SKYRIZI SAFETY PROFILE

UP TO ~9 YEARS OF CLINICAL TRIAL EXPERIENCE ACROSS 4 INDICATIONS²

Approved for 4 Indications: Starting with plaque psoriasis (Ps), followed by psoriatic arthritis (PsA), Crohn’s disease, and ulcerative colitis (UC)¹

Clinical Trials Across Indications²*^†

>8,700

Patients Evaluated in Global Clinical Trials Across All Doses²*^‡

>26,800

Patient-Years of Clinical Trial Exposure²*^§

307,124

Patients Prescribed Worldwide Since 2019 Starting With Plaque Psoriasis^3ll

*Safety data were evaluated for all patients receiving ≥1 dose of SKYRIZI from clinical trials, including open-label extension and dose-ranging studies.²

WELL-STUDIED SAFETY PROFILE IN UC & CROHN’S^1,4-6

Induction

Maintenance

SWIPE TABLE TO VIEW MORE

INSPIRE UC at week 12. Columns from left to right: Adverse events (AEs), Placebo (n=383), and SKYRIZI 1200mg IV (n=712). Treatment-emergent AEs: Any AE: 51.7% & 42.3%. Serious AE: 10.2% & 2.7%. AE leading to discontinuation of study drug: 4.4% & 0.8%. Death: 0% & 0.1%. AEs of Special Interest: Infections: Infections: 16.7% & 14.9%. Serious Infection: 1% & 0.7%. Opportunistic Infection (excluding TB/Herpes Zoster): 0% & 0%. Active Tuberculosis (TB): 0% & 0%. Herpes Zoster: 0.3% & 0.3%. Malignancy: NMSC: 0% & 0%. Malignancy (excluding NMSC): 0.8% & 0%. Cardiovascular events: Adjudicated MACE: 0% & 0%. Other: Hypersensitivity (Serious events only): 0.3% & 0%. Adjudicated Anaphylactic Reaction: 0% & 0%. Hepatic Events: 4.2% & 1.5%. Infusion-related reactions: 1.6% & 0.7%.

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Pooled induction trial data ADVANCE & MOTIVATE CD at week 12. Columns from left to right: Adverse events (AEs), Placebo (n=432), and SKYRIZI 600mg IV (n=620). Treatment-emergent AEs: Any AE: 63.4% & 54.7%. Serious AE: 15.5% & 6.6%. AE leading to discontinuation of study drug: 8.6% & 2.1%. Death: 0.5% & 0%. AEs of Special Interest: Infections: Infections: 24.8% & 19.7%. Serious Infection: 3.7% & 1.0%. Opportunistic Infection (excluding TB/Herpes Zoster): 0.7% & 0%. Active Tuberculosis (TB): 0.2% & 0.2%. Herpes Zoster: 0.2% & 0.3%. Malignancy: NMSC: 0% & 0%. Malignancy excluding NMSC: 0% & 0%. Cardiovascular events: Adjudicated MACE: 0% & 0%. Other: Hypersensitivity (Serious events only): 0.2% & 0.2%. Adjudicated Anaphylactic Reaction: 0% & 0%. Hepatic Events: 1.6% & 1.6%. Infusion-related reactions: 1.2% & 0.8%.

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COMMAND UC at week 52. Columns from left to right: Adverse events (AEs), Placebo induction responders (n=173; PYs=155.7), SKYRIZI 180mg SC (n=170; PYs=163.4), and SKYRIZI 360mg SC (n=177; PYs=159.0). Treatment-emergent AEs: Any AE: 75%, 70%, & 70%. Serious AE: 8%, 4%, & 5%. AE leading to discontinuation of study drug: 1%, 2%, & 2%. Death: 0%, 0%, & 0.6%. AEs of Special Interest: % (E/100 PYs): Infections: Infections: 36 (60.4), 32 (69.1), & 36 (59.1). Serious Infection: 2 (1.9), 1.2 (1.2), & 0.6 (0.6). Opportunistic Infection (excluding TB/Herpes Zoster): 0, 0, & 0.6 (0.6). Active Tuberculosis (TB): 0, 0, & 0. Herpes Zoster: 2 (1.9), 0.6 (0.6), & 0.6 (0.6). Malignancy: NMSC: 0.6 (0.6), 0, & 0. Malignancy excluding NMSC: 0, 0, & 1 (1.3). Cardiovascular events: Adjudicated MACE: 0, 0, & 0. Other: Hypersensitivity (Serious events only): 0, 0, 0, & 0. Adjudicated Anaphylactic Reaction: 0, 0, 0, & 0. Hepatic Events: 0.6 (1.9), 2 (1.8), 7 (11.3). Injection Site Reaction: 1 (1.9), 3 (7.3), 3 (6.3).

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FORTIFY CD at week 52. Columns from left to right: Adverse events (AEs), Placebo induction responders (n=143; PYs=124.4), SKYRIZI 180mg SC (n=155; PYs=149.4), and SKYRIZI 360mg SC (n=142; PYs=134.8). Treatment-emergent AEs: Any AE: 71%, 69%, & 70%. Serious AE: 10%, 11%, & 13%. AE leading to discontinuation of study drug: 2%, 2%, & 3%. Death: 0%, 0%, & 0%. AEs of Special Interest: % (E/100 PYs) Infections: Infections: 36 (60.3), 32 (50.2), & 37 (60.8). Serious Infection: 2 (2.4), 3 (2.7), & 6 (7.4). Opportunistic Infection (excluding TB/Herpes Zoster): 0, 0, & 1 (0.7). Active Tuberculosis (TB): 0, 0, & 0. Herpes Zoster: 1 (0.8), 1 (1.3), & 0. Malignancy: NMSC: 1 (0.8), 0, & 0. Malignancy excluding NMSC: 0, 0, & 0. Cardiovascular events: Adjudicated MACE: 1 (0.8), 0, & 1 (0.7). Other: Hypersensitivity (Serious events only): 0, 0, & 0. Adjudicated Anaphylactic Reaction: 0, 0, & 0. Hepatic Events: 2 (2.4), 3 (4.7), & 5 (6.7). Injection site reaction: 3 (4.8), 5 (10.0), & 6 (13.4).

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

IN THE TREATMENT OF CROHN’S, DRUG-INDUCED LIVER INJURY DURING INDUCTION HAS BEEN REPORTED. FOR THE TREATMENT OF CROHN’S DISEASE AND ULCERATIVE COLITIS, EVALUATE LIVER ENZYMES AND BILIRUBIN LEVELS AT BASELINE AND DURING INDUCTION, (12 WEEKS) OF TREATMENT. MONITOR THEREAFTER ACCORDING TO ROUTINE PATIENT MANAGEMENT.¹

IN THE UC 12-WEEK INDUCTION STUDY, THE MOST COMMON ADVERSE REACTIONS (≥3% OF PATIENTS AND AT A HIGHER RATE THAN PLACEBO) INCLUDE ARTHRALGIA.¹

IN THE CROHN'S 12-WEEK INDUCTION STUDY, THE MOST COMMON ADVERSE REACTIONS (>3% OF PATIENTS AND AT A HIGHER RATE THAN PLACEBO) INCLUDE UPPER RESPIRATORY INFECTIONS, HEADACHE, AND ARTHRALGIA.¹

AEs (WEEK 24 & WEEK 16)

AEs (LONG-TERM)

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Adverse events table for psoriatic arthritis (WEEK 24) ACROSS 2 PIVOTAL TRIALS. Columns from left to right: Skyrizi n=707 % (n), Placebo n=700 % (n). Any serious adverse event: 3.0 (21), 4.4 (31). Any infection: 19.0 (134), 19.3 (135). Serious infections: 1.0 (7), 1.6 (11). Active TB: 0.0, 0.0. Any Malignancy: 0.1 (1), 0.4 (3). Malignancies (excluding NMSC): 0 (0), 0.3 (2). Adjudicated MACE: 0.1 (1), 0 (0). Adverse events table for psoriasis (WEEK 16) ACROSS 4 PIVOTAL TRIALS. Columns from left to right: Skyrizi n=1306 % (n), Placebo n=300 % (n). Any serious adverse event: 2.4 (31), 4.0 (12). Any infection: 22.1 (288), 14.7 (44). Serious infections: 0.4 (5), 0.3 (1). Active TB: 0.0, 0 (0). Any Malignancy: 0.5 (6), 0.3 (1). Malignancies (excluding NMSC): 0.2 (3), 0 (0). Adjudicated MACE: <0.1 (1), 0.3 (1).

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

INITIALLY EVALUATE FOR TUBERCULOSIS (TB) AND INSTRUCT PATIENTS TO REPORT SIGNS AND SYMPTOMS OF INFECTION.¹

In Ps and PsA, the most common adverse reactions (≥1%) associated with SKYRIZI include upper respiratory infections, headache, fatigue, injection site reactions, and tinea infections.¹

In PsA Phase 3 trials, the incidence of hepatic events for SKYRIZI was 5.4% (16.7 events per 100 patient-years) compared to 3.9% (12.6 events per 100 patient-years) with placebo.¹

STUDY DESIGNS

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 long-term, open-label extensions for up to an additional 204 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.^1,14,15

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.¹⁶

IMMvent was a Phase 3, randomized, double-blind, double-dummy, active-controlled study to evaluate the efficacy and safety of SKYRIZI compared to another biologic in adult patients with moderate to severe plaque psoriasis over 44 weeks.¹⁷

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.¹⁸

SWIPE TABLE TO VIEW MORE

Adverse events table. Columns from left to right: psoriatic arthritis LONG-TERM (UP TO ~3 YEARS OF EXPOSURE), psoriasis AT WEEK 52, and psoriasis LONG-TERM (UP TO ~8 YEARS OF EXPOSURE). Sub-columns from left to right: Integrated analysis of 4 clinical trials (n=1542, PYs=3803.3 Events/100 PYs), Integrated analysis of 2 clinical trials (n=598, PYs=618.0 Events/100 PYs), Integrated analysis of 20 clinical trials (n=3658, PYs=13329.3 Events/100 PYs). Any serious adverse event: 8.6, 9.4, 7.5. Serious infections: 1.5, 1.8, 1.2. Active TB: 0.0, 0.0, <0.1. Any Malignancy: 1.0, 0.5, 1.2. Malignancies (excluding NMSC): 0.5, 0.0, 0.6. Adjudicated MACE: 0.4, 0.3, 0.3.

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

INITIALLY EVALUATE FOR TUBERCULOSIS (TB) AND INSTRUCT PATIENTS TO REPORT SIGNS AND SYMPTOMS OF INFECTION¹

In Ps and PsA, the most common adverse reactions (≥1%) associated with SKYRIZI include upper respiratory infections, headache, fatigue, injection site reactions, and tinea infections.¹

In PsA Phase 3 trials, the incidence of hepatic events for SKYRIZI was 5.4% (16.7 events per 100 patient-years) compared to 3.9% (12.6 events per 100 patient-years) with placebo.¹

Data are integrated from 20 phase 1-4 clinical trials in Ps with a median (range) treatment duration of 4.1 years (81 days-8.8 years) and from 4 Phase 2-3 trials in PsA with a median (range) treatment duration of 2.8 years (84 days-4.0 years).¹⁹

LONG-TERM RESULTS PRESENTED INCLUDE VARYING LENGTHS OF TREATMENT EXPOSURE AND ALL EXPLORED DOSING REGIMENS FOR SKYRIZI.

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.¹⁹

STUDY DESIGN

LIMMitless is an ongoing, single-arm, multicenter, open-label extension of Phase 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.²¹

RECOMMENDED FOR YOU

LAB MONITORING FOR SKYRIZI

SKYRIZI treatment considerations in UC.

LEARN ABOUT LAB MONITORING

SKYRIZI ACCESS & REIMBURSEMENT

AbbVie can help your patients access SKYRIZI.

VIEW ACCESS RESOURCES

ENDOSCOPIC OUTCOMES WITH SKYRIZI¹

An opportunity for endoscopic control.¹

SEE ENDOSCOPIC DATA

SKYRIZI SAFETY PROFILE

UP TO ~9 YEARS OF CLINICAL TRIAL EXPERIENCE ACROSS 4 INDICATIONS²

Approved for 4 Indications: Starting with plaque psoriasis (Ps), followed by psoriatic arthritis (PsA), Crohn’s disease, and ulcerative colitis (UC)¹

WELL-STUDIED SAFETY PROFILE IN UC & CROHN’S^1,4-6

RECOMMENDED FOR YOU

Adverse reactions reported in ≥3% of patients^1,2

Adverse reactions reported in ≥3% of patients¹

Primary endpoint¹:

Select secondary endpoints¹:

Primary endpoint (All Subjects Maintenance Population)¹:

Select secondary endpoints (All Subjects Maintenance Population)¹:

Primary endpoint¹:

Select secondary endpoints¹:

Primary endpoint (All Subjects Maintenance Population)¹:

Select secondary endpoints (All Subjects Maintenance Population)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

SKYRIZI SAFETY PROFILE

UP TO ~9 YEARS OF CLINICAL TRIAL EXPERIENCE ACROSS 4 INDICATIONS2

Approved for 4 Indications: Starting with plaque psoriasis (Ps), followed by psoriatic arthritis (PsA), Crohn’s disease, and ulcerative colitis (UC)1

WELL-STUDIED SAFETY PROFILE IN UC & CROHN’S1,4-6

RECOMMENDED FOR YOU

Primary endpoint1:

Select secondary endpoints1:

Primary endpoint (All Subjects Maintenance Population)1:

Select secondary endpoints (All Subjects Maintenance Population)1:

Primary endpoint1:

Select secondary endpoints1:

Primary endpoint (All Subjects Maintenance Population)1:

Select secondary endpoints (All Subjects Maintenance Population)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

UP TO ~9 YEARS OF CLINICAL TRIAL EXPERIENCE ACROSS 4 INDICATIONS²

Approved for 4 Indications: Starting with plaque psoriasis (Ps), followed by psoriatic arthritis (PsA), Crohn’s disease, and ulcerative colitis (UC)¹

WELL-STUDIED SAFETY PROFILE IN UC & CROHN’S^1,4-6

Primary endpoint¹:

Select secondary endpoints¹:

Primary endpoint (All Subjects Maintenance Population)¹:

Select secondary endpoints (All Subjects Maintenance Population)¹:

Primary endpoint¹:

Select secondary endpoints¹:

Primary endpoint (All Subjects Maintenance Population)¹:

Select secondary endpoints (All Subjects Maintenance Population)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