Approved in 9 indications¹

INDICATIONS

RINVOQ is indicated for the treatment of adults with:

Moderately to severely active Crohn’s disease who have had an inadequate response or intolerance to one or more tumor necrosis factor (TNF) blockers.
Moderately to severely active ulcerative colitis who have had an inadequate response or intolerance to one or more TNF blockers.

Limitations of Use: RINVOQ is not recommended for use in combination with other Janus kinase (JAK) inhibitors, biological therapies for Crohn’s disease or ulcerative colitis, or with potent immunosuppressants such as azathioprine and cyclosporine.

27 CLINICAL TRIALS
establishing a breadth of experience across indications^1-5

12 years
of clinical experience* and approved
in 9 indications

>15,000
patients in global clinical trials across US-approved indications, including 2+ years in pJIA and pediatrics 12+ years in AD

Up to 6 years
of safety data in IBD

>45,000 patient-years
of exposure in clinical trials

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

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

Learn more about these and the full Important Safety Information below

Safety Profile

Maintenance

Induction

Safety Data Up to Week 52 at 15 mg and 30 mg doses

<<Swipe table to see more

	CROHN'S AT WEEK 52⁶			UC AT WEEK 52⁷
U-ENDURE (CD) and U-ACHIEVE (UC): Maintenance data through Week 52	Placebo	RINVOQ 15 mg QD	RINVOQ 30 mg QD	Placebo	RINVOQ 15 mg QD	RINVOQ 30 mg QD
ADVERSE EVENTS (AEs)	(N=223, PY=111.5)	(N=221, PY=153.7)	(N=229, PY=177.2)	(N=245, PY=135)	(N=250, PY=199.4)	(N=251, PY=218.5)
TREATMENT-EMERGENT AEs	%	%	%	%	%	%
Serious adverse event	14.3	11.8	10.5	9.4	8.4	8.0
AE leading to discontinuation of study drug	3.6	7.2	5.7	10.2	2.0	4.8
Death	0	0	0	0	0	0
AEs OF SPECIAL INTEREST	% (N/100 PY)	% (N/100 PY)	% (N/100 PY)	% (N/100 PY)	% (N/100 PY)	% (N/100 PY)
INFECTIONS
Serious infections	4.5 (9.2)	3.2 (4.6)	4.8 (6.4)	3.3 (6.0)	3.6 (4.6)	3.2 (3.7)
Opportunistic infection (excluding TB and herpes zoster)	0	0.5 (0.7)	0.4 (0.6)	0.8 (1.5)	0.8 (1.0)	0.8 (0.9)
Active TB	0	0	0	0	0	0
Herpes zoster	2.2 (4.6)	2.7 (4.0)	5.7 (7.7)	0	4.8 (6.2)	5.6 (6.6)
MALIGNANCY
Malignancy (excluding NMSC)	0	0.5 (0.7)	0.9 (1.1)	0.4 (0.7)	0.4 (0.5)	0.8 (0.9)
Lymphoma	0	0	0	0	0	0
NMSC	0	0	0	0	0	1.2 (1.4)
CARDIOVASCULAR EVENTS
Adjudicated MACE^a	0	0	0	0.4 (0.7)	0	0.4 (0.5)
Adjudicated VTE^b	0	0	0	0	0.8 (1.0)	0.8 (0.9)
GASTROENTEROLOGICAL EVENTS
Adjudicated gastrointestinal perforations^§	0.4 (0.9)	0.5 (0.7)	0.4 (0.6)	0.4 (0.7)	0	0

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.

Week 52 CD Data: Patients responding to 12-week induction therapy with RINVOQ 45 mg randomized into the maintenance study. Data as of 1/2023.

Week 52 UC Data: Patients responding to 8-week induction therapy with RINVOQ 45 mg randomized into the maintenance study. Data as of 08/2023.

^§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.

Pooled safety data at 45 mg induction dose

<<Swipe table to see more

	CROHN'S AT WEEK 12^9,10		UC AT WEEK 8^7,8
ADVERSE EVENTS OF SPECIAL INTEREST % (N/100 PY) unless otherwise noted	Placebo (N=347)	RINVOQ 45 mg QD (N=674)	Placebo (N=378)	RINVOQ 45 mg QD (N=719)
TREATMENT-EMERGENT AEs	%	%	%	%
Serious adverse event	8.4	8.0	5.8	3.1
AE leading to discontinuation of study drug	5.5	4.9	7.1	2.4
Death	0	0	0	0
AEs OF SPECIAL INTEREST	% (N/100 PY)	% (N/100 PY)	% (N/100 PY)	% (N/100 PY)
INFECTIONS
Serious infections	1.7 (7.9)	1.9 (8.7)	1.3 (9.0)	1.3 (8.2)
Opportunistic infections (excluding TB and herpes zoster)	0	0.3 (1.3)	0.3 (1.8)	0.4 (2.7)
Active TB	0	0	0	0
Herpes zoster	0	2.2 (10)	0	0.6 (3.6)
MALIGNANCY
Malignancy (excluding NMSC)	0	0	0	0
Lymphoma	0	0	0	0
NMSC	0	0	0	0
CARDIOVASCULAR EVENTS
Adjudicated MACE^a	0	0	0	0
Adjudicated VTE^b	0	0	0.3 (1.8)	0.1 (0.9)
GASTROENTEROLOGICAL EVENTS
Adjudicated gastrointestinal perforations*	0	0.1 (0.7)	0.3 (1.8)	0

Induction studies for CD: (Phase 3 U-EXCEL and Phase3 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).⁹

Induction studies for UC: (Phase 2b U-ACHIEVE, Phase 3 U-ACHIEVE, and Phase 3 U-ACCOMPLISH); integrated to represent placebo-controlled safety through 8 weeks for placebo (n=378) and RINVOQ (upadacitinib) 45 mg (n=719).⁸

*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 patient-years).

Safety Considerations

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

Common Adverse Events

Maintenance

Induction

Adverse reactions reported in ≥2% of patients^1†

<<Swipe table to see more

	CROHN'S AT WEEK 52
	Placebo N=223 (%)	RINVOQ 15 mg QD N=221 (%)	RINVOQ 30 mg QD N=229 (%)
ADVERSE REACTION
Upper respiratory tract infection^a	11	14	12
Pyrexia	2	3	7
Herpes zoster^a	2	3	5
Headache^a	1	3	5
Acne^a	3	2	5
Gastroenteritis^a	2	3	3
Fatigue	2	3	3
Increased blood creatine phosphokinase	1	2	3
Elevated liver enzymes^b	<1	2	3
Leukopenia^a	<1	1	2
Neutropenia^a	<1	1	2
Bronchitis^a	0	1	2
Pneumonia^a	1	4	1
Cough	2	3	1

	UC AT WEEK 52
	Placebo N=245 (%)	RINVOQ 15 mg QD N=250 (%)	RINVOQ 30 mg QD N=251 (%)
ADVERSE REACTION
Upper respiratory tract infection^a	18	16	20
Increased blood creatine phosphokinase	2	6	8
Neutropenia^a	2	3	6
Elevated liver enzymes^b	1	6	4
Rash^a	4	5	5
Herpes zoster	0	4	4
Folliculitis	2	2	4
Hypercholesterolemia^a	1	2	4
Influenza	1	3	3
Herpes simplex^a	1	2	3
Lymphopenia^a	2	3	2
Hyperlipidemia^a	0	2	2

Crohn's: 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.

UC: 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 8 included herpes zoster and pneumonia.

^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 reactions reported in ≥2% of patients^1,*

<<Swipe table to see more

	CROHN'S AT WEEK 12
	Placebo (N=347) %	RINVOQ 45 mg QD (N=674) %
ADVERSE REACTION
Upper respiratory tract infection^a	8	13
Anemia^a	6	7
Acne^a	2	6
Pyrexia	3	4
Increased blood creatine phosphokinase	1	3
Influenza	1	3
Herpes simplex^a	1	3
Leukopenia^a	1	2
Neutropenia^a	<1	2
Herpes zoster	0	2

	UC AT WEEK 8
	Placebo (N=378) %	RINVOQ 45 mg QD (N=719) %
ADVERSE REACTION
Upper respiratory tract infection^a	7	9
Acne^a	1	6
Increased blood creatine phosphokinase	1	5
Neutropenia^a	<1	5
Elevated liver enzymes^b	2	3
Rash^a	1	4
Lymphopenia^a	1	3
Folliculitis	1	2
Herpes simplex^a	<1	2

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.

UC: 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 8 included herpes zoster and pneumonia.

^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.

IR=intolerance or inadequate response; TNFi=tumor necrosis factor inhibitor.

Long-Term Exposure Data

Long-term exposure inclusive of ~2000 patient-years¹¹

<<Swipe table to see more

	CROHN'S					ULCERATIVE COLITIS
	Week 52¹²			5.1 YEARS MAX EXPOSURE¹³		Week 52¹¹			6.3 YEARS MAX EXPOSURE¹¹
ADVERSE EVENTS OF SPECIAL INTEREST (E/100 PYs unless otherwise noted)	Placebo (N=223, PY=111.5)	RINVOQ 15 mg QD (N=221, PY=153.7)	RINVOQ 30 mg QD (N=229, PY=177.2)	RINVOQ 15 mg QD (N=221, PY=326.9)	RINVOQ 30 mg QD (N=229, PY=398.3)	Placebo (N=245, PY=135)	RINVOQ 15 mg QD (N=250, PY=199.4)	RINVOQ 30 mg QD (N=251, PY=218.5)	RINVOQ 15 mg QD (N=285, PY=622.7)	RINVOQ 30 mg QD (N=291, PY=721.9)
INFECTIONS
Serious infections	9.0	5.9	7.3	3.7	4.3	5.9	5.0	3.7	2.9	4.4
Opportunistic infection (excluding TB, herpes zoster)	0	0.7	0.6	0.6	0.3	1.5	1.0	0.9	0.3	0.6
Active TB	0	0	0	0	0	0	0	0	0	0
Herpes zoster	4.5	3.9	7.3	2.8	5.5	0	6.0	7.3	4.3	6.6
MALIGNANCY^¶
Malignancy (excluding NMSC)	0	0.7	1.1	0.6	0.8	0.7	0.5	0.9	0.6	0.6
Lymphoma	0	0	0	0	0	0	0	0	0	0
NMSC	0	0	0	0	0.5	0	0	1.4	0	1.0
CARDIOVASCULAR EVENTS^¶
Adjudicated MACE^a	0	0	0	0	0	0.7	0	0.5	0	0.4
Adjudicated VTE^b	0	0	0	0	0.3	0	1.0	0.9	0.5	0.6
GASTROENTEROLOGICAL EVENTS^¶
Adjudicated gastrointestinal perforations	0.9	0.7	0.6	0.9	0.3	0.7	0	0	0	0

Week 52 UC Data: Patients responding to 8-week induction therapy with RINVOQ 45 mg randomized into the maintenance study. Data as of 08/2023.^1,11

Long-Term Safety in UC: Patients from induction studies responding to RINVOQ 45 mg at Week 8 or 16 randomized into the maintenance study and additional time in the open-label extension study. Data as of 08/2023. UC maximum exposure: 15 mg ~6.3 years / 30 mg ~5.3 years. UC median exposure: 15 mg ~1.6 years / 30 mg ~3.0 years.

Week 52 CD Data: Patients responding to 12-week induction therapy with RINVOQ 45 mg randomized into the maintenance study. Data as of 1/2023.^1,6

Long-Term Safety in CD: Patients from induction studies responding to RINVOQ 45 mg at Week 12 randomized into the maintenance study and additional time in the open-label extension study. Data as of 08/2023. CD maximum exposures: 15 mg ~5.1 years / 30 mg ~5.3 years, CD median exposure: 15 mg ~1.0 year / 30 mg ~1.8 years.

<<Swipe table to see more

ADVERSE EVENTS OF SPECIAL INTEREST (E/100 PYs unless otherwise noted)	Placebo n=245 (%) PYs=135	RINVOQ 15 mg QD n=250 (%) PYs=199.4	RINVOQ 30 mg QD n=251 (%) PYs=218.5	RINVOQ 15 mg QD n=285 (%) PYs=622.7	RINVOQ 30 mg QD n=291 (%) PYs=721.9
	Week 52²			6.3 MAX EXPOSURE²
INFECTIONS
Serious infections	5.9	5.0	3.7	2.9	4.4
Opportunistic Infection (excluding TB, herpes zoster)	1.5	1.0	0.9	0.3	0.6
Active TB	0	0	0	0	0
Herpes Zoster	0	6.0	7.3	4.3	6.6
MALIGNANCY
Malignancy (excluding NMSC)	0.7	0.5	0.9	0.6	0.6
Lymphoma	0	0	0	0	0
NMSC	0	0	1.4	0	1.0
CARDIOVASCULAR EVENTS
Adjudicated MACE^a	0.7	0	0.5	0	0.4
Adjudicated VTE^b	0	1.0	0.9	0.5	0.6
GASTROENTEROLOGICAL EVENTS
Adjudicated gastrointestinal perforations	0.7	0	0	0	0

Week 52 Safety: Patients responding to 8 week induction therapy with RINVOQ 45 mg randomized into the maintenance study. Data as of 08/2022.

Long-term Safety: Patients from induction studies responding to RINVOQ 45 mg at Week 8 or 16 randomized into the maintenance study and additional time in the open label extension study. Data as of 08/2023. UC maximum exposure: 15 mg - 6.3 years/5.3 years. UC median exposure: 15 mg - 1.6 years / 30 mg - 3 years.

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.

<<Swipe table to see more

	U-EXCEL MIXED POPULATION^a		U-EXCEED BIOLOGIC-FAILURE POPULATION^b
Baseline Characteristics²	Placebo (N=143)	RINVOQ 45 mg (upadacitinib)(N=295)	Placebo (N=146)	RINVOQ 45 mg (upadacitinib)(N=273)
Female, %	48	44	45	47
Race (White), %	74	75	76	70
Median age, years	40.0	37.0	34.5	36.0
Median disease duration, years	5.7	6.5	9.9	9.4
Median weight, kg	68.9	67.0	64.0	64.5
Median body mass index, kg/m²	24.4	22.9	22.6	22.8
Mean very soft/liquid stool frequency	5.4	5.4	6.4	6.0
Median CDAI	313.0	297.1	322.9	314.8
Mean AP score	2.0	2.0	1.9	2.0
Median SES-CD^c	12.0	12.0	12.5	13.0
Median fecal calprotectin, μg/g	1003.0	910.5	1161.5	1107.0
Median hs-CRP, mg/L	8.1	8.7	11.4	11.8
Baseline immunosuppressant use, %	2	4	9	7
Baseline aminosalicylates use, %	28	23	16	14
Baseline corticosteroid use,^c %	38	37	36	35
BASELINE BIOLOGIC EXPERIENCE^c
Bio-naive,^d %	57	54	N/A	N/A
Bio-failure,^b %	43	46	100	100
1 bio-failure, %	27	34	36	39
2 bio-failures, %	34	34	34	29
≥3 bio-failures, %	39	32	30	32

Baseline Characteristics²(At baseline of induction)	Placebo (N=111)	RINVOQ 15 mg (upadacitinib)(N=113)	RINVOQ 30 mg (upadacitinib)(N=119)
	U-ENDURE MIXED POPULATION^a
Female, %	47	43	41
Race (White), %	74	73	66
Median age, years	34.0	33.0	32.0
Median disease duration, years	7.8	8.4	6.5
Median weight, kg	63.0	65.0	63.0
Median body mass index, kg/m²	22.7	22.2	22.1
Mean very soft/liquid stool frequency	5.9	5.7	5.6
Median CDAI	330.0	326.6	319.8
Mean AP score	2.1	2.1	2.1
Median SES-CD	15.0	16.0	14.0
Median fecal calprotectin, mg/kg	1274.0	1778.0	1739.0
Median hs-CRP, mg/L	12.9	15.2	13.2
Baseline immunosuppressant use, %	7	4	4
Baseline aminosalicylates use, %	18	20	16
Baseline corticosteroid use, %^c	41	39	38
BASELINE BIOLOGIC EXPERIENCE
Bio-naive^b, %	22	25	24
Bio-failure^c, %	78	75	76
1 bio-failure, %	37	44	36
2 bio-failures, %	26	26	31
>3 bio-failures, %	37	31	33

	U-ACHIEVE Induction		U-ACCOMPLISH Induction
Baseline Characteristics²	Placebo (N=154)	RINVOQ 45 mg (upadacitinib) 45 mg(N=319)	Placebo (N=174)	RINVOQ 45 mg(N=341)
Female, %	37	38	39	37
Race (White), %	65	65	71	69
Median age, years	45	43	42	40
Median disease duration, years	6.0	6.6	4.9	5.6
Median weight, kg	70	69	72	71
Disease extent
Left-sided, %	48	50	51	48
Extensive/pancolitis, %	52	50	49	52
Median fecal calprotectin, mg/kg	1902	1780	1552	1655
Median hs-CRP, mg/L	4.7	4.1	4.7	3.8
Baseline immunosuppressant use, %	2	1	2	<1
Baseline aminosalicylates use, %	67	69	69	68
Baseline corticosteroid use,^a %	40	39	41	35
Baseline biologic experience^a
Bio-naïve,^b %	49	47	49	50
Bio-failure, %	51	53	51	50
Baseline Adapted Mayo Score^a
≤7,%	61	61	59	60
>7,%	39	39	41	40

Baseline Characteristics²	Placebo (N=149)	RINVOQ (upadacitinib) 15 mg QD(N=148)	RINVOQ 30 mg QD(N=154)
	U-ACHIEVE Maintenance
Female, %	43	36	44
Race (White), %	62	66	66
Median age, years	40	40	41
Median disease duration, years	6.2	6.4	6.0
Median weight, kg	70	72	69
Disease extent
Left-sided, %	53	45	44
Extensive/pancolitis, %	47	55	56
Median fecal calprotectin, mg/kg	1991	1718	1465
Median hs-CRP, mg/L	4	4	4
Baseline immunosuppressant use, %	0	<1	<1
Baseline aminosalicylates use, %	66	67	69
Baseline corticosteroid use^a, %	40	37	37
Baseline biologic experience^a
Bio-naïve,^b%	46	52	53
Bio-failure, %	54	48	47

WELL-STUDIED
SAFETY
PROFILE

Approved in 9 indications¹

Safety Profile

Safety Considerations

Common Adverse Events

Long-Term Exposure Data

IMPORTANT SAFETY INFORMATION & INDICATIONS¹

INDICATIONS¹

IMPORTANT SAFETY INFORMATION FOR RINVOQ/RINVOQ LQ (upadacitinib)

SERIOUS INFECTIONS

MORTALITY

MALIGNANCIES

MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE)

THROMBOSIS

HYPERSENSITIVITY

GASTROINTESTINAL PERFORATIONS

LABORATORY ABNORMALITIES

EMBRYO-FETAL TOXICITY

VACCINATION

MEDICATION RESIDUE IN STOOL

LACTATION

HEPATIC IMPAIRMENT

ADVERSE REACTIONS

IMPORTANT SAFETY INFORMATION & INDICATIONS¹

INDICATIONS¹

IMPORTANT SAFETY INFORMATION FOR RINVOQ/RINVOQ LQ (upadacitinib)

SERIOUS INFECTIONS

MORTALITY

MALIGNANCIES

MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE)

THROMBOSIS

HYPERSENSITIVITY

GASTROINTESTINAL PERFORATIONS

LABORATORY ABNORMALITIES

EMBRYO-FETAL TOXICITY

VACCINATION

MEDICATION RESIDUE IN STOOL

LACTATION

HEPATIC IMPAIRMENT

ADVERSE REACTIONS

WELL-STUDIED SAFETY PROFILE

Approved in 9 indications1

Safety Profile

Safety Considerations

Common Adverse Events

Long-Term Exposure Data

IMPORTANT SAFETY INFORMATION & INDICATIONS1

INDICATIONS1

IMPORTANT SAFETY INFORMATION FOR RINVOQ/RINVOQ LQ (upadacitinib)

SERIOUS INFECTIONS

MORTALITY

MALIGNANCIES

MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE)

THROMBOSIS

HYPERSENSITIVITY

GASTROINTESTINAL PERFORATIONS

LABORATORY ABNORMALITIES

EMBRYO-FETAL TOXICITY

VACCINATION

MEDICATION RESIDUE IN STOOL

LACTATION

HEPATIC IMPAIRMENT

ADVERSE REACTIONS

IMPORTANT SAFETY INFORMATION & INDICATIONS1

INDICATIONS1

IMPORTANT SAFETY INFORMATION FOR RINVOQ/RINVOQ LQ (upadacitinib)

SERIOUS INFECTIONS

MORTALITY

MALIGNANCIES

MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE)

THROMBOSIS

HYPERSENSITIVITY

GASTROINTESTINAL PERFORATIONS

LABORATORY ABNORMALITIES

EMBRYO-FETAL TOXICITY

VACCINATION

MEDICATION RESIDUE IN STOOL

LACTATION

HEPATIC IMPAIRMENT

ADVERSE REACTIONS

WELL-STUDIED
SAFETY
PROFILE

Approved in 9 indications¹

IMPORTANT SAFETY INFORMATION & INDICATIONS¹

INDICATIONS¹

IMPORTANT SAFETY INFORMATION & INDICATIONS¹

INDICATIONS¹