or inadequate response;
TNFi=tumor necrosis factor inhibitor
RESULTS YOUR PATIENTS CAN FEEL
AND YOU CAN SEE
DURABLE
CLINICAL
REMISSION1
Clinical remission† achieved at Weeks 12 and 52. Steroid-free clinical remission‡ achieved at Week 52.
SIGNIFICANT
ENDOSCOPIC
CONTROL1
Visible mucosal improvement with endoscopic response§ and endoscopic remission|| endpoints achieved at Weeks 12 and 52.
WELL-STUDIED SAFETY1-3
Safety profile studied since 2012 with 25 clinical trials across 7 approved indications in rheumatology, dermatology, and gastroenterology.
*Clinical response was defined as a reduction of CDAI ≥100 points from baseline.
†Clinical remission was defined as CDAI <150 points.
‡Steroid-free clinical remission at Week 52 was defined as no corticosteroid use for CD ≥90 days prior to Week 52 and achievement of CDAI clinical remission (among the subset of patients who were on steroids at induction baseline).
§Endoscopic response was defined as a 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).
||Endoscopic remission was defined as SES-CD ≤4 and no subscore >1 in any individual variable, as scored by a central reviewer.
CD=Crohn's disease; CDAI=Crohn's disease activity index; IR=intolerance or inadequate response; SES-CD=simple endoscopic score for Crohn's disease; TNFi=tumor necrosis factor inhibitor
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IN CROHN'S, RINVOQ ACHIEVED ITS CO-PRIMARY ENDPOINTS OF CLINICAL REMISSION & ENDOSCOPIC RESPONSE AT WEEKS 12 AND 521
The STRIDE-II Recommendations include Endoscopic Response as a short-term goal
and Clinical Remission as an intermediate-term goal in CD4
RINVOQ is indicated for TNFi-IR patients.
INDUCTION DATA
MAINTENANCE DATA
CLINICAL
REMISSION*
(PER CDAI)
INDUCTION DATA
U-EXCEL WEEK 12
Mixed Population‡
U-EXCEED WEEK 12
Biologic-Failure Population§
RINVOQ 45 mg
N=295
RINVOQ 45 mg
N=273
vs
23%
PLACEBO
N=143
P<0.001
vs
18%
PLACEBO
N=146
P<0.001
MAINTENANCE DATA
U-ENDURE WEEK 52
Mixed Population‡
RINVOQ 15 mg
N=113
RINVOQ 30 mg
N=119
vs
14%
PLACEBO
N=111
P<0.001
ENDOSCOPIC
RESPONSE†
(PER SES-CD)
INDUCTION
U-EXCEL WEEK 12
Mixed Population‡
U-EXCEED WEEK 12
Biologic-Failure Population§
RINVOQ 45 mg
N=295
RINVOQ 45 mg
N=273
vs
13%
PLACEBO
N=143
P<0.001
vs
3%
PLACEBO
N=146
P<0.001
MAINTENANCE
U-ENDURE WEEK 52
Mixed Population‡
RINVOQ 15 mg
N=113
RINVOQ 30 mg
N=119
vs
7%
PLACEBO
N=111
P<0.001
All P-values are RINVOQ treatment arms vs. placebo.
RECOMMENDED
MAINTENANCE DOSING
A maintenance dose of 30 mg may be considered for patients with refractory, severe, or extensive disease. Discontinue RINVOQ if an adequate therapeutic response is not achieved with the 30 mg dose.
*Clinical remission was defined as CDAI <150 points.
†Endoscopic response was defined as a 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).
‡The mixed population included patients who had inadequate response, loss of response, or intolerance to one or more biologics (biologic failure), as well some patients who were not bio-exposed and some patients who were bio-exposed but did not have an inadequate response, loss of response, or intolerance to biologics (biologic naïve).
§Prior biologic failure includes inadequate response, loss of response, or intolerance to one or more biologics.
U-EXCEL Induction & U-EXCEED Induction Study Design Intro:1 12-week, double-blind, placebo-controlled Phase 3 induction studies that evaluated the efficacy and safety of RINVOQ in 857 adult patients (419 patients for U-EXCEED and 438 patients for U-EXCEL) with moderately to severely active Crohn's disease who demonstrated prior failure to biologic treatment (U-EXCEED) or prior failure to conventional and/or biologic treatment (U-EXCEL). Patients were randomized to receive RINVOQ 45 mg or placebo once daily for 12 weeks. The co-primary endpoints were the proportion of patients who achieved clinical remission (by CDAI) and endoscopic response (by SES-CD) at Week 12.
U-ENDURE Maintenance Study Design Intro:1 52-week, double-blind, placebo-controlled Phase 3 maintenance study of 343 adult patients with moderately to severely active Crohn’s disease who achieved clinical response (decrease in CDAI ≥100 points from baseline from RINVOQ induction) in the U-EXCEL and U-EXCEED studies. Patients were re-randomized to receive a maintenance regimen of either RINVOQ 15 mg, RINVOQ 30 mg or placebo once daily for 52 weeks. The co-primary endpoints were the proportion of patients who achieved clinical remission (by CDAI) and endoscopic response (by SES-CD) at Week 52.
CDAI=Crohn's disease activity index; SES-CD=simple endoscopic score for Crohn's disease
OF CLINICAL
EXPERIENCE* ACROSS
7 INDICATIONS
RINVOQ is a JAK Inhibitor approved in Rheumatology,
Dermatology, and Gastroenterology¹
25
CLINICAL TRIALS
establishing a breadth of experience
across indications1-3†
>33,200
PATIENT-YEARS
of exposure to RINVOQ 15, 30 or 45 mg2,3
>12,500
PATIENTS IN GLOBAL
CLINICAL TRIALS
across US-approved indications,
including pediatrics 12+ years in AD2,3†
>190,000
PATIENTS PRESCRIBED
GLOBALLY
across indications since 20195‡
*Clinical experience encompasses the time from first RINVOQ patient dosed in RA clinical trial to present.
†Includes 1 phase 2 and 3 phase 3 CD trials, 3 phase 3 UC trials, 2 phase 3 PsA trials, 3 phase 2 trials and 6 phase 3 RA trials, 1 phase 2/3 and 1 phase 3 AS trials, 1 phase 3 nr-axSpA trial, and 1 phase 2 and 3 phase 3 AD trials. CD: RINVOQ 15 mg, 30 mg, and 45 mg; UC: RINVOQ 15 mg, 30 mg, and 45 mg; PsA: RINVOQ 15 mg, upadacitinib 30 mg; RA: RINVOQ 15 mg, upadacitinib 30 mg; AS: RINVOQ 15 mg; nr-axSpA: RINVOQ 15 mg; AD: RINVOQ 15 mg and 30 mg. RINVOQ 15 mg is the approved dose in PsA, RA, AS, and nr-axSpA; RINVOQ 15 mg and 30 mg are the approved doses in AD; RINVOQ 15 mg, 30 mg and 45 mg are the approved doses in UC and CD.1
‡Based on prescription data with RINVOQ in patients with RA, PsA, AD, AS, or UC as of December 2022.5
AD=atopic dermatitis; AS=ankylosing spondylitis; CD=Crohn’s disease; JAK=Janus kinase; nr-axSpA=non-radiographic axial spondyloarthritis; PsA=psoriatic arthritis; PY=patient-years; RA=rheumatoid arthritis; UC=ulcerative colitis
ONE PILL, ONCE DAILY
RINVOQ is a once-daily pill that comes in
three dosage strengths: one strength for
induction and two strengths for maintenance1
Images not reflective of actual pill size.
Limitations of Use: RINVOQ is not recommended for use in combination with other JAK inhibitors, biological therapies for Crohn's disease, or with potent immunosuppressants such as azathioprine and cyclosporine.
COMMITTED TO EXCEPTIONAL ACCESS AND PATIENT SUPPORT
ONE-TO-ONE
SUPPORT
Nurse Ambassadors* and Access Specialists provide 1-to-1 support to help navigate insurance.
AFFORDABILITY
Eligible, commercially insured patients may pay as little as $5 per month on their prescription and can be reimbursed for the cost of related lab tests and monitoring.†
ACCESS
No charge for eligible 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 criteria: Available to patients with commercial insurance coverage for RINVOQ® (upadacitinib) 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 RINVOQsavingscard.com or call 1-800-2RINVOQ (1-800-274-6867) 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 RINVOQ® (upadacitinib) 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. Continued eligibility for the program requires the submission of an appeal of the coverage denial every 180 days. Program provides for RINVOQ® (upadacitinib) 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.
