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 indications1-4*
>33,200
patient-years of exposure to RINVOQ 15, 30 or 45 mg1-4*
>12,500
patients in global clinical trials across US-approved indications, including pediatrics 12+ years in AD1-4*
10 YEARS
of clinical trial experience across indications1,5†
*Includes 1 phase 2 and 3 phase 3 CD trials, 3 phase 3 UC trials, 2 phase 3 PsA trials, 3 phase 2 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. 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. 1,4
†Clinical experience encompasses the time from first RINVOQ patient dosed in RA clinical trial to present.1,5
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
Pooled induction safety data up to Week 86,7*
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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.
RINVOQ is taken once daily.
Long-term safety up to Week 526,7
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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
Pooled induction: Adverse reactions reported in ≥2% of patients1*
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†
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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 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
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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.
Long-Term Safety Data Across 7 Indications
Long-term exposure inclusive of >23,200 patient years2-4
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| RHEUMATOLOGY | DERMATOLOGY | GASTROENTEROLOGY | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| RA | PsA | AS | nr-axSpA | AD | UC | CD | ||||
| TEAE OF SPECIAL INTERESTa (E/100 PY unless otherwise noted) | RINVOQ 15 mg | RINVOQ 15 mg | RINVOQ 30 mg | RINVOQ 15 mg | RINVOQ 30 mg | RINVOQ 15 mg | RINVOQ 30 mg | |||
| (N=3209, PY=10782.7) | (N=907, PY=2426.4) | (N=596, PY=939.1) | (N=286, PY=323.9) | (N=1340, PY=3055.3) | (N=1353, PY=3231.0) | (N=285, PY=504.1) | (N=291, PY=549.7) | (N=221, PY=295.8) | (N=739, PY=1179.2) | |
| INFECTIONS | ||||||||||
| Serious infection | 3.6 | 3.9 | 2.6 | 0.9 | 2.2 | 2.8 | 3.6 | 4.5 | 3.0 | 7.1 |
| Opportunistic infection (excluding TB and herpes zoster) |
0.3 | 0.4 | 0.2 | 0 | 1.8 | 2.4 | 0.4 | 0.5 | 0.7 | 0.4 |
| Active TB | <0.1 | 0 | 0 | 0 | <0.1 | <0.1 | 0 | 0 | 0 | <0.1 |
| Herpes zoster | 3.2 | 3.1 | 2.8 | 1.9 | 3.1 | 5.8 | 4.8 | 6.4 | 3.0 | 4.8 |
| MALIGNANCYb | ||||||||||
| Malignancy (excluding NMSC) | 0.7 | 0.7 | 0.2 | 0.3 | 0.4 | 0.3 | 0.4 | 0.5 | 0.7 | 0.9 |
| Lymphoma | <0.1 | 0.1c | 0.1c | 0.3 | <0.1 | <0.1 | 0 | 0 | 0 | 0.2 |
| NMSC | 0.4 | 0.7 | 0.2 | 0.3 | 0.4 | 0.3 | 0 | 1.1 | 0 | 0.5 |
| CARDIOVASCULAR EVENTSb | ||||||||||
| Adjudicated MACEd | 0.3 | 0.2 | 0.1 | 0.3 | <0.1 | <0.1 | 0 | 0.4 | 0 | 0.2 |
| Adjudicated VTEe | 0.4 | 0.2 | 0.3 | 0.6 | <0.1 | <0.1 | 0.8 | 0.7 | 0 | 0.3 |
| GASTROENTEROLOGICAL EVENTSb | ||||||||||
| Adjudicated gastrointestinal perforations | <0.1 | <0.1 | 0 | 0 | 0 | 0 | 0 | 0 | 0.3 | 0.4 |
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.
RINVOQ is taken once daily.
Lab monitoring
Perform lab testing for:
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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 studies1,8
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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.8
WELL-STUDIED SAFETY
Watch experts discuss the data from the safety profile for RINVOQ.
Explore RINVOQ videos to see experts
showcase the latest clinical data.
