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

Giant Cell Arteritis

Atopic Dermatitis

Ulcerative Colitis

Crohn’s Disease

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Plaque Psoriasis

Psoriatic Arthritis

Ulcerative Colitis

Crohn's Disease

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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

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US-MULT-250253

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

The IL-23 inhibitor from AbbVie indicated for the treatment of adults with: active psoriatic arthritis (PsA);
moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy; moderately
to severely active Crohn's disease (CD); or moderately to severely active ulcerative colitis (UC)

MDA RESPONSE RATES ACHIEVED

In Patients with PsA

IN KEEPsAKE 1 AND KEEPsAKE 2, THE PRIMARY ENDPOINT WAS ACR20 RESPONSE AT WEEK 24.¹

KEEPsAKE 1:
SKYRIZI 57% (n=483), PLACEBO 34% (n=481)

KEEPsAKE 2:
SKYRIZI 51% (n=224), PLACEBO 27% (n=219)

Study Design:

KEEPsAKE 1 (N=964) and KEEPsAKE 2 (N=443) were 2 randomized, double-blind, placebo-controlled studies that evaluated the efficacy and safety of SKYRIZI 150 mg vs placebo over 24 weeks with a long-term, open-label extension for up to an additional 292 weeks. Both studies enrolled adult patients with active psoriatic arthritis. In KEEPsAKE 1, the study population had an inadequate response or intolerance to at least 1 csDMARD, while in KEEPsAKE 2 patients had an inadequate response or intolerance to at least 1 biologic therapy OR to at least 1 csDMARD.^1-3

SIGNIFICANT IMPROVEMENT IN DISEASE CONTROL AT WEEK 24 (AFTER 3 DOSES)⁴

MDA ACHIEVED AT WEEK 24 (SKYRIZI: 25%, N=483; PLACEBO: 10%, N=481), NRI-C⁴*

*KEEPsAKE 1 patients achieving MDA at Week 24 was a ranked secondary endpoint P<0.001.

Minimal Disease Activity is an important measure of disease control in PsA.

MDA criteria offer a robust assessment of your patient's changes in the multiple disease domains of PsA over time.

MDA is achieved when meeting 5 of 7 criteria⁵:

Tender joint count ≤1
Swollen joint count ≤1
PASI ≤1 or BSA-Psoriasis ≤3%
Pain (VAS ≤15 mm)
PtGA (VAS ≤20 mm)
HAQ-DI ≤0.5
Tender entheseal points ≤1

MDA RESPONSE ACHIEVED AT ~5 YEARS⁶

KEEPsAKE 1: csDMARD-IR

ALL DATA IS AS OBSERVED

KEEPsAKE 1 MDA response rates over 5 years

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:

In an OLE, there is a potential for enrichment of the long-term data in remaining patient populations since patients who are unable to tolerate or do not respond to the drug often drop out.

BSA=body surface area; csDMARD-IR=intolerance or inadequate response to conventional synthetic disease-modifying antirheumatic drug(s); HAQ-DI=Health Assessment Questionnaire Disability Index; MDA=minimal disease activity; NRI=nonresponder imputation; OLE=open-label extension; PASI=Psoriasis Area and Severity Index; PtGA=Patient Global Assessment; RCT=randomized controlled trial; VAS=visual analog scale.

WELL-STUDIED SAFETY PROFILE

across 4 pivotal trials in PsA & Ps¹

Review safety

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

Indications

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

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

Crohn's Disease: SKYRIZI is indicated for the treatment of moderately to severely active Crohn's disease in adults.

Ulcerative Colitis: SKYRIZI is indicated for the treatment of moderately to severely active ulcerative colitis in adults.

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 Inflammatory Bowel 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 and ulcerative colitis, 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.

Most common (≥3%) adverse reactions associated with SKYRIZI in ulcerative colitis are arthralgia in induction, and arthralgia, pyrexia, injection site reactions, and rash 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. Lipid elevations observed in patients with ulcerative colitis were similar to those in Crohn's disease.

Dosage Forms and Strengths: SKYRIZI (risankizumab-rzaa) is available in a 150 mg/mL prefilled syringe and pen, a 600 mg/10 mL single-dose vial for intravenous infusion, and a 180 mg/1.2 mL or 360 mg/2.4 mL single-dose prefilled cartridge with on-body injector.

INDICATIONS

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

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

Crohn's Disease: SKYRIZI is indicated for the treatment of moderately to severely active Crohn's disease in adults.

Ulcerative Colitis: SKYRIZI is indicated for the treatment of moderately to severely active ulcerative colitis in adults.

Please see Full Prescribing Information.

US-SKZG-240258

REFERENCES

SKYRIZI [package insert]. North Chicago, IL: AbbVie Inc.
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.
Kristensen LE, Keiserman M, Papp K, et al. Efficacy and safety of risankizumab for active psoriatic arthritis: 24-week results from the randomised, double-blind, phase 3 KEEPsAKE 1 trial. Ann Rheum Dis. 2022;81(2):225-231. doi:10.1136/annrheumdis-2021-221019
Coates LC, Fransen J, Helliwell PS. Defining minimal disease activity in psoriatic arthritis: a proposed objective target for treatment. Ann Rheum Dis. 2010;69(1):48-53. doi:10.1136/ard.2008.102053
Data on File. AbbVie Inc. ABVRRTI81133.

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,

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

Indications

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

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

Crohn's Disease: SKYRIZI is indicated for the treatment of moderately to severely active Crohn's disease in adults.

Ulcerative Colitis: SKYRIZI is indicated for the treatment of moderately to severely active ulcerative colitis in adults.

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 Inflammatory Bowel Disease

Administration of Vaccines

Adverse Reactions

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 ulcerative colitis are arthralgia in induction, and arthralgia, pyrexia, injection site reactions, and rash in maintenance.

INDICATIONS

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

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

Crohn's Disease: SKYRIZI is indicated for the treatment of moderately to severely active Crohn's disease in adults.

Ulcerative Colitis: SKYRIZI is indicated for the treatment of moderately to severely active ulcerative colitis in adults.

Please see Full Prescribing Information.

US-SKZG-240258

MDA RESPONSE RATES ACHIEVED

In Patients with PsA

IN KEEPsAKE 1 AND KEEPsAKE 2, THE PRIMARY ENDPOINT WAS ACR20 RESPONSE AT WEEK 24.1

Study Design:

Minimal Disease Activity is an important measure of disease control in PsA.

MDA RESPONSE ACHIEVED AT ~5 YEARS6

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

IN KEEPsAKE 1 AND KEEPsAKE 2, THE PRIMARY ENDPOINT WAS ACR20 RESPONSE AT WEEK 24.¹

MDA RESPONSE ACHIEVED AT ~5 YEARS⁶

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