HUMIRA® for HCPs
SkyRizi™ for HCPs
RINVOQ™ for HCPs

The IL-23 inhibitor from AbbVie indicated for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy1

WELL-STUDIED SAFETY PROFILE across 4 pivotal trials1

Safety through 16 weeks1-4

Safety through 16 weeks Safety through 16 weeks Safety through 16 weeks

Safety Through 52 Weeks:

Rates of adverse events with SKYRIZI at 52 weeks were similar to the safety profile observed during the first 16 weeks.1

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 over 52 weeks in adult patients with moderate to severe plaque psoriasis.1,5

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.4

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.1,6

Warnings and precautions include infections, tuberculosis, and immunizations.

NO LABELED WARNINGS or precautions on: malignancy, IBD, or depression.1

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

No routine lab monitoring required during treatment.1

Active Comparator

The ustekinumab used as a biologic active control in UltIMMa-1 and UltIMMa-2 was sourced from the European Union. Comparability between non–US-approved ustekinumab and US-approved ustekinumab has not been established. See Full Prescribing Information for US-approved ustekinumab, which reflects different rates of adverse events from those observed for EU-approved ustekinumab in the UltIMMa trials.

At Week 16, see results of patients achieving  PASI 90 in the UltIMMa studies.

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

Warnings and precautions include infections, tuberculosis, and immunizations.

NO LABELED WARNINGS or precautions on: malignancy, IBD, or depression.1

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

No routine lab monitoring required during treatment.1

Active Comparator

The ustekinumab used as a biologic active control in UltIMMa-1 and UltIMMa-2 was sourced from the European Union. Comparability between non–US-approved ustekinumab and US-approved ustekinumab has not been established. See Full Prescribing Information for US-approved ustekinumab, which reflects different rates of adverse events from those observed for EU-approved ustekinumab in the UltIMMa trials.

ADVERSE EVENTS OF INTEREST
THROUGH 16 WEEKS1-3,7,8

Adverse effects of interest of treatments through 16 weeks Adverse effects of interest of treatments through 16 weeks Adverse effects of interest of treatments through 16 weeks

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 over 52 weeks in adult patients with moderate to severe plaque psoriasis.1,5

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.4

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.1,6

ADVERSE EVENTS OF INTEREST
THROUGH 52 WEEKS1,9,10

ultIMMA-1 & ultIMMA-2 pooled data

Adverse events of interest of treatments through 52 weeks Adverse events of interest of treatments through 52 weeks Adverse events of interest of treatments through 52 weeks

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 over 52 weeks in adult patients with moderate to severe plaque psoriasis.1,5

Warnings and precautions include infections, tuberculosis, and immunizations.

NO LABELED WARNINGS or precautions on: malignancy, IBD, or depression.1

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

No routine lab monitoring required during treatment.1

Active Comparator

The ustekinumab used as a biologic active control in UltIMMa-1 and UltIMMa-2 was sourced from the European Union. Comparability between non–US-approved ustekinumab and US-approved ustekinumab has not been established. See Full Prescribing Information for US-approved ustekinumab, which reflects different rates of adverse events from those observed for EU-approved ustekinumab in the UltIMMa trials.

Safety analyses were performed using a safety analysis set (all patients who received ≥1 dose of study drug). No safety data for adalimumab or placebo was obtained beyond Week 16.

  1. aIncludes data from UltIMMa-1, UltIMMa-2, IMMhance, and IMMvent studies.
  2. bIncludes data from UltIMMa-1, UltIMMa-2, and phase 2 study 1311.2.
  3. cIncludes data from IMMvent study.
  4. dIncludes data from UltIMMa-1, UltIMMa-2, and IMMhance studies.
  5. eIncludes respiratory tract infection (viral, bacterial, or unspecified), sinusitis (including acute), rhinitis, nasopharyngitis, pharyngitis (including viral), and tonsillitis.
  6. fIncludes headache, tension headache, sinus headache, and cervicogenic headache.
  7. gIncludes fatigue and asthenia.
  8. hIncludes injection site bruising, erythema, extravasation, hematoma, hemorrhage, infection, inflammation, irritation, pain, pruritus, reaction, swelling, and warmth.
  9. iIncludes tinea pedis, tinea cruris, body tinea, tinea versicolor, tinea manuum, and tinea infection.
  10. jSKYRIZI (150 mg), adalimumab, and placebo were only evaluated in phase 3 trials; the ustekinumab group includes phase 3 patients (N=199) in addition to phase 2 patients (n=40).
  11. kMycobacterium tuberculosis complex test positive.
  12. lIdentified by standard MedDra query (SMQ).
  13. mIncludes data from UltIMMa-1 and UltIMMa-2 studies.

 

MACE=Major Adverse Cardiac Events;

NMSC=Non-melanoma Skin Cancer;

TB=Tuberculosis;

PYs=Patient-years;

IBD=Inflammatory Bowel Disease.

See SkyriziResults

after 1 dose

View patient case studies and clinical efficacy

Only 4 doses per year

3-month dosing after 2 initiation doses at Weeks 0 and 41

SKYRIZI 3-Month Dosing
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. 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.
  3. Data on file, ABVRRTI68139.
  4. 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.
  5. 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.
  6. Langley RG, Blauvelt A, Gooderham M, et al. Efficacy and safety of continuous Q12W risankizumab versus treatment withdrawal: results from the phase 3 IMMhance trial. Poster presented at: American Academy of Dermatology Annual Meeting; March 1-5, 2019; Washington, DC.
  7. Strober B, Blauvelt A, Menter A, et al. Risankizumab treatment is associated with low and consistent infection rates over time 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.
  8. Reich K, Gordon KB, Tyring S, et al. Malignancy rates in patients with moderate to severe psoriasis during treatment with risankizumab: analysis of pooled clinical trial data. Poster presented at: American Academy of Dermatology Annual Meeting; March 1-5, 2019; Washington, DC.
  9. 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.
  10. Data on file, ABVRRTI68164.
  11. 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 and Inflammation and Psoriasis International Network; April 25-27, 2019; Paris, France.
  12. BI 655066/ABBV-066 (risankizumab) in moderate to severe plaque psoriasis with randomized withdrawal and re-treatment. ClinicalTrials.gov website. https://clinicaltrials.gov/ct2/show/NCT02672852. Updated August 9, 2018. Accessed March 29, 2019.
  13. Data on file, ABVRRTI68151.
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