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
Dr. Siegel and Dr. Tate discuss the long-term safety profile of RINVOQ across various indications
WELL-STUDIED
Safety Profile in PsA1
Safety data at Week 24
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,*
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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 |
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.
Well-studied
safety profile
Most Common Adverse Reactions from RINVOQ clinical trials
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.

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
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.

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
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

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
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

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

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*
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.
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.

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