Active

Psoriatic Arthritis

Active

Ankylosing Spondylitis

Moderate to Severe

Juvenile Idiopathic Arthritis

Non-Infectious

Intermediate, Posterior and Panuveitis

Active

Psoriatic Arthritis

Moderate to Severe

Hidradenitis Suppurativa

Gastroenterology

Moderate to Severe

Crohn's Disease

Moderate to Severe

Pediatric Crohn's Disease

Moderate to Severe

Ulcerative Colitis

Moderate to Severe

Pediatric Ulcerative Colitis

Ophthalmology

Non-Infectious

Intermediate, Posterior and Panuveitis

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SKYRIZI VS HUMIRA® (adalimumab)2

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

PRIMARY DATA FROM PIVOTAL TRIALS

In Part A of IMMvent,
a 2-part, phase 3 study

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

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

WEEK 16 RESULTS (PART A)

Chart depicting 72% of SKYRIZI®  patients achieved PASI 90 vs 47% of HUMIRA patients (NRI) Chart depicting 72% of SKYRIZI®  patients achieved PASI 90 vs 47% of HUMIRA patients (NRI) Chart depicting 72% of SKYRIZI®  patients achieved PASI 90 vs 47% of HUMIRA patients (NRI)

*P<0.0001

 

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.3

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.3

NRI=Non-responder imputation.

NRI=Non-responder imputation.

Click to see HUMIRA® (adalimumab) Indication and Important Safety Information, including BOXED WARNING for Serious Infections and Malignancy

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

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

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

WEEK 44 RESULTS (PART B)

Chart depicting 66% of SKYRIZI®  patients achieved PASI 90 vs 21% of HUMIRA patients (NRI) Chart depicting 66% of SKYRIZI®  patients achieved PASI 90 vs 21% of HUMIRA patients (NRI) Chart depicting 66% of SKYRIZI®  patients achieved PASI 90 vs 21% of HUMIRA patients (NRI)

*P<0.0001

 

PART B Primary Endpoint: PASI 90 at Week 44

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.3

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.3

NRI=Non-responder imputation.

Click to see HUMIRA® (adalimumab) Indication and Important Safety Information, including BOXED WARNING for Serious Infections and Malignancy


Well-Studied Safety Profile

across 4 pivotal trials1

Checklist Icon

Only 4 doses per year

3-month dosing after 2 initiation doses at
Weeks 0 and 4 (150 mg/dose)1

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

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

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.

Pre-Treatment Evaluation for 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.

Immunizations

Prior to initiating SKYRIZI, consider completion of all age appropriate immunizations according to current immunization guidelines. Avoid use of live vaccines in patients treated with SKYRIZI.

Adverse Reactions

Most common (≥1%) adverse reactions associated with SKYRIZI include upper respiratory infections, headache, fatigue, injection site reactions, and tinea infections.

Please see Full Prescribing Information.

US-SKZD-190350

REFERENCES

  1. SKYRIZI [package insert]. North Chicago, IL: AbbVie Inc.
  2. 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.
  3. Reich K, Gooderham M, Thaçi D, et al. Efficacy and safety of continuous risankizumab or switching from adalimumab to risankizumab treatment in patients with moderate-to-severe plaque psoriasis: results from the phase 3 IMMvent trial. Poster presented at: American Academy of Dermatology Annual Meeting; March 1-5, 2019; Washington, DC.
  4. 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.
  5. Ryan C, Crowley J, Valdecantos WC, Wu T, Reich K. Efficacy of switching to risankizumab compared with continued adalimumab treatment in patients with moderate-to-severe plaque psoriasis. Poster presented at: 6th Congress of the Skin Inflammation and Psoriasis International Network; April 25-27, 2019; Paris, France.
IMPORTANT SAFETY INFORMATION AND INDICATION FOR SKYRIZI® (risankizumab-rzaa)1
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. 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.
IMPORTANT SAFETY INFORMATION AND INDICATION FOR SKYRIZI® (risankizumab-rzaa)1
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
IMPORTANT SAFETY INFORMATION AND INDICATION FOR SKYRIZI® (risankizumab-rzaa)1
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. 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.
IMPORTANT SAFETY INFORMATION AND INDICATION FOR SKYRIZI® (risankizumab-rzaa)1
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
IMPORTANT SAFETY INFORMATION AND INDICATION FOR SKYRIZI® (risankizumab-rzaa)1
Indication

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

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.

Pre-Treatment Evaluation for 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.

Immunizations

Prior to initiating SKYRIZI, consider completion of all age appropriate immunizations according to current immunization guidelines. Avoid use of live vaccines in patients treated with SKYRIZI.

Adverse Reactions

Most common (≥1%) adverse reactions associated with SKYRIZI include upper respiratory infections, headache, fatigue, injection site reactions, and tinea infections.

Please see Full Prescribing Information.

US-SKZD-190350