SKYRIZI (risankizumab) is a selective IL-23/p19 inhibitor indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.
High levels of durable clearance in the majority of patients 1,2
81% of SKYRIZI patients achieved PASI 90 at Week 521,2
PASI 90: UltIMMa-2 (NRI)
Durable, complete skin clearance with twice the rate of response as with ustekinumab at Week 521-3
60% of SKYRIZI patients achieved complete skin clearance at Week 521-3
PASI 100: UltIMMa-2 (NRI)
High levels of durable clearance in the majority of patients1-3
82% of SKYRIZI patients achieved PASI 90 at Week 521-3
PASI 90: UltIMMa-1 (NRI)
Durable, complete skin clearance with more than twice the rate of response as with ustekinumab at Week 521-3
56% of SKYRIZI patients achieved complete skin clearance at Week 521-3
PASI 100: UltIMMa-2 (NRI)
UltIMMa-1 and UltIMMa-2 were replicate Phase 3 studies
PASI 90 and PASI 100 clearance of psoriatic lesions at Week 52 vs ustekinumab was a ranked secondary endpoint.1,2
UltIMMa-1 and UltIMMa-2: Missing data were imputed as nonresponders (NRI) for categorical endpoints and by last observation carried forward for continuous endpoints.
Co-primary endpoints: Proportion of patients who achieved PASI 90 response and an sPGA score of clear or almost clear (sPGA 0 or 1) at Week 16 vs placebo.
Ranked secondary endpoints: sPGA 0 (clear), PASI 100, Dermatology Life Quality Index (DLQI) of 0 or 1, Psoriasis Symptom Scale (PSS) score of 0, PASI 75, and change from baseline in PSS total score at Week 12, Week 16, or Week 52.
Dosing: SKYRIZI 150 mg (two 75-mg subcutaneous injections) at Week 0, Week 4, and every 12 weeks thereafter. Ustekinumab 45 mg or 90 mg (weight-based per label). Ustekinumab is dosed every 12 weeks after 2 starter doses at Week 0 and Week 4.
Part A (baseline to Week 16): Patients received either SKYRIZI 150 mg, ustekinumab 45/90 mg, or placebo.
Part B (Weeks 16 to 52): SKYRIZI and ustekinumab patients continued on treatment. Placebo group switched to SKYRIZI.
Ranked secondary endpoints:
| 1st | sPGA 0 (clear) at Week 16 vs placebo | |||
| 2nd | PASI 100 at Week 16 vs placebo | |||
| 3rd | DLQI 0 or 1 at Week 16 vs placebo | |||
| 4th | PSS 0 at Week 16 vs placebo | |||
| 5th | PASI 90 at Week 16 vs ustekinumab | |||
| 6th | sPGA 0/1 (clear or almost clear) at Week 16 vs ustekinumab | |||
| 7th | PASI 100 at Week 16 vs ustekinumab | |||
| 8th | sPGA 0 (clear) at Week 16 vs ustekinumab | |||
| 9th | PASI 90 at Week 52 vs ustekinumab | |||
| 10th | PASI 100 at Week 52 vs ustekinumab | |||
| 11th | sPGA 0 (clear) at Week 52 vs ustekinumab | |||
| 12th | PASI 75 at Week 12 vs ustekinumab | |||
| 13th | sPGA 0/1 (clear or almost clear) at Week 12 vs ustekinumab | |||
| 14th | DLQI 0 or 1 at Week 16 vs ustekinumab | |||
| 15th | Change from baseline in PSS at Week 16 vs placebo |
Study design
UltIMMa-1 and UltIMMa-2 were replicate Phase 3, randomized, double-blind, placebo-controlled and active comparator-controlled trials done at 139 sites in Australia, Austria, Belgium, Canada, Czech Republic, France, Germany, Japan, Mexico, Poland, Portugal, South Korea, Spain, and the United States. Eligible patients were 18 years or older, with moderate to severe chronic plaque psoriasis. In each study, patients were stratified by weight and previous exposure to TNF inhibitor and randomly assigned (3:1:1) by use of interactive response technology to receive 150 mg risankizumab, 45 mg or 90 mg ustekinumab (weight-based per label), or placebo.
Following the 16-week double-blind treatment period (Part A), patients initially assigned to placebo switched to 150 mg risankizumab at Week 16; other patients continued their originally randomized treatment (Part B, double-blind, Weeks 16–52).
Study drug was administered subcutaneously at Weeks 0 and 4 during Part A and at Weeks 16, 28, and 40 during Part B.
Co-primary endpoints were proportions of patients achieving a 90% improvement in the Psoriasis Area Severity Index (PASI 90) and a static Physician’s Global Assessment (sPGA) score of 0 or 1 at Week 16 (nonresponder imputation). All efficacy analyses were done in the intention-to-treat population.
4 maintenance doses per year with SKYRIZI
Reliable every-3-month maintenance dosing
Dose adjustment is not required regardless of patient subgroup1*
- SKYRIZI is dosed 150 mg (two 75-mg subcutaneous injections) at Week 0, Week 4, and every 12 weeks thereafter.1
- Local tolerability: Low rate of injection site reactions at Week 16 (based on an analysis of 5 clinical trials:
SKYRIZI 1.5% vs placebo 1.0%)6 - Consideration should be given to discontinuing treatment in patients who have shown no response after 16 weeks of treatment. Some patients with initial partial response may subsequently improve with continued treatment beyond 16 weeks.
| * | Risankizumab clearance and volume of distribution increase as body weight increases, which may result in reduced efficacy in subjects with high body weight (>130 kg). However, this observation is based on a limited number of subjects. | |
Favorable safety profile at Week 16 and Week 521,2
UltIMMa-1 and UltIMMa-2:
Favorable safety profile at Week 16 and Week 521,2
UltIMMa-1 and UltIMMa-2:
Indication1
SKYRIZI (risankizumab) is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.
SKYRIZI is contraindicated in patients with hypersensitivity to the active substance or to any of the excipients.
SKYRIZI may increase the risk of infection. In patients with a chronic infection, a history of recurrent infection, or known risk factors for infection, SKYRIZI should be used with caution. Treatment with SKYRIZI should not be initiated in patients with any clinically important active infection until the infection resolves or is adequately treated.
Prior to initiating treatment with SKYRIZI, patients should be evaluated for tuberculosis (TB) infection. Patients receiving SKYRIZI should be monitored for signs and symptoms of active TB. Anti-TB therapy should be considered prior to initiating SKYRIZI 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 SKYRIZI, completion of all appropriate immunizations should be considered according to current immunization 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 SKYRIZI. Patients treated with SKYRIZI should not receive live vaccines during treatment and for at least 21 weeks after treatment.
The most frequently reported adverse reactions were upper respiratory infections, which occurred in 13% of patients. Commonly (≥1/100 to <1/10) reported adverse reactions included tinea infections, headache, pruritus, fatigue, and injection site reactions.
A favorable safety profile:1,2
Favorable safety profile2
- Reported TEAEs were consistent across all 4 clinical trials, with no new safety signals observed in the Phase 3 program1,2
- Safety profile similar to ustekinumab through Week 521,2
- No new safety signals identified through Week 77 in comparator trials vs ustekinumab1
Conversion to active TB not observed across Phase 3 trials1
- Prior and during SKYRIZI treatment, evaluate and monitor patients for TB
- Consider anti-TB therapy prior to initiating SKYRIZI in patients with history of latent or active TB1
- In the IMMhance study, of the 31 subjects with latent TB who did not receive prophylaxis, none developed active TB during the mean follow-up of 55 weeks1
No routine laboratory monitoring requirements1
- Advise patients to seek medical advice if signs or symptoms of clinically important chronic or acute infection occur
- Patients with infection should be closely monitored
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References
- SKYRIZI [Summary of Product Characteristics]. AbbVie Ltd; April 2019.
- 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. doi:10.1016/S0140-6736(18):31713-6
- Data on File, AbbVie Inc. ABVRRTI67790
- Data on File, AbbVie Inc. ABVRRT167791
- Gordon KB, Strober B, Lebwohl M, et al. Supplement to: 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 [published online August 7, 2018]. Lancet. doi:10.1016/S0140-6736(18):31713-6
- 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: 2019 American Academy of Dermatology Annual Meeting; March 1–5, 2019; Washington, DC. Poster 9891.