MedicalResearch.com Interview with:
Anne Robinson, Pharm D
Executive Scientific Director
MedicalResearch.com: What is the background for the risankizumab data presented at the American Academy of Dermatology 2019 Annual Meeting?
Response: Abstracts presented by AbbVie at the American Academy of Dermatology (AAD) 2019 Annual Meeting highlight additional data from the Phase 3 clinical trial program evaluating the safety and efficacy of risankizumab, an investigational interleukin-23 (IL-23) inhibitor. The registrational program for risankizumab evaluated more than 2,000 adult patients with moderate to severe plaque psoriasis across four pivotal studies.
MedicalResearch.com: What are the main findings?
Key risankizumab data presented at the AAD Annual Meeting include:
- The first integrated efficacy analyses of ultIMMa-1 and ultIMMa-2, two replicate trials comparing risankizumab to ustekinumab or placebo. Study results demonstrate that risankizumab provided high levels of durable skin clearance through 52 weeks, compared to treatment with ustekinumab. Risankizumab efficacy was significantly better than ustekinumab as early as week 4 (sPGA 0/1) or week 8 (PASI 90), and at every time point thereafter through week 52. At week 52, the proportions of patients who achieved PASI 90 and sPGA 0/1 were significantly higher among patients receiving risankizumab compared with patients receiving ustekinumab. Notably, rresponses were durable over time and were seen across various patient sub groups regardless of baseline demographics, disease characteristics or prior treatment history.
- Data from the IMMvent trial, which evaluated the efficacy and safety of switching to risankizumab versus continued adalimumab use in patients with moderate to severe psoriasis with intermediate response to adalimumab after 16 weeks. Patients treated with adalimumab with a PASI score between 50 and 90 at week 16 who switched to risankizumab experienced superior efficacy compared to those who continued treatment with adalimumab. Of those patients who switched from adalimumab to risankizumab, the majority (66%) achieved PASI 90 at week 44, compared to 21.4% who remained on adalimumab.
- Long-term (up to 40 months) risankizumab safety data, which showed the exposure-adjusted safety profile of risankizumab remains consistent with long-term use.
MedicalResearch.com: What should readers take away from your report?
Response: Our data at the American Academy of Dermatology 2019 Annual Meeting show that patients with moderate to severe plaque psoriasis treated with risankizumab in clinical trials achieved high rates of durable skin clearance through one year. These data add to the body of evidence supporting risankizumab’s potential as a future treatment option for patients with moderate to severe plaque psoriasis.
MedicalResearch.com: What recommendations do you have for future research as a result of this work?
Response: We look forward to continuing to advance research that assesses the longer-term safety, durable efficacy and place in the treatment paradigm of risankizumab in moderate to severe plaque psoriasis.
Citation: AAD2019 abstract
Efficacy and Safety of Continuous Risankizumab or Switching from Adalimumab to Risankizumab Treatment in Patients with Moderate-to-Severe Plaque Psoriasis: Results from the Phase 3 IMMvent Trial. Reich et al.
Oral Presentation; Friday, March 1, 2019, 12:05-12:10 p.m. EST
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