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      Durable efficacy achieved by SKYRIZI patients through to 3.3 years*2

      85% of SKYRIZI patients achieved PASI 90 at 172 weeks*2

      Adapted from Papp K, et al. 2020.

      *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. LOCF (last observation carried forward): used completed evaluation from the most recent visit to impute missing data at later visits. PASI 90 = 90% improvement in Psoriasis Area and Severity Index.

      61% of SKYRIZI patients achieved PASI 100 at 172 weeks*2

      Adapted from Papp K, et al. 2020.

      *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. LOCF (last observation carried forward): used completed evaluation from the most recent visit to impute missing data at later visits. PASI 100 =100% improvement in Patients, Psoriasis Area and Severity Index.

      Efficacy in Psoriasis

      Superior efficacy with fewer injections vs. secukinumab at 52 Weeks3,4

      87% of SKYRIZI patients achieved PASI 90 at Week 52 after 5 doses compared with 57% of secukinumab patients after 16 doses†3,4

      Adapted from Warren et al. 2020

      Data from IMMerge, a phase III, global, multicentre, randomised, open-label, efficacy assessor-blinded active-comparator study in adult patients with moderate to severe plaque psoriasis.
      NRI, non-responder imputation; PASI, Psoriasis Area and Severity Index. P-values for comparison vs secukinumab: *P<0.001 multiplicity controlled.
      Data assessed for intent-to-treat population. Adjusted difference CI values: 96.25% at Week 16 and 95%; P values calculated from the Cochran-Mantel-Haenszel test, stratified by weight (≤100 kg vs >100 kg) and prior systemic biologic use for psoriasis.
      Each dose for SKYRIZI given as two 75-mg subcutaneous injections, each dose for secukinumab given as two 150-mg subcutaneous injections.
      SKYRIZI demonstrated superiority at Week 52 across primary and all ranked secondary endpoints.3,4
      Co-primary endpoints were met:

    • Non-inferiority of SKYRIZI vs secukinumab at Week 16 (PASI 90: 74% vs 66%)
    • Superiority of SKYRIZI vs secukinumab at Week 52 (PASI 90: 87% vs 57%, P<0.001)
    •  

      66% of SKYRIZI patients achieved PASI 100 at Week 52 after 5 doses compared with 40% of secukinumab patients after 16 doses†3,4

      Adapted from Warren et al. 2020

      Data from IMMerge, a phase III, global, multicentre, randomised, open-label, efficacy assessor-blinded active-comparator study in adult patients with moderate to severe plaque psoriasis.
      NRI, non-responder imputation; PASI, Psoriasis Area and Severity Index. P-values for comparison vs secukinumab: *P<0.001 multiplicity controlled.
      Data assessed for intent-to-treat population. Adjusted difference CI set at 95%; P values calculated from the Cochran-Mantel-Haenszel test, stratified by weight (≤100 kg vs >100 kg) and prior systemic biologic use for psoriasis.
      Each dose for SKYRIZI given as two 75-mg subcutaneous injections, each dose for secukinumab given as two 150-mg subcutaneous injections.
      All ranked secondary endpoints were met, including statistically significant superiority of SKYRIZI vs secukinumab at Week 52 (PASI 100: 66% vs 40%, P<0.001). Co-primary endpoints were met: PASI 90 at Week 16 (non-inferiority) and PASI 90 at Week 52 (superiority)3,4

       

      Superior efficacy vs. ustekinumab5,6

      Over 80% of patients achieve PASI 90 with SKYRIZI at 52 weeks.a6

      Proportion of patients (NRI) achieving PASI 90 through to Week 52 in UltIMMa-1 and UltIMMA-2.

       

      Result from UltIMMa-1 and UltIMMa-2 integrated analysis, two Phase III double-blind randomised, placebo- and active-comparator controlled studies of SKYRIZI in adult patients with moderate to severe plaque psoriasis.6 
      aRanked secondary endpoint.
      Co-primary endpoints were proportions of patients achieving PASI 90 and sPGA 0 or 1 at Week 16 with SKYRIZI vs. placebo. Both co-primary endpoints were met (P<0.0001).

      At least twice as many patients achieve completely clear skin (PASI 100) with SKYRIZI vs. ustekinumab at 52 weeks.a6

      Proportion of patients (NRI) achieving PASI 100 through to Week 52 in UltIMMa-1 and UltIMMA-2.

      Result from UltIMMa-1 and UltIMMa-2 integrated analysis, two Phase III double-blind randomised, placebo- and active-comparator controlled studies of SKYRIZI in adult patients with moderate to severe plaque psoriasis.6
      aRanked secondary endpoint.
      Co-primary endpoints were proportions of patients achieving PASI 90 and sPGA 0 or 1 at Week 16 with SKYRIZI vs. placebo. Both co-primary endpoints were met (P<0.0001).

      More than 80% of SKYRIZI patients maintained PASI 90 through to 2.5 years5

      UltIMMa open-label extension PASI 90 (LOCF)5

      Adapted from Strober B, et al. 2019

      The UltIMMa open-label extension is an ongoing, Phase III, single arm, multi-centre study assessing the long-term safety and efficacy of SKYRIZI, following 52-week completion of UltIMMa-1 and UltIMMa-2. Of the 598 patients randomised to SKYRIZI in UltIMMa-1 and UltIMMa-2, 525 entered UltIMMa open label extension and continued SKYRIZI 150mg every 12 weeks.

      More than 60% of SKYRIZI patients maintained PASI 100 through to 2.5 years5

      UltlMMa open-label extension PASI 100 (LOCF)5

      Adapted from Strober B, et al. 2019

      The UltIMMa open-label extension is an ongoing, Phase III, single arm, multi-centre study assessing the long-term safety and efficacy of SKYRIZI, following 52-week completion of UltIMMa-1 and UltIMMa-2. Of the 598 patients randomised to SKYRIZI in UltIMMa-1 and UltIMMa-2, 525 entered UltIMMa open label extension and continued SKYRIZI 150mg every 12 weeks.

      Significantly higher rates of PASI 90 and sPGA O or 1 vs. placebo at Week 166

      Co-primary endpoints: Proportion of patients who achieved PASI 90 response and sPGA of 0 or 1 (clear or almost clear) at Week 16 with SKYRIZI vs. placebo. Both co-primary endpoints were met in both studies (P<0.0001).1

      Over 70% of patients reach DLQI 0 or 1 at one year with SKYRIZI

      Compared with up to 47% with ustekinumaba7

      How many of your patients could reach a point where psoriasis no longer affects their quality of life? 

      Adapted from Gordon et al. 20187

      P<0.0001 vs. ustekinumab

      Data from UltlMMa-1 and UltlMMa-2. two Phase III double-blind randomised, placebo- and active-comparator controlled studies of SKYRIZI in adult patients with moderate to severe plaque psoriasis.7
      DLQI, Dermatology Life Quality Index
      aRanked secondary endpoint.
      Co-primary endpoints were proportions of patients achieving PASI 90 and sPGA 0 or 1 at Week 16 with SKYRIZI vs. placebo. Both co-primary endpoints were met (P<0.0001).

      How many of your patients could reach a point where psoriasis no longer affects their quality of life? 

      Superior efficacy vs. adalimumab8

      Significantly more patients achieve PASI 90 with SKYRIZI vs. adalimumab at 16 weeks.8

      Proportion of patients achieving PASI 90 through to Week 16 in the IMMvent pivotal trial 

      IMMvent was a phase III, randomised, double-blind, active-controlled study evaluating the efficacy and safety of SKYRIZI compared with adalimumab in adult patients with moderate to severe plaque psoriasis. SKYRIZI n=301. adalimumab n=304.
      Co-primary endpoints for Part A - PASI 90 & sPGA 0/1 at Week 16. SKYRIZI vs. adalimumab were met P<0.001.
      Intention to treat population.

      Significantly more patients achieve PASI 100 with SKYRIZI vs. adalimumab at 16 weeks.8

      Proportion of patients achieving PASI 100 through to Week 16 in the IMMvent pivotal trial 

      IMMvent was a phase III, randomised, double-bllnd. active-controlled study evaluating the efficacy and safety of SKYRIZI compared with adalimumab In adult patients with moderate to severe plaque psoriasis. SKYRIZI n=301, adalimumab n=304.
      Co-primary endpoints for Part A - PASI 90 & sPGA 0/1 at Week 16. SKYRIZI vs. adalimumab were met P<0.001.
      Intention to treat population.

      SKYRIZI significantly improved PASI 90 in inadequate or partial responders after switching from adalimumaba8

      66% of SKYRIZI patients achieved PASI 90 at Week 44 vs 21% continuing on adalimumab8

      Inadequate or partial response In the IMMvent study was defined as >PASI 50 to <PASI 90 at Week 16 in patients receiving adalimumab.
      Not depicted: IMMvent Part A (baseline to Week 16). SKYRIZI (n=301): adalimumab (n=304). PASI 90 at Week 16: SKYRIZI 72.4%; adalimumab 47.4% (P<0.001), Inadequate or partial responders only (≤PASI 50 to <PASI 90).
      Co-primary endpoints for Part A - PASI 90 & sPGA 0/1 at Week 16. SKYRIZI vs. adalimumab were met P<0.001.
      aPrimary endpoint for Part B, PASI 90 at Week 44 in re-randomised patients.

      SKYRIZI significantly improved skin clearance (PASI 100) in inadequate or partial responders after switching from adalimumab8

      40% of SKYRIZI patients achieved PASI 100 at Week 44 vs 7% continuing on adalimumab8

      Inadequate or partial response In the IMMvent study was defined as ≥PASI 50 to <PASI 90 at Week 16 in patients receiving adalimumab. Not depicted: IMMvent Part A (baseline to Week 16). SKYRIZI (n=301); adalimumab (n=304). PASI 90 at Week 16: SKYRIZI 72.4%; adalimumab 47.4% (P<0.001). Inadequate or partial responders only (≥PASI 50 to <PASI 90) were rerandomised to Part B. Primary endpoint for Part B was PASI 90 at Week 44 with SKYRIZI vs. adalimumab among those with PASI 50-<PASI 90 after 16 weeks of adalimumab treatment. Part B endpoint was met (P<0.001).
      Co-primary endpoints for Part A - PASI 90 & sPGA 0/1 at Week 16. SKYRIZI vs. adalimumab were met P<0.001.
      aRanked secondary endpoint.

      SKYRIZI efficacy vs ustekinumab6

      SKYRIZI efficacy vs secukinmab3,4

      SKYRIZI efficacy vs adalimumab8


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      References

      1. SKYRIZI: Summary of Product Characteristics 2020.
      2. Papp K, et al. Poster 1366, presented at European Academy of Dermatology and Venereology (EADV) Congress, October 2020.
      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. Strober B, et al. Poster 1714, presented at the 28th European Academy of Dermatology and Venereology (EADV) Congress, 9-13 October 2019, Madrid, Spain.
      6. Lebwohl MD et al. Integrated analysis of UltIMMa 1&2. Poster presented at ADD March 2019 P8108.
      7. Gordon KB 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: 650-661.
      8. Reich K 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: 576-586.

      UK-RISN-210108. 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