Safety Profile | Rheumatoid Arthritis | RINVOQ® (upadacitinib)

For moderate to severe rheumatoid arthritis (RA) in adult TNFi-IR patients¹

Safety data
21 CLINICAL TRIALS
ACROSS 6 INDICATIONS^1,2,*
RA, PsA, AS, NR-AXSPA, AD & UC

>11,300
patients in global clinical trials across US‑approved indications, including pediatrics 12+ years in AD^2,^*

>31,200
patient-years of exposure to RINVOQ 15, 30, or 45 mg^2,^*

>6.5 Years
max. exposure in RA (~4 yrs median) to RINVOQ 15 mg as of 8/15/22^2,^†

For active psoriatic arthritis (PsA) 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

^*Includes 3 phase 2 trials and 6 phase 3 RA trials, 2 phase 3 PsA trials, 1 phase 2/3 and 1 phase 3 AS trials, 1 phase 3 nr-axSpA trial, 1 phase 2 and 3 phase 3 AD trials, and 3 phase 3 UC trials. RA: RINVOQ 15 mg, upadacitinib 30 mg; PsA: 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. 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.^1,2

^†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; IR=intolerance or inadequate response; JAK=Janus kinase; max.=maximum; nr-axSpA=non-radiographic axial spondyloarthritis; PsA=psoriatic arthritis; RA=rheumatoid arthritis; TNFi=tumor necrosis factor inhibitor; UC=ulcerative colitis

Well-studied
safety profile¹

Data from 5 robust Phase 3 clinical trials

Adverse Events of Special Interest^1,3

Patients could advance or switch to RINVOQ from placebo, or be rescued
to RINVOQ from active comparator or placebo as early as Week 12
depending on the study design.¹

*TEAE=treatment-emergent adverse event is defined as any adverse event with an onset date on or after the first dose of study drug and no more than 30 days after the last dose of study drug if subject discontinued study drug prematurely.³

SAFETY CONSIDERATIONS

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

WARNINGS & PRECAUTIONS

consistent SAFETY PROFILE OF AEs
OBSERVED IN LONG-TERM ANALYSIS^2,6

Phase 3 Program AEs^2,4-7,*

Any RINVOQ 15 mg QD^†

(E/100 PYs unless otherwise stated)

Adverse reaction rates observed in clinical trials and LTE studies may not predict the rates observed in clinical practice.

ADVERSE REACTIONS: The most common adverse reactions in RA RINVOQ clinical trials (≥1%) were upper respiratory tract infections, nausea, cough, pyrexia, pneumonia, herpes zoster, herpes simplex, and oral candidiasis.¹

LONG-TERM SAFETY DATA ACROSS 6 INDICATIONS^1,2,6,*

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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.

AbbVie is conducting the long-term safety studies, including post-marketing studies, to continue to evaluate the safety of RINVOQ. Certain adverse events may require longer observation periods and larger patient exposure to ascertain risk.

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Well-studied
safety profile¹

Common Adverse Reactions

Most Common Adverse Reactions from SELECT-BEYOND,
SELECT-NEXT, and
SELECT-COMPARE (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.¹

Infections

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

^aPatients were on background MTX or csDMARDS.
^bURTI includes: acute sinusitis, laryngitis, nasopharyngitis, oropharyngeal pain, pharyngitis, pharyngotonsillitis, rhinitis, sinusitis, tonsillitis, viral upper respiratory tract infection.

Lab Monitoring and Dosing
considerations¹

LAB MONITORING

LAB ABNORMALITIES

Treatment with RINVOQ should not be initiated, or should be interrupted if:

*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.

Lab Abnormalitiesfrom the Controlled Period
of the RA Phase 3 program
(Week 12 or 14)¹

Neutropenia: Decreases in absolute neutrophil count (<1000 cells/mm³) occurred in 1.1% of patients treated with RINVOQ in the first 3 months of exposure.

Lymphopenia: Decreases in lymphocyte counts (<500 cells/mm³) occurred in 0.9% of patients treated with RINVOQ in the first 3 months of exposure.

Anemia: Hemoglobin decreases below 8 g/dL in at least one measurement occurred in <0.1% of patients treated with RINVOQ in the first 3 months of exposure.

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

Liver Enzyme Elevations: Confirmed increases in liver enzyme levels >3 times the upper limit of normal were observed in patients treated with RINVOQ.

Creatine Phosphokinase Elevations: Increases in creatine phosphokinase (CPK) levels >5 times the upper limit of normal were observed in patients treated with RINVOQ. Most elevations >5x ULN were transient and did not require treatment discontinuation.