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A similar safety profile to ustekinumab, secukinumab and adalimumab in Phase III in psoriasis clinical trials.2-5

No contraindications / warnings for Crohn's disease and ulcerative colitis1*

Consistent safety profile in psoriasis through to 4.9 years6

Demonstrated safety profile in psoriatic arthritis through to 52 weeks.7

*Contraindications include hypersensitivity to the active substance or to any of the excipients and clinically important active infections e.g. active tuberculosis.

Safety Profile in Psoriasis

Consistent safety profile through to 256 weeks6

Adapted from Papp K, et al. 2021.

aPrimary psoriasis safety pool includes NCT02054481, UltIMMA-1, UltIMMa-2, IMMhance (NCT02672852), and IMMvent.
bDue to natural causes (n = 1), car accident (n = 1), cardiopulmonary arrest (n = 1), cause unknown (n = 2), COVID-19 (n = 1); none determined by the investigator to be related to Skyrizi.
cMACE rate in the LIMMitless study is consistent with the incidence rate of MACE in the Psoriasis Longitudinal Assessment and Registry (PSOLAR; 0.57 events/100 PYs; 95% CI, 0.50–0.65)
dSerious hypersensitivity reactions (none of which were determined by the investigator to be related to Skyrizi) were paraphenylenediamine allergy (n = 1; mild, attributed to hair dye application), generalized microbial eczema (n = 1; moderate, attributed to prolonged duration of generalized eczema and lack of response to treatment with hydrocortisone), and Stevens-Johnson syndrome (n = 1; severe, attributed to addition of chlorpromazine).
AE, adverse event; MACE, major adverse cardiovascular event; NMSC, non-melanoma skin cancer; PYs, patient years; RZB, risankizumab; TEAEs, treatment-emergent adverse events.

 

Long term safety data with no new safety signals at 2.5 years2

Adapted from Strober B. et al. 20192

aEvents with onset after the first dose of risankizumab until 20 weeks after last dose of risankizumab. E/100PY, events per 100 patient years. 
Deaths were reported as not related to treatment. 

Consistent safety profile through to 52 Weeks in the IMMerge trial3,4

No new safety signals were observed3,4

Adapted from Warren et al. 2020

*Defined as AEs occurring with an onset within 20 weeks after the last dose of study drug administration.
AE, adverse event; MACE, major adverse cardiovascular event, NMSC, non-melanoma skin cancer; TEAEs, treatment-emergent adverse events.

 

A similar safety profile to adalimumab5

Summary of treatment-emergent adverse events with SKYRIZI vs. adalimumab in Part A (Weeks 0-16) of the IMMvent phase III clinical trials5

Randomised controlled trial, intention to treat population (Part A).
aInvestigator assessed AE as possibly related to study drug. bThe most frequently reported infectious AE were viral upper respiratory tract infection and upper resporatory tract infarction. cOne patient with acute myocardial infarction on study day 73 (event was not considered to be study grud related by investigator). dOne patient diagnosed with invasive lobular breast carcinoma on study day 63 following routine mammogram (event was not considered to be study drug related by investigator). eOne patient with stage IV gall bladder cancer. fOne patient with cholelithiasis, underwent gall bladder surgery, developed cardiopulmonary arrest and died due to abdominal abscess, sepsis, and gastric perforation (events were not considered to be study drug related by investigator).
AE, adverse event; MACE, major adverse cardiovascular events; NMSC. non-melanoma skin cancer. 

Summary of treatment-emergent adverse events with SKYRIZI vs. adalimumab in Part B (Weeks 16-44) of the IMMvent phase III clinical trial6

Randomised controlled trial. lntention to population (Part B). Patients previously treated with adailmumab. randomised to adallrnumab or SKYRIZI at Week 16;
aInvestigator assessed AE as possibly related to study drug. bThe most frequently reported Infectious AE were viral upper respiratory tract Infection and upper respiratory tract Infection. cOne patient with latent tuberculosis. positive TB test during the study.
AE, adverse event; MACE, major adverse cardiovascular events; NMSC,non-melanoma skin cancer.

Demonstrated safety profile in psoriatic arthritis
through to Week 527

Safety events from KEEPsAKE 1 and KEEPsAKE 2 through to week 527

Adapted from Kristensen LE et al. 2021.

aSafety reported through data cutoff date (19 April 2021), which includes data through week 52. Data are from any RZB 150-mg group that includes all patients who received RZB 150 mg, including those who started on RZB 150 mg at randomization and who switched from placebo to RZB 150 mg after week 24.
b10 of the 27 events were cases of COVID-19. 
cAn 81-year-old male patient randomized to RZB died of urosepsis on day 96, and a 41-year-old male patient randomized to RZB experienced sudden death on day 502.

E, events; MACE, major adverse cardiovascular events; NMSC, non-melanoma skin cancer; PY, patient-years; RZB, risankizumab; TB, tuberculosis; TEAE, treatment-emergent adverse events.

References

  1. SKYRIZI: Summary of Product Characteristics.
  2. Strober B, et al. Poster 1714, presented at the 28th European Academy of Dermatology and Venereology (EADV) Congress, 9-13 October 2019, Madrid, Spain. 
  3. Warren RB et al. Risankizumab vs Secukinumab in Patients with Moderate-to-Severe Plaque Psoriasis: A Phase 3 Trial, Presented at AAD 2020.
  4. Risankizumab versus secukinumab for subjects with moderate to severe plaque psoriasis. ClinicalTrials.gov identifier: NCT03478787. Updated September 20, 2019. Accessed March 2, 2020. https://clinicaltrials.gov/ct2/show/NCT03478787.
  5. Reich K, et al. Poster 1813,  Efficacy and Safety of Risankizumab Compared with Adalimumab in Patients with Moderate-to-Severe Plaque Psoriasis: Results from the Phase 3 IMMvent Trial. 2018.
  6. Papp K, et al. Long-Term Efficacy and Safety of Risankizumab for the Treatment of Moderate-to-Severe Plaque Psoriasis: Interim Analysis of the LIMMitless Open-Label Extension Trial Beyond 3.5 Years of Follow-Up. Poster 1354. Presented at the 30th European Academy of Dermatology and Venereology Congress, 29 September–2 October 2021, EADV Virtual Congress.
  7. Kristensen LE et al. Efficacy and Safety of Risankizumab for Active Psoriatic Arthritis: 52-Week Results From the KEEPsAKE 1 and KEEPsAKE 2 Trials. Oral presentation EADV 30th Congress 2021 - Anniversary Edition 29 Sept – 2 Oct 2021.

UK-RISN-210506. Date of preparation: November 2021. 


SKYRIZI® (risankizumab) is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.1
SKYRIZI® (risankizumab) alone or in combination with methotrexate, 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.1
The recommended dose of SKYRIZI is 150mg administered by subcutaneous injection at Week 0, Week 4, and every 12 weeks thereafter.
SKYRIZI is intended for use under the guidance and supervision of a physician experienced in the diagnosis and treatment of psoriasis.
Some patients may not be suitable for SKYRIZI. You are advised to read the Prescribing Information (which can be found on tab above). Please also refer to the SKYRIZI Summary of Product Characteristics for important information including special warnings/precautions for use and summary of adverse reactions.
Study design information can be found on the Study Design page.

Adverse events should be reported. Reporting forms and information can be found at yellowcard.mhra.gov.uk.
Adverse events should also be reported to AbbVie on GBPV@abbvie.com