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

Rheumatoid Arthritis

Psoriatic Arthritis

Ankylosing Spondylitis

Non-radiographic Axial Spondyloarthritis

Atopic Dermatitis

Ulcerative Colitis

Crohn’s Disease

Visit RINVOQhcp.com

Plaque Psoriasis

Psoriatic Arthritis

Ulcerative Colitis

Crohn's Disease

Visit SKYRIZIhcp.com

Please see Important Safety Information, including BOXED WARNING on Serious Infections and Malignancy.

Hidradenitis Suppurativa

Juvenile Idiopathic Arthritis

Pediatric Crohn's Disease

Pediatric Ulcerative Colitis

Pediatric Uveitis

Uveitis (Adult)

Other Indications

Visit HUMIRApro.com

US-MULT-240253

Immunology Therapies

Full Prescribing Information

Patient Site

The IL-23 inhibitor from AbbVie indicated for the treatment of adults with
active psoriatic arthritis (PsA) and for moderate to severe plaque psoriasis (Ps)
in adults who are candidates for systemic therapy or phototherapy.¹

Well-Studied Safety Profile Established in PsA & Ps¹

LONG-TERM SAFETY DATA FROM 4 YEARS OF EXPOSURE IN PsA and ~9 YEARS IN Ps²*

PsA SAFETY PROFILE IS GENERALLY CONSISTENT

WITH THAT OBSERVED IN PATIENTS WITH Ps¹

See safety data for Week 24 for PsA and Week 16 for Ps.

~9 YEARS EXPOSURE IN Ps^2†‡

7.4^§

SERIOUS ADVERSE EVENTS

PER 100 PYs on SKYRIZI

(n=3658, PYs=13,329.3)

^§Representing different pools of patients with varying lengths of treatment exposure.

SKYRIZI IS CONTRAINDICATED IN PATIENTS WITH A HISTORY OF SERIOUS HYPERSENSITIVITY REACTION TO RISANKIZUMAB-RZAA OR ANY OF THE EXCIPIENTS¹

Warnings and precautions include hypersensitivity, infections, TUBERCULOSIS, and immunizations

NO LABELED WARNINGS OR PRECAUTIONS ON MALIGNANCY, IBD, DEPRESSION, OR CANDIDIASIS¹

Initially evaluate for tuberculosis and instruct patients to report signs and symptoms of infection

NO ROUTINE LAB MONITORING REQUIRED DURING TREATMENT¹

*Includes 4 PsA Phase 2-3 studies (including KEEPsAKE 1 and KEEPsAKE 2). Includes 20 Phase 1-4 studies in Ps encompassing 5 trials using integrated data evaluated at Week 16 (including UltIMMa-1, UltIMMa-2, IMMhance, and IMMvent), and 15 additional trials including LIMMitless.²

^†Long-term data include all administered doses ranging from 18 mg to 180 mg of SKYRIZI in 3,658 patients. The FDA-approved dose is 150 mg at Week 0, Week 4, and every 12 weeks thereafter.^1,2

^‡Long-term safety from a 20-study pool, includes Phase 1 through Phase 4 data, representing different pools of patients with varying lengths of treatment exposure.²

The long-term all-SKYRIZI psoriasis analysis set assessed safety of patients with psoriasis who received ≥1 dose of all explored doses of SKYRIZI through the end of exposure.²

STUDY DESIGN:

KEEPsAKE 1 (N=964) and KEEPsAKE 2 (N=443) were 2 randomized, double-blind, placebo-controlled studies to evaluate the efficacy and safety of SKYRIZI (150 mg) vs placebo over 24 weeks with a long-term extension for up to an additional 292 weeks in adult patients with active psoriatic arthritis.^1,3,4

UltIMMa-1 (N=506) and UltIMMa-2 (N=491) were replicate Phase 3, randomized, double-blind, placebo- and active-controlled studies to evaluate the efficacy and safety of SKYRIZI (150 mg) vs placebo over 16 weeks and ustekinumab (45 mg or 90 mg, based on screening weight) over 52 weeks in adult patients with moderate to severe plaque psoriasis.^1,5

IMMvent was a Phase 3, randomized, double-blind, double-dummy, active-controlled study to evaluate the efficacy and safety of SKYRIZI compared to HUMIRA (adalimumab) in adult patients with moderate to severe plaque psoriasis over 44 weeks.⁶

IMMhance was a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the impact of treatment withdrawal and re-treatment of SKYRIZI compared to placebo in adult patients with moderate to severe plaque psoriasis.^1,7

LIMMitless is an ongoing, single-arm, multicenter, open-label extension of Phase 2 and 3 studies evaluating the long-term efficacy and safety of SKYRIZI (150 mg). Patients who completed UltIMMa-1 or -2, IMMvent, or IMMhance were eligible to participate.^8-10

ADVERSE EVENTS OF INTEREST FROM POOLED TRIAL DATA

SELECT PsA & Ps AEs (WEEKS 24 & 16) SELECT PsA & Ps AEs (WEEKS 24 & 16)

SELECT PsA & Ps AEs (1, 4 & ~9 YEARS) SELECT PsA & Ps AEs (1, 4 & ~9 YEARS)

COMPELLING SAFETY AND
TOLERABILITY RECORD IN PsA & Ps¹

Adverse events of interest from pooled trial data^1,9,11-16

Adverse events of interest for PsA & Ps through 24 weeks and Ps through 16 weeks.

PsA SAFETY PROFILE IS GENERALLY

CONSISTENT

WITH THAT OBSERVED IN PATIENTS WITH Ps¹

Initially evaluate for tuberculosis (TB) and instruct patients to report signs and symptoms of infection

NO ROUTINE LAB MONITORING REQUIRED DURING TREATMENT¹

Warnings and precautions include hypersensitivity, infections, tuberculosis (TB), and immunizations

NO LABELED WARNINGS OR PRECAUTIONS ON MALIGNANCY, IBD, DEPRESSION, OR CANDIDIASIS¹

SKYRIZI IS CONTRAINDICATED IN PATIENTS WITH A HISTORY OF SERIOUS HYPERSENSITIVITY REACTION TO RISANKIZUMAB-RZAA OR ANY OF THE EXCIPIENTS.¹

Most common (≥1%) adverse reactions associated with SKYRIZI include upper respiratory infections, headache, fatigue, injection site reactions, and tinea infections. In PsA Phase 3 trials, the incidence of hepatic events for SKYRIZI was 5.4% (16.7 events per 100 PYs) compared to 3.9% (12.6 events per 100 PYs) with placebo.

^aIncludes data from KEEPsAKE 1 and KEEPsAKE 2 studies.

^bIncludes data from UltIMMa-1, UltIMMa-2, IMMhance, and IMMvent studies.

IBD=inflammatory bowel disease; MACE=major adverse cardiovascular event; NMSC=nonmelanoma skin cancer; Ps=psoriasis; PsA=psoriatic arthritis; TB=tuberculosis; TEAE=treatment-emergent adverse event.

COMPELLING SAFETY AND TOLERABILITY RECORD IN
PsA & Ps¹

ADVERSE EVENTS OF INTEREST FROM 4 PsA AND 20 Ps CLINICAL TRIALS^2,14,17,18

Adverse events of interest from trial data up to ~1, ~4, and ~8 years. Any serious infection, any active TB, any malignancy, malignancy (excluding NMSC), adjudicated MACE, IBD, depression, candidiasis and discontinuation rates were considered.

Initially evaluate for tuberculosis (TB) and instruct patients to report signs and symptoms of infection

NO ROUTINE LAB MONITORING REQUIRED DURING TREATMENT¹

Warnings and precautions include hypersensitivity, infections, tuberculosis (TB), and immunizations

NO LABELED WARNINGS OR PRECAUTIONS ON MALIGNANCY, IBD, DEPRESSION, OR CANDIDIASIS¹

SKYRIZI IS CONTRAINDICATED IN PATIENTS WITH A HISTORY OF SERIOUS HYPERSENSITIVITY REACTION TO RISANKIZUMAB-RZAA OR ANY OF THE EXCIPIENTS.¹

Long-term results presented include varying lengths of treatment exposure and all explored dosing regimens for SKYRIZI, including the approved 150 mg dose.²

IN AN INTEGRATED ANALYSIS OF 2 CLINICAL TRIALS, Ps PATIENTS ON SKYRIZI EXPERIENCED ANY INFECTION AT A RATE OF 73.9 EVENTS PER 100 PYs AT WEEK 52 (N=598, PYs=618).^1,17

*Data are integrated from 4 Phase 2-3 clinical trials in PsA. Median treatment duration was 2.8 years (84 days-4.0 years).²

^†Long-term safety was evaluated in an all-SKYRIZI data set comprising 20 Phase 1-4 studies in patients with moderate to severe plaque psoriasis.²

^aIncludes data from UltIMMa-1 and UltIMMa-2 studies.¹⁷

IBD=inflammatory bowel disease; MACE=major adverse cardiac event; NMSC=nonmelanoma skin cancer; PYs=patient years.

ACR20/50/70 RESPONSE RATES

In patients with PsA at Week 24 and ~3 years^1,3,4

Primary endpoint ACR20 at 24 weeks¹

View the results in joints

IMPORTANT SAFETY INFORMATION AND INDICATIONS FOR SKYRIZI® (risankizumab-rzaa)¹

Indications

Psoriatic Arthritis: SKYRIZI is indicated for the treatment of active psoriatic arthritis in adults.

Plaque Psoriasis: SKYRIZI is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.

Important Safety Information

Hypersensitivity Reactions

SKYRIZI® (risankizumab-rzaa) is contraindicated in patients with a history of serious hypersensitivity reaction to risankizumab-rzaa or any of the excipients. Serious hypersensitivity reactions, including anaphylaxis, have been reported with the use of SKYRIZI. If a serious hypersensitivity reaction occurs, discontinue SKYRIZI and initiate appropriate therapy immediately.

Infection

SKYRIZI may increase the risk of infection. Do not initiate treatment with SKYRIZI in patients with a clinically important active infection until it resolves or is adequately treated.

In patients with a chronic infection or a history of recurrent infection, consider the risks and benefits prior to prescribing SKYRIZI. Instruct patients to seek medical advice if signs or symptoms of clinically important infection occur. If a patient develops such an infection or is not responding to standard therapy, closely monitor and discontinue SKYRIZI until the infection resolves.

Tuberculosis (TB)

Prior to initiating treatment with SKYRIZI, evaluate for TB infection and consider treatment in patients with latent or active TB for whom an adequate course of treatment cannot be confirmed. Monitor patients for signs and symptoms of active TB during and after SKYRIZI treatment. Do not administer SKYRIZI to patients with active TB.

Hepatotoxicity in Treatment of Crohn’s Disease

Drug-induced liver injury was reported in a patient with Crohn’s disease who was hospitalized for a rash during induction dosing of SKYRIZI. For the treatment of Crohn’s disease, evaluate liver enzymes and bilirubin at baseline and during induction (12 weeks); monitor thereafter according to routine patient management. Consider an alternate treatment for patients with evidence of liver cirrhosis. Interrupt treatment if drug-induced liver injury is suspected, until this diagnosis is excluded. Instruct your patient to seek immediate medical attention if they experience symptoms suggestive of hepatic dysfunction.

Administration of Vaccines

Avoid use of live vaccines in patients treated with SKYRIZI. Medications that interact with the immune system may increase the risk of infection following administration of live vaccines. Prior to initiating SKYRIZI, complete all age-appropriate vaccinations according to current immunization guidelines.

Adverse Reactions

Most common (≥1%) adverse reactions associated with SKYRIZI in plaque psoriasis and psoriatic arthritis include upper respiratory infections, headache, fatigue, injection site reactions, and tinea infections.

In psoriatic arthritis phase 3 trials, the incidence of hepatic events was higher with SKYRIZI compared to placebo.

Most common (>3%) adverse reactions associated with SKYRIZI in Crohn’s disease are upper respiratory infections, headache, and arthralgia in induction and arthralgia, abdominal pain, injection site reactions, anemia, pyrexia, back pain, arthropathy, and urinary tract infection in maintenance.

Lipid Elevations: Increases from baseline and increases relative to placebo were observed at Week 4 and remained stable to Week 12 in patients treated with SKYRIZI in Crohn’s disease.

Dosage Forms and Strengths: SKYRIZI is available in a 150 mg/mL prefilled syringe and pen, and a 600 mg/10 mL single-dose vial for intravenous infusion.

Please see Full Prescribing Information.

US-SKZG-220547

REFERENCES

SKYRIZI [package insert]. North Chicago, IL: AbbVie Inc.
Gordon KB, Blauvelt A, Bachelez H, et al. Long-term safety of risankizumab in patients with psoriatic disease: integrated analysis of psoriasis and psoriatic arthritis clinical trial data. Poster presented at: European Academy of Dermatology and Venereology; October 11-14, 2023; Berlin, Germany.
Kristensen LE, Keiserman M, Papp K, et al. Long-term efficacy and safety of risankizumab for csDMARD-IR patients with active psoriatic arthritis: 148-week results from the KEEPsAKE 1 trial. Poster presented at: American College of Rheumatology Convergence; November 10-15, 2023; San Diego, CA.
Östör A, Van den Bosch F, Papp K, et al. Long-term efficacy and safety of risankizumab for active psoriatic arthritis: 148-week results from the KEEPsAKE 2 trial. Poster presented at: American College of Rheumatology Convergence; November 10-15, 2023; San Diego, CA.
Gordon KB, Strober B, Lebwohl M, et al. Efficacy and safety of risankizumab in moderate-to-severe plaque psoriasis (UltIMMa-1 and UltIMMa-2): results from two double-blind, randomised, placebo-controlled and ustekinumab-controlled phase 3 trials. Lancet. 2018;392(10148):650-661.
Reich K, Gooderham M, Thaçi D, et al. Efficacy and safety of continuous risankizumab or switching from adalimumab to risankizumab treatment in patients with moderate-to-severe plaque psoriasis: results from the phase 3 IMMvent trial. Poster presented at: American Academy of Dermatology; March 1-5, 2019; Washington, DC.
Blauvelt A, Leonardi CL, Gooderham M, et al. Efficacy and safety of continuous risankizumab therapy vs treatment withdrawal in patients with moderate to severe plaque psoriasis: a phase 3 randomized clinical trial. JAMA Dermatol. 2020;156(6):649-658.
Papp K, Lebwohl M, Puig L, et al. Long-term efficacy and safety of continuous risankizumab every 12 weeks: an interim analysis from the open-label extension trial, LIMMitless. Poster presented at: European Academy of Dermatology and Venereology; October 29-31, 2020; virtual.
Leonardi C, Bachelez H, Wu JJ, et al. Long-term safety of risankizumab in patients with moderate to severe psoriasis: analysis of pooled clinical trial data. Poster presented at: American Academy of Dermatology; March 1-5, 2019; Washington, DC.
Leonardi C, Lebwohl M, Bachelez H, et al. Maintenance of clinical response with continued risankizumab treatment for moderate-to-severe psoriasis through 232 weeks: interim analysis of the LIMMitless open-label extension study. Poster presented at: Fall Clinical Dermatology Conference; October 21-24, 2021; Las Vegas, NV; hybrid.
Östör A, Papp K, Moreno M, et al. Efficacy and safety of risankizumab for active psoriatic arthritis: 24-week integrated results from the phase 3, randomized, double-blind KEEPsAKE-1 and -2 trials for csDMARD-IR and bio-IR patients. Poster presented at: European Academy of Dermatology and Venereology; September 29-October 2, 2021; virtual.
Data on file, AbbVie Inc. ABVRRTI73417.
Data on file, AbbVie Inc. ABVRRTI73487.
Data on file, AbbVie Inc. ABVRRTI73738.
Strober B, Blauvelt A, Menter A, et al. Risankizumab treatment is associated with low and constant infection rates over time in patients with moderate to severe psoriasis: analysis of pooled clinical trial data. Poster presented at: American Academy of Dermatology; March 1-5, 2019; Washington, DC.
Reich K, Gordon KB, Tyring S, et al. Malignancy rates in patients with moderate to severe psoriasis during treatment with risankizumab: analysis of pooled clinical trial data. Poster presented at: American Academy of Dermatology; March 1-5, 2019; Washington, DC.
Lebwohl M, Bachelez H, Valdecantos WC, Wu T, Gordon K. Efficacy and safety of risankizumab in moderate-to-severe plaque psoriasis: an integrated analysis of UltIMMa-1 and UltIMMa-2. Poster presented at: American Academy of Dermatology Annual Meeting; March 1-5, 2019; Washington, DC.
Data on file, AbbVie Inc. ABVRRTI77623.

IMPORTANT SAFETY INFORMATION AND INDICATIONS FOR SKYRIZI® (risankizumab-rzaa)¹

Hypersensitivity Reactions, Infections, Tuberculosis (TB), Administration of Vaccines

Hypersensitivity Reactions

SKYRIZI is contraindicated in patients with a history of serious hypersensitivity reaction to risankizumab-rzaa or any of the excipients. Serious hypersensitivity reactions, including anaphylaxis, have been reported with the use of SKYRIZI. If a serious hypersensitivity reaction occurs, discontinue SKYRIZI and initiate appropriate therapy immediately

IMPORTANT SAFETY INFORMATION AND INDICATIONS FOR SKYRIZI® (risankizumab-rzaa)¹

Hypersensitivity Reactions, Infections, Tuberculosis (TB), Administration of Vaccines

Hypersensitivity Reactions

SKYRIZI is contraindicated in patients with a history of serious hypersensitivity reaction to risankizumab-rzaa or any of the excipients. Serious hypersensitivity reactions,

IMPORTANT SAFETY INFORMATION AND INDICATIONS FOR SKYRIZI® (risankizumab-rzaa)¹

Hypersensitivity Reactions, Infections, Tuberculosis (TB), Administration of Vaccines

Hypersensitivity Reactions

IMPORTANT SAFETY INFORMATION AND INDICATIONS FOR SKYRIZI® (risankizumab-rzaa)¹

Hypersensitivity Reactions, Infections, Tuberculosis (TB), Administration of Vaccines

Hypersensitivity Reactions

SKYRIZI is contraindicated in patients with a history of serious hypersensitivity reaction to risankizumab-rzaa or any of the excipients. Serious hypersensitivity reactions,

IMPORTANT SAFETY INFORMATION AND INDICATIONS FOR SKYRIZI® (risankizumab-rzaa)¹

Indications

Psoriatic Arthritis: SKYRIZI is indicated for the treatment of active psoriatic arthritis in adults.

Plaque Psoriasis: SKYRIZI is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.

Important Safety Information

Hypersensitivity Reactions

Infection

SKYRIZI may increase the risk of infection. Do not initiate treatment with SKYRIZI in patients with a clinically important active infection until it resolves or is adequately treated.

Tuberculosis (TB)

Hepatotoxicity in Treatment of Crohn’s Disease

Administration of Vaccines

Adverse Reactions

In psoriatic arthritis phase 3 trials, the incidence of hepatic events was higher with SKYRIZI compared to placebo.

Lipid Elevations: Increases from baseline and increases relative to placebo were observed at Week 4 and remained stable to Week 12 in patients treated with SKYRIZI in Crohn’s disease.

Dosage Forms and Strengths: SKYRIZI is available in a 150 mg/mL prefilled syringe and pen, and a 600 mg/10 mL single-dose vial for intravenous infusion.

Please see Full Prescribing Information.

US-SKZG-220547

Well-Studied Safety Profile Established in PsA & Ps1

LONG-TERM SAFETY DATA FROM 4 YEARS OF EXPOSURE IN PsA and ~9 YEARS IN Ps2*

IMPORTANT SAFETY INFORMATION AND INDICATIONS FOR SKYRIZI® (risankizumab-rzaa)1

Indications

STUDY DESIGN–IMMvent1

REFERENCE

SELECTED BASELINE CHARACTERISTICS1,2

STUDY DESIGN—IMMhance1,2

SELECTED BASELINE CHARACTERISTICS1,2

STUDY DESIGN–UltIMMa-1 and UltIMMa-2 LIMMitless OLE1-5

SELECTED BASELINE CHARACTERISTICS1

STUDY DESIGN–UltIMMa-1 AND UltIMMa-21-3

SELECTED BASELINE CHARACTERISTICS1

STUDY DESIGN–IMMvent1

SELECTED BASELINE CHARACTERISTICS1,2

STUDY DESIGN–IMMerge1

SELECTED BASELINE CHARACTERISTICS1

STUDY DESIGN—IMMhance1,2

SELECTED BASELINE CHARACTERISTICS1,2

STUDY DESIGN–UltIMMa-1 and UltIMMa-2 LIMMitless OLE1-5

SELECTED BASELINE CHARACTERISTICS1

STUDY DESIGN–UltIMMa-1 and UltIMMa-21,2

SELECTED BASELINE CHARACTERISTICS1

STUDY DESIGN–UltIMMa-1 and UltIMMa-21,2

SELECTED BASELINE CHARACTERISTICS1

STUDY DESIGN—KEEPsAKE 1 and KEEPsAKE 21-5

SELECTED BASELINE CHARACTERISTICS IN PsA CLINICAL TRIALS1,2

STUDY DESIGN—KEEPsAKE 1 AND KEEPsAKE 21-7

SELECTED BASELINE CHARACTERISTICS1,2

IMPORTANT SAFETY INFORMATION AND INDICATIONS FOR SKYRIZI® (risankizumab-rzaa)1

IMPORTANT SAFETY INFORMATION AND INDICATIONS FOR SKYRIZI® (risankizumab-rzaa)1

IMPORTANT SAFETY INFORMATION AND INDICATIONS FOR SKYRIZI® (risankizumab-rzaa)1

IMPORTANT SAFETY INFORMATION AND INDICATIONS FOR SKYRIZI® (risankizumab-rzaa)1

IMPORTANT SAFETY INFORMATION AND INDICATIONS FOR SKYRIZI® (risankizumab-rzaa)1

Indications

Well-Studied Safety Profile Established in PsA & Ps¹

LONG-TERM SAFETY DATA FROM 4 YEARS OF EXPOSURE IN PsA and ~9 YEARS IN Ps²*

IMPORTANT SAFETY INFORMATION AND INDICATIONS FOR SKYRIZI® (risankizumab-rzaa)¹

STUDY DESIGN–IMMvent¹

SELECTED BASELINE CHARACTERISTICS^1,2

STUDY DESIGN—IMMhance^1,2

SELECTED BASELINE CHARACTERISTICS^1,2

STUDY DESIGN–UltIMMa-1 and UltIMMa-2 LIMMitless OLE^1-5

SELECTED BASELINE CHARACTERISTICS¹

STUDY DESIGN–UltIMMa-1 AND UltIMMa-2^1-3

SELECTED BASELINE CHARACTERISTICS¹

STUDY DESIGN–IMMvent¹

SELECTED BASELINE CHARACTERISTICS^1,2

STUDY DESIGN–IMMerge¹

SELECTED BASELINE CHARACTERISTICS¹

STUDY DESIGN—IMMhance^1,2

SELECTED BASELINE CHARACTERISTICS^1,2

STUDY DESIGN–UltIMMa-1 and UltIMMa-2 LIMMitless OLE^1-5

SELECTED BASELINE CHARACTERISTICS¹

STUDY DESIGN–UltIMMa-1 and UltIMMa-2^1,2

SELECTED BASELINE CHARACTERISTICS¹

STUDY DESIGN–UltIMMa-1 and UltIMMa-2^1,2

SELECTED BASELINE CHARACTERISTICS¹

STUDY DESIGN—KEEPsAKE 1 and KEEPsAKE 2^1-5

SELECTED BASELINE CHARACTERISTICS IN PsA CLINICAL TRIALS^1,2

STUDY DESIGN—KEEPsAKE 1 AND KEEPsAKE 2^1-7

SELECTED BASELINE CHARACTERISTICS^1,2

IMPORTANT SAFETY INFORMATION AND INDICATIONS FOR SKYRIZI® (risankizumab-rzaa)¹

IMPORTANT SAFETY INFORMATION AND INDICATIONS FOR SKYRIZI® (risankizumab-rzaa)¹

IMPORTANT SAFETY INFORMATION AND INDICATIONS FOR SKYRIZI® (risankizumab-rzaa)¹

IMPORTANT SAFETY INFORMATION AND INDICATIONS FOR SKYRIZI® (risankizumab-rzaa)¹

IMPORTANT SAFETY INFORMATION AND INDICATIONS FOR SKYRIZI® (risankizumab-rzaa)¹