For moderate to severe ulcerative colitis (UC)
in adult TNFi-IR patients.1

DURABLE REMISSION.1
POWERFUL HEALING.1
IN A ONCE-DAILY PILL.1

PUT UC
IN CHECK
AND KEEP IT THERE

Results were measured at Weeks 8 and 52.1

Explore the Data

IR=intolerance or inadequate response; TNFi=tumor necrosis factor inhibitor

IT'S TIME

See how RINVOQ can impact patients' lives

RAPID. DURABLE.
POWERFUL.1

  • Rapid relief of rectal bleeding and stool frequency evaluated at Week 2*

  • No bowel urgency at Week 8

  • Durable clinical remission† at Week 8 and Week 52 and steroid-free clinical remission‡ at Week 52

  • Powerful endoscopic§ and histo-endoscopic|| results measured at Week 8 and Week 52

    The relationship between histo-endoscopic mucosal improvement to disease progression and long-term outcomes was not evaluated.

See the data  

WELL-STUDIED
SAFETY1, 2

  • Long-term safety data in UC is available, reflecting up to 6.3 years max exposure for RINVOQ 15 mg and 30 mg2

  • Safety profile studied since 2012 with 25 clinical trials

  • 7 approved indications across rheumatology, dermatology, and gastroenterology

Discover the long-term safety

EXCEPTIONAL
ACCESS & SUPPORT

  • >95% preferred commercial coverage achieved in UC3¶#

    National Commercial Formulary coverage under the pharmacy benefit as of April 2024

  • Committed to AbbVie's legacy of reliable access and patient support

  • RINVOQ Complete offers the patient support you have come to expect from AbbVie

See access and patient support

*Clinical response per partial modified Mayo Score is a composite of Mayo stool frequency and rectal bleeding subscores and is defined as a decrease in total score ≥30% and ≥1 point from baseline and a decrease in rectal bleeding subscore ≥1 or rectal bleeding subscore of 0 or 1.

†Clinical remission is defined as stool frequency subscore ≤1 and not greater than baseline, rectal bleeding subscore of 0, and endoscopic subscore ≤1 without friability.

‡Steroid-free clinical remission is defined as clinical remission at Week 52 and corticosteroid-free for ≥90 days immediately prior to visit (among patients achieving remission in induction).

§Endoscopic improvement was defined as Mayo endoscopic subscore of 0 or 1 without friability. Endoscopic results are based on a full colonoscopy or flexible sigmoidoscopy, depending on the extent of disease at study entry.

||Histo-endoscopic mucosal improvement was defined as Mayo endoscopy subscore of 0 or 1 without friability and Geboes score ≤3.1 (neutrophil infiltration in <5% of crypts, no crypt destruction, and no erosions, ulcerations, or granulation tissue). Endoscopic results are based on a full colonoscopy of flexible sigmoidoscopy, depending on the extent of disease at study entry, and histology results are based on a set of 2 biopsies.

RINVOQ is on a preferred tier or otherwise has preferred status on the plan’s formulary.3

#Coverage requirements and benefit designs vary by payer and may change over time. Please consult with payers directly for the most current reimbursement policies.

RINVOQ Reels

Hear from the Experts

Tune in as leading gastroenterologists gather for in-depth, one-on-one conversations with host David Rubin, M.D. Dr. Rubin is Chief of the Section of Gastroenterology, Hepatology, and Nutrition and Director of the Inflammatory Bowel Disease Center at the University of Chicago. Gut Reactions features his discussions with other experts in the field about the evolving landscape, patient outcomes, and treatment options.

Explore the Gut Reactions Podcast

SEE HOW RINVOQ
PUTS UC IN CHECK.
AND KEEPS IT THERE.

Results were measured at Weeks 8 and 52.1

INDUCTION DATA1

Achieved clinical remission* at Week 8
Primary endpoint

RINVOQ induction data RINVOQ induction data RINVOQ induction data

MAINTENANCE DATA1

Achieved clinical remission* at Week 52
Primary endpoint

RINVOQ maintenance data RINVOQ maintenance data RINVOQ maintenance data

Recommended Maintenance Dosing:

A dose of 30 mg may be considered for patients with refractory, severe, or extensive disease. Discontinue if therapeutic response is not achieved with the 30 mg dose.

OPEN-LABEL LONG-TERM EXTENSION: INTERIM ANALYSIS (AS OBSERVED)4

Clinical remission* up to ~2 years

U-Activate 78% RINVOQ 15 mg (n=78) and 69% RINVOQ 30 mg (n=15)

In the long-term extension (LTE) analysis, the data is segmented as follows:

• RINVOQ 15 mg arm: Patients who achieved clinical remission (remitters) on RINVOQ 15 mg at Week 52 of Maintenance Trial and received continuous RINVOQ 15 mg in LTE period (n=101)

• RINVOQ 30 mg arm: All patients on RINVOQ 30 mg who completed Week 52 of Maintenance Trial (remitters and non-remitters) and received continuous RINVOQ 30 mg in the LTE period (n=175)

OLE LIMITATIONS: In an open-label extension (OLE), there is a potential for enrichment of the long-term data in the remaining patient populations since patients who are unable to tolerate or do not respond to the drug often drop out. 

AO DISCLOSURE: In an as observed (AO) analysis, missing visit data was excluded from calculations for that visit, which may increase the percent of responders. All observed data was used regardless of premature discontinuation of study drug, or initiation of concomitant medications. The same patient may not have a response at each timepoint.

*Clinical remission is defined as stool frequency subscore ≤1 and not greater than baseline, rectal bleeding subscore of 0, and endoscopic subscore ≤1 without friability.

Additional Information: U-ACTIVATE Open-Label Extension

U-ACHIEVE INDUCTION & U-ACCOMPLISH Study Design Intro1: 8-week, double-blind, placebo-controlled Phase 3 clinical studies of 988 patients (473 patients for U-ACHIEVE and 515 patients for U-ACCOMPLISH) with moderately to severely active ulcerative colitis and demonstrated prior treatment failure to oral aminosalicylates, corticosteroids, immunosuppressants, and/or biologic treatment. Patients were randomized to receive either RINVOQ 45 mg or placebo once daily for 8 weeks. The primary endpoint was clinical remission per modified Mayo Score at Week 8.

U-ACHIEVE MAINTENANCE Study Design Intro1: 52-week, double-blind, placebo-controlled Phase 3 clinical study of 746 patients enrolled were randomized to the maintenance study. The primary efficacy analysis population was the first randomized 451 patients. Patients were randomized to receive RINVOQ 15 mg, 30 mg, or placebo once daily for up to 52 weeks. The primary endpoint was clinical remission per modified Mayo Score at Week 52.

U-ACTIVATE Long-Term Extension (LTE) Open-Label Study: Data presented at approximately 2 years is an interim analysis at 48 weeks of the U-ACTIVATE study, which is an ongoing 288-week, long-term study evaluating the efficacy and safety from patients who came from the U-ACHIEVE trial. Analysis includes patients from both primary (the first 451 patients to enter the maintenance study) and full maintenance populations (n=681). At the time of analysis, not all patients have reached 48 weeks of the LTE study.4

Study details
Explore the results

WELL-STUDIED SAFETY PROFILE
ACROSS 7 INDICATIONS1

WELL-STUDIED
SAFETY PROFILE
ACROSS 7 INDICATIONS1

RINVOQ is a JAK inhibitor
approved in
rheumatology,
dermatology, and gastroenterology1

RA, PSA, AS, NR-AXSPA,
AD, UC & CD

25

clinical trials,
establishing a breadth of
experience across
indications2

>37,700

patient-years of clinical trial exposure to RINVOQ
15, 30, or 45 mg2

>13,000

patients in global clinical
trials across US-approved
indications, including
pediatrics 12+ years in AD2

11 YEARS

of clinical trial
experience across
indications2*

See safety data

*Clinical experience encompasses the time from first RINVOQ patient dosed in RA clinical trial to present.2,5

AD=atopic dermatitis; AS=ankylosing spondylitis; CD=Crohn’s disease; JAK=Janus kinase; nr-axSpA=non-radiographic axial spondyloarthritis; PsA=psoriatic arthritis; RA=rheumatoid arthritis; UC=ulcerative colitis

Reliable Access.
Dependable
Patient Support.

Encourage your patients to enroll in RINVOQ Complete:

1-to-1 Support:

Nurse Ambassadors* and Field Access Specialists
provide 1:1 support to help navigate insurance.

Affordability:

Eligible, commercially insured patients may pay as little as $0 per month on their prescription and can be reimbursed for the cost of related lab tests and monitoring.†

Zero dollar

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.

Enroll patients in RINVOQ® 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 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. To learn about AbbVie’s privacy practices and your privacy choices, visit https://abbv.ie/corpprivacy.

‡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.