Health Canada Approves SKYRIZI (risankizumab) for the Treatment of Moderate to Severe Plaque Psoriasis
- SKYRIZI?(risankizumab)??is ?a novel, humanized immunoglobulin monoclonal antibody designed to selectively inhibit IL-23 by binding to its p19 subunit to treat moderate to severe plaque psoriasis1?. IL-23 is a naturally occurring cytokine that is involved in inflammatory and immune responses.
- Approval of SKYRIZI??(risankizumab)?is based on results from clinical studies showing significant improvement in levels of skin clearance after just 16 weeks and at 52 weeks with every 3 month dosing?in ?more than 2000 adult patients?2-5
- In the ultIMMa-1 and ultIMMa-2 studies, SKYRIZI? I met the co-primary endpoints of sPGA 0/1 and PASI 90 at Week 16 (p<0.001).1,4?After 16 weeks of treatment, 88 percent (ultIMMa-1) and 84 percent (ultIMMa-2) of SKYRIZI? ?patients achieved sPGA 0/1 and 75 percent of patients receiving SKYRIZI? ?in both studies achieved PASI 90.2,4,5
- Among patients with sPGA of 0/1 at Week 28 in the IMMhance study, 87.4% (97/111) maintained response with continued treatment with SKYRIZI? compared to 61.3% (138/225) with withdrawal (placebo) at Week 525.
- SKYRIZI? demonstrated superiority versus adalimumab in the IMMvent study, with 72 percent of patients achieving PASI 90 compared to 47 percent of patients treated with adalimumab at Week 16 (p<0.001).2,4?Following re-randomization at Week 16, 66 percent of patients who started on adalimumab and switched to SKYRIZI? ?achieved PASI 90, compared to 21 percent who continued on adalimumab at Week 44 (p<0.001).2,4?The co-primary endpoints of sPGA 0/1 and PASI 90 at Week 16 were met (p<0.001).2,4, 5
- SKYRIZI??was also reported to improve health-related quality of life in Phase 3 studies. In ultIMMa-1 and ultIMMa-2, significantly more patients treated with SKYRIZI? ?self-reported a Dermatology Life Quality Index (DLQI) score of 0/1 (no impact on health-related quality of life) at Week 16 ?(66 percent in ultIMMa-1 and 67 percent in ultIMMa-2) compared with ustekinumab (43 percent in ultIMMa-1 and 47 percent in ultIMMa-2)2,5
- The most frequently reported adverse drug reactions through the 16-week placebo-controlled period in the SKYRIZI? group were upper respiratory tract infections (13%) compared with 10% in the placebo group. Common adverse reactions occurring in = 1% of patients treated with SKYRIZI? included tinea infections, headache, pruritus, fatigue and injection site reactions.4, 5
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- Papp K.A., et al. Risankizumab versus Ustekinumab for Moderate-to-Severe Plaque Psoriasis. N Engl J Med. 2017 Apr 20; 376:1551-1560.
- Gordon K, 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. The Lancet. 2018 Aug 25;392(10148):650-661.
- Reich, K., et al. Efficacy and Safety of Risankizumab Compared with Adalimumab in Patients with Moderate-to-Severe Plaque Psoriasis: Results from the Phase 3 IMMvent Trial. ePoster #P1813. European Academy of Dermatology and Venereology Congress. 2018.
- Blauvelt, A. et al. Risankizumab Efficacy/Safety in Moderate-to-Severe Plaque Psoriasis: 16-Week Results From IMMhance [abstract P066]. Acta Derm Venereol. 2018; 98(suppl 219): 30.
- SKYRIZI? (risankizumab) [Canadian Product Monograph]. ?AbbVie Corporation, 2019.