WELL-STUDIED
SAFETY
PROFILE

Now Approved First-Line For Giant Cell Arteritis (GCA).

Approved in 9 Indications1

12 YEARS
of clinical trial experience2*

27 CLINICAL TRIALS ACROSS 9
INDICATIONS: RA, PsA, AS, nr-axSpA, pJIA, GCA, AD, UC & CD1,3,4

>15,000
patients in global clinical trials across US‑approved indications, including 2+ years in pJIA and pediatrics 12+ years in AD1,3,4

~6 YEARS
of real-world experience1

OVER 375,000
patients prescribed globally across indications since 20191,5†

>45,000
patient-years of exposure to RINVOQ (15, 30, 45 mg) or RINVOQ LQ (1 mg/mL)3,4

*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, nr-axSpA, AS, AD, UC, or CD as of June 2024.5

AD=atopic dermatitis; AS=ankylosing spondylitis; CD=Crohn’s disease; GCA=giant cell arteritis; IR=intolerance or inadequate response; nr-axSpA=non-radiographic axial spondyloarthritis; pJIA=polyarticular juvenile idiopathic arthritis; PsA=psoriatic arthritis; RA=rheumatoid arthritis; TNFi=tumor necrosis factor inhibitor; UC=ulcerative colitis.

Please see Important Safety Information, including BOXED WARNING on Serious Infections, Mortality, Malignancies, Major Adverse Cardiovascular Events, and Thrombosis, below.

Long-Term Safety Data Across Indications5

<<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=11,661.5) (N=907, PY=2823.7) (N=596, PY=1022.2) (N=286, PY=388.4) (N=1337, PY=3823.0) (N=1346, PY=4076.9) (N=285, PY=622.7) (N=291, PY=721.9) (N=221, PY=329.5) (N=760, PY=1371.2)
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

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.

 

Learn more about RINVOQ safety in specific conditions

Visit the disease state of interest for details

Safety Profile in

RHEUMATOLOGY

Safety Profile in

DERMATOLOGY

Safety Profile in

GASTROENTEROLOGY

Safety Considerations

Consider the Benefits and Risks for the Individual Patient Prior to Initiating Therapy with RINVOQ