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

SKYRIZI VS HUMIRA® (adalimumab)²

SUPERIOR RATES OF PASI 90 AT WEEK 16 IN A PHASE 3,
RANDOMIZED, DOUBLE-BLIND STUDY OF PATIENTS WITH Ps

CO-PRIMARY ENDPOINTS IN ULTIMMA-1 AND ULTIMMA-2 (NRI)^1,3

PASI 90 at Week 16
UltIMMa-1:
SKYRIZI 75% (229/304), placebo 5% (5/102)
UltIMMa-2:
SKYRIZI 75% (220/294), placebo 2% (2/98)

P<0.0001.

sPGA 0/1 at Week 16
UltIMMa-1:
SKYRIZI 88% (267/304), placebo 8% (8/102)
UltIMMa-2:
SKYRIZI 84% (246/294), placebo 5% (5/98)

NRI=Non-responder imputation.

Study Design:

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 biologic active control (45 mg or 90 mg, based on screening weight) over 52 weeks in adult patients with moderate to severe plaque psoriasis. Patients received SKYRIZI 150 mg at Week 0, Week 4, and every 12 weeks thereafter.^1,3

PASI 90 PASI 90

PASI 100 PASI 100

In Part A of IMMvent,
a 2-part, Phase 3 study of patients with Ps

SKYRIZI DEMONSTRATED SUPERIOR RATES OF PASI 90 VS HUMIRA® (adalimumab) AT WEEK 16²

72% OF SKYRIZI PATIENTS WITH Ps ACHIEVED PASI 90 VS 47% OF HUMIRA PATIENTS (NRI)²

WEEK 16 RESULTS (PART A)

72% of SKYRIZI® patients achieved PASI 90 vs 47% of HUMIRA® patients at week 16.

Part A Co-Primary Endpoints: PASI 90 and sPGA 0/1 at Week 16

STUDY DESIGN:

IMMvent was a Phase 3, randomized, double-blind, double-dummy, active-controlled study to evaluate the efficacy and safety of SKYRIZI (150 mg) compared to HUMIRA in adult patients with moderate to severe plaque psoriasis over 44 weeks.²

In Part A of the study, patients were randomized 1:1 to either SKYRIZI (150 mg) at Weeks 0 and 4, and every 12 weeks thereafter, or HUMIRA at an initial dose of 80 mg followed by 40 mg every other week starting 1 week after the initial dose. At Week 16, in Part B, patients taking HUMIRA with a PASI score of ≥50 but <90 were re-randomized 1:1 to either receive SKYRIZI (150 mg) at Weeks 16, 20, and 32, or continue HUMIRA. Patients who continued SKYRIZI in Part B remained on every-12-week dosing.²

NRI=Non-responder imputation.

In Part B, HUMIRA patients who achieved PASI 50 to <90 were re-randomized 1:1

3x MORE PATIENTS ACHIEVED PASI 90 AFTER SWITCHING TO SKYRIZI THAN THOSE WHO REMAINED ON HUMIRA® (adalimumab)²

66% OF SKYRIZI PATIENTS WITH Ps ACHIEVED PASI 90 VS 21% OF HUMIRA PATIENTS (NRI)²

WEEK 44 RESULTS (PART B)

66% of SKYRIZI® patients achieved PASI 90 vs 21% of HUMIRA® patients at week 44.

*P<0.0001

Part B Primary Endpoint: PASI 90 at Week 44

STUDY DESIGN:

NRI=Non-responder imputation.

Click to see HUMIRA® (adalimumab)

Indication and Important Safety Information, including BOXED WARNING for Serious Infections and Malignancy.

See Full Prescribing Information

VIEW PASI 100 DATA

In Part A of IMMvent,
a 2-part, Phase 3 study of patients with Ps

SKYRIZI DEMONSTRATED SUPERIOR RATES OF PASI 100 VS HUMIRA® (adalimumab) AT WEEK 16²

40% OF SKYRIZI PATIENTS WITH Ps ACHIEVED COMPLETE CLEARANCE (PASI 100) VS 23% OF HUMIRA PATIENTS (NRI)²

WEEK 16 RESULTS (PART A)

40% of SKYRIZI® patients achieved PASI 100 vs 23% of HUMIRA® patients at week 16.

*P<0.0001

Part A Ranked Secondary Endpoints: PASI 75 and PASI 100 at Week 16

STUDY DESIGN:

NRI=Non-responder imputation.

In Part B, HUMIRA patients who achieved PASI 50 to <90 were re-randomized 1:1

MORE PATIENTS ACHIEVED PASI 100 AFTER SWITCHING TO SKYRIZI THAN THOSE WHO REMAINED ON HUMIRA® (adalimumab)²

40% OF SKYRIZI PATIENTS WITH Ps ACHIEVED Complete clearance (PASI 100) VS 7% OF HUMIRA PATIENTS (NRI)²

WEEK 44 RESULTS (PART B)

40% of SKYRIZI® patients achieved PASI 100 vs 7% of HUMIRA® patients at week 44.

*P<0.0001

Part B Ranked Secondary Endpoint: PASI 100 at Week 44

STUDY DESIGN:

NRI=Non-responder imputation.

Click to see HUMIRA® (adalimumab)

Indication and Important Safety Information, including BOXED WARNING for Serious Infections and Malignancy.

See Full Prescribing Information

VIEW PASI 90 DATA

Well-Studied Safety Profile

across 4 pivotal trials¹

REVIEW SAFETY

4 DOSES PER YEAR

4 doses per year after 2 initiation doses at Weeks 0 and 4 (150 mg/dose)¹

VIEW DOSING SCHEDULE

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.
Reich K, Gooderham M, Thaçi D, et al. Risankizumab compared with adalimumab in patients with moderate-to-severe plaque psoriasis (IMMvent): a randomised, double-blind, active-comparator-controlled phase 3 trial. Lancet. 2019;394(10198):576-586.
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.

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

SKYRIZI VS HUMIRA® (adalimumab)2

SUPERIOR RATES OF PASI 90 AT WEEK 16 IN A PHASE 3, RANDOMIZED, DOUBLE-BLIND STUDY OF PATIENTS WITH Ps

CO-PRIMARY ENDPOINTS IN ULTIMMA-1 AND ULTIMMA-2 (NRI)1,3

Study Design:

72% OF SKYRIZI PATIENTS WITH Ps ACHIEVED PASI 90 VS 47% OF HUMIRA PATIENTS (NRI)2

66% OF SKYRIZI PATIENTS WITH Ps ACHIEVED PASI 90 VS 21% OF HUMIRA PATIENTS (NRI)2

40% OF SKYRIZI PATIENTS WITH Ps ACHIEVED COMPLETE CLEARANCE (PASI 100) VS 23% OF HUMIRA PATIENTS (NRI)2

40% OF SKYRIZI PATIENTS WITH Ps ACHIEVED Complete clearance (PASI 100) VS 7% OF HUMIRA PATIENTS (NRI)2

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

Indications

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

SKYRIZI VS HUMIRA® (adalimumab)²

SUPERIOR RATES OF PASI 90 AT WEEK 16 IN A PHASE 3,
RANDOMIZED, DOUBLE-BLIND STUDY OF PATIENTS WITH Ps

CO-PRIMARY ENDPOINTS IN ULTIMMA-1 AND ULTIMMA-2 (NRI)^1,3

72% OF SKYRIZI PATIENTS WITH Ps ACHIEVED PASI 90 VS 47% OF HUMIRA PATIENTS (NRI)²

66% OF SKYRIZI PATIENTS WITH Ps ACHIEVED PASI 90 VS 21% OF HUMIRA PATIENTS (NRI)²

40% OF SKYRIZI PATIENTS WITH Ps ACHIEVED COMPLETE CLEARANCE (PASI 100) VS 23% OF HUMIRA PATIENTS (NRI)²

40% OF SKYRIZI PATIENTS WITH Ps ACHIEVED Complete clearance (PASI 100) VS 7% OF HUMIRA PATIENTS (NRI)²

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

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