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)

WELL-STUDIED SAFETY PROFILE
ESTABLISHED IN PsA & Ps¹

When deciding treatment for bio-naïve PsA patients,
start with a well-studied safety profile:

NO labeled warnings or precautions on malignancy, IBD, or candidiasis¹

Warnings and precautions include hypersensitivity, infections, TB, and immunizations.¹

NO labeled warnings or precautions on depression¹

Warnings and precautions include hypersensitivity, infections, TB, and immunizations.¹

NO routine lab monitoring required during treatment¹

Initially evaluate for TB and instruct patients to report signs and symptoms of infection.¹

NO labeled liver testing for Ps or PsA¹

Required for initiation or during treatment.

NO labeled drug interactions^1,||

NO labeled boxed warning¹

SKYRIZI is contraindicated in patients with a history of serious hypersensitivity reaction to risankizumab-rzaa or any of the excipients¹

^||Based on CYP450 studies, no clinically significant changes in the exposure of caffeine (CYP1A2 substrate), warfarin (CYP2C9 substrate), omeprazole (CYP2C19 substrate), metoprolol (CYP2D6 substrate), or midazolam (CYP3A substrate) were observed when used concomitantly with risankizumab-rzaa in subjects with plaque psoriasis (risankizumab-rzaa 150 mg administered subcutaneously at Weeks 0, 4, 8, and 12).¹

LONG-TERM SAFETY DATA UP TO 6 YEARS OF EXPOSURE IN PsA and ~9 YEARS IN Ps^2*

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†‡

7.2^§

SERIOUS ADVERSE EVENTS

PER 100 PYs on SKYRIZI

(n=4,281, PYs=14,181.1)³

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

*Includes 5 PsA Phase 2-3 studies (including KEEPsAKE 1 and KEEPsAKE 2). Includes 23 Phase 1-4 studies in Ps encompassing 5 trials (including UltIMMa-1, UltIMMa-2, IMMhance, and IMMvent), and 18 additional trials including LIMMitless.²

^†Long-term data include all administered doses ranging from 18 mg to 180 mg of SKYRIZI in 3,849 patients. The FDA-approved dose is 150 mg at Week 0, Week 4, and every 12 weeks thereafter.^1,3

^‡Long-term safety from a 23-study pool, includes Phase 1 through Phase 4 data, representing different pools of patients with varying lengths of treatment exposure.³

^§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.³

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.^1,4,5

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.^1,6

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.⁷

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.^1,8

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.⁹

IMMpulse was a 52-week, Phase 4, multicenter, randomized, open-label, efficacy assessor-blinded study of SKYRIZI compared to OTEZLA® (apremilast) for the treatment of adults with moderate plaque psoriasis who are candidates for systemic therapy.¹⁰

TEAEs OF SAFETY INTEREST AND TEAEs FROM POOLED TRIAL DATA

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

SELECT PsA & Ps AEs (1, 6 & 9 YEARS) SELECT PsA & Ps AEs (1, 6 & 9 YEARS)

COMPELLING SAFETY AND
TOLERABILITY RECORD IN PsA & Ps¹

TEAEs OF SAFETY INTEREST AND TEAEs FROM POOLED TRIAL DATA^1,4-13

Adverse events in 2 PsA trials at Week 24 and 4 Ps trials at Week 16

PsA SAFETY PROFILE IS GENERALLY

CONSISTENT

WITH THAT OBSERVED IN PATIENTS WITH Ps¹

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

NO ROUTINE LAB MONITORING REQUIRED DURING TREATMENT¹

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

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

NO LABELED WARNINGS OR PRECAUTIONS ON DEPRESSION¹

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.¹

^¶Includes data from KEEPsAKE 1 and KEEPsAKE 2 studies.⁴

^#Includes data from UltIMMa-1, UltIMMa-2, IMMhance, and IMMvent studies.⁵

**Opportunistic infection excluding tuberculosis and herpes zoster.

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

TEAEs OF SAFETY INTEREST AND TEAEs FROM 5 PsA AND 23 Ps CLINICAL TRIALS³

VIEW STUDY DESIGN AND BASELINE CHARACTERISTICS

Adverse events in 5 PsA trials at 6 years, 2 Ps trials at Week 52, and 23 Ps trials at ~9 years

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

NO ROUTINE LAB MONITORING REQUIRED DURING TREATMENT¹

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

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

NO LABELED WARNINGS OR PRECAUTIONS ON DEPRESSION¹

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).^1,14,#

^††Long-term safety was evaluated in an all-SKYRIZI data set comprising 23 Phase 1-4 studies in patients with moderate or moderate to severe plaque psoriasis.²

^¶Data are integrated from 5 Phase 2-3 clinical trials in PsA. Median treatment duration was 4.6 years (56 days-6.0 years).²

^#Includes data from UltIMMa-1 and UltIMMa-2 studies.¹⁴

IBD=inflammatory bowel disease; MACE=major adverse cardiovascular event; NMSC=nonmelanoma skin cancer; PYs=patient years; TB=tuberculosis; TEAEs=treatment-emergent adverse events.