Risankizumab

Unassigned

New Medicines

Skyrizi · Moderate-to-severe chronic plaque psoriasis in adults

Information

Skyrizi
New molecular entity
AbbVie
AbbVie

Development and Regulatory status

Launched
Launched
Approved (Licensed)
May 2019

May 19: Available through AbbVie (direct orders from hospital pharmacy) or via the homecare providers : Alcura, Healthcare at Home or Healthnet [19].


May 19: Launched in the UK. £3,326.09 per pack. Packsize = 2 x 75mg pre-filled syringe [18] [19].


May 19: Approved in EU [17]


Apr 19: Approved in US where it will be priced at $88,500 for the first year and $59,000 per year for maintenance doses [15,16]


Mar 19: A new market research report identifies risankizumab as one of seven new drugs it believes will hit sales of $1 billion or more, the so-called “blockbuster” mark, by 2023 [14].


Feb 19: recommended for EU approval by CHMP - the full indication is "for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy”. It is proposed that the drug be prescribed by physicians experienced in the treatment of psoriasis [13].


May 18: Filed in the EU for treatment of moderate-to-severe plaque psoriasis. The application is supported by data from four pivotal PIII studies: ultIMMA-1, ultIMMa-2, IMMhance and IMMvent [10].


Apr 18: Filed in the US [9] .


May 17: Global launches predicted in 2019 [5].


Mar 16: AbbVie pays over $595 million to partner with Boehringer Ingelheim on BI-655066. AbbVie will share in late-stage development while gaining sole marketing rights [3].

Category

A humanised IgG1 monoclonal antibody that binds to and neutralises the p19 subunit of interleukin-23.
The prevalence of psoriasis is around 1.3-2.2% in the UK.
Moderate-to-severe chronic plaque psoriasis in adults
Subcutaneous injection

Further information

Yes
August 2019

Trial or other data

Jun 19: New 2-year data from the ongoing PIII IMMhance study reported at the World Congress of Dermatology showed 73% and 72% of patients treated with continuous risankizumab experienced complete skin clearance (defined as sPGA 0 and PASI 100, respectively) at week 94, among patients who achieved sPGA 0/1 at week 28. No new safety findings observed at 2 years (104 weeks) [20].


Sep 18: Pooled analyses from ultIMMa-1 and ultIMMa-2 studies showed significantly more pts treated with risankizumab were symptom-free vs. placebo and ustekinumab. At week 16, 30% of pts receiving risankizumab had a PSS score of 0 vs. 15% and 1% receiving ustekinumab and placebo, respectively (p<0.001). At 1 year, 56% of risankizumab-treated pts reported being symptom free (PSS=0) vs. 30% of pts receiving ustekinumab (p<0.001).[12]


Aug 18: Results of UltIMMa-1 and UltIMMa-2 published in The Lancet [11].


Feb 18: Abbvie present data from PIII UltIMMa-1 trial (NCT02684370) and UltIMMa-2 trial (NCT02684357) at conference. Results at weeks 16 and 52 demonstrate significantly higher rates of clear skin (as measured by static Physician Global Assessment), both ranked secondary endpoints, in patients treated with risankizumab, compared to ustekinumab or placebo (P<0.001) [8].


Nov 17: IMMhance (NCT02672852) study (n=500) meets all primary endpoints. At week 16, 73% of patients receiving risankizumab achieved PASI90 vs 2% of patients receiving placebo. Additionally, 47% of patients on risankizumab achieved PASI100 vs 7% on placebo (p<0.001 for both comparisons vs placebo) [7].


Oct 17: Three phase III trials found that risankizumab was better than either ustekinumab or adalimumab in moderate-severe plaque psoriasis. In ultIMMa-1 (NCT02684370) and ultIMMa-2 (NCT02684357), patients were given risankizumab (150 mg) or ustekinumab 45 mg or 90 mg at week 0, 4, 16, 28, 40. After 16 weeks, PASI 90 was 75% in the risankizumab group compared with 42% in the ustekinumab group and 5% in the placebo group; 75%, 48% and 2% respectively in the ultiMMa-2 trial. The PIII IMMvent study (NCT02694523) compared risankizumab with adalimumab. Patients were randomized to either risankizumab (150 mg), given as a subcutaneous injection at baseline, 4 weeks later and every 12 weeks thereafter or adalimumab, given as a subcutaneous injection, with an initial dose of 80 mg followed by 40 mg every other week starting one week after the initial dose. PASI 90 at 16 weeks was 72% (n=301) with risankizumab and 47% in the adalimumab group (n=304) [6].


Feb 17: Open-label PIII LIMMITLESS extension trial to assess the long term safety and efficacy of 150mg risankizumab in the treatment of moderate to severe chronic plaque psoriasis starts. The trial will enrol approximately 1900 subjects aged 18 to 99 years in the US and Canada. Patients from the previous PII/III studies will be rolled over in this study [5].


Apr 17: PIII UltIMMa-1 trial (NCT02684370) and UltIMMa-2 trial (NCT02684357) have completed recruitment. Collection of primary outcome data was due to complete Dec 16 [4].


Feb 16: Boehringer Ingelheim plans to conduct the PIII UltIMMa-2 trial to investigate safety and efficacy of risankizumab to support registration for treatment of patients with moderate to severe chronic plaque psoriasis (NCT02684357). The randomised, double-blind trial will enrol approximately 500 participants in Belgium, Canada, the Netherlands, Spain, the US, France, Germany, Italy, Mexico, Portugal, Austria and Poland [2].


Feb 16: Boehringer Ingelheim plans to conduct the PIII UltIMMa-1 trial to investigate safety and efficacy of risankizumab to support registration for thtreatment of patients with moderate to severe chronic plaque psoriasis (NCT02684370). The randomised, double-blind trial will enrol approximately 500 participants in the US, Canada, Czech Republic, France, Germany, Japan, South Korea and Australia [2].


Feb 16: Boehringer Ingelheim initiates the PIII IMMhance trial to evaluate safety and efficacy of risankizumab in patients with moderate to severe plaque psoriasis (NCT02672852). The study will assess maintenance of response following treatment withdrawal, as well as response to re-treatment for patients who relapse. The randomised, double-blind trial has initiated enrolment of approximately 500 patients in the US, Canada, and is expected to expand in Belgium, France, South Korea and Germany [2].


NCT02694523 = IMMvent trial [2].


Feb 16: PIII study (NCT02694523) to assess safety and efficacy of BI 655066 compared to adalimumab to support registration for treatment of moderate to severe chronic plaque psoriasis in adults begins. 600 adults will be recruited from sites in Finland, France, Germany, Great Britain, Italy, Mexico, Poland, Portugal, Taiwan, US, Canada, Czech Republic, & Sweden. Co-primary outcomes are Achievement of >=90% reduction from baseline Psoriasis Area and Severity Index (PASI) score (PASI 90) at Week 16 and Achievement of a static Physician Global Assessment (sPGA) score of clear or almost clear at Week 16. Collection of these data are expected to complete Mar 17 [1].

Evidence based evaluations

Skyrizi · Moderate-to-severe Crohn's disease

Information

Skyrizi
Licence extension / variation
AbbVie
AbbVie

Development and Regulatory status

Phase III Clinical Trials
Phase III Clinical Trials
Phase III Clinical Trials
Yes

Category

Humanised IgG monoclonal antibody that selectively blocks IL-23
There are currently at least 115,000 people in the UK with Crohns disease [3].
Moderate-to-severe Crohn's disease
Intravenous infusion and
Subcutaneous injection

Skyrizi · Moderate-to-severe ulcerative colitis (UC) in adults who have had an inadequate response to or were intolerant to aminosalicylate, corticosteroid, or immunomodulator, or biologic therapy

Information

Skyrizi
Licence extension / variation
AbbVie
AbbVie

Development and Regulatory status

Phase III Clinical Trials
Phase III Clinical Trials
Phase III Clinical Trials

Category

Humanised IgG monoclonal antibody that selectively blocks IL-23
Ulcerative colitis is the most common type of inflammatory disease of the bowel. It has an incidence in the UK of approximately 10 per 100,000 people annually and a prevalence of approximately 240 per 100,000 [1].
Moderate-to-severe ulcerative colitis (UC) in adults who have had an inadequate response to or were intolerant to aminosalicylate, corticosteroid, or immunomodulator, or biologic therapy
Subcutaneous injection