RAPID & DURABLE
DISEASE CONTROL IN nr-axSpA

Not an actual AS or nr-axSpA patient

RINVOQ achieved its primary endpoint of ASAS40 at Week 14 vs placebo,
and responses observed at Week 2, up to 2 years.^1-3

INDICATION

RINVOQ is indicated for the treatment of adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation who have had an inadequate response or intolerance to tumor necrosis factor (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.

NRI-MI Data From SELECT-AXIS 2 Study 2: nr-axSpA (mixed*)^1,2,4

RINVOQ 15 mg (n=156), placebo (n=157)

ASAS40 | PRIMARY ENDPOINT

45%^† RINVOQ vs 22% placebo at Week 14

*Mixed=67% bDMARD-naïve & 33% bDMARD-IR.
^†P<0.0001.²
RINVOQ is indicated for TNFi-IR patients.¹

SELECT-AXIS 2 Study 2: nr-axSpA Design Intro^1,2: 52-week, double-blind, placebo‑controlled Phase 3 study of 313 patients with nr-axSpA and one objective sign of active inflammation based on MRI of the sacroiliac joints and/or hsCRP greater than the upper limit of normal (ULN; 2.87 mg/L). Patients had an intolerance or inadequate response to at least 2 NSAIDs and, in 33%, to 1 bDMARD. Patients were randomized to receive RINVOQ 15 mg once daily or placebo. Patients could continue background NSAIDs.

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

Rapid and Durable ASDAS-Low Disease Activity Rates Up to 2 Years^2-4

NRI-MI Data From SELECT-AXIS 2 Study 2: nr-axSpA (mixed*)^2,3

RINVOQ 15 mg (n=156), placebo (n=157)

ASDAS-CRP LDA | RANKED SECONDARY ENDPOINT

42%^† RINVOQ vs 18% placebo at Week 14

INACTIVE DISEASE ACTIVITY | RANKED SECONDARY ENDPOINT

14% RINVOQ vs 5% placebo at Week 14

*Mixed=67% bDMARD-naïve & 33% bDMARD-IR.

^†P<0.0001.

3 Out of 4 (75%) RINVOQ Patients Achieved ASDAS-LDA at 2 Years^3,4

SELECT-AXIS 2 Study 2: mixed patients^3,4*
ALL DATA ARE AS OBSERVED

Durable efficacy of RINVOQ 15 mg over time in Select-Axis 2 study 1 (nr-axSpA -ASDAS-CRP): Percentage of patients achieving LDA, plotted against weeks. Notable points: Week 14 (49% and Placebo 20%), Week 52 (70%), Week 104 or 2 years (75%).

*Mixed=67% bDMARD-naïve & 33% bDMARD-IR.²

BASED ON A POST HOC ANALYSIS:
In patients who achieved ASDAS-LDA at Weeks 14 and 52 (n=53/156),

MAINTAINED LDA RESPONSE AT 2 YEARS (OLE) (AO)^5†

^†DATA LIMITATIONS: Post hoc analysis was not included as a prespecified ranked endpoint or controlled for multiplicity. Therefore, no clinical or statistical conclusions can be drawn.

As Observed (AO) analysis: Patients with missing data at a specific time are not included, which may enrich the population and increase the response rates.

OLE LIMITATIONS: There is potential for enrichment of OLE data; unblinding patients may cause bias related to the overall treatment effect.

Achieving ASDAS-Low Disease Activity May Indicate Disease Control, Making It a Measure to Strive for in Patients With nr-axSpA

Distribution of RINVOQ Patients by ASDAS-CRP State at Baseline and Week 104

SELECT-AXIS 2 Study 2: mixed patients^3,6*

ALL DATA ARE AS OBSERVED | Open-Label Extension (OLE)

RINVOQ is indicated for TNFi-IR patients.

*Mixed=67% bDMARD-naïve & 33% bDMARD-IR.²

Safety Considerations

Serious Infections: RINVOQ-treated patients are at increased risk of serious bacterial (including tuberculosis [TB]), fungal, viral, and opportunistic infections leading to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants, such as methotrexate or corticosteroids.

Mortality: A higher rate of all-cause mortality, including sudden cardiovascular (CV) death, was observed with a Janus kinase inhibitor (JAKi) in a study comparing another JAKi with tumor necrosis factor (TNF) blockers in rheumatoid arthritis (RA) patients ≥50 years with ≥1 CV risk factor.

Malignancies: Malignancies have occurred in RINVOQ-treated patients. A higher rate of lymphomas and lung cancer (in current or past smokers) was observed with another JAKi when compared with TNF blockers in RA patients.

Major Adverse Cardiovascular Events: A higher rate of CV death, myocardial infarction, and stroke was observed with a JAKi in a study comparing another JAKi with TNF blockers in RA patients ≥50 years with ≥1 CV risk factor. History of smoking increases risk.

Thromboses: Deep venous thrombosis, pulmonary embolism, and arterial thrombosis have occurred in patients treated for inflammatory conditions with JAK inhibitors, including RINVOQ. A higher rate of thrombosis was observed with another JAKi when compared with TNF blockers in RA patients.

Hypersensitivity: RINVOQ is contraindicated in patients with hypersensitivity to RINVOQ or its excipients.

Other Serious Adverse Reactions: Hypersensitivity Reactions, Gastrointestinal Perforations, Laboratory Abnormalities, and Embryo-Fetal Toxicity.

Learn more about these and the full Important Safety Information below

Improvement in ASDAS-CRP Score Seen as Early as Week 14

MMRM Data From SELECT-AXIS 2 Study 2: nr-axSpA (mixed*)²

RINVOQ 15 mg (n=154), placebo (n=156)

Mean Change in ASDAS-CRP Score |
RANKED SECONDARY ENDPOINT

-1.36* RINVOQ vs -0.71 placebo at Week 14

*P<0.0001.

The ASDAS-CRP score is a composite measure that assesses common patient symptoms and objective signs of inflammation. The score is calculated by assessing the following components on a numerical rating scale (from 0 to 10)⁸ or blood serum level (mg/L).

ASDAS-CRP Disease Activity Score Components at 2 Years

SELECT-AXIS 2 Study 2: mixed patients⁷*

ALL DATA ARE AS OBSERVED | Open-Label Extension (OLE)

Patient distribution rates: Baseline (bDMARD-IR) 0.5% LDA. Patients at 2 years (bDMARD-IR) 33.1% LDA.

RINVOQ is indicated for TNFi-IR patients.

DATA LIMITATIONS: ASDAS component analyses were prespecified nonranked endpoints not controlled for multiplicity. Therefore, no clinical or statistical conclusions can be drawn.

As Observed (AO) analysis: Patients with missing data at a specific time are not included, which may enrich the population and increase the response rates.

OLE LIMITATIONS: There is potential for enrichment of OLE data; unblinding patients may cause bias related to the overall treatment effect.

*Mixed=67% bDMARD-naïve and 33% bDMARD-IR.²

Improvement in Total Back Pain and Nocturnal Back Pain

Total Back Pain

Nocturnal Back Pain

Ranked Secondary Endpoint at Week 14 with Response Rates Out to 2 Years

SELECT-AXIS 2 Study 2: mixed patients^2-4*

ΔTotal Back Pain from baseline, MMRM^†

Durable efficacy of RINVOQ® 15 mg over time in Select-AXIS 2 study 1 (nr-axSpA - Total Back Pain): Mean change from baseline (MMRM), plotted against weeks. Notable points: Week 14 (-2.92 and Placebo -2.00), Week 52 (-4.14), Week 104 or 2 years (-4.47). Mean baseline in AS patients: Placebo = 7.29, RINVOQ® = 7.23.

*Mixed=67% bDMARD-naïve & 33% bDMARD-IR.²

^†Total back pain defined on a numeric rating scale (0–10) based on the following question: “What is the amount of back pain that you experienced at any time during the last week?”²

^‡P=0.0004.²

improvement (n=143) vs 28% (n=148) with placebo at Week 14 as observed⁹ and

improvement (n=124) at 2 years as observed³

DATA LIMITATIONS: Data labeled as a primary or ranked secondary endpoint at Week 14 were multiplicity-controlled. All other comparisons were not adjusted for multiplicity; statistical significance has not been established.

As Observed (AO) analysis: Patients with missing data at a specific time are not included, which may enrich the population and increase the response rates.

OLE LIMITATIONS: There is potential for enrichment of OLE data; unblinding patients may cause bias related to overall treatment effect.

Ranked Secondary Endpoint at Week 14 with Response Rates Out to 2 Years

SELECT-AXIS 2 Study 2: mixed patients^2-4*

ΔNocturnal Pain from baseline, MMRM^†

Durable efficacy of RINVOQ® 15 mg over time in Select-AXIS 2 study 2 (nr-axSpA - Nocturnal Back Pain): Mean change from baseline (MMRM), plotted against weeks. Notable points: Week 14 (-2.95 and Placebo -1.84), Week 52 (-4.07 and Placebo -3.57), Week 104 or 2 years (-4.33). Mean baseline in nr-axSpA patients: Placebo = 6.97, RINVOQ = 6.71.

*Mixed=67% bDMARD-naïve & 33% bDMARD-IR.²

^†Nocturnal back pain defined on a numeric rating scale (0–10) based on the following question: “What is the amount of back pain at night that you experienced during the last week?”⁸

^‡P<0.001.²

improvement (n=138) vs 26% (n=146) with placebo at Week 14 as observed⁹ and

improvement (n=123) at 2 years as observed¹⁰

As Observed (AO) analysis: Patients with missing data at a specific time are not included, which may enrich the population and increase the response rates.

OLE LIMITATIONS: There is potential for enrichment of OLE data; unblinding patients may cause bias related to overall treatment effect.

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

Durable Rates of ASAS40 Response Up to 2 Years^1-4

72% of RINVOQ nr-axSpA Patients Achieved ASAS40 at 2 Years^3,4

SELECT-AXIS 2 Study 2: mixed patients*

ALL DATA ARE AS OBSERVED

Durable efficacy of RINVOQ® 15 mg over time in Select-AXIS 2 study 2 (nr-axSpA - ASAS40 response rates): Percentage of patients achieving ASAS40 response, plotted against weeks. Notable points: Week 14 (49% and Placebo 24%), Week 52 (77% and Placebo 57%), Week 104 or 2 years (72%).

*Mixed=67% bDMARD-naïve and 33% bDMARD-IR.²

^†Total back pain defined on an NRS (0–10) based on the following question: "What is the amount of back pain that you experienced at any time during the last week?"²

^‡Mean score of BASDAI questions 5 and 6 on severity and duration of morning stiffness.

ASAS40 reflects a ≥40% improvement in 3 of the 4 following domains with no worsening in the fourth domain²:

ASAS Domains

Total back pain^†
Inflammation (morning stiffness)^‡
Physical function (BASFI)
Patient global assessment of disease activity

As Observed (AO) analysis: Patients with missing data at a specific time are not included, which may enrich the population and increase the response rates.

OLE LIMITATIONS: There is potential for enrichment of OLE data; unblinding patients may cause bias related to the overall treatment effect.

Interested in the safety data for RINVOQ?

See RINVOQ’s safety data across clinical trials

See Safety Profile

Explore RINVOQ data in gastroenterology

For moderate to severe Crohn's disease (CD) or moderate to severe ulcerative colitis (UC) in adult TNFi-IR patients¹

Go to CD Data

Go to UC Data

	MEASURE UP 1			MEASURE UP 2
	Placebo (n=281)	RINVOQ® (upadacitinib) 15 mg (n=281)	RINVOQ 30 mg (n=285)	Placebo (n=278)	RINVOQ 15 mg (n=276)	RINVOQ 30 mg (n=282)
Female, %	49	44	46	45	44	43
Mean age, years	34	34	34	33	33	34
<18 years age, %	14	15	15	13	12	12
≥18 years age, %	86	85	85	87	88	88
Race,%
White	65	65	67	70	67	70
Black or African American	7	9	3	6	6	6
Asian	25	25	25	20	24	22
Mean disease duration since diagnosis, years	21	21	20	21	19	21
Mean weight, kg	76	74	73	77	74	75
Mean BSA affected, %	46	49	47	48	45	47
Moderate vIGA-AD, %	56	55	54	45	46	45
Severe vIGA-AD, %	45	45	46	55	54	55
Mean EASI	29	31	29	29	29	30
Mean worst pruritus NRS, weekly average	7	7	7	7	7	7

	Placebo + TCS (n=304)	RINVOQ® (upadacitinib) 15 mg + TCS (n=300)	RINVOQ 30 mg + TCS (n=297)
Female, %	41	40	36
Mean age, years	34	33	36
<18 years age, %	13	13	12
≥18 years age, %	87	87	88
Race,%
White	74	68	73
Asian	20	21	21
Mean disease duration since diagnosis, years	24	23	23
Mean weight, kg	76	75	76
Mean BSA affected, %	49	47	49
Moderate vIGA-AD, %	46	48	47
Severe vIGA-AD, %	54	52	53
Mean EASI	30	29	30
Mean worst pruritus NRS, weekly average	7	7	7

DISEASE ACTIVITY STATE	ASDAS VALUE
ASDAS inactive disease	<1.3
ASDAS low disease activity (ASDAS-LDA)	<2.1
ASDAS high disease activity	2.1–3.5
ASDAS very high disease activity	>3.5

IMPROVEMENT SCORE	ASDAS VALUE
Clinically important improvement	Change ≥1.1 units
Major improvement	Change ≥2.0 units

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)
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%)

RAPID & DURABLE DISEASE CONTROL IN nr-axSpA

Rapid and Durable ASDAS-Low Disease Activity Rates Up to 2 Years2-4

Safety Considerations

Improvement in Total Back Pain and Nocturnal Back Pain

Durable Rates of ASAS40 Response Up to 2 Years1-4

Interested in the safety data for RINVOQ?

Explore RINVOQ data in gastroenterology

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

RAPID & DURABLE
DISEASE CONTROL IN nr-axSpA

Rapid and Durable ASDAS-Low Disease Activity Rates Up to 2 Years^2-4

Durable Rates of ASAS40 Response Up to 2 Years^1-4

IMPORTANT SAFETY INFORMATION & INDICATIONS¹

INDICATIONS¹

IMPORTANT SAFETY INFORMATION & INDICATIONS¹

INDICATIONS¹