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

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

      Consistent safety profile through to 4 years6

       

      *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 208 weeks*6

      Adapted from Papp K, et al. 2020.

      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); none related to RZB.
      AE, adverse event; MACE, major adverse cardiovascular event; NMSC, non-melanoma skin cancer; PYs, patient years; RZB, risankizumab; TEAEs, treatment-emergent adverse events.
      *Data from LIMMitless; an ongoing phase 3, single-arm, multicentre, international, open-label extension in which all patients receive SKYRIZI (150 mg) every 12 weeks. The 172 week analysis included patients who were initially randomized to receive SKYRIZI (150 mg) in 1 of 5 base phase II/III studies. Results from 172 week interim analysis including integrated data from five phase 2/3 studies (UltIMMA-1, UltIMMa-2, SustaIMM, IMMvent, and NCT03255382)2-5 and the LIMMitless study). Efficacy was assessed every 12 weeks by PASI 90, PASI 100, sPGA 0/1, mean PASI percent improvement. Quality of life was assessed every 24 weeks by DLQI 0/1.

       

      A safety profile established in more than 2,100 patients1

      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.


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      References

      1. SKYRIZI: Summary of Product Characteristics 2020.
      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. Poster 1366, presented at European Academy of Dermatology and Venereology (EADV) Congress, October 2020.

      UK-RISN-210106. Date of preparation: March 2021. 


      SKYRIZI™  (risankizumab) is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.1
      The recommended dose of SKYRIZI is 150mg (two 75mg injections) 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