For moderate to severe Crohn's disease (CD) in adult TNFi-IR patients.1
For moderate to severe ulcerative colitis (UC) in adult TNFi-IR patients.1
OF CLINICAL
EXPERIENCE* ACROSS
8 INDICATIONS
RINVOQ is a JAK Inhibitor
approved in Rheumatology,
Dermatology, and
Gastroenterology1
26
CLINICAL TRIALS
establishing a breadth of
experience across indications1,2
>13,000
PATIENTS IN GLOBAL
CLINICAL TRIALS
across US-approved indications,
including pediatrics 2+ years in pJIA1,2†
†pJIA: in pediatric TNFi-IR patients 2 years of age and older with active polyarticular juvenile idiopathic arthritis (pJIA)
>37,800
PATIENT YEARS
of clinical trial exposure across
approved doses1,2
>267,000
PATIENTS PRESCRIBED GLOBALLY
across indications since 20193‡
*Clinical experience encompasses the time from first RINVOQ patient dosed in RA clinical trial to present.
‡Based on prescription data with RINVOQ in patients with RA, PsA, AD, AS, or UC as of December 2022.4
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 SAFETY PROFILE
Pooled safety data at 45 mg induction dose5
<<Swipe table to see more
*In all Crohn's patients treated with RINVOQ 45 mg (N=938) during the induction studies, gastrointestinal perforations were reported in 4 patients (2 per 100 patients years).
Induction studies for CD: (Phase 3 U-EXCEL and Phase 3 U-EXCEED); integrated data inclusive of bio-failure* and bio-naïve† patients to represent placebo-controlled safety through 12 weeks for placebo (n=347) and RINVOQ (upadacitinib) 45 mg (n=674).
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 Data up to Week 52 at 15 mg and 30 mg doses5,6
<<Swipe table to see more
*In patients who lost response on placebo or RINVOQ 15 mg in U-ENDURE and were rescued with RINVOQ 30 mg (N=336): Gastrointestinal perforation was reported in 3 patients (1 per 100 patient-years) through long-term treatment.
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.
Consider the benefits and risks for the individual patient
prior to initiating therapy with RINVOQ
WARNINGS & PRECAUTIONS
COMMON ADVERSE EVENTS
Adverse reactions reported in ≥2% of patients1*
<<Swipe table to see more
aComposed of several similar terms.
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.
CD: 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 12 included folliculitis, hypercholesterolemia, bronchitis, pneumonia, oral candidiasis, and hyperlipidemia.
Adverse reactions reported in ≥2% of patients1†
<<Swipe table to see more
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.
CD: Other adverse reactions reported in less than 2% of patients in the RINVOQ 15 and 30 mg group and at a higher rate than in the placebo group through Week 52 included hyperlipidemia, oral candidiasis, and hypercholesterolemia.
SAFETY ACROSS INDICATIONS
Long-term safety data across 7 indications1-3,7
Long-term exposure inclusive of >23,200 patient-years2,3,7
<<Swipe table to see more
| 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=11,661.5) | (N=907, PY=2,823.7) | (N=596, PY=1,022.2) | (N=286, PY=388.4) | (N=1337, PY=3,823) | (N=1346, PY=4,076.9) | (N=285, PY=622.7) | (N=291, PY=721.9) | (N=221, PY=329.5) | (N=760, PY=1,371.2) | |
| INFECTIONS | ||||||||||
| Serious infection | 3.6 | 3.3 | 2.4 | 1.3 | 2.2 | 2.6 | 2.9 | 4.4 | 3.6 | 6.7 |
| Opportunistic infection (excluding TB and herpes zoster) |
0.3 | 0.4 | 0.2 | 0.3 | 1.7 | 2.2 | 0.3 | 0.6 | 0.6 | 0.4 |
| Active TB | <0.1 | 0 | 0 | 0 | <0.1 | <0.1 | 0 | 0 | 0 | <0.1 |
| Herpes zoster | 3.2 | 3.1 | 3.1 | 2.6 | 3.1 | 5.5 | 4.3 | 6.6 | 2.7 | 5.0 |
| MALIGNANCYb | ||||||||||
| Malignancy (excluding NMSC) | 0.7 | 0.7 | 0.2 | 0.3 | 0.3 | 0.4 | 0.6 | 0.6 | 0.6 | 0.9 |
| Lymphoma | <0.1 | 0.1c | <0.1c | 0.3 | <0.1 | <0.1 | 0 | 0 | 0 | 0.1 |
| NMSC | 0.4 | 0.7 | 0.3 | 0.3 | 0.4 | 0.3 | 0 | 1.0 | 0 | 0.6 |
| CARDIOVASCULAR EVENTSb | ||||||||||
| Adjudicated MACEd | 0.3 | 0.4 | 0.2 | 0.5 | 0.2 | <0.1 | 0 | 0.4 | 0 | 0.1 |
| Adjudicated VTEe | 0.4 | 0.2 | 0.3 | 0.8 | 0.1 | 0.1 | 0.5 | 0.6 | 0 | 0.3 |
| GASTROENTEROLOGICAL EVENTSb | ||||||||||
| Adjudicated gastrointestinal perforations | <0.1 | <0.1 | 0 | 0 | 0 | <0.1 | 0 | 0 | 0.9 | 0.5 |
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 &
DOSING CONSIDERATIONS
Perform lab testing for:
<<Swipe table to see more
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 studies5
<<Swipe table to see more
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.
Images not reflective of actual pill size
ONE PILL, ONCE DAILY
RINVOQ is a once-daily pill that comes in one strength for
induction and two strengths for maintenance.
