For active psoriatic arthritis (PsA) in adult TNFi‑IR patients1

WELL-STUDIED
SAFETY PROFILE
10 YEARS OF CLINICAL EXPERIENCE
ACROSS
7 INDICATIONS1-4,*
RA, PsA, AS, nr-axSpA, AD, UC & CD

>12,500
patients in 25 global clinical trials
across US-approved indications,
including pediatrics 12+ years
in AD2,3,†

>33,200
patient-years of exposure to
RINVOQ 15, 30 or 45 mg2,3,†

>6.5 Years
max. exposure in RA
(~4 yrs median) to RINVOQ 15 mg
as of 8/15/222,‡

For moderate to severe rheumatoid arthritis (RA) in adult TNFi-IR patients1
For active ankylosing spondylitis (AS) in adult TNFi-IR patients1
For active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation in adult TNFi-IR patients1

*Clinical experience encompasses the time from first RINVOQ patient dosed in RA clinical trial to present.4

†Includes 2 phase 3 PsA trials, 3 phase 2 and 6 phase 3 RA trials, 1 phase 2/3 trial and 1 phase 3 AS trials, 1 phase 3 nr-axSpA trial, 1 phase 2 and 3 phase 3 AD trials, 3 phase 3 UC trials, and 1 phase 2 and 3 phase 3 CD trials. 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; UC: RINVOQ 15 mg, 30 mg, and 45 mg; CD: RINVOQ 15 mg, 30 mg, and 45 mg. RINVOQ 15 mg is the approved dose in RA, PsA, 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

‡In PsA: ~5.0 years maximum exposure (~2.9 years median) to RINVOQ 15 mg as of 08/2022. In AS: ~3.8 years maximum exposure (~1.7 years median) to RINVOQ 15 mg as of 08/2022. In nr-axSpA: ~2.4 years maximum exposure (~1.0 years median) to RINVOQ 15 mg as of 08/2022.2

AD=atopic dermatitis; AS=ankylosing spondylitis; CD=Crohn's disease; IR=intolerance or inadequate response; max.=maximum; nr-axSpA=non-radiographic axial spondyloarthritis; PsA=psoriatic arthritis; RA=rheumatoid arthritis; TNFi=tumor necrosis factor inhibitor; UC=ulcerative colitis;

RINVOQ Reels
RINVOQ®(upadacitinib) Reels

Dr. Siegel and Dr. Tate discuss the long-term safety profile of RINVOQ across various indications

Transcript

WELL-STUDIED
Safety Profile in PsA1
Safety data at Week 24

Adverse events of special interest5

Safety data in PsA

<< Swipe table to see more

Safety data in PsA

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.

bTEAEs were defined as AEs with an onset date that is on or after the first dose of study drug, and no more than 30 days after the last dose of RINVOQ and placebo if subject discontinued study drug prematurely.5

See Study Details
See Footnotes and Definitions
SAFETY CONSIDERATIONS

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

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

WARNINGS & PRECAUTIONS

Long-term
Safety Data Across
7 Indications1-3,6,*

<< Swipe table to see more

Safety Table of Long-Term Safety Data Across 7 Indications
  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

Overall, the safety profile observed in patients with active PsA treated with RINVOQ 15 mg is consistent with the safety profile observed in patients with RA, with the addition of herpes zoster, herpes simplex, acne, and bronchitis.

See RA Safety Up to ~6.5 Years
See Study Details
See Baseline Characteristics
See Footnotes and Definitions

Well-studied
safety profile

Most Common Adverse Reactions from RINVOQ clinical trials

PsA
RA
AS
nr-axSpA

PSORIATIC ARTHRITIS5

Most Common Adverse Reactions from SELECT-PsA 1 and
SELECT-PsA 2 (24 Weeks)

Adverse reactions reported in ≥1% of psoriatic arthritis patients treated with
RINVOQ 15 mg pooled from the placebo‑controlled studies.

Common adverse events

Infections

  • In the placebo-controlled studies SELECT-PsA 1 and SELECT-PsA 2 through 24 weeks, infections were reported in 33.5% of patients treated with placebo and 37.5% of patients treated with RINVOQ 15 mg.8

aPsA patients could be on background non-biologic DMARDs.1

ADVERSE REACTIONS: The most common adverse reactions in RINVOQ clinical trials were upper respiratory tract infections, herpes zoster, herpes simplex, bronchitis, nausea, cough, pyrexia, acne, headache, increased blood creatine phosphokinase, hypersensitivity, folliculitis, abdominal pain, increased weight, influenza, fatigue, neutropenia, myalgia, influenza-like illness, elevated liver enzymes, and rash.1

Inform patients that retinal detachment has been reported in clinical trials with RINVOQ. Advise patients to immediately inform their healthcare provider if they develop any sudden changes in vision while receiving RINVOQ.1

See Study Details
See Footnotes and Definitions

RHEUMATOID ARTHRITIS1

Most Common Adverse Reactions from SELECT-BEYOND, SELECT-COMPARE, and SELECT-NEXT (12 Weeks)1

Adverse reactions reported in ≥1% of moderate to severe rheumatoid arthritis patients treated with RINVOQ 15 mg pooled from the placebo-controlled studies.

Common adverse events

Infections

  • In the placebo-controlled studies SELECT-COMPARE, SELECT-NEXT, and SELECT-BEYOND through 12/14 weeks, infections were reported in 20.9% of patients treated with placebo and 27.4% of patients treated with RINVOQ 15 mg.9
  • In the 12-month exposure dataset, the incident rate of infection was 83.8 per 100 patient-years for patients treated with RINVOQ 15 mg.9

aRA patients were on background MTX or csDMARDs.1

ADVERSE REACTIONS: The most common adverse reactions in RINVOQ clinical trials were upper respiratory tract infections, herpes zoster, herpes simplex, bronchitis, nausea, cough, pyrexia, acne, headache, increased blood creatine phosphokinase, hypersensitivity, folliculitis, abdominal pain, increased weight, influenza, fatigue, neutropenia, myalgia, influenza-like illness, elevated liver enzymes, and rash.1

Inform patients that retinal detachment has been reported in clinical trials with RINVOQ. Advise patients to immediately inform their healthcare provider if they develop any sudden changes in vision while receiving RINVOQ.1

See Study Details
See Footnotes and Definitions

ANKYLOSING SPONDYLITIS10

Most Common Adverse Reactions from SELECT-AXIS 2 Study 1 (14 Weeks)

Adverse reactions reported in >2% of ankylosing spondylitis patients treated with RINVOQ 15 mg from the placebo-controlled study.10

Common adverse events

Infections

  • In the placebo-controlled study SELECT-AXIS 2 Study 1 through 14 weeks, infections were reported in 13% of patients treated with placebo and 15% of patients treated with RINVOQ 15 mg.11

aAS patients could be on background NSAIDs.

ADVERSE REACTIONS: The most common adverse reactions in RINVOQ clinical trials were upper respiratory tract infections, herpes zoster, herpes simplex, bronchitis, nausea, cough, pyrexia, acne, headache, increased blood creatine phosphokinase, hypersensitivity, folliculitis, abdominal pain, increased weight, influenza, fatigue, neutropenia, myalgia, influenza-like illness, elevated liver enzymes, and rash.1

Inform patients that retinal detachment has been reported in clinical trials with RINVOQ. Advise patients to immediately inform their healthcare provider if they develop any sudden changes in vision while receiving RINVOQ.1

See Study Details
See Footnotes and Definitions

NON-RADIOGRAPHIC AXIAL SPONDYLOARTHRITIS12

Most Common Adverse Reactions from SELECT-AXIS 2 Study 2 (14 Weeks)

Adverse reactions reported in >2% of non-radiographic axial spondyloarthritis patients treated with RINVOQ 15 mg from the placebo-controlled study.12

Common adverse events

Infections

  • In the placebo-controlled study SELECT-AXIS 2 Study 2 through 14 weeks, infections were reported in 23% of patients treated with placebo and 23% of patients treated with RINVOQ 15 mg.13

anr-axSpA patients could be on background NSAIDs.

ADVERSE REACTIONS: The most common adverse reactions in RINVOQ clinical trials were upper respiratory tract infections, herpes zoster, herpes simplex, bronchitis, nausea, cough, pyrexia, acne, headache, increased blood creatine phosphokinase, hypersensitivity, folliculitis, abdominal pain, increased weight, influenza, fatigue, neutropenia, myalgia, influenza-like illness, elevated liver enzymes, and rash.1

Inform patients that retinal detachment has been reported in clinical trials with RINVOQ. Advise patients to immediately inform their healthcare provider if they develop any sudden changes in vision while receiving RINVOQ.1

See Study Details
See Footnotes and Definitions

Lab monitoring and
Dosing considerations1

Lab
Monitoring
Lab Abnormalities
Lab monitoring

TREATMENT WITH RINVOQ SHOULD NOT BE INITIATED, OR SHOULD BE INTERRUPTED IF:

Absolute neutrophil count
<1000 cells/mm3*

Absolute lymphocyte count
<500 cells/mm3*

Hemoglobin levels
<8 g/dL*

Liver enzyme elevations
and a
drug-induced liver
injury is suspected*

Patient has or 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.

In RA, PsA, AS, and nr-axSpA:

No dose adjustment is required for mild, moderate, or severe renal impairment.1

No dose adjustment is required for mild or moderate hepatic impairment.1

RINVOQ is not recommended in patients with:

  • Active hepatitis B or hepatitis C

  • Severe hepatic impairment (Child-Pugh C)

RINVOQ has not been studied in end-stage renal disease (eGFR <15 mL/min/1.73m2)

HYPERSENSITIVITY:1 RINVOQ is contraindicated in patients with known hypersensitivity to upadacitinib or any of its excipients. If a clinically significant hypersensitivity reaction occurs, discontinue RINVOQ and institute appropriate therapy.

See Additional Dosing and
Monitoring Considerations
See Footnotes and Definitions

Lab Abnormalities from the Package Insert1

Neutropenia: Decreases in absolute neutrophil count (<1000 cells/mm3) were associated with RINVOQ treatment.

Lymphopenia: Decreases in lymphocyte counts (<500 cells/mm3) were reported with RINVOQ treatment.

Anemia: Hemoglobin decreases below 8 g/dL were reported with RINVOQ treatment.

Lipid Elevations: Increases in lipid parameters including total cholesterol, triglycerides, LDL, and HDL were observed in patients treated with RINVOQ. Elevations in LDL and HDL cholesterol peaked by week 8 and remained stable thereafter.

Liver Enzyme Elevations: Increased incidences in liver enzyme elevations were associated with RINVOQ compared to placebo.

See Footnotes and Definitions
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