See VALUE real-world data   ׀  See UltIMMa-1/2 pivotal trials efficacy data  ׀  See UltIMMa-1/2 pivotal trials safety data  ׀  See study designs

Schedule a discussion with an AbbVie representative

PIVOTAL TRIALS DATA¹

In the UltIMMa-1 and -2 trials in adults with moderate to severe psoriasis, SKYRIZI patients met the co-primary endpoints of PASI 90 and sPGA of 0 or 1 at Week 16 vs placebo (NRI). UltIMMa-1 PASI 90 at W16: SKYRIZI 75.3% vs 4.9% placebo. UltIMMa-2 PASI 90 at W16: SKYRIZI 74.8% vs 2% placebo. UltIMMa-1 sPGA 0 or 1 at W16: SKYRIZI 87.8% vs 7.8% placebo. UltIMMa-2 sPGA 0 or 1 at W16: SKYRIZI 83.7% vs 5.1% placebo. All comparisons achieved P<0.001.
 

Real-world results from the VALUE study support SKYRIZI PsO pivotal trial data^1,5

Real-world data from VALUE: an ongoing, postmarketing observational study in adult patients with psoriasis

IMPROVEMENTS WERE OBSERVED FROM BASELINE IN PASI SCORES AND DLQI WITH SKYRIZI (mNRI)⁵

Data from bio-naïve PsO subgroup shown:

Descriptive statistics were summarized from an interim database lock on September 26, 2022.

Patients were treated with SKYRIZI as prescribed by their physician.

mNRI: Patients who switched to another biologic or discontinued the initiated biologic due to lack of effectiveness or intolerability are judged as treatment failure for subsequent visits.

Endpoints:

Endpoints were assessed at baseline, Week 4, and every 12 weeks thereafter.⁵

Limitations:

• Real-world evidence is collected outside of controlled clinical trials and has inherent limitations, including a lesser ability to control for confounding factors.

• A large, broader patient population is being enrolled, and methodology to account for confounding is employed. However, there could be residual confounding that may have not been fully accounted for.

• Results are not multiplicity controlled and conclusions cannot be drawn.

• Data shown are from interim analysis.

• Safety was not assessed in this analysis.

In the UltIMMa-2 Phase 3 trial in adult patients with moderate to severe PsO

PASI RESULTS^1,4

Limitations:

• This analysis is post hoc, does not assess a prespecified endpoint, and was not adjusted for multiplicity. Therefore, no clinical or statistical conclusions can be drawn.

UltIMMa-1/2: Safety profile

ADVERSE EVENTS AT WEEK 16 AND WEEK 52 IN UltIMMa-1 AND UltIMMA-2^1,4

UltIMMa-1/2: Phase 3 pivotal trial in patients with moderate to severe PsO study design

UltIMMa-1 and UltIMMa-2 Phase 3 studies^1,4

UltIMMa-1 (N=506) and UltIMMa-2 (N=491) were replicate Phase 3 multi-national, 52-week, randomized, double-blind, placebo-controlled, active comparator, controlled trials. Patients 18 years or older with moderate to severe plaque psoriasis were stratified by weight and previous exposure to TNF inhibitor and randomly assigned (3:1:1) to receive subcutaneous risankizumab 150 mg, ustekinumab 45 mg/90 mg (based on weight per label), or placebo.

Dosing occurred at Weeks 0 and 4 (during Part A) and Weeks 16, 28, and 40 (during Part B). Following the 16-week placebo-controlled treatment period (Part A), patients initially assigned to placebo switched to 150 mg of risankizumab at Week 16. Other patients continued double blind with their originally randomized treatment (Part B) for Weeks 16–52.

All efficacy analyses were done in the ITT population.

Co-primary endpoints: Proportion of patients achieving PASI 90 and an sPGA 0/1 at Week 16 (NRI).
 

VALUE: Study design

VALUE postmarketing observational study⁵

VALUE is an ongoing, multi-country, prospective postmarketing observational study comparing SKYRIZI to other biologics approved for the treatment of PsO. Treatment decisions for participants were made independent of the study enrollment, and patients were enrolled at a 2:1 allocation ratio of SKYRIZI to other biologics. Patients were treated with their biologic as prescribed by their physician.

Baseline demographics and clinical disease characteristics for bio-naïve patients.
 

Clinical endpoints assessed:

PASI and DLQI assessments were collected at baseline, Week 4, and every 12 weeks thereafter. Descriptive statistics were summarized for both continuous and categorical variables from an interim database lock on September 26, 2022.

• mNRI: Patients who switched to another biologic or discontinued the initiated biologic due to lack of effectiveness or intolerability are judged as treatment failure for subsequent visits.

• PSM: A 1:1 propensity score match using greedy algorithm and exact match for bio-naïve/bio-experienced status.

Limitations:

• Real-world evidence is collected outside of controlled clinical trials and has inherent limitations including a lesser ability to control for confounding factors.

• A large, broader patient population is being enrolled, and methodology to account for confounding is employed. However, there could be residual confounding that may have not been fully accounted for.

• Results are not multiplicity controlled and conclusions cannot be drawn.

• Data shown are from interim analysis.

• Safety was not assessed in this analysis.

Dosing: Patients were treated with their biologic as prescribed by their physician.
 

EU INDICATIONS AND IMPORTANT SAFETY INFORMATION ABOUT SKYRIZI (risankizumab)

Indications¹

Skyrizi (risankizumab) is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.

Skyrizi, alone or in combination with methotrexate (MTX), is indicated for the treatment of active psoriatic arthritis in adults who have had an inadequate response or who have been intolerant to one or more disease-modifying antirheumatic drugs (DMARDs).

Skyrizi is indicated for the treatment of adult patients with moderately to severely active Crohn's disease who have had an inadequate response to, lost response to, or were intolerant to conventional therapy or a biologic therapy.

Important Safety Information¹

Risankizumab is contraindicated in patients hypersensitive to the active substance or to any of the excipients, and in patients with clinically important active infections (e.g. active tuberculosis). Risankizumab may increase the risk of infection. In patients with a chronic infection, a history of recurrent infection, or known risk factors for infection, risankizumab should be used with caution. Treatment with risankizumab should not be initiated in patients with any clinically important active infection until the infection resolves or is adequately treated.

Patients treated with risankizumab should be instructed to seek medical advice if signs or symptoms of clinically important chronic or acute infection occur. If a patient develops such an infection or is not responding to standard therapy for the infection, the patient should be closely monitored and risankizumab should not be administered until the infection resolves.

Prior to initiating treatment with risankizumab, patients should be evaluated for tuberculosis (TB) infection. Patients receiving risankizumab should be monitored for signs and symptoms of active TB. Anti-TB therapy should be considered prior to initiating risankizumab in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed.

Prior to initiating therapy with risankizumab, completion of all appropriate immunisations should be considered according to current immunisation guidelines. If a patient has received live vaccination (viral or bacterial), it is recommended to wait at least 4 weeks prior to starting treatment with risankizumab. Patients treated with risankizumab should not receive live vaccines during treatment and for at least 21 weeks after treatment.

If a serious hypersensitivity reaction occurs, administration of risankizumab should be discontinued immediately and appropriate therapy initiated.

The most frequently reported adverse reactions were upper respiratory infections (from 13% in psoriasis to 15.6% in Crohn’s disease). Commonly (≥ 1/100 to < 1/10) reported adverse reactions included tinea infections, headache, pruritus, rash, fatigue, and injection site reactions.

This is not a complete summary of all safety information.

Please see the SmPC for complete prescribing information.