SKYRIZI (risankizumab) is an IL-23/p19 inhibitor indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. SKYRIZI, alone or in combination with MTX, is also 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 DMARDs.1
SKYRIZI: An IL-23/p19 inhibitor2-7
IMMerge: SKYRIZI vs secukinumab in patients with moderate to severe PsO
HEAD-TO-HEAD DATA:
SKYRIZI DEMONSTRATED SUPERIORITY at achieving PASI 90 and PASI 100 vs secukinumab at Week 52 (NRI)20,26
DURABLE CLEARANCE:
PASI 90 AT WEEK 5220,26
DURABLE, COMPLETE CLEARANCE:
PASI 100 AT WEEK 5220,26
| PASI 90 and PASI 100 data are computed using NRI. | |
| Weeks 0-12 and 20-48 were not multiplicity controlled. | |
| * | SKYRIZI doses denoted in blue: Participants received 150 mg SKYRIZI at Week 0, Week 4, and every 12 weeks thereafter.1 |
| † | Secukinumab is dosed 300 mg at Week 0, Week 1, Week 2, Week 3, Week 4, and every 4 weeks thereafter. |
| ‡ | P=0.039. |
| § | P<0.001 vs secukinumab. |
| || | 30% absolute difference in patients achieving PASI 90 at Week 52 with SKYRIZI (95% CI: adjusted difference; 20.8, 38.8).20,26 |
| ¶ | 26% absolute difference in patients achieving PASI 100 at Week 52 with SKYRIZI (95% CI: adjusted difference; 15.9, 36.5).20,26 |
FPO link to approved material content related to IMMerge study
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Title
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IMMerge study design20,26
SKYRIZI vs secukinumab assessor-blinded, head-to-head trial
A Phase 3b, multicenter, randomized, open-label, efficacy assessor-blinded, active-comparator study designed to evaluate the safety and efficacy of SKYRIZI compared to secukinumab in adult patients with moderate to severe plaque psoriasis.
Primary endpoints were PASI 90 at Week 16 (noninferiority) and PASI 90 at Week 52 (superiority).
Nothing more than 4 INJECTIONS PER YEAR after initiation doses for both PsO and PsA patients1*
NO DOSE ADJUSTMENT regardless of baseline characteristics, including BMI and weight1,11,12†
- SKYRIZI is dosed 150 mg (one 150-mg subcutaneous injection) at Week 0, Week 4, and every 12 weeks thereafter for adult patients with moderate to severe PsO or active PsA.1
- Low rate of injection site reactions at Week 16 (based on an analysis of 5 PsO clinical trials: SKYRIZI 1.5% vs placebo 1.0%)13
—In a long-term PsO analysis (up to 8.8 years), rates of injection site reactions were low for SKYRIZI patients (2.8 E/100 PY).14‡
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.
| * | Maintenance dosing (one 150-mg subcutaneous injection/dose) every 12 weeks following a starter dose at Week 0 and Week 4. If a dose is missed, the dose should be administered as soon as possible. Thereafter, dosing should be resumed at the regular scheduled time. |
| † | 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. |
| ‡ | Week 16 (5-study pool) and long-term (median duration of treatment 4.1 years [ranging from 81 days to 8.8 years], 20-study pool) represent different pools of patients with varying lengths of treatment exposure included in the long-term data set.14 |
SKYRIZI one injection per dose:
SAME EFFICACY AND SAFETY PROFILE
Same active ingredient | Demonstrated bioequivalence1
NOW EVEN SIMPLER WITH
Note to Affiliate: “New” is a regulated term to be used for up to one year per EFPIA code of practice. Please evaluate use of "Now" in relation to 150 mg presentation, given dates of availability in your country and local requirements.
SKYRIZI 150 mg bioequivalence data1
Bioequivalence was demonstrated between a single SKYRIZI 150-mg injection and two SKYRIZI 75-mg injections in a prefilled syringe. Bioeqivalence was also demonstrated between SKYRIZI 150 mg in a prefilled syringe and a prefilled pen.
REGARDLESS OF BMI AND PsO TREATMENT EXPERIENCE
more SKYRIZI patients achieved PASI 90 at Week 52 than patients on ustekinumab12
Proportion of PsO patients achieving PASI 90 at Week 52 by baseline BMI (NRI)12
Median PASI at baseline was 18.
Pooled data: UltIMMa-1 and UltIMMa-212
Proportion of PsO patients achieving PASI 90 at Week 52 by treatment experience (NRI)12
Pooled data: UltIMMa-1 and UltIMMa-212
A FAVORABLE PsO SAFETY PROFILE1
AEs of special interest in
PsO patients studied up
to 8.8 years14,19*
TEAEs consistent in
PsO across 4 trials with
no new safety signals
observed in the
Phase 3 program1,8,9,16-18
Safety profile in PsO
similar to ustekinumab
through Week 52
during RCTs1,8,9
No reports of active TB in controlled periods of PsO and PsA trials, including 31 IMMhance study patients with
latent TB who did not receive prophylaxis1,8,16-18
Prior to 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 TB.1
Studied in
>3,650 PsO patients across
>13,300 PYs in an OLE14*
No routine
lab 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.
Safety profile in PsA consistent with safety profile observed in PsO1
| * | Integrated all-risankizumab safety data set from 20 completed or ongoing Phase 1-4 risankizumab clinical trials in plaque psoriasis (data cutoff March 25, 2023). Median duration of treatment was 4.1 years (ranging from 81 days to 8.8 years).14 |
Important contextual information1
SKRYIZI is contraindicated in patients with clinically important active infections (e.g., active tuberculosis).
Tuberculosis: 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.
Lab monitoring: 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. Patients treated with SKYRIZI 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 SKYRIZI should not be administered until the infection resolves.
| * | UltIMMa: One non–treatment-emergent death of unknown cause on study Day 189 that occurred 161 days after the last dose of study drug. |
| † | IMMvent: One patient with acute myocardial infarction on study Day 73 (event was not considered to be study drug–related by investigator). |
| ‡ | IMMhance: One patient with stroke reported as ischemic stroke on study Day 95. |
| § | IMMhance: One patient with esophageal carcinoma reported on study Day 16, with patient experiencing 40 lbs weight loss six months prior to study participation; 1 patient with malignant melanoma in situ reported on study Day 102, study drug was not interrupted; 1 patient with a cutaneous squamous cell carcinoma reported on study Day 89, study drug was not interrupted.
|
A safety profile similar to ustekinumab in PsO through Week 52 during RCTs:8
- UltIMMa-1—Any AE: SKYRIZI 61.3% (n=182/297) vs ustekinumab 66.7% (n=66/99); Serious AEs: SKYRIZI 5.4% (n=16/297) vs ustekinumab 4.0% (n=4/99); Infections: SKYRIZI 37.7% (n=112/297) vs ustekinumab 41.4% (n=41/99)
- UltIMMa-2—Any AE: SKYRIZI 55.7% (n=162/291) vs ustekinumab 74.5% (n=70/94); Serious AEs: SKYRIZI 4.5% (n=13/291) vs ustekinumab 4.3% (n=4/94); Infections: SKYRIZI 34.7% (n=101/291) vs ustekinumab 48.9% (n=46/94)
The safety profile of SKYRIZI with up to 77 weeks of exposure was consistent with the profile observed up to 16 weeks.1
Safety findings at Week 52 in IMMerge Phase 3b PsO trial (N=327)20
Rates of treatment-emergent adverse events: SKYRIZI (n=164) 71.3%, secukinumab (n=163) 71.2%
Rates of serious adverse events: SKYRIZI 5.5%, secukinumab 3.7%
Adverse events leading to discontinuation: SKYRIZI 1.2%, secukinumab 4.9%
- Safety was assessed in all patients
- The most commonly reported treatment-emergent adverse events for SKYRIZI were nasopharyngitis, upper respiratory tract infection, headache, arthralgia, diarrhea, and bronchitis
- Safety profile consistent with SKYRIZI pivotal trials
- No new safety signals were observed through Week 52
A FAVORABLE SAFETY PROFILE EVALUATED UP TO 8.8 YEARS IN PsO WITH PsA DATA UP TO 4 YEARS14,19*
Treatment-emergent AEs from an integrated analysis of PsO and PsA clinical trials14
SKYRIZI warnings and precautions include infections, tuberculosis, and immunizations.1
Additional study results14
- Nasopharyngitis and upper respiratory infection were the most common infections in patients with psoriasis and patients with psoriatic arthritis.
- Excluding COVID-related infections, the most common serious infections (sepsis, pneumonia, and cellulitis) were similar in psoriasis and psoriatic arthritis.
- The rates of serious infections excluding COVID-related infections with SKYRIZI were within the reference rates for serious infections reported for psoriasis (PSOLAR: 0.93–2.91 E/100 PY and psoriatic arthritis (PSOLAR: 1.00–3.01 E/100 PY).
- Rates of opportunistic infections excluding tuberculosis and herpes zoster (both <0.1 E/100 PY) and herpes zoster (0.5 and 0.3 E/100 PY) were comparable for psoriasis and psoriatic arthritis, respectively.
| * | Long-term safety was evaluated using integrated all-risankizumab safety data sets (data cutoff March 25, 2023) from 20 Phase 1–4 clinical trials in PsO and 4 Phase 2 and 3 trials in PsA. Median (range) of treatment duration for PsO was 4.1 years (81 days to 8.8 years) and for PsA was 2.8 years (84 days to 4.0 years). For all patients who received ≥1 dose of risankizumab (all administered doses, 18 mg to 180 mg), AEs and AEs of special interest were assessed and recorded through the end of exposure (last dose to first dose + 5 geometric-mean half-lives [20 weeks]). |
| † | Excluding COVID-related infections. |
| ‡ | Excluding tuberculosis and herpes zoster. |
| § | One case of active tuberculosis was reported from Taiwan. The patient in a long-term open-label psoriasis study had latent tuberculosis diagnosed at screening of the feeder study and received isoniazid prophylaxis. He presented with a cough for 4 years after study initiation and was diagnosed based on positive sputum and chest X-ray (diagnostic results such as PCR/culture not provided). |
| || | By system organ class. |
| ¶ | Reported events: eczema (2), Stevens-Johnson syndrome (2), urticaria (2), angioedema (1), drug hypersensitivity (1), erythema multiforme (1), hypersensitivity (1). |
Measurements were taken at each time point prior to administration of the next dose.
Patient depicted was a participant in the UltIMMa-2 pivotal trial undergoing continuous treatment with SKYRIZI for moderate to severe plaque psoriasis.1,8
DoF ABVRRTI67530
ACR=American College of Rheumatology; ADA=adalimumab; AE=adverse events; bio-IR=inadequate response to a biologic; BMI=body mass index; CI=confidence interval; csDMARD-IR=inadequate response to a conventional synthetic DMARD; DLQI=Dermatology Life Quality Index; DMARD=disease-modifying antirheumatic drug; E=event; IBD=inflammatory bowel disease; IL=interleukin; LDI=Leeds Dactylitis Index; LEI=Leeds Enthesitis Index; MACE=major adverse cardiovascular event; MTX=methotrexate; NMSC=nonmelanoma skin cancer; NRI=nonresponder imputation; OC=observed case; OLE=open-label extension; PASI=Psoriasis Area and Severity Index; PBO=placebo; PsA=psoriatic arthritis; PsO=psoriasis; PSS=psoriasis symptom scale; PY=patient-year; RCT=randomized controlled trial; sPGA=static Physician’s Global Assessment; TB=tuberculosis; TEAE=treatment-emergent adverse event; TNF=tumor necrosis factor; UST=ustekinumab.
EU Indications and Important Safety Information for SKYRIZI
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 arthritisin adults who have had an inadequate response or who have been intolerant to one or more disease-modifying antirheumaticdrugs (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.
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References
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