EFFICACY

OUTCOMES
ACROSS KEY PsA DOMAINS

INDICATION

RINVOQ is indicated for the treatment of adults with active psoriatic arthritis (PsA) who have had an inadequate response or intolerance to one or more tumor necrosis factor (TNF) blockers.

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 Data From SELECT-PsA 2 (bDMARD-IR)^1,2

RINVOQ 15 mg (n=211), placebo (n=212)

ACR20 | PRIMARY ENDPOINT

57%* RINVOQ vs 24% placebo at Week 12

*P<0.001²

SELECT-PsA 2 Study Design Intro: 24-week, double‑blind, placebo‑controlled study of 642 adult patients with moderately to severely active PsA who had an inadequate response or intolerance to at least 1 biologic DMARD. Patients were randomized to receive upadacitinib or placebo. The primary endpoint was proportion of patients achieving ACR20 response at Week 12 vs placebo.¹

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

Up to ~3 Years of Data Across Key Domains of PsA^2-9

NRI Data From SELECT-PsA 2 (bDMARD-IR)^2-4

ACR50

32%* RINVOQ (n=211) vs
5% placebo (n=212) at Week 12

Dactylitis Resolution (LDI=0)^‡

58%* RINVOQ (n=55) vs
28% placebo (n=64) at Week 24

Enthesitis Resolution (LEI=0)^§

43%* RINVOQ (n=133) vs
15% placebo (n=144) at Week 24

PASI 75 | RANKED SECONDARY ENDPOINT^||

52%^†RINVOQ (n=130) vs
16% placebo (n=131) at Week 16

BASDAI50^¶

32%* RINVOQ (n=76) vs
4% placebo (n=75) at Week 24

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

*P<0.001; analyses were not controlled for multiplicity; P-value obtained through nominal statistical testing.²

^†P<0.001²

SELECT-PsA 2: bDMARD-IR patients

ALL DATA ARE AS OBSERVED

PERIPHERAL JOINTS^#

60%

of PsA patients achieved ACR50
at Week 152 (OLE) (n=139)

DACTYLITIS

94%

of PsA patients achieved complete resolution
of dactylitis (LDI=0^‡) at Week 152 (OLE) (n=36)

ENTHESITIS

69%

of PsA patients achieved complete resolution
of enthesitis (LEI=0^§) at Week 152 (OLE) (n=88)

SKIN

66%

of PsA patients achieved skin clearance**
(PASI 75^||) at Week 152 (OLE) (n=89)

AXIAL

63%

of PsA patients achieved BASDAI50^¶ response
rates at Week 152 (OLE) (n=46)

DATA LIMITATIONS: BASDAI50 was a prespecified nonranked
endpoint and was not adjusted for multiplicity. Therefore, no statistical
or clinical conclusions can be made.

**RINVOQ is not indicated for the treatment of plaque psoriasis.

^‡For patients with baseline presence of dactylitis (LDI>0).

^§For patients with baseline presence of enthesitis (LEI>0).

^||PASI assessed in patients with psoriatic skin involvement of ≥3% BSA at baseline.

^¶For patients with presence of psoriatic spondylitis as assessed by the investigator.

^#PsA patients in the SELECT-PsA 2 trial presented with peripheral arthritis, which manifested as tender or swollen peripheral joints.

The 2021 GRAPPA (Group for Research and Assessment of Psoriasis and Psoriatic Arthritis) guidelines recommend a domain-based approach for assessing psoriatic arthritis (PsA).⁸

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.

^‡For patients with baseline presence of dactylitis (LDI>0).

^§For patients with baseline presence of enthesitis (LEI>0).

^||PASI assessed in patients with psoriatic skin involvement of ≥3% BSA at baseline.

^¶For patients with presence of psoriatic spondylitis as assessed by the investigator.

^#PsA patients in the SELECT-PsA 2 trial presented with peripheral arthritis, which manifested as tender or swollen peripheral joints.

Rapid and Durable Minimal Disease Activity Rates^2,9*

OF RINVOQ PATIENTS ACHIEVED MDA vs 3% (n=6/212) placebo at
Week 24 (NRI) (ranked secondary endpoint, P<0.001)²

Nearly Half (44%) of RINVOQ Patients Achieved MDA at ~3 Years⁹

SELECT-PsA 2: bDMARD-IR patients⁹
ALL DATA ARE AS OBSERVED

SELECT-PsA 2 Biologic DMARD-IR Patient data: 29% of patients taking RINVOQ 15 mg achieved MDA at 24 weeks, 44% of patients taking RINVOQ 15 mg achieved MDA at 3 years, and 3% of patients taking a placebo achieved MDA at 24 weeks.

OF RINVOQ PATIENTS ACHIEVED MDA vs 3% (n=6/212) placebo at
Week 24 (NRI) (ranked secondary endpoint, P<0.001)²

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.

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

Durable Joint Efficacy in PsA^2,4,9

ACR20/50/70: Durable Joint Response Rates Out to ~3 Years

NRI Data From SELECT-PsA 2 (bDMARD-IR)²

RINVOQ 15 mg (n=211), placebo (n=212)

ACR20 | PRIMARY ENDPOINT

57%* RINVOQ vs 24% placebo
at Week 12

ACR50

32%^† RINVOQ vs 5% placebo
at Week 12

ACR70

9%^† RINVOQ vs 1% placebo
at Week 12

*P<0.001²

^†P<0.001; analyses were not controlled for multiplicity; P-value obtained through nominal statistical testing.²

NRI Data From SELECT-PsA 2⁴

RINVOQ (n=211), Placebo (n=212)

RAPID ACR20 RESPONSES

33% vs 11% placebo* at Week 2

57% vs 24% placebo at Week 12 PRIMARY ENDPOINT

ACR50

32% vs 5% placebo* at Week 12

ACR70

9% vs 1% placebo* at Week 12

*P<0.001; analyses were not controlled for multiplicity; P-value obtained through nominal statistical testing⁴

^†P<0.001⁴

RAPID RESPONSE

FOR ACR20 (NRI)

SELECT-PsA 2: bDMARD-IR patients⁹

ALL DATA ARE AS OBSERVED

SELECT-PsA 2 Biologic DMARD-IR Patient data for RINVOQ 15 mg: 58% of patients achieved ACR20 at 12 weeks, 33% of patients achieved ACR50 at 12 weeks, and 8% of patients achieved ACR70 at 12 weeks. 81% of patients achieved ACR20 at 152 weeks, 60% of patients achieved ACR50 at 152 weeks, and 36% of patients achieved ACR70 at 152 weeks.

RAPID RESPONSE

FOR ACR20 (NRI)

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.

Complete Resolution of Enthesitis and Dactylitis Data⁴

NRI Data From SELECT-PsA 2 (bDMARD-IR)⁴

RINVOQ 15 mg (n=133), placebo (n=144)

Enthesitis Resolution (LEI=0)^‡

43%^|| RINVOQ vs 15% placebo at Week 24

NRI Data From SELECT-PsA 2 (bDMARD-IR)⁴

RINVOQ 15 mg (n=55), placebo (n=64)

Dactylitis Resolution (LDI=0)^§

58%^|| RINVOQ vs 28% placebo at Week 24

^||P≤0.05; analyses were not controlled for multiplicity; P-value obtained through nominal statistical testing.⁴

SELECT-PsA 2: bDMARD-IR patients⁹

ALL DATA ARE AS OBSERVED

Comparison of psoriatic arthritis enthesitis (LEI=0) complete resolutions rates: Select-PsA 2: bDMARD-IR patients at 24 weeks (RINVOQ 15 mg QD: 53%, & Placebo: 27%) & at 152 weeks (RINVOQ 15 mg QD: 69%).

^‡For subjects with baseline presence of enthesitis (LEI>0).

^§For subjects with baseline presence of dactylitis (LDI>0).

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.

Durable HAQ-DI Responses for RINVOQ Up to ~3 Years⁶

IMPROVEMENT IN
PHYSICAL FUNCTION
SELECT-PsA 2 MMRM DATA⁴
LS MEAN ∆HAQ-DI
RANKED SECONDARY ENDPOINT
Week 12: -0.30 vs -0.10 placebo^¶
RINVOQ (n=199), placebo (n=180)
^¶P<0.001

SELECT-PsA 2: bDMARD-IR patients⁶

ALL DATA ARE AS OBSERVED

Durable HAQ-DI responses for RINVOQ 15 mg over time in Select PsA-2: Biologic DMARD-IR patients: mean change from baseline (AO) plotted against weeks. Notable points: Week 12 (-0.29 and Placebo -0.12) and Week 152 or ~3 years (-0.42).

IMPROVEMENT IN
PHYSICAL FUNCTION
SELECT-PsA 2 MMRM DATA⁴
LS MEAN ∆HAQ-DI
RANKED SECONDARY ENDPOINT
Week 12: -0.30 vs -0.10 placebo^¶
RINVOQ (n=199), placebo (n=180)
^¶P<0.001

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.

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

Noticeably Clearer Skin in PsA^2,7

As measured by PASI 75 for RINVOQ vs placebo at Week 16

PsA Skin Clearance Before and After

In SELECT-PsA 2, 52% of RINVOQ patients achieved PASI 75 vs 16% placebo at Week 16
(ranked secondary endpoint, NRI, P<0.001)²

Drag the slider below to see results.

Clear skin on arm after week 16 on RINVOQ®.

BEFORE

AFTER

Illustration of PASI assessed in patient with
psoriatic skin involvement ≥3% BSA at baseline

BEFORE

AFTER

Illustration of PASI assessed in patient with
psoriatic skin involvement ≥3% BSA at baseline

RINVOQ has not been studied in and is not indicated for the treatment of plaque psoriasis.¹

Skin Clearance Data Through ~3 Years^7,9*^§

NRI Data From SELECT-PsA 2 (bDMARD-IR)²

RINVOQ 15 mg (n=130), placebo (n=131)

PASI 75* | RANKED SECONDARY ENDPOINT

52%^† RINVOQ vs 16% placebo
at Week 16

PASI 90*

35%^‡ RINVOQ vs 8% placebo
at Week 16

PASI 100*

25%^‡ RINVOQ vs 6% placebo
at Week 16

RINVOQ is not indicated for the treatment of plaque psoriasis.¹

*PASI assessed in patients with psoriatic skin involvement of ≥3% BSA at baseline.²

^†P<0.001²

^‡P<0.001; analyses were not controlled for multiplicity; P-value obtained through nominal statistical testing.²

NRI Data From SELECT-PsA 2⁴

RINVOQ (n=211), Placebo (n=212)

RAPID ACR20 RESPONSES

33% vs 11% placebo* at Week 2

57% vs 24% placebo at Week 12 PRIMARY ENDPOINT

ACR50

32% vs 5% placebo* at Week 12

ACR70

9% vs 1% placebo* at Week 12

*P<0.001²

^†PASI assessed in patients with psoriatic skin involvement of ≥3% BSA at baseline^2,4

SELECT-PsA 2: bDMARD-IR patients⁹

ALL DATA ARE AS OBSERVED

SELECT-PsA 2 Biologic DMARD-IR Patient data: 66% of patients achieved PASI 75 at 3 years, 46% patients achieved PASI 90 at 3 years, and 30% of patients achieved PASI 100 at 3 years.

*PASI assessed in patients with psoriatic skin involvement of ≥3% BSA at baseline.²

^§After Week 16, the use of concomitant treatments for psoriasis was permitted.²

RINVOQ is not indicated for the treatment of plaque psoriasis.¹

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

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)

	Placebo n=212			RINVOQ 15 mg QD n=211
MEAN (SD)	Baseline	Week 12	Mean Change From Baseline	Baseline	Week 12	Mean Change From Baseline
Number of tender/painful joints (0–68)	25.3 (17.6)	19.3 (18.5)	-6.2	24.9 (17.3)	12.6 (15.6)	-12.4
Number of swollen joints (0–66)	12.0 (8.9)	7.3 (9.4)	-4.8	11.3 (8.2)	4.4 (5.7)	-7.1
Patient assessment of pain^a	6.6 (2.1)	5.9 (2.3)	-0.5	6.4 (2.1)	4.4 (2.5)	-1.9
Patient global assessment^a	6.8 (2.0)	6.1 (2.3)	-0.6	6.8 (1.9)	4.5 (2.5)	-2.3
Disability index (HAQ-DI)^b	1.2 (0.7)	1.1 (0.6)	-0.1	1.1 (0.6)	0.8 (0.7)	-0.3
Physician global assessment^a	6.5 (1.8)	5.0 (2.2)	-1.4	6.5 (1.8)	3.4 (2.1)	-3.1
hsCRP (mg/L)	10.4 (18.5)	9.4 (13.4)	0.3	11.2 (18.6)	4.3 (7.9)	-6.6

RINVOQ PATIENTS AT BASELINE SELECT-PsA 2 (n=211)	MDA CRITERIA (patients must achieve 5 of 7)
CHARACTERISTICS*
JOINT/MUSCULOSKELETAL
Tender Joint Count = 24.9	TJC ≤1
Swollen Joint Count = 11.3	SJC ≤1
Leeds Enthesitis Index = 3	LEI ≤1
SKIN
BSA-Psoriasis ≥3%, n (%) = 130 (61.6%) or PASI (for baseline BSA-Ps ≥3%) = 10.1	BSA-Psoriasis ≤3%, n (%) or PASI ≤1
PATIENT-REPORTED OUTCOMES
HAQ-DI = 1.1	HAQ-DI Score ≤0.5
Pain (0–10 NRS) = 6.4	Pain ≤1.5 (0–10 NRS)
PtGA Disease Activity (0–10 NRS) = 6.8	PtGA Disease Activity ≤2 (0–10 NRS)

EFFICACY

OUTCOMES ACROSS KEY PsA DOMAINS

Up to ~3 Years of Data Across Key Domains of PsA2-9

Rapid and Durable Minimal Disease Activity Rates2,9*

Safety Considerations

Durable Joint Efficacy in PsA2,4,9

Noticeably Clearer Skin in PsA2,7

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

OUTCOMES
ACROSS KEY PsA DOMAINS

Up to ~3 Years of Data Across Key Domains of PsA^2-9

Rapid and Durable Minimal Disease Activity Rates^2,9*

Durable Joint Efficacy in PsA^2,4,9

Noticeably Clearer Skin in PsA^2,7

IMPORTANT SAFETY INFORMATION & INDICATIONS¹

INDICATIONS¹

IMPORTANT SAFETY INFORMATION & INDICATIONS¹

INDICATIONS¹