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

Well-StudiedWell-Studied

SAFETY PROFILE ACROSS 7 INDICATIONS1

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

 25

clinical trials,
establishing a breadth of
experience across indications1,2,6,8*

 

 >33,200

patient-years of exposure to
RINVOQ 15, 30 or 45 mg1,2,6,8*

 

 >12,500

patients in global clinical trials across US-approved indications, including pediatrics 12+ years in AD,1,2,6,8*

10 YEARS

of clinical trial
experience across
indications3†

 

*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

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

Well-Studied

Pooled induction safety data up to Week 84,5*

<<Swipe table to see more

Adverse reactions

Adverse Reaction rates observed in clinical trials may not fully characterize the risks of RINVOQ. Certain adverse events may require longer observation periods and longer-term patient exposure to ascertain risk.

Long-term safety up to Week 524,5

<<Swipe table to see more

Maintenance safety

Adverse Reaction rates observed in clinical trials may not fully characterize the risks of RINVOQ. Certain adverse events may require longer observation periods and longer-term patient exposure to ascertain risk.

SAFETY CONSIDERATIONS

Consider the benefits and risks for the individual patient
prior to initiating therapy with RINVOQ

WARNINGS & PRECAUTIONS

Common adverse events

Pooled induction: Adverse reactions reported in ≥2% of patients1*

Adverse reactions

aComposed of several similar terms

bElevated liver enzymes composed of elevated ALT, AST, GGT, ALP, liver transaminases, hepatic enzymes, bilirubin, drug-induced liver injury and cholestasis

Other adverse reactions reported in less than 2% of patients in the RINVOQ 45 mg group and at a higher rate than in the placebo group through Week 8 included herpes zoster and pneumonia.

Adverse reactions reported in ≥2% of patients1†

<<Swipe table to see more

Adverse reactions

aComposed of several similar terms

bElevated liver enzymes composed of elevated ALT, AST, GGT, ALP, liver transaminases, hepatic enzymes, bilirubin, drug-induced liver injury and cholestasis

Adverse Reaction rates observed in clinical trials may not fully characterize the risks of RINVOQ. Certain adverse events may require longer observation periods and longer-term patient exposure to ascertain risk.

Long-term safety in uc

Long-Term Safety Data in UC: Consistent Safety Profile

Long-term exposure inclusive of
>1,050 patient-years2

Maximum exposure: ~5.6 years
Median exposure: Up to 2.1 years

<<Swipe table to see more

Long-term safety in uc graph

Week 52 Safety: Patients responding to 8 week induction therapy with RINVOQ 45 mg randomized into the maintenance study. Data as of 08/2022.

Long-term Safety: Patients from induction studies responding to RINVOQ 45 mg at Week 8 or 16 randomized into the maintenance study and additional time in the open label extension study. Data as of 08/2022.

Adverse Reaction rates observed in clinical trials may not fully characterize the risks of RINVOQ. Certain adverse events may require longer observation periods and longer-term patient exposure to ascertain risk.

Safety across indications

Long-Term Safety Data Across 7 Indications

Long-term exposure inclusive of >23,200 patient years2,6,8

<<Swipe table to see more

Long-term safety

In CD studies: Includes 3 phase 3 trials as of 2/2023. Includes those who responded to 45 mg indication dose to RINVOQ at Week 12. In UC studies: Includes 2 sequential phase 3 studies as of 8/2022. Includes those who responded to 45 mg induction dose to RINVOQ at week 8 or 16. In RA studies: Includes 6 phase 3 trials as of 8/2022. In AS studies: Includes 1 phase 2/3 trial for SELECT-AXIS 1 as of 8/2022. In AD studies: Includes 3 phase 3 trials including adults and adolescents as of 8/2022. In PsA studies: Includes 2 phase 3 trials as of 8/2022. In nr-axSpA studies: Includes 1 phase 3 trials as of 8/2022.

Adverse Reaction rates observed in clinical trials may not fully characterize the risks of RINVOQ. Certain adverse events may require longer observation periods and longer-term patient exposure to ascertain risk.

Lab monitoring

Lab monitoring

Perform lab testing for:

<< Swipe table to see more

Lab monitoring and dosing considerations

INTERRUPT IF PATIENT DEVELOPS A SERIOUS OR OPPORTUNISTIC INFECTION

*Treatment can be initiated or restarted after levels return above specified values, drug-induced liver injury diagnosis is excluded, or infection is controlled.1

Lab abnormalities across doses from the placebo-controlled induction and maintenance studies1,7

<<Swipe table to see more

Lab abnormalities

Lipid Elevations: RINVOQ treatment was associated with increases in lipid parameters including total cholesterol, LDL cholesterol, and HDL cholesterol in placebo-controlled induction and maintenance studies.7

WELL-STUDIED SAFETY

Watch experts discuss the data from the safety profile for RINVOQ.

RINVOQ Reels

Explore RINVOQ videos to see experts
showcase the latest clinical data.

Committed to AbbVie’s legacy of reliable access and patient support

Committed to AbbVie’s legacy of reliable access and patient support