DURABLE REMISSION.1
POWERFUL HEALING.1
IN A ONCE-DAILY PILL.1
IR=intolerance or inadequate response; TNFi=tumor necrosis factor inhibitor
IR=intolerance or inadequate response;
TNFi=tumor necrosis factor inhibitor
IT'S TIME
See how RINVOQ can impact patients' lives
RAPID. DURABLE.
POWERFUL.1
|
WELL-STUDIED
SAFETY1-3
Safety profile studied since 2012 with 25 clinical trials¶
7 approved indications across rheumatology, dermatology and gastroenterology
EXCEPTIONAL
ACCESS & SUPPORT
>95% preferred** commercial coverage achieved in UC4††
- National Commercial Formulary coverage under the pharmacy benefit as of January 2023
Committed to Abbvie’s legacy of reliable access and patient support
RINVOQ Complete offers the same patient support you have come to expect from AbbVie
*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.
¶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.1,3
**RINVOQ is on a preferred tier or otherwise has preferred status on the plan’s formulary.
††Coverage requirements and benefit designs vary by payer and may change over time. Please consult with payers directly for the most current reimbursement policies.
Explore RINVOQ videos and listen to experts
showcase the latest clinical data.
Stringent EndpointS in UC
Dr. Miguel Regueiro and Dr. Remo Panaccione discuss stringent endpoints of RINVOQ clinical trials that include endoscopic improvement and histo-endoscopic mucosal improvement.
SEE HOW RINVOQ
INDUCTION DATA1
Achieved clinical remission* at Week 8
Primary endpoint
MAINTENANCE DATA1
Achieved clinical remission* at Week 52
Primary endpoint
Recommended Maintenance Dosing:
A dose of 30 mg once daily may be considered for patients with refractory, severe or extensive disease. Discontinue RINVOQ if therapeutic response is not achieved with the 30 mg dose.
*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.
U-ACHIEVE INDUCTION & U-ACCOMPLISH Study Design Intro:1 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 Intro:1 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.
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 indications1,3,6,7*
>33,200
patient-years of exposure to
RINVOQ 15, 30 or 45 mg1,3,6,7*
>12,500
patients in global clinical
trials across US-approved
indications, including
pediatrics 12+ years in AD1,3,6,7*
10 YEARS
of clinical trial
experience across
indications5†
*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.1,3
†Clinical experience encompasses the time from first RINVOQ patient dosed in RA clinical trial to present.
AD=atopic dermatitis; AS=ankylosing spondylitis; CD=Crohn’s disease; IR=intolerance or inadequate response; JAK=Janus kinase; nr-axSpA=non-radiographic axial spondyloarthritis; PsA=psoriatic arthritis; PY=patient-year; RA=rheumatoid arthritis; TNFI=tumor necrosis factor inhibitor; 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 $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. 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 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.
Study Design and Baseline Characteristics
For adult patients with moderately to severely active ulcerative colitis (UC).1
U-ACHIEVE Induction & U-ACCOMPLISH Induction
Primary Endpoint1
- Clinical remission at Week 8*
Select Secondary Endpoints1,2
- Clinical response at Week 2†
- Clinical response at Week 8‡
- Endoscopic improvement at Week 8§
- Histo-endoscopic mucosal improvement at Week 8II
*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.
†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 response per modified Mayo Score is a composite of Mayo stool frequency, rectal bleeding, and endoscopy subscores and is defined as a decrease in total score ≥30% and ≥2 points from baseline and a decrease in rectal bleeding subscore ≥1 or rectal bleeding subscore of 0 or 1.
§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.
IIHisto-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 or flexible sigmoidoscopy, depending on the extent of disease at study entry, and histology results are based on a set of 2 biopsies.
aStratification factors for randomization.
bBio-naïve patients include patients who were exposed to a biologic but did not experience treatment failure.
RINVOQ is indicated for TNFi-IR patients.
References: 1. RINVOQ [package insert]. North Chicago, IL: AbbVie Inc. 2. Danese S, Vermeire S, Zhou W, et al. Upadacitinib as induction and maintenance therapy for moderately to severely active ulcerative colitis: results from three phase 3, multicentre, double-blind, randomised trials. Lancet. 2022;399(10341):2113‑2128.
US-MULT-221304
U-ACHIEVE Maintenance
Primary Endpoint1
- Clinical remission at Week 52*
Select Secondary Endpoints at Week 521
- Corticosteroid-free clinical remission at Week 52†
- Endoscopic improvement at Week 52‡
- Histo-endoscopic mucosal improvement at Week 52§
*Clinical remission is defined as Mayo 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 preceding Week 52 (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 or flexible sigmoidoscopy, depending on the extent of disease at study entry, and histology results are based on a set of 2 biopsies.
aStratification factors for randomization.
bBio-naïve patients include patients who were exposed to a biologic but did not experience treatment failure.
RINVOQ is indicated for TNFi-IR patients.
References: 1. RINVOQ [package insert]. North Chicago, IL: AbbVie Inc. 2. Danese S, Vermeire S, Zhou W, et al. Upadacitinib as induction and maintenance therapy for moderately to severely active ulcerative colitis: results from three phase 3, multicentre, double-blind, randomised trials. Lancet. 2022;399(10341):2113‑2128.
US-MULT-221304
