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

Ophthalmology

Non-Infectious

Intermediate, Posterior and Panuveitis

For Healthcare
Professionals

Nothing less than the opportunity for RAPID RESPONSE

On average, patients saw 58% clearer skin 4 weeks after 1st dose2

Integrated results from UltIMMa-1 and UltIMMa-2 at specific time points2,3

VIEW PRIMARY ENDPOINT DATA

On average, patients saw 58% clearer skin 4 weeks after 1st dose2

Integrated results from UltIMMa-1 and UltIMMa-2 at specific time points2,3

After 1 dose
Week 4

58%

MEAN PASI IMPROVEMENT*†‡

(n=598)

VS 9% for placebo

(n=200)

PASI 90 AT Week 4 was 6%

After 2 doses
Week 16

91%

MEAN PASI IMPROVEMENT*†‡

(n=598)

VS 10% for placebo

(n=200)

PASI 90 AT Week 16 was 75%

After 5 doses
Week 52

95%

MEAN PASI IMPROVEMENT*†‡

(n=598)

placebo N/A

()

PASI 90 AT Week 52 was 81%

Open-Label Extension (OLE), as observed3

After 12 doses
Week 136

96%

MEAN PASI IMPROVEMENT*†‡

(n=464)

Placebo N/A

()

()

Analysis conducted using LOCF method.
MAINTENANCE OF RESPONSE1: 88% of PASI 90 responders at Week 16 maintained response at Week 52.
*As measured by change in PASI score from baseline; last observation carried forward.

LIMITATIONS: Mean change in PASI at all time points and PASI 90 response at Week 4 were pre-specified, non-ranked endpoints and were not adjusted for multiplicity.  Therefore, treatment differences cannot be regarded as statistically significant.

OLE LIMITATIONS: In an open-label extension, there is a potential for enrichment of the long-term data in the remaining patient populations since patients who are unable to tolerate or do not respond to the drug often drop out.

LIMMitless is an open-label extension for which patients who completed UltIMMa-1 or -2, IMMvent, or IMMhance were eligible to participate. The data presented here are a sub-analysis of LIMMitless and include only patients from UltIMMa-1 and -2. 524 patients from UltIMMa-1 and -2 have enrolled in LIMMitless at this time.3-5

STUDY DESIGNS:

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 at 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.1,6

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.3-5

Mean PASI improvement is an assessment of the average improvement from baseline to a set point in time in psoriatic signs of redness, thickness, scale, and body surface area of involvement.7

Analysis 7/22/19.

Skyrizi long term effect Icon

EXPLAINING SKIN CLEARANCE AND SAFETY TO PATIENTS

Hear from Cynthia Trickett, PA-C, MPAS and Jason M. Cheyney, PA-C, MPAS as they cover how they discuss SKYRIZI skin clearance and safety data with patients.

SKYRIZI® is the #1 prescribed biologic in new and switching plaque psoriasis patients

As of 9/2019. New patients defined as bio-naïve; switch patients
defined as bio-experienced switching biologics. Source: Integrated
Symphony Health (PatientSource) and IQVIA (NPA, NSP) through
proprietary method on diagnosis classification.

See what clearer skin can look like 4 WEEKS AFTER 1 DOSE AND BEYOND WITH SKYRIZI9

Patient case studies representing mean PASI improvement through 52 weeks of dosing

BASELINE

PASI OF TRUNK=16

Baseline PASI of chest
Baseline PASI of back

AFTER 1 DOSE

WEEK 4 – PASI=6

63%

PASI IMPROVEMENT FROM BASELINE

1 dose Week 4 PASI improvement of chest
1 dose Week 4 PASI improvement of back

AFTER 2 DOSES

WEEK 16 – PASI=2

88%

PASI IMPROVEMENT FROM BASELINE

2 doses Week 16 PASI improvement of chest
2 doses Week 16 PASI improvement of back

AFTER 5 DOSES

WEEK 52 – PASI=1

94%

PASI IMPROVEMENT FROM BASELINE

5 doses Week 52 PASI improvement of chest
5 doses Week 52 PASI improvement of back

Images are of clinical trial patients. Individual results may vary.

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.1,6


Mean PASI improvement is an assessment of the population-level average percentage improvement from baseline in PASI score.7

SKYRIZI elimination in clinical trials

For a typical participant, terminal elimination half-life of SKYRIZI
was 28 days with systemic clearance of 0.31 L/day1

Well-Studied Safety Profile

across 4 pivotal trials1

Safety Icon

Only 4 doses per year

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

Calendar Icon
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. Lebwohl M, Bachelez H, Valdecantos WC, Wu T, Gordon K. Efficacy and safety of risankizumab in moderate-to-severe plaque psoriasis: an integrated analysis of UltIMMa-1 and UltIMMa-2. Poster presented at: American Academy of Dermatology Annual Meeting; March 1-5, 2019; Washington, DC.
  3. Leonardi C, Lebwohl M, Bachelez H, et al. Maintenance of response through 136 weeks of long-term continuous risankizumab treatment: an analysis of patients from UltIMMa-1 and UltIMMa-2. Presented at the Virtual Annual Meeting of the American Academy of Dermatology; June 12-14, 2020.
  4. Papp K, Lebwohl M, Ohtsuki M, et al. Long-term efficacy and safety of continuous Q12W risankizumab: results from open-label extension study LIMMitless. Presented at the Virtual Annual Meeting of the American Academy of Dermatology; June 12-14, 2020.
  5. Leonardi C, Bachelez H, Wu JJ, et al. Long-term safety of risankizumab in patients with moderate to severe psoriasis: analysis of pooled clinical trial data. Poster presented at: American Academy of Dermatology Annual Meeting; March 1-5, 2019; Washington, DC.
  6. 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.
  7. Vender R, Lovell P. A practical understanding of mean percent PASI reduction for biologics. J Am Acad Dermatol. 2008;58(2)(suppl 2):AB5.
  8. Data on file, AbbVie Inc. In-play patient share. 2020.
  9. Data on file, ABVRRTI67285.
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