SAFETY PROFILE ACROSS 6 INDICATIONS1
RINVOQ is a JAK Inhibitor approved in rheumatology, dermatology, and gastroenterology1
21
clinical trials,
establishing a breadth of
experience across indications1,2*
>31,200
patient-years of exposure to
RINVOQ 15, 30 or 45 mg2*
>11,300
patients in global clinical trials across US-approved indications, including pediatrics 12+ years in AD2*
~10 YEARS
of clinical trial
experience across
indications3
*Includes 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. 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.1,2
AD=atopic dermatitis; AS=ankylosing spondylitis; IR=intolerance or inadequate response; JAK=Janus kinase; nr-axSpA=non-radiographic axial spondyloarthritis; PsA=psoriatic arthritis; PYs=patient-years; RA=rheumatoid arthritis; TNFi=tumor necrosis factor inhibitor; UC=ulcerative colitis
Pooled induction safety data up to Week 84,5*
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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.
Long-term safety up to Week 524,5
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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 6 Indications
Long-term exposure inclusive of >20,600 patient years2,6
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In UC studies: Includes 2 sequential phase 3 trials as of 08/2022. Includes those who responded to 45 mg induction dose to RINVOQ at Week 8 or 16. In PsA studies: Includes 2 phase 3 trials as of 08/2022. In RA studies: Includes 6 phase 3 trials as of 08/2022. In AS studies: Includes 1 phase 2/3 trial and 1 phase 3 trial as of 08/2022 for SELECT-AXIS 1. In nr‑axSpA studies: Includes 1 phase 3 trial as of 08/2022. In AD studies: Includes 3 phase 3 trials including adults and adolescents as of 08/2022.2,6
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
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 studies1,7
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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.7
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.
