For active psoriatic arthritis (PsA) in adult TNFi‑IR patients¹

Durable
JOINT EFFICACY IN PSA^2,3

RINVOQ met its primary endpoint (ACR20 at Week 12) and several secondary
endpoints at Week 12 or 24.^1,4

ACR=American College of Rheumatology; ACR20=improvement of at least 20% in tender joint count, swollen joint count, and at least 3 other core criteria (patient assessment of pain, patient global assessment, HAQ-DI, physician global assessment, and hs-CRP); IR=intolerance or inadequate response; TNFi=tumor necrosis factor inhibitor

Durable JOINT RESPONSE RATES
OUT TO 3 YEARS⁵

SELECT-PsA 2 Study Design Intro:¹ 24-week, double-blind, placebo-controlled study of 642 adult patients with moderate to severe active PsA who had an inadequate response or intolerance to at least one biologic DMARD. Patients were randomized to receive upadacitinib or placebo.

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

†P<0.001⁴

DATA LIMITATIONS:⁴ Data labeled as a primary or ranked secondary endpoint were multiplicity controlled for comparisons. All other comparisons were not adjusted for multiplicity; therefore, statistical significance has not been established.

SELECT-PsA 2: Biologic DMARD-IR patients⁵

ALL DATA ARE OBSERVED CASES

SELECT-PsA 2: MDA over time - 29% at week 24 (n=194), 44% at week 152 (n=144) (AO)

In an 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 Data⁵

NRI Data from SELECT-PsA 2: Enthesitis & Dactylitis

*For subjects with baseline presence of enthesitis (LEI>0).
†For subjects with baseline presence of dactylitis (LDI>0).
‡P<0.001; analyses were not controlled for multiplicity; P-value obtained through nominal statistical testing⁴

SELECT-PsA 2: Biologic DMARD-IR patients⁵

ALL DATA ARE OBSERVED CASES

Complete Resolution of Enthesitis (LEI=0)

SELECT-PsA 2: Complete Resolution of Enthesitis

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

In an 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 Dactylitis (LDI=0)

SELECT-PsA 2: Complete Resolution of Dactylitis

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

In an 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.

POWER to helpStop further joint damage¹
RINVOQ vs placebo in ∆mTSS at Week 24

SELECT-PsA 1 Study Design Intro:¹ 24-week, double-blind, placebo and active comparator-controlled study of 1705 adult patients with moderate to severe active PsA who had an inadequate response or intolerance to at least one non-biologic DMARD. Patients were randomized to receive either upadacitinib, active comparator, or placebo.

SELECT-PsA 1 in non-biologic DMARD-IR patients^1,7

RINVOQ is indicated for TNFi-IR patients

SELECT-PsA 1: RINVOQ vs placebo in ∆mTSS at Week 24

*P=0.0021⁷
†P=0.0003⁷
‡P=0.0386; analyses were not controlled for multiplicity. P-values obtained through nominal statistical testing⁷
^||P<0.001⁸

At Week 24 the mean change from baseline in mTSS was -0.02 for RINVOQ (random coefficient model)¹
At Week 56 the mean change from baseline in mTSS was -0.04 for RINVOQ (random coefficient model)⁹
93% of RINVOQ patients showed no radiographic progression (ΔmTSS≤0) at 24 weeks vs 89% on placebo (LE)¹
95% of RINVOQ patients showed no radiographic progression (ΔmTSS≤0) at 56 weeks (LE)^10,a

NRI Data from SELECT-PsA 1: Radiographic Inhibition

DATA LIMITATIONS:¹¹ Data labeled as a ranked secondary endpoint was multiplicity controlled for comparisons. All other comparisons were not adjusted for multiplicity; therefore, statistical significance has not been established.

Improvement in physical function⁴
LS mean ∆HAQ-DI from baseline at Week 12 was -0.30* for RINVOQ (n=199) vs
-0.10 for placebo (n=180) (MMRM) (ranked secondary endpoint)⁴

SELECT-PsA 2: Biologic DMARD-IR patients¹²

Durable HAQ-DI responses for RINVOQ up to ~1 year¹²

SELECT-PsA 2 HAQ-DI responses for RINVOQ up to ~1 year (AO)

*P<0.001 for RINVOQ vs placebo⁴

Durable HAQ-DI responses for RINVOQ up to ~1 year¹²

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

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RINVOQ SAFETY DATA

Review the safety profile of RINVOQ,
including both short- and long-term analyses

SEE SAFETY PROFILE

To achieve an ACR20, 50, or 70 response, a patient must have at least a 20%, 50%, or 70%, respectively, improvement in tender and swollen joint counts and three of five scores of individual elements:

patient pain;
physician's global assessment of disease activity;
patient's global assessment;
physical function (HAQ-DI);
and an acute phase reactant (hs‑CRP).

IMPROVEMENTS IN ACR COMPONENTS OF DISEASE ACTIVITY IN SELECT-PsA 2²

IMPROVEMENTS IN ACR
COMPONENTS OF DISEASE
ACTIVITY IN SELECT-PsA 2²

SELECT-PsA 2: ACR Components of Disease Activity

^aNumeric rating scale (NRS) from 0=best, to 10=worst
^bHealth Assessment Questionnaire Disability Index ranked from 0=best, to 3=worst; 20 questions; 8 categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and activities

ACR=American College of Rheumatology; HAQ‑DI=health assessment questionnaire disability index; hs‑CRP=high‑sensitivity C‑reactive protein; NRS=numeric rating scale; QD=once per day; SD=standard deviation; ULN=upper limit of normal

REFERENCES

US-MULT-221361

n values represent the total number of patients per treatment group.

ACR=American College of Rheumatology; ACR20/50/70=improvement of at least 20%/50%/70% in tender joint count, swollen joint count, and at least 3 other core criteria (patient assessment of pain, patient global assessment, HAQ-DI, physician global assessment, and hs-CRP); AO=as observed; DMARD=disease‑modifying antirheumatic drug; IR=intolerance or inadequate response; NRI=nonresponder imputation; OLE=open-label extension; QD=once per day; RCT=randomized controlled trial

Nonresponder imputation analysis assumes that every participant dropout is a nonresponder at time of dropout.

RINVOQ® and its design are registered trademarks of AbbVie Biotechnology Ltd.

^aPer study design, all patients in the placebo group were switched to receiving upadacitinib 15 mg QD or upadacitinib 30 mg QD at Week 24. All placebo data at Week 56 was derived using linear extrapolation.

ACR=American College of Rheumatology; ACR20=improvement of at least 20% in tender joint count, swollen joint, and at least 3 other core criteria (patient assessment of pain, patient global assessment, HAQ-DI, physician global assessment, and hs-CRP); DMARD=disease-modifying antirheumatic drug; IR=intolerance or inadequate response; JE=joint erosion; JSN=joint space narrowing; LE=linear extrapolation; mTSS=modified total Sharp score; QD=once per day; TNFi=tumor necrosis factor inhibitor

RINVOQ® and its design are registered trademarks of AbbVie Biotechnology Ltd.

The degree of difficulty a person has in accomplishing tasks was measured in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and errands and chores) over one week. Responses in each functional area are scored from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area.

REFERENCE

US-MULT-221361

AO=as observed; DMARD=disease-modifying antirheumatic drug; HAQ-DI=health assessment questionnaire disability index; IR=intolerance or inadequate response; LS=least squares; MMRM=mixed models repeated measurement; QD=once per day

RINVOQ® and its design are registered trademarks of AbbVie Biotechnology Ltd.

LEI CRITERIA¹

The presence or absence of enthesitis was assessed at 3 bilateral sites. Tenderness on examination was recorded as either present or absent for an overall score range 0‑6.¹

LDI CRITERIA¹

Presence or absence of dactylitis was assessed in all 20 of the patient's digits. Tenderness was also assessed along with circumference of dactylitis digits measured with a dactylometer.¹

LDI=Leeds dactylitis index; LEI=Leeds enthesitis index

REFERENCE

US-MULT-221361

n values represent the total number of patients per treatment group.

AO=as observed; DMARD=disease-modifying antirheumatic drug; IR=intolerance or inadequate response; LDI=Leeds dactylitis index; LEI=Leeds enthesitis index; NRI=nonresponder imputation; OLE=open-label extension; QD=once per day

Nonresponder imputation analysis assumes that every participant dropout is a nonresponder at time of dropout.

RINVOQ® and its design are registered trademarks of AbbVie Biotechnology Ltd.

Durable JOINT EFFICACY IN PSA2,3

Durable JOINT RESPONSE RATES OUT TO 3 YEARS5

Complete Resolution of ENTHESITIS AND DACTYLITIS Data5

POWER to helpStop further joint damage1 RINVOQ vs placebo in ∆mTSS at Week 24

Improvement in physical function4 LS mean ∆HAQ-DI from baseline at Week 12 was -0.30* for RINVOQ (n=199) vs -0.10 for placebo (n=180) (MMRM) (ranked secondary endpoint)4

RINVOQ SAFETY DATA

IMPORTANT SAFETY INFORMATION & INDICATION1

INDICATION1

IMPORTANT SAFETY INFORMATION

SERIOUS INFECTIONS

MORTALITY

MALIGNANCIES

MAJOR ADVERSE CARDIOVASCULAR EVENTS

THROMBOSIS

HYPERSENSITIVITY

GASTROINTESTINAL PERFORATIONS

LABORATORY ABNORMALITIES

EMBRYO-FETAL TOXICITY

VACCINATION

MEDICATION RESIDUE IN STOOL

LACTATION

HEPATIC IMPAIRMENT

ADVERSE REACTIONS

SELECT‑PsA 2

SELECT‑PsA 1

IMPORTANT SAFETY INFORMATION & INDICATIONS1

INDICATIONS1

IMPORTANT SAFETY INFORMATION

SERIOUS INFECTIONS

MORTALITY

MALIGNANCIES

MAJOR ADVERSE CARDIOVASCULAR EVENTS

THROMBOSIS

HYPERSENSITIVITY

GASTROINTESTINAL PERFORATIONS

LABORATORY ABNORMALITIES

EMBRYO-FETAL TOXICITY

VACCINATION

MEDICATION RESIDUE IN STOOL

LACTATION

HEPATIC IMPAIRMENT

ADVERSE REACTIONS

INDICATION & LIMITATION OF USE1

IMPORTANT SAFETY INFORMATION1

WARNING: Serious Infections, Mortality, Malignancies, Major Adverse Cardiovascular Events, and Thrombosis.

SERIOUS INFECTIONS

IMPORTANT SAFETY INFORMATION1

WARNING: Serious Infections, Mortality, Malignancies, Major Adverse Cardiovascular Events, and Thrombosis.

SERIOUS INFECTIONS

INDICATION & LIMITATION OF USE1

IMPORTANT SAFETY INFORMATION1

WARNING: Serious Infections, Mortality, Malignancies, Major Adverse Cardiovascular Events, and Thrombosis.

SERIOUS INFECTIONS

IMPORTANT SAFETY INFORMATION1

WARNING: Serious Infections, Mortality, Malignancies, Major Adverse Cardiovascular Events, and Thrombosis.

SERIOUS INFECTIONS

IMPORTANT SAFETY INFORMATION & INDICATION1

INDICATION1

IMPORTANT SAFETY INFORMATION

SERIOUS INFECTIONS

MORTALITY

MALIGNANCIES

MAJOR ADVERSE CARDIOVASCULAR EVENTS

THROMBOSIS

HYPERSENSITIVITY

GASTROINTESTINAL PERFORATIONS

LABORATORY ABNORMALITIES

EMBRYO-FETAL TOXICITY

VACCINATION

MEDICATION RESIDUE IN STOOL

LACTATION

HEPATIC IMPAIRMENT

ADVERSE REACTIONS

Durable
JOINT EFFICACY IN PSA^2,3

Durable JOINT RESPONSE RATES
OUT TO 3 YEARS⁵

Complete Resolution of
ENTHESITIS AND DACTYLITIS Data⁵

POWER to helpStop further joint damage¹
RINVOQ vs placebo in ∆mTSS at Week 24

Improvement in physical function⁴
LS mean ∆HAQ-DI from baseline at Week 12 was -0.30* for RINVOQ (n=199) vs
-0.10 for placebo (n=180) (MMRM) (ranked secondary endpoint)⁴

IMPORTANT SAFETY
INFORMATION & INDICATION¹

INDICATION¹

IMPORTANT SAFETY INFORMATION & INDICATIONS¹

INDICATIONS¹

INDICATION & LIMITATION OF USE¹

IMPORTANT SAFETY INFORMATION¹

IMPORTANT SAFETY INFORMATION¹

INDICATION & LIMITATION OF USE¹

IMPORTANT SAFETY INFORMATION¹

IMPORTANT SAFETY INFORMATION¹

IMPORTANT SAFETY
INFORMATION & INDICATION¹

INDICATION¹