Risankizumab Promising for Psoriasis; Plus Canada Approves Brodalumab

Treatments for the various forms of psoriasis are seeing positive results during clinical trials and coming to market. The results of two Phase 3 clinical trials show that patients with psoriasis taking risankizumab achieved greater skin clearance than those on ustekinumab. And in Canada, health authorities approved brodalumab to treat moderate to severe plaque psoriasis.

Risankizumab Promising for Psoriasis Compared with Ustekinumab
Risankizumab is an investigational agent that selectively blocks interleukin (IL) 23 from binding to its p19 subunit. It is currently in Phase 3 trials to treat psoriasis, psoriatic arthritis and Crohn’s disease.

At the 2018 American Academy of Dermatology Annual Meeting in February, the results from two Phase 3 studies on plaque psoriasis, ultIMMa-1 and ultIMMa-2, were presented.¹ Both studies evaluated the safety and efficacy of 150 mg risankizumab compared with placebo or 45 or 90 mg ustekinumab (based on patient weight). At Weeks 16 and 52, patients treated with risankizumab showed significantly higher rates of clear skin on the static Physician Global Assessment (sPGA 0) compared with ustekinumab-treated patients.

At Week 16 in both studies, 37% and 51% of risankizumab-treated patients achieved clear skin (sPGA 0) compared with 14% and 25% of ustekinumab-treated patients, respectively. At Week 52, 58% and 60% of risankizumab-treated patients achieved clear skin (sPGA 0) compared with 21% and 30% of ustekinumab-treated patients, respectively. These sPGA skin clearance rates are in agreement with previously reported Week 52, PASI 100 rates.

The risankizumab safety profile was consistent with those reported in other Phase 3 studies. Additionally at Week 52, significantly more risankizumab-treated patients self-reported a Dermatology Life Quality Index (DLQI) score of 0 or 1 compared with ustekinumab-treated patients. DLQI measures health-related quality of life and ranges from zero to 30. Higher scores indicate the disease has a high impact on quality of life.

Canada Approves Brodalumab for Plaque Psoriasis
On March 6, Health Canada granted an Notice of Compliance (NOC) for brodalumab (Siliq) subcutaneous injection, an IL-17 receptor targeting monoclonal antibody. A NOC is issued to a manufacturer following the satisfactory review of a new drug submission, which indicates regulatory compliance.²

Brodalumab is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. Sales and marketing in Canada will begin in the second half of this year.

Michele B. Kaufman, PharmD, BCGP, is a freelance medical writer based in New York City and a pharmacist at New York Presbyterian Lower Manhattan Hospital.

References

1. AbbVie. News release: AbbVie presents new positive late-breaking data from two Phase 3 psoriasis trials of Risankizumab at the 2018 American Academy of Dermatology Annual Meeting. 2018 Feb 17.
2. Valeant Canada. News release: Valeant receives Health Canada approval of Siliq (brodalumab) for moderate to severe plaque psoriasis. FirstWord Pharma. 2018 Mar 14.