DURABILITY:
Nothing less than the opportunity
for durable, complete skin clearance in PsO^1,4

SKYRIZI: DEMONSTRATED SUPERIORITY
at achieving complete skin clearance in PsO versus 3 agents in different biologic classes

Durable, complete clearance

Superior to ustekinumab
at Week 16 and Week 52: UltIMMa pivotal trials (P<0.001)^1,4

2x the percentage of patients achieved PASI 100 at Week 16 and Week 52 with SKYRIZI (UltIMMa-2)

of patients achieved PASI 100 at Week 52 with SKYRIZI vs 30% ustekinumab

— Week 16: 51% vs 24%, respectively

of patients achieved PASI 90 at Week 52 with SKYRIZI vs 51% ustekinumab

— Week 16: 75% vs 47%, respectively*

UltIMMa-1/2 study design >

Superior to secukinumab
at Week 52: IMMerge assessor-blinded Phase 3b trial (P<0.001)^11,12

of patients achieved PASI 100 at Week 52 with SKYRIZI vs 40% secukinumab

— 26% absolute difference at Week 52 with SKYRIZI (95% CI: adjusted difference; 15.9, 36.5)

of patients achieved PASI 90 at Week 52 with SKYRIZI vs 57% secukiunumab

— 30% absolute difference in patients achieving PASI 90* at Week 52 with SKYRIZI (95% CI: adjusted difference; 20.8, 38.8)
PASI 90 at Week 16 (noninferiority)*: SKYRIZI 74% vs secukinumab 66%

IMMerge study design >

Superior to adalimumab
at Week 16 and Week 44: IMMvent pivotal trial (P<0.001)¹³

of patients achieved PASI 100 at Week 16 with SKYRIZI vs 23% adalimumab

— 72% vs 47% achieved PASI 90*, respectively

Among adalimumab intermediate responders (PASI 50 to <PASI 90) who were rerandomized at Week 16:

—	Week 44: 40% SKYRIZI vs 7% adalimumab achieved PASI 100
—	Week 44: 66% SKYRIZI vs 21% adalimumab achieved PASI 90*

IMMvent study design >

*	Primary endpoint. Note: Some studies were designed with primary endpoints in two parts (Part A and Part B), per protocol. All other endpoints were ranked secondary.

See more PsO DURABILITY data

See PsA DURABILITY data

See Important Safety Information >

SIMPLICITY:
Nothing more than 4 INJECTIONS PER YEAR after initiation doses for both PsO and PsA patients¹*

NO DOSE ADJUSTMENT REQUIRED, regardless of baseline characteristics, including BMI and weight^1,14-16†

1 injection/dose for both the SKYRIZI prefilled pen and syringe
SKYRIZI is dosed 150 mg (one 150-mg subcutaneous injection) at Week 0, Week 4, and every 12 weeks thereafter¹

*	Maintenance dosing (one 150-mg subcutaneous injection/dose) every 12 weeks following a starter dose at Week 0 and Week 4.
^†	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.

See DOSING information

See Important Safety Information >

SAFETY:
Favorable safety profile in PsO through ~7 years^1,17*

Consistent AEs of special interest in PsO in a pooled analysis from the first 16 weeks of treatment through ~7 years⁴*
PsO safety profile similar to ustekinumab through Week 52 during RCTs^1,4
Studied in ~3,200 PsO patients across ~10,000 PYs in an OLE¹⁷

PsA safety profile consistent with the safety profile observed in PsO¹

*

Integrated all-risankizumab safety data set from 17 completed or ongoing Phase 1–3 risankizumab clinical trials in plaque psoriasis (data cutoff March 25, 2021): UltIMMa-1, UltIMMa-2, IMMhance, IMMvent, Trials 1311.1, 1311.2, 1311.13, 1311.38, M15-999, M16-176, M16-177, M16-178, M16-766, M16-005, M16-007, M19-164, and LIMMitless. Median duration of treatment was 3.7 years (ranging from 1 day to 6.9 years).

See Important Safety Information

Download the SKYRIZI digital brochure

Download

UltIMMa-1 and UltIMMa-2 replicate Phase 3 study designs^1,4

UltIMMa-1/2 were two replicate 52-week, randomized, placebo-controlled comparative studies of SKYRIZI vs ustekinumab in adult patients with moderate to severe chronic plaque psoriasis.^1,4

PASI 90 and PASI 100 clearance of psoriatic lesions at Week 52 vs ustekinumab were ranked secondary endpoints.

Data analysis: 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: All 15 secondary ranked endpoints vs placebo and/or ustekinumab at Week 16 and/or Week 52 were met in both UltIMMa-1 and UltIMMa-2 (P<0.0001).

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 was dosed every 12 weeks after 2 starter doses at Week 0 and Week 4.

IMMerge SKYRIZI vs secukinumab assessor-blinded, head-to-head study design^11,12

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.

Patients were randomized 1:1 to SKYRIZI (n=164) (150 mg), given as two 75-mg subcutaneous injections at baseline, 4 weeks later, and every 12 weeks thereafter, or secukinumab (n=163) (300 mg) given as two 150-mg subcutaneous injections, at baseline, Weeks 1, 2, 3, and 4, and then every 4 weeks thereafter.

Safety was assessed in all patients.

Data analysis: Missing data were imputed as nonresponders (NRI) for all primary and ranked secondary endpoints.

Primary endpoints:

• PASI 90 at Week 52 (superiority)
• PASI 90 at Week 16 (noninferiority)

Ranked secondary endpoints:

• PASI 100 at Week 52
• PASI 75 at Week 52
• sPGA 0/1 at Week 52

IMMvent pivotal Phase 3 study design¹³

A 44-week, randomized comparative study vs adalimumab in adult patients with moderate to severe chronic plaque psoriasis (N=605). IMMvent was powered to show superiority of SKYRIZI over adalimumab in achieving:

• PASI 90 response and sPGA scores of clear or almost clear at Week 16
• PASI 90 response at Week 44 after switching from adalimumab to SKYRIZI vs continuing adalimumab among patients with a ≥PASI 50 to <PASI 90 response after 16 weeks of adalimumab treatment

Primary endpoint after rerandomization: PASI 90 at Week 44 (rerandomized patients)

Secondary endpoints:

• PASI 75 at Week 16
• PASI 100 at Weeks 16 and 44 (rerandomized patients only at Week 44)

Part A (baseline to Week 16): Patients received either SKYRIZI 150 mg or adalimumab (80 mg at baseline, 40 mg at Week 1, and then once every 2 weeks).

Part B (Weeks 16 to 44): The SKYRIZI group continued on treatment. For the adalimumab group, treatment regimen was dependent on the level of PASI response:

• PASI <50 switched to SKYRIZI
• PASI 50 to <PASI 90 (rerandomized to either SKYRIZI or adalimumab)
• ≥PASI 90 continued with adalimumab

Adalimumab patients who switched to risankizumab in Part B were dosed at Weeks 16, 20, and 32.

Adalimumab Important Safety Information

HUMIRA (adalimumab)

Indication¹⁸

Adalimumab is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy.

Safety considerations¹⁸Contraindications
Hypersensitivity to adalimumab or any of the excipients, active tuberculosis, or other severe infections, such as sepsis and opportunistic infections, and moderate to severe heart failure (NYHA class III/IV) are contraindications to the use of adalimumab.

Serious infection and malignancy
Fatal and life-threatening infections (including sepsis, opportunistic infections, and TB), HBV reactivation, and various malignancies (including leukemia, lymphoma, and HSTCL) have also been reported with use of adalimumab.

Other serious adverse events
Serious adverse reactions have been reported for adalimumab. TNF-antagonists, such as adalimumab, affect the immune system and their use may affect the body’s defense against infection and cancer. Serious hematological, neurological, and autoimmune reactions have been reported in patients treated with adalimumab. These include rare reports of pancytopenia, aplastic anemia, central and peripheral demyelinating events, and reports of lupus, lupus-related conditions, and Stevens-Johnson syndrome.

Most frequent adverse events
The most frequently reported adverse events across all indications include respiratory infections, injection site reactions, headache, and musculoskeletal pain.

Pediatric population
In general, the adverse events in pediatric patients treated with adalimumab were similar in frequency and type to those seen in adult patients.

Vaccinations
It is recommended that pediatric patients, if possible, be brought up to date with all immunizations in agreement with current immunization guidelines prior to initiating adalimumab therapy. Patients on adalimumab may receive concurrent vaccinations, except for live vaccines. The risks and benefits of adalimumab should be carefully considered prior to initiating therapy.

Please see the product labeling for complete safety information.

SUMMARY OF PRODUCT CHARACTERISTICS

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References

SKYRIZI [Summary of Product Characteristics]. AbbVie Ltd; November 2021.
Blome C, Gosau R, Radtke MA, et al. Patient-relevant treatment goals in psoriasis. Arch Dermatol Res. 2016;308(2):69-78. doi:10.1007/s00403-015-1613-8
Ryan C, Puig Z, Zema C, et al. Incremental benefits on patient-reported outcomes for achieving PASI 90 or PASI 100 over PASI 75 in patients with moderate to severe psoriasis. Poster presented at: 2018 European Academy of Dermatology and Venerology (EADV) Congress; September 12–16, 2018; Paris, France. Poster 2002.
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
Puig L. PASI90 response: the new standard in therapeutic efficacy for psoriasis. J Eur Acad Dermatol Venereol. 2015;29(4):645-648. doi:10.1111/jdv.12817
Strober B, Papp KA, Lebwohl M, et al. Clinical meaningfulness of complete skin clearance in psoriasis. J Am Acad Dermatol. 2016;75(1):77-82.e7. doi:10.1016/j.jaad.2016.03.026
Gooderham MJ, Papp KA, Lynde CW. Shifting the focus – the primary role of IL-23 in psoriasis and other inflammatory disorders. J Eur Acad Derm Venereol. 2018;32(7):1111-1119. doi:10.1111/jdv.14868
Gaffen SL, Jain R, Garg AV, Cua DJ. The IL-23-IL-17 immune axis: from mechanisms to therapeutic testing. Nature Rev Immunol. 2014;14(9):585-600. doi:10.1038/nri3707
Girolomoni G, Strohal R, Puig L, et al. The role of IL-23 and the IL-23/TH17 immune axis in the pathogenesis and treatment of psoriasis. J Eur Acad Dermatol Venereol. 2017;31(10):1616-1626. doi:10.1111/jdv.14433
Lynde CW, Poulin Y, Vender R, Bourcier M, Khalil S. Interleukin 17A: toward a new understanding of psoriasis pathogenesis. J Am Acad Dermatol. 2014;71(1):141-150. doi:10.1016/j.jaad.2013.12.036
Warren RB, Blauvelt A, Poulin Y, et al. Efficacy and safety of risankizumab vs. secukinumab in patients with moderate-to-severe plaque psoriasis (IMMerge): results from a phase III, randomized, open-label, efficacy-assessor-blinded clinical trial. Br J Dermatol. 2021;184(1):50-59. doi:10.1111/bjd.19341
Risankizumab versus secukinumab for subjects with moderate to severe plaque psoriasis. ClinicalTrials.gov identifier: NCT03478787. https://clinicaltrials.gov /ct2/show/NCT03478787. Updated July 13, 2021. Accessed November 30, 2021.
Reich K, Gooderham M, Thaçi D, et al. Risankizumab compared with adalimumab in patients with moderate-to-severe plaque psoriasis (IMMvent): a randomised, double-blind, active-comparator-controlled phase 3 trial. Lancet. 2019;394(10198):576-586. doi:10.1016/S0140-6736(19)30952-3
Leonardi C, Gordon K, Longcore M, Gu Y, Puig L. Weight-based analysis of psoriasis area and severity index improvement at 52 weeks of risankizumab or ustekinumab treatment: an integrated analysis of patients with moderate-to-severe plaque psoriasis. Poster presented at: 24th World Congress of Dermatology (WCD); June 10–15, 2019; Milan, Italy. Poster 5248.
Strober B, Menter A, Leonardi C, et al. Efficacy of risankizumab in patients with moderate-to-severe plaque psoriasis by baseline demographics, disease characteristics and prior biologic therapy: an integrated analysis of the phase III UltIMMa-1 and UltIMMa-2 studies. J Eur Acad Dermatol Venereol. 2020;34(12):2830-2838. doi:10.1111/jdv.16521
Strober B, Valdecantos WC, Zhan T, Lambert H, Menter A. Efficacy of risankizumab in moderate-to-severe plaque psoriasis by baseline characteristics and prior therapies. Poster presented at: Skin Inflammation & Psoriasis International Network (SPIN) 6th Congress; April 25–27, 2019; Paris, France. Poster P081.
Gordon KB, Blauvelt A, Bachelez, H, et al. Long-term safety of risankizumab in patients with moderate-to-severe plaque psoriasis: integrated analysis of clinical study data. Poster presented at: 2021 European Academy of Dermatology and Venerology (EADV) Virtual Congress; September 29-October 2, 2021. Poster 1389.
HUMIRA [Summary of Product Characteristics]. AbbVie Deutschland GmbH & Co. KG; September 2021.

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SKYRIZI: An IL-23/p19 inhibitor^5-10

DURABILITY:
Nothing less than the opportunity
for durable, complete skin clearance in PsO^1,4

SKYRIZI: DEMONSTRATED SUPERIORITY
at achieving complete skin clearance in PsO versus 3 agents in different biologic classes

Durable, complete clearance

Superior to ustekinumab
at Week 16 and Week 52: UltIMMa pivotal trials (P<0.001)^1,4

SIMPLICITY:
Nothing more than 4 INJECTIONS PER YEAR after initiation doses for both PsO and PsA patients¹*

NO DOSE ADJUSTMENT REQUIRED, regardless of baseline characteristics, including BMI and weight^1,14-16†

SAFETY:
Favorable safety profile in PsO through ~7 years^1,17*

PsA safety profile consistent with the safety profile observed in PsO¹

UltIMMa-1 and UltIMMa-2 replicate Phase 3 study designs^1,4

IMMerge SKYRIZI vs secukinumab assessor-blinded, head-to-head study design^11,12

IMMvent pivotal Phase 3 study design¹³

You may also be interested in

Find out more about SKYRIZI

References

Οι Θεραπευτικές κατηγορίες μας

Our therapy areas

Additional info

Additional info

Αυτή η ιστοσελίδα απευθύνεται σε Έλληνες Επαγγελματίες Υγείας

This website is intended for Italy Healthcare Professionals

—	30% absolute difference in patients achieving PASI 90* at Week 52 with SKYRIZI (95% CI: adjusted difference; 20.8, 38.8)
PASI 90 at Week 16 (noninferiority)*: SKYRIZI 74% vs secukinumab 66%

Africa

Asia Pacific

Europe

Middle East

North America

Latin America / Caribbean

South America

Global

SKYRIZI: An IL-23/p19 inhibitor5-10

DURABILITY: Nothing less than the opportunity for durable, complete skin clearance in PsO1,4

SKYRIZI: DEMONSTRATED SUPERIORITY at achieving complete skin clearance in PsO versus 3 agents in different biologic classes

Durable, complete clearance

Superior to ustekinumab at Week 16 and Week 52: UltIMMa pivotal trials (P<0.001)1,4

SIMPLICITY: Nothing more than 4 INJECTIONS PER YEAR after initiation doses for both PsO and PsA patients1*

NO DOSE ADJUSTMENT REQUIRED, regardless of baseline characteristics, including BMI and weight1,14-16†

SAFETY: Favorable safety profile in PsO through ~7 years1,17*

PsA safety profile consistent with the safety profile observed in PsO1

UltIMMa-1 and UltIMMa-2 replicate Phase 3 study designs1,4

IMMerge SKYRIZI vs secukinumab assessor-blinded, head-to-head study design11,12

IMMvent pivotal Phase 3 study design13

You may also be interested in

Find out more about SKYRIZI

References

Οι Θεραπευτικές κατηγορίες μας

Our therapy areas

Additional info

Additional info

Αυτή η ιστοσελίδα απευθύνεται σε Έλληνες Επαγγελματίες Υγείας

This website is intended for Italy Healthcare Professionals

SKYRIZI: An IL-23/p19 inhibitor^5-10

DURABILITY:
Nothing less than the opportunity
for durable, complete skin clearance in PsO^1,4

SKYRIZI: DEMONSTRATED SUPERIORITY
at achieving complete skin clearance in PsO versus 3 agents in different biologic classes

Superior to ustekinumab
at Week 16 and Week 52: UltIMMa pivotal trials (P<0.001)^1,4

SIMPLICITY:
Nothing more than 4 INJECTIONS PER YEAR after initiation doses for both PsO and PsA patients¹*

NO DOSE ADJUSTMENT REQUIRED, regardless of baseline characteristics, including BMI and weight^1,14-16†

SAFETY:
Favorable safety profile in PsO through ~7 years^1,17*

PsA safety profile consistent with the safety profile observed in PsO¹

UltIMMa-1 and UltIMMa-2 replicate Phase 3 study designs^1,4

IMMerge SKYRIZI vs secukinumab assessor-blinded, head-to-head study design^11,12

IMMvent pivotal Phase 3 study design¹³