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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

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

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US-MULT-250253

Immunology Therapies

Full Prescribing Information

Patient Site

PRIMARY PRIMARY

SECONDARY including sPGA 0/1 SECONDARY including sPGA 0/1

In an open-label, assessor-blinded
study, IMMerge

SKYRIZI DEMONSTRATED SUPERIOR RATES OF PASI 90 AT WEEK 52²

SOURCING:

In this study, 46 patients outside of the US received non–US-licensed secukinumab. Data regarding comparability between US and non-US secukinumab is not publicly available.⁴

The adverse events observed in this study were consistent with those observed in previously reported studies and as described in the full Prescribing Information for SKYRIZI and COSENTYX.^1,2,*

*COSENTYX is a registered trademark of Novartis AG. See US Prescribing Information for further information.

87% OF SKYRIZI PATIENTS WITH Ps ACHIEVED PASI 90 AT WEEK 52 VS 57% OF COSENTYX® (SECUKINUMAB) PATIENTS (NRI)²

IMMerge PASI 90 response rates over 52 weeks

SKYRIZI 5 doses in year one

and COSENTYX 16 doses in year one²

SOURCING:

In this study, 46 patients outside of the US received non–US-licensed secukinumab. Data regarding comparability between US and non-US secukinumab is not publicly available.⁴

The adverse events observed in this study were consistent with those observed in previously reported studies and as described in the full Prescribing Information for SKYRIZI and COSENTYX.^1,2,*

*COSENTYX is a registered trademark of Novartis AG. See US Prescribing Information for further information.

STUDY DESIGN:

The head-to-head study was an open-label, assessor-blinded, 52-week study where patients were randomized 1:1 to receive either SKYRIZI 150 mg (two 75 mg injections) at Weeks 0, 4, and every 12 weeks until the last dose at Week 40; or COSENTYX* 300 mg (two 150 mg injections) at Weeks 0, 1, 2, 3, 4, and every 4 weeks until the last dose at Week 48.²

ITT=Intent-to-treat; NRI=Non-responder imputation.

In an open-label, assessor-blinded
study, IMMerge

SKYRIZI DEMONSTRATED SUPERIOR RATES OF PASI 100 AND sPGA 0/1 AT WEEK 52²

SOURCING:

In this study, 46 patients outside of the US received non–US-licensed secukinumab. Data regarding comparability between US and non-US secukinumab is not publicly available.⁴

The adverse events observed in this study were consistent with those observed in previously reported studies and as described in the full Prescribing Information for SKYRIZI and COSENTYX.^1,2,*

*COSENTYX is a registered trademark of Novartis AG. See US Prescribing Information for further information.

SECONDARY ENDPOINT DATA²

IMMerge PASI 100 and sPGA 0/1 results at 52 weeks

SOURCING:

In this study, 46 patients outside of the US received non–US-licensed secukinumab. Data regarding comparability between US and non-US secukinumab is not publicly available.⁴

The adverse events observed in this study were consistent with those observed in previously reported studies and as described in the full Prescribing Information for SKYRIZI and COSENTYX.^1,2,*

*COSENTYX is a registered trademark of Novartis AG. See US Prescribing Information for further information.

STUDY DESIGN:

The head-to-head study was an open-label, assessor-blinded, 52-week study where patients were randomized 1:1 to receive either SKYRIZI 150 mg (two 75 mg injections) at Weeks 0, 4, and every 12 weeks until the last dose at Week 40, or COSENTYX* 300 mg (two 150 injections); at Weeks 0, 1, 2, 3, 4, and every 4 weeks until the last dose at Week 48.²

ITT=Intent-to-treat;

NRI=Non-responder imputation.

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

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

87% OF SKYRIZI PATIENTS WITH Ps ACHIEVED PASI 90 AT WEEK 52 VS 57% OF COSENTYX® (SECUKINUMAB) PATIENTS (NRI)2

SECONDARY ENDPOINT DATA2

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

87% OF SKYRIZI PATIENTS WITH Ps ACHIEVED PASI 90 AT WEEK 52 VS 57% OF COSENTYX® (SECUKINUMAB) PATIENTS (NRI)²

SECONDARY ENDPOINT DATA²

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