WELL-STUDIED
SAFETY
PROFILE

INDICATIONS¹

RINVOQ is indicated for the treatment of:

Moderately to severely active rheumatoid arthritis (RA) in adults who have had an inadequate response or intolerance to one or more tumor necrosis factor (TNF) blockers.
Active ankylosing spondylitis (AS) in adults who have had an inadequate response or intolerance to one or more TNF blockers.
Active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation in adults who have had an inadequate response or intolerance to TNF blocker therapy.

Limitations of Use: RINVOQ is not recommended for use in combination with other Janus kinase (JAK) inhibitors, biologic disease-modifying antirheumatic drugs (bDMARDs), or with potent immunosuppressants such as azathioprine and cyclosporine.

RINVOQ/RINVOQ LQ is indicated for the treatment of:

Active psoriatic arthritis (PsA) in adults and pediatric patients 2 years of age and older who have had an inadequate response or intolerance to one or more TNF blockers.
Active polyarticular juvenile idiopathic arthritis (pJIA) in patients 2 years of age and older who have had an inadequate response or intolerance to one or more TNF blockers.

11 YEARS of clinical experience* & approved in 8 different indications RA, PsA, AS, nr-axSpA, AD, UC, CD & pJIA^1,2

>13,000 patients in 26 global clinical trials
across US-approved indications, including pediatric patients 2+ years in pJIA and 12+ years in AD^1,3

>37,800
patient years of exposure in
clinical trials³

>7.5 YEARS
maximum exposure in RA (~4.2 years median) to RINVOQ 15 mg as of 8/15/23^4†

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

^†In PsA: ~5.7 years maximum exposure (~3.7 years median) to RINVOQ 15 mg as of 08/2023. In AS: ~3.8 years maximum exposure (~1.7 years median) to RINVOQ 15 mg as of 08/2023. In nr‑axSpA: ~3.4 years maximum exposure (~1.1 years median) to RINVOQ 15 mg as of 08/2023.⁴

AD=atopic dermatitis; AS=ankylosing spondylitis; CD=Crohn’s disease; 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.

Learn more about these and the full Important Safety Information below

Well-Studied Safety Profile With Up to 12 Months of Data

PsA

nr-axSpA

Adverse Events of Special Interest at Weeks 12/14 and Week 52 in RA^1,5

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	Week 12/14		Week 12/14		Week 52
	Placebo-controlled trials NEXT, COMPARE, and BEYOND		MTX-controlled trials EARLY and MONOTHERAPY		Pooled 12-month data EARLY, MONOTHERAPY, NEXT, and BEYOND
TEAEs of Special Interest* n/100 PYs^a (n/PYs)	Placebo + csDMARDs n=1042	RINVOQ 15 mg QD + csDMARDs n=1035	MTX n=530	RINVOQ 15 mg QD n=534	RINVOQ 15 mg QD n=1213
INFECTIONS
Serious infections	2.3 (6/256.6)	4.6 (12/258.3)	1.6 (2/121.6)	2.4 (3/126.4)	3.5 (38/1081.6)
Active tuberculosis (TB)	0	0	0	0	0.18 (2/1089.2)
Opportunistic infection (excluding TB)	1.2 (3/256.8)	1.9 (5/258.5)	0.8 (1/121.5)	0	0.6 (7/1088.9)
Herpes zoster	1.2 (3/256.4)	2.7 (7/258.7)	1.6 (2/121.4)	4.8 (6/126.0)	3.8 (41/1073)
MALIGNANCY
Malignancy (excluding NMSC)	0.4 (1/256.8)	0.4 (1/259.3)	0.8 (1/121.6)	2.4 (3/126.8)	1.2 (13/1090.2)
Lymphoma	0	0	0	0.8 (1/126.8)	<0.1 (1/1091.6)
NMSC	0.4 (1/256.7)	0	0.8 (1/121.7)	0	0.4 (4/1090.4)
CARDIOVASCULAR EVENTS
Adjudicated VTE^b	0.4 (1/256.8)	0.8 (2/259.2)	0	0.8 (1/126.7)	0.5 (5/1090.8)
Adjudicated MACE^c	1.2 (3/256.8)	0.4 (1/259.3)	0.8 (1/121.7)	1.6 (2/126.8)	0.8 (9/1090.1)
GASTROENTEROLOGICAL EVENTS
Adjudicated GI perforations	0	0	0	0	<0.1 (1/1091.4)

Data from 5 robust phase 3 clinical trials in RA¹

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

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.

*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.⁵

Adverse Events of Special Interest at Week 24 in PsA^10,*

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	SELECT-PsA 2¹⁰ (bDMARD-IR)		SELECT-PsA 1 & SELECT-PsA 2 POOLED¹⁰ (non-bDMARD-IR & bDMARD-IR)
TEAEs of Special Interest^† n/100 PYs (n/PYs)	Placebo n=212	RINVOQ 15 mg QD n=211	Placebo n=635	RINVOQ 15 mg QD n=640
INFECTIONS
Serious infections	1.2 (1/85.1)	1.1 (1/91.9)	1.9 (5/268.0)	2.1 (6/281.2)
Active tuberculosis (TB)	0	0	0	0
Opportunistic infection (excluding TB and herpes zoster)	0	0	0	0.4 (1/281.7)
Herpes zoster	2.4 (2/84.8)	3.3 (3/91.1)	1.9 (5/267.9)	2.5 (7/280.5)
MALIGNANCY
Malignancy (excluding NMSC)	0	2.2 (2/91.8)	0	1.1 (3/281.8)
Lymphoma	0	1.1 (1/91.5)^a	0	0.4 (1/281.5)^a
NMSC	0	1.1 (1/91.8)	0.4 (1/268.4)	0.4 (1/281.8)
CARDIOVASCULAR EVENTS
Adjudicated VTE^b	0	1.1 (1/91.9)	0.4 (1/268.6)	0.4 (1/281.9)
Adjudicated MACE^c	0	1.1 (1/91.5)	0.4 (1/268.6)	0.4 (1/281.5)
GASTROENTEROLOGICAL EVENTS
Adjudicated GI perforations	0	0	0	0

Adverse Events of Special Interest at Week 14 and Week 52 in AS^17-20

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	Week 14				Week 52
	SELECT-AXIS 2 Study 1 (Phase 3; bDMARD-IR)		SELECT-AXIS 1 (Phase 2/3; bDMARD-naïve)		SELECT-AXIS 2 Study 1 (Phase 3; bDMARD-IR)
TEAEs of Special Interest*	Placebo n=209 n (%)	RINVOQ 15 mg QD n=211 n (%)	Placebo n=94 n (%)	RINVOQ 15 mg QD n=93 n (%)	Any RINVOQ 15 mg QD n=414 PYs=534.4 E (E/100 PYs)
INFECTIONS
Serious infections	0 (0.0)	5 (2)^a	0 (0.0)	0 (0.0)	24 (4.5)
Active TB	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)
Opportunistic infection (excluding TB and herpes zoster)	0 (0.0)	0 (0.0)	0 (0.0)	1 (1)^b	0 (0.0)
Herpes zoster	0 (0.0)	2 (1)^c	0 (0.0)	0 (0.0)	19 (3.6)
MALIGNANCY
Malignancy (excluding NMSC)	1 (1)^d	0 (0.0)	0 (0.0)	0 (0.0)	1 (0.2)
Lymphoma	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	1 (0.2)
NMSC	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	2 (0.4)
CARDIOVASCULAR EVENTS
Adjudicated VTE^e	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	2 (0.4)
Adjudicated MACE^f	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	1 (0.2)
GASTROENTEROLOGICAL EVENTS
Adjudicated Gl perforations	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)
Inflammatory bowel disease^g	0 (0.0)	1 (0.5)^h	1 (1.1)	0(0.0)	1 (0.2)

Adverse Events of Special Interest at Week 14 and Week 52 in nr-axSpA^22,23

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	Week 14		Week 52
	SELECT-AXIS 2 Study 2 (Phase 3; mixed*)		SELECT-AXIS 2 Study 2 (Phase 3; mixed*)
TEAEs of Special Interest^†	Placebo n=157 n (%)	RINVOQ 15 mg QD n=156 n (%)	Placebo n=157 PYs=140.2 E (E/100 PYs)	RINVOQ 15 mg QD n=156 PYs=137.4 E (E/100 PYs)
INFECTIONS
Serious infections	1 (1)^a	2 (1)^b	1 (0.7)	2 (1.5)
Active (TB)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)
Opportunistic infection (excluding TB and herpes zoster)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)
Herpes zoster	1 (1)	2 (1)^c	1 (0.7)	5 (3.6)
MALIGNANCY
Malignancy (excluding NMSC)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)
Lymphoma	0 (0.0)	0 (0.0)	0 (0.0)	1 (0.7)
NMSC	1 (1)^d	0 (0.0)	1 (0.7)	0 (0.0)
CARDIOVASCULAR EVENTS
Adjudicated VTE^e	0 (0.0)	0 (0.0)	2 (1.4)	0 (0.0)
Adjudicated MACE^f	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)
GASTROINTESTINAL EVENTS
Adjudicated GI perforations	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)
Inflammatory bowel disease^g	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)

Safety Considerations

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

Consistent Safety Profile of AEs Observed in Long-Term Analysis

PsA

nr-axSpA

RA Phase 3 Program AEs^4,6-8,*
Any RINVOQ 15 mg QD^†

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Data as of August 15, 2023⁴
TEAEs of Special Interest^‡ (E/100 PYs unless otherwise stated)	2.8 yrs. max. exposure(1.4 yrs. median) Data as of November 14, 2018 n=2630, PYs=3446.2	~6.5 yrs. max. exposure(~4 yrs. median) Data as of August 15, 2022 n=3209, PYs=10782.7	~7.5 yrs. max. exposure(-4.2 yrs. median) n=3209, PYs=11661.5
	INFECTIONS
Serious infections	3.5	3.6	3.6
Active tuberculosis (TB)	0.1	<0.1	<0.1
Opportunistic infection (excluding TB, herpes zoster, and oral candidiasis)	0.3	0.3	0.3
Herpes zoster	3.5	3.2	3.2
MALIGNANCY^a
Malignancy (excluding NMSC)	0.8	0.7	0.7
Lymphoma	<0.1	<0.1	<0.1
NMSC	0.3	0.4	0.4
CARDIOVASCULAR EVENTS^a
Adjudicated VTE^b	0.6	0.4	0.4
Adjudicated MACE^c	0.6	0.3	0.3
GASTROENTEROLOGICAL EVENTS^a
Adjudicated GI perforations	0.1	<0.1	<0.1

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. Other adverse reactions reported in less than 1% of patients in the RINVOQ 15 mg group and at a higher rate than in the placebo group through Week 12 included pneumonia, herpes zoster, herpes simplex (includes oral herpes), and oral candidiasis.

PsA Phase 3 Program AEs^4,11-15
Any RINVOQ 15 mg QD*

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Data as of August 15, 2023⁴
TEAE of Special Interest^† (E/100 PYs unless otherwise stated)	~3 yrs. max. exposure(-1.3 yrs. median) Data as of June 30, 2020 n=907, PYs=1247.2	~4 yrs. max. exposure(-2.3 yrs. median) Data as of June 30, 2021 n=907, PYs=1872.3	~5.7 yrs. max. exposure(-3.7 yrs. median) n=907, PYs=2823.7
	INFECTIONS
Serious infection	2.3	3.9	3.3
Active tuberculosis (TB)	0	0	0
Opportunistic infection (excluding TB, herpes zoster, and oral candidiasis)	0.4	0.5	0.4
Herpes zoster	3.8	3.6	3.1
MALIGNANCY^a
Malignancy (excluding NMSC)	0.7	0.6	0.7
Lymphoma^b	0.2	0.1	0.1
NMSC	0.7	0.6	0.7
CARDIOVASCULAR EVENTS^a
Adjudicated VTE^c	0.3	0.2	0.2
Adjudicated MACE^d	0.3	0.3	0.4
GASTROENTEROLOGICAL EVENTS^a
Adjudicated Gl perforations	<0.1	0.1	<0.1

No Warnings or Precautions for IBD
with RINVOQ in the FDA-approved label.^1†

BOXED WARNING on Serious Infections, Mortality, Malignancies, Major Adverse Cardiovascular Events, and Thrombosis with additional Warnings and Precautions including Hypersensitivity reactions, Gastrointestinal perforations, Lab abnormalities, Embryo-fetal toxicity, Vaccinations, and Medication residue in stool.

^†Does not preclude events from occurring in RINVOQ-treated patients.

AS Phase 2/3 & 3 Program AEs⁴
Any RINVOQ 15 mg QD

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Data as of August 15, 2023⁴
TEAEs of Special Interest* (E/100 PYs unless otherwise stated)	~3.8 years max. exposure (-1.7 years median) n=596, PYs=1022.2
	INFECTIONS^a
Serious infections	2.4
Active tuberculosis (TB)	0
Opportunistic infection (excluding TB, herpes zoster, and oral candidiasis)	0.2
Herpes zoster	3.1
MALIGNANCY^a
Malignancy (excluding NMSC)	0.2
Lymphoma	<0.1
NMSC	0.3
CARDIOVASCULAR EVENTS^a
Adjudicated VTE^b	0.3
Adjudicated MACE^c	0.2
GASTROENTEROLOGICAL EVENTS^a
Adjudicated GI perforations	0
IBD^d	0.2

No Warnings or Precautions for IBD
with RINVOQ in the FDA-approved label.^1†

^†Does not preclude events from occurring in RINVOQ-treated patients.

nr-axSpA Phase 3 Program AEs⁴

Data as of August 15, 2023⁴
TEAEs of Special Interest* (E/100 PYs unless otherwise stated)	RINVOQ 15 mg QD ~3.4 years max. exposure (~1.1 years median) n=286, PYs=388.4
	INFECTIONS
Serious infections	1.3
Active tuberculosis (TB)	0
Opportunistic infection (excluding TB, herpes zoster, and oral candidiasis)	0.3
Herpes zoster	2.6
MALIGNANCY^a
Malignancy (excluding NMSC)	0.3
Lymphoma	0.3
NMSC	0.3
CARDIOVASCULAR EVENTS^a
Adjudicated VTE^b	0.8
Adjudicated MACE^c	0.5
GASTROENTEROLOGICAL EVENTS^a
Adjudicated GI perforations	0
IBD^d	0.3

No Warnings or Precautions for IBD
with RINVOQ in the FDA-approved label.^1†

^†Does not preclude events from occurring in RINVOQ-treated patients.

Explore Long-Term Safety Data Across Indications

Review Safety

Well-Studied Safety Profile

Most Common Adverse Reactions From RINVOQ Clinical Trials

PsA

nr-axSpA

RHEUMATOID ARTHRITIS¹
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.

ADVERSE REACTION	Placebo^a n=1042 (%)	RINVOQ 15 mg QD^a n=1035 (%)
Upper respiratory tract infection (URTI)^b	9.5	13.5
Nausea	2.2	3.5
Cough	1.0	2.2
Pyrexia	0	1.2

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 mg⁹
In the 12-month exposure dataset, the incident rate of infection was 83.8 per 100 patient-years for patients treated with RINVOQ 15 mg⁹

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

PSORIATIC ARTHRITIS¹⁰
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.

ADVERSE REACTION	Placebo^a n=635 (%)	RINVOQ 15 mg QD^a n=640 (%)
Upper respiratory tract infection (URTI)^b	6.9	8.9
Bronchitis	2.2	3.8
Cough	1.6	2.5
Nausea	2.4	2.0
Herpes simplex^c	1.2	1.4
Acne	0.3	1.3
Herpes zoster	0.8	1.1

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 mg¹⁶

ANKYLOSING SPONDYLITIS²¹
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.²¹

ADVERSE REACTION	Placebo^a n=209 (%)	RINVOQ 15 mg QD^a n=211 (%)
COVID-19	1.9	3.3
Headache	1.4	3.3
Neutropenia	0.5	2.8
Hyperuricemia	0	2.4
Nasopharyngitis	1.4	2.4

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 mg¹⁷

NON-RADIOGRAPHIC AXIAL SPONDYLOARTHRITIS²⁴
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.²⁴

ADVERSE REACTION	Placebo^a n=157 (%)	RINVOQ 15 mg QD^a n=156 (%)
Headache	2.5	5.8
Nausea	1.9	3.2
Abdominal pain	0.6	2.6
Diarrhea	1.9	2.6
Neutropenia	0	2.6

^anr-axSpA patients could be on background NSAIDs.

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 mg²²

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MEAN (SD) OR N (%)	PBO + csDMARDs n=169	RINVOQ 15 mg + csDMARDs n=164
Female, n (%)	143 (85)	137 (84)
Age (years), mean (SD)	57.6 (11.4)	56.3 (11.3)
Duration since RA diagnosis (years), mean (SD)	14.5 (9.2)	12.4 (9.4)
RF+ and/or ACPA+, n (%)	128 (76)	131 (80)
csDMARD use at baseline*
- MTX alone,^† n (%)	122 (73)	118 (73)
- MTX plus other csDMARD,^‡ n (%)	17 (10)	19 (12)
- MTX dose^§ (mg), mean (SD)	16.6 (4.7)	17.3 (4.6)
- csDMARD other than MTX, n (%)	29 (17)	24 (15)
- Missing, n	1	3
Prior bDMARD exposure
- 1, n (%)	83 (49)	86 (52)
- 2, n (%)	46 (27)	40 (24)
- ≥3, n (%)	40 (24)	38 (23)
Inadequate response or intolerance to ≥1 anti-TNF drug	152 (90)	146 (89)
- Lack of efficacy with ≥1 bDMARD	159 (94)	146 (89)
- Lack of efficacy with ≥1 anti-IL-6	30 (18)	27 (16)
Oral glucocorticoid use, n (%)	74 (44)	83 (51)
- Oral glucocorticoid dose^ll (mg), mean (SD)	6.3 (2.4)	5.7 (2.4)
TJC68, mean (SD)	28.5 (15.3)	27.8 (16.3)
SJC66, mean (SD)	16.3 (9.6)	17.0 (10.8)
PtGA (0-100 mm VAS), mean (SD)	66.3 (22.7)	67.2 (19.6)
PhGA (0-100 mm VAS), mean (SD)	66.9 (16.9)	68.7 (16.6)
Pain (0-100 mm VAS), mean (SD)	68.9 (21.0)	68.2 (19.8)
hsCRP (mg/L), mean (SD)	16.3 (21.1)	16.2 (18.6)
DAS28-CRP, mean (SD)	5.8 (1.0)	5.9 (1.0)
HAQ-DI, mean (SD)	1.6 (0.6)	1.7 (0.6)
CDAI, mean (SD)	41.0 (13.3)	41.7 (13.3)
SDAI, mean (SD)	42.6 (13.9)	43.3 (13.8)

MEAN (SD) OR N (%)	MTX n=314	RINVOQ 15 mg QD n=317
Female, n (%)	240 (76)	241 (76)
Age (years), mean (SD)	53.3 (12.9)	51.9 (12.6)
Duration since RA diagnosis (years), mean (SD)	2.6 (5.1)	2.9 (5.4)
RF+ and/or ACPA+, n (%)	255 (81)	279 (88)
MTX exposure, n (%)	19 (6)	30 (9.5)
csDMARD exposure, n (%)	79 (25)	80 (25)
Oral glucocorticoid use, n (%)	163 (52)	147 (46)
- Dose (mg),* mean (SD)	6.4 (2.4)	6.4 (3.1)
TJC68, mean (SD)	26.4 (16.2)	25.4 (14.4)
SJC66, mean (SD)	16.9 (10.6)	16.9 (10.4)
PtGA (0-100 mm VAS), mean (SD)	65.8 (21.5)	66.6 (22.0)
PhGA (0-100 mm VAS), mean (SD)	68.7 (16.5)	67.1 (17.0)
Pain (0-100 mm VAS), mean (SD)	65.7 (21.5)	68.4 (20.6)
hsCRP (mg/L), mean (SD)	21.2 (22.1)	23.0 (27.4)
DAS28-CRP, mean (SD)	5.9 (1.0)	5.9 (1.0)
HAQ-DI, mean (SD)	1.6 (0.7)	1.6 (0.7)
CDAI, mean (SD)	40.5 (13.3)	40.4 (13.3)
SDAI, mean (SD)	42.6 (14.0)	42.7 (13.9)
mTSS, mean (SD)	13.3 (30.6)	18.1 (38.2)
- Erosion Score, mean (SD)	6.1 (15.5)	8.6 (19.3)
- Joint Space Narrowing Score, mean (SD)	7.2 (16.2)	9.6 (20.1)

MEAN (SD) OR N (%)	cMTX n=216	RINVOQ 15 mg QD n=217
Female, n (%)	179 (83)	174 (80)
Age (years), mean (SD)	55.3 (11.1)	54.5 (12.2)
Duration since RA diagnosis (years), mean (SD)	5.8 (6.6)	7.5 (8.9)
RF+ and/or ACPA+, n (%)	169 (78)	172 (79)
*Prior MTX dose (mg/week),** mean (SD)	16.7 (4.4)	16.8 (4.2)
Prior MTX duration (years), mean (SD)	3.3 (3.9)	3.8 (4.8)
Oral glucocorticoid use, n (%)	115 (53)	114 (53)
- Oral glucocorticoid dose^† (mg), mean (SD)	6.2 (2.6)	6.1 (2.5)
TJC68, mean (SD)	25.2 (16.0)	24.5 (15.1)
SJC66, mean (SD)	16.9 (11.5)	16.4 (10.9)
PtGA (0-100 mm VAS), mean (SD)	59.6 (21.8)	62.2 (22.3)
PhGA (0-100 mm VAS), mean (SD)	62.1 (17.5)	65.7 (18.5)
Pain (0-100 mm VAS), mean (SD)	62.5 (21.3)	62.3 (22.5)
hsCRP (mg/L), mean (SD)	14.5 (17.3)	14.0 (16.5)
DAS28-CRP, mean (SD)	5.6 (1.0)	5.6 (0.9)
HAQ-DI, mean (SD)	1.5 (0.7)	1.5 (0.7)
CDAI, mean (SD)	37.8 (14.4)	38.0 (13.1)
SDAI, mean (SD)	39.2 (14.6)	39.4 (13.4)

MEAN (SD) OR N (%)	PBO + csDMARDs n=221	RINVOQ 15 mg QD + csDMARDs n=221
Female, n (%)	166 (75)	182 (82)
Age (years), mean (SD)	56.0 (12.2)	55.3 (11.5)
Duration since RA diagnosis (years), mean (SD)	7.2 (7.5)	7.3 (7.9)
RF+ and/or ACPA+, n (%)	181 (82)	184 (83)
csDMARD use at baseline
- MTX alone, n (%)	141 (64)	122 (55)
- MTX plus other csDMARD, n (%)	49 (22)	47 (21)
- csDMARD other than MTX, n (%)	30 (14)	51 (23)
- Missing, n (%)	1 (<1)	1 (<1)
Prior bDMARD exposure, n (%)	29 (13)	27 (12)
Oral glucocorticoid use, n (%)	106 (48)	96 (43)
- Oral glucocorticoid dose* (mg), mean (SD)	6.3 (2.6)	6.0 (2.4)
TJC68, mean (SD)	24.7 (15.0)	25.2 (13.8)
SJC66, mean (SD)	15.4 (9.2)	16.0 (10.0)
PtGA (0-100 mm VAS), mean (SD)	60.3 (20.5)	63.1 (21.9)
PhGA (0-100 mm VAS), mean (SD)	64.4 (17.7)	64.3 (16.2)
Pain (0-100 mm VAS), mean (SD)	61.5 (20.8)	64.1 (19.5)
hsCRP (mg/L), mean (SD)	12.6 (14.0)	16.6 (19.2)
DAS28-CRP, mean (SD)	5.6 (0.8)	5.7 (1.0)
HAQ-DI, mean (SD)	1.4 (0.6)	1.5 (0.6)
CDAI, mean (SD)	37.8 (11.8)	38.3 (11.9)
SDAI, mean (SD)	39.0 (11.9)	39.9 (12.5)

MEAN (SD) OR N (%)	PBO + MTX n=651	RINVOQ 15 mg QD + MTX n=651
Female, n (%)	512 (79)	521 (80)
Age (years), mean (SD)	54 (12)	54 (12)
Duration since RA diagnosis (years), mean (SD)	8 (8)	8 (8)
RF+ and/or anti-CCP+, n (%)	571 (88)	566 (87)
MTX dose (mg/week), mean (SD)	16.8 (3.8)	17.0 (4.2)
Prior bDMARD use, n (%)	63 (10)	54 (8)
Oral glucocorticoid use, n (%)	392 (60)	388 (60)
- Dose (mg),* mean (SD)	6.3 (2.4)	6.2 (2.3)
TJC68, mean (SD)	26 (14)	26 (15)
SJC66, mean (SD)	16 (9)	17 (10)
PtGA (0-100 mm VAS), mean (SD)	64 (21)	64 (22)
PhGA (0-100 mm VAS), mean (SD)	66 (18)	66 (17)
Pain (0-100 mm VAS), mean (SD)	65 (21)	66 (21)
hsCRP (mg/L), mean (SD)	18 (22)	18 (22)
DAS28-CRP, mean (SD)	5.8 (0.9)	5.8 (1.0)
HAQ-DI, mean (SD)	1.6 (0.6)	1.6 (0.6)
CDAI, mean (SD)	40 (13)	40 (13)
SDAI, mean (SD)	41.8 (13.3)	41.5 (13.6)
mTSS, mean (SD)	36 (52)	34 (50)
- JE score, mean (SD)	17 (27)	17 (26)
- JSN score, mean (SD)	19 (26)	18 (25)

MEAN (SD) OR N (%)	Placebo n=212	RINVOQ 15 mg QD n=211
Female, n (%)	120 (56.6)	113 (53.6)
Age (years), mean (SD)	54.1 (11.5)	53.0 (12.0)
Race, n (%)
- White	186 (87.7)	183 (86.7)
- Black or African American	7 (3.3)	5 (2.4)
- American Indian/Alaska Native	0	3 (1.4)
- Native Hawaiian or other Pacific Islander	1 (0.5)	1 (0.5)
- Asian	17 (8.0)	19 (9.0)
- Multiple	1 (0.5)	0
Duration of PsA symptoms (years), mean (SD)	14.6 (11.7)	12.2 (8.8)
Duration since PSA diagnosis (years), mean (SD)	11.0 (10.3)	9.6 (8.4)
Number of prior failed biologic DMARDs, n (%) Total population included ~78% of patients with prior inadequate response to TNF inhibitors
- 0*	18 (8.5)	16 (7.6)
- 1	135 (63.7)	126 (59.7)
- 2	35 (16.5)	35 (16.6)
- ≥3	24 (11.3)	34 (16.1)
Monotherapy, n (%)	112 (52.8)	113 (53.6)
Any non-biologic DMARD at baseline, n (%)
- MTX alone	75 (35.4)	74 (35.1)
- MTX + another nonbiologic DMARD	7 (3.3)	6 (2.8)
- Non-biologic DMARD other than MTX	18 (8.5)	18 (8.5)
MTX dose for patients with concomitant MTX alone at baseline (mg/week)
- Mean	16.3	15.1
- Median	17.5	15.0
Steroid use at baseline, n (%)	24 (11.3)	22 (10.4)
NSAID use at baseline, n (%)	125 (59.0)	124 (58.8)
RF status positive, n (%)	6 (2.8)	11 (5.2)
Anti-CCP status positive, n (%)	10 (4.7)	7 (3.3)
TJC68, mean (SD)	25.3 (17.6)	24.9 (17.3)
SJC66, mean (SD)	12.0 (8.9)	11.3 (8.2)
hsCRP >ULN^† (mg/L), n (%)	121 (57.1)	126 (59.7)
hsCRP (mg/L), mean (SD)	10.4 (18.5)	11.2 (18.5)
HAQ-DI, mean (SD)	1.2 (0.7)	1.1 (0.6)
Patient's assessment of pain (NRS 0-10), mean (SD)	6.6 (2.1)	6.4 (2.1)
≥3% BSA-Psoriasis, n (%)	131 (61.8)	130 (61.6)
- PASI, mean (SD)	11.7 (11.4)	10.1 (9.2)
BSA-Psoriasis >0%, n (%)	198 (93.4)	202 (95.7)
BSA-Psoriasis (for baseline >0%), mean (SD)	12.8 (18.4)	10.0 (15.7)
LEI >0, n (%)	144 (67.9)	133 (63.0)
LDI >0, n (%)	64 (30.2)	55 (26.1)

MEAN (SD) OR N (%)	Placebo n=423	RINVOQ 15 mg QD n=429
Female, n (%)	211 (49.9)	238 (55.5)
Age (years), mean (SD)	50.4 (12.2)	51.6 (12.2)
White race, n (%)	377 (89.1)	386 (90.0)
BMI ≥25 kg/m², n (%)	329 (77.8)	342 (79.7)
Duration since PsA diagnosis (years), mean (SD)	6.2 (7.0)	6.2 (7.4)
Any non-biologic DMARD at baseline, n (%)	347 (82.0)	353 (82.3)
- MTX alone, n (%)	267 (63.1)	279 (65.0)
- MTX + another non-biologic DMARD, n (%)	26 (6.1)	20 (4.7)
- Non-biologic DMARD other than MTX, n (%)	54 (12.8)	54 (12.6)
Glucocorticoid use at baseline, n (%)	70 (16.5)	73 (17.0)
TJC68, mean (SD)	20.0 (14.3)	20.4 (14.7)
SJC66, mean (SD)	11.0 (8.2)	11.6 (9.3)
*hsCRP >ULN (mg/L),** n (%)	324 (76.6)	324 (75.5)
HAQ-DI, mean (SD)	1.1 (0.6)	1.2 (0.7)
Patient's assessment of pain (NRS 0-10), mean (SD)	6.1 (2.1)	6.2 (2.1)
≥3% BSA-Psoriasis, n (%)	211 (49.9)	214 (49.9)
- PASI, mean (SD)	11.2 (11.4)	9.8 (10.0)
LEI >0, n (%)	241 (57.0)	270 (62.9)
LDI >0, n (%)	126 (29.8)	136 (31.7)
PtGA - Disease Activity (NRS), mean (SD)	6.3 (2.04)	6.6 (2.03)
mTSS, mean (SD)	13.3 (31.2)	13.1 (42.4)
Joint space narrowing score, mean (SD)	7.31 (16.4)	7.08 (21.1)
Joint erosion score, mean (SD)	6.01 (15.5)	6.04 (21.8)

MEAN (SD) or N (%)	Placebo n=209	RINVOQ 15 mg QD n=211
Male, n (%)	158 (76%)	153 (73%)
Female, n (%)	51 (24%)	58 (27%)
Age, mean years (SD)	42.2 (11.8)	42.6 (12.4)
Body mass index, kg/m², mean (SD)	26.4 (5)	27.2 (5.7)
Race, n (%)
- White	169 (81%)	168 (80%)
- Asian	37 (18%)	42 (20%)
- African American	3 (1%)	1 (0.5%)
Region, n (%)
- North America	25 (12%)	25 (12%)
- South/Central America	14 (7%)	13 (6%)
- Western Europe	25 (12%)	16 (8%)
- Eastern Europe	98 (47%)	109 (52%)
- Asia*	34 (16%)	41 (19%)
- Other^†	13 (6%)	7 (3%)
HLA-B27 positive, n (%)	168 (81%)	180 (85%)
Duration since ankylosing spondylitis diagnosis, mean years (SD)	7.5 (7.5)	7.9 (7.5)
Duration of ankylosing spondylitis symptoms, mean years (SD)	12.6 (9.3)	12.9 (9.1)
Baseline medication use, mean years (SD)
- NSAIDs	163 (78%)	163 (77%)
- Oral corticosteroids	18 (9%)	27 (13%)
- csDMARDs	62 (30%)	68 (32%)
- Opioids	14 (6.7%)	9 (4.3%)
Prior bDMARD use, n (%)
- One TNF inhibitor	158 (76%)	154 (73%)
- One IL-17 inhibitor	24 (11%)	29 (14%)
- Two bDMARDs	26 (12%)	28 (13%)
- Missing (no prior bDMARD use)	1 (0.5%)	0
Total back pain (NRS 0-10), mean (SD)	7.4 (1.4)	7.5 (1.5)
Nocturnal back pain (NRS 0-10),^‡ mean (SD)	7.2 (1.5)	7.1 (1.8)
Patient global assessment of disease activity (NRS 0-10), mean (SD)	7.2 (1.4)	7.4 (1.5)
Inflammation (NRS 0-10), mean (SD)	6.8 (1.6)	6.9 (1.8)
ASDAS (CRP), mean (SD)	3.9 (0.8)	3.9 (0.8)
BASDAI score, mean (SD)	6.8 (1.3)	6.8 (1.3)
SPARCC MRI spine score (0-108),^§ mean (SD)	8.8 (12.5)	10.7 (15.4)
SPARCC MRI sacroiliac joint score (0-72),^§ mean (SD)	5.6 (10.6)	5.0 (10.8)
hsCRP at screening, mg/L, mean (SD)	14.5 (17.8)	15.8 (17.7)
hsCRP >ULN (2.87 mg/L) at screening, n (%)	163 (78%)	165 (78%)

MEAN (SD) or N (%)	Placebo n=157	RINVOQ 15 mg QD n=156
Male, n (%)	63 (40%)	67 (43%)
Female, n (%)	94 (60%)	89 (57%)
Age, mean years (SD)	42.5 (12.4)	41.6 (12.0)
Body mass index, kg/m², mean (SD)	27.7 (5.2)	28.2 (6.4)
Race, n (%)
- White	127 (81%)	134 (86%)
- Asian	28 (18%)	19 (12%)
- African American	1 (1%)	2 (1%)
- American Indian or Alaskan Native	0	1 (1%)
- Multiple	1 (1%)	0
Region, n (%)
- North America	19 (12%)	26 (17%)
- South/Central America	13 (8%)	12 (8%)
- Western Europe	19 (12%)	24 (15%)
- Eastern Europe	72 (46%)	68 (44%)
- Asia*	27 (17%)	19 (12%)
- Other^†	7 (5%)	7 (5%)
HLA-B27 positive, n (%)	93 (60%)	90 (59%)
Duration since nr-axSpA diagnosis, mean years (SD)	4.4 (5.8)	4.5 (5.5)
Duration of nr-axSpA symptoms, mean years (SD)	9.2 (8.1)	9.0 (7.9)
Baseline medication use, mean years (SD)
- NSAIDs	113 (72%)	121 (78%)
- Oral corticosteroids	17 (11%)	18 (12%)
- csDMARDs	50 (32%)	41 (26%)
- Opioids	18 (11.5%)	6 (3.8%)
Prior bDMARD use,^‡ n (%)	54 (34%)	49 (31%)
- One TNF inhibitor, n (%)	40 (25.5%)	44 (28.2%)
- One IL-17 inhibitor, n (%)	11 (7.0%)	5 (3.2%)
Total back pain (NRS 0-10), mean (SD)	7.3 (1.4)	7.2 (1.6)
Nocturnal back pain (NRS 0-10),^§ mean (SD)	7.0 (1.6)	6.7 (1.9)
Patient Global Assessment of disease activity (NRS 0-10), mean (SD)	7.3 (1.4)	7.0 (1.6)
Inflammation (NRS 0-10),^\|\| mean (SD)	6.7 (1.7)	6.6 (1.8)
ASDAS (CRP), mean (SD)	3.7 (0.6)	3.6 (0.7)
SPARCC MRI sacroiliac joint score (0-72),^¶ mean (SD)	3.5 (7.6)	4.4 (8.7)
SPARCC MRI spine score (0-108),^¶ mean (SD)	1.4 (3.7)	2.7 (6.9)
BASDAI score, mean (SD)	6.9 (1.2)	6.8 (1.3)
BASFI, mean (SD)	6.0 (2.1)	5.9 (2.1)
hsCRP >ULN (2.87 mg/L) at screening, mean (SD)	10.5 (13.5)	13.6 (24.8)
MRI-negative and hsCRP-positive,** n (%)	91 (58%)	86 (55%)
MRI-positive and hsCRP-negative,** n (%)	31 (20%)	32 (21%)
MRI-positive and hsCRP-positive,** n (%)	35 (22%)	38 (24%)

MEAN (SD) unless otherwise stated	RINVOQ 15 mg pooled (N=3209, 11661.5 PY)
Parameter
Age (years)	54.3 (12.0)
Age ≥65 years	643 (20.0)
Female, n (%)	2581 (80.4)
BMI	29.1 (6.7)
Time since RA diagnosis (years)	8.5 (8.4)
Concomitant therapies, n (%)
Concomitant MTX alone	2180 (67.9)
Concomitant csDMARD other than MTX	198 (6.2)
Concomitant NSAIDs	2032 (63.3)
Concomitant csDMARDs	2548 (79.4)
Concomitant steroids	1757 (54.8)
Patient history, n (%)
Contraceptive use at baseline (Females only)	216 (8.4)
Prior bDMARD use	979 (30.5)
Seropositive (RF or ACPA)	2707 (84.4)
CRP (mg/L)	17.8 (21.6)
DAS28-CRP^a	5.8 (1.0)
History of HZ	71 (2.2)
HZ vaccination	92 (2.9)
History of VTE	53 (1.7)
History of CV event^b	385 (12.0)
*Number of CV risk factors,** n (%)
0	738 (23.0)
1	1072 (33.4)
2	883 (27.5)
3	396 (12.3)
4+	120 (3.7)
CV risk factors at baseline, n (%)
History of hypertension	1302 (40.6)
Diabetes mellitus	383 (11.9)
History of tobacco/nicotine use (current + former)	1223 (38.1)
Elevated LDL-C^c	869 (27.2)
Lowered HDL-C^d	354 (11.0)
Statin use	321 (10.0)

MEAN (SD) unless otherwise stated As of date	UPA 15 mg QD (N=907, PYs=2426.4) 08/2022
Parameter
Age (years)	51.5 (12.1)
Age ≥65 years	129 (14.2)
Female, n (%)	478 (52.7)
BMI (kg/m²)	30.6 (6.9)
Time since RA diagnosis (years)	7.2 (7.8)
Concomitant therapies, n (%)
csDMARD(s)	652 (71.9)
MTX alone	517 (57.0)
csDMARD other than MTX	99 (10.9)
Corticosteroids	134 (14.8)
NSAIDs	565 (62.3)
Statin use	123 (13.6)
Oral contraceptive (females only), n (%)	34/478 (7.1)
Patient history, n (%)
HZ	27 (3.0)
HZ vaccination	35 (3.9)
VTE	23 (2.5)
*Number of CV risk factors,** n (%)
0	149 (16.4)
1	306 (33.7)
2	253 (27.9)
3	152 (16.8)
4+	47 (5.2)
Presence of any CV risk factor^a	758 (83.6)
Prior CV event	119 (13.1)
History of hypertension	403 (44.4)
Diabetes mellitus	124 (13.7)
Tobacco/nicotine use^b	385 (42.4)
Elevated LDL-C^c	253 (28.7)
Lowered HDL-C^d	176 (19.6)

MEAN (SD) unless otherwise stated	RINVOQ 15 mg pooled (N=596, PYs=1022.2)
Parameter
Age (years)	43 (12.3)
Age ≥65 years	32 (5.4)
Female, n (%)	162 (27.2)
BMI (kg/m²)	26.8 (5.2)
Years since AS diagnosis	7.4 (7.9)
Concomitant therapies, n (%)
MTX alone	47 (7.9)
csDMARD other than MTX	78 (13.1)
NSAIDs	471 (79.0)
csDMARDs	129 (21.6)
Steroids	59 (9.9)
Patient history, n (%)
Oral contraceptive (females only)	36/162 (22.2)
History of HZ	10 (1.7)
HZ vaccination	11 (1.8)
History of VTE	1 (0.2)
Number of CV risk factors,* n (%)
0	142 (23.8)
1	208 (34.9)
2	174 (29.2)
3	59 (9.9)
4+	13 (2.2)
CV risk factors at baseline, n (%)
History of CV event	62 (10.4)
History of hypertension	117 (19.6)
Diabetes mellitus	24 (4.0)
Tobacco/nicotine use (current/former)	264 (44.3)
Elevated LDL-C^b	186 (31.3)
Lowered HDL-C^c	135 (22.7)
Statin use	17 (2.9)

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