Aberdeen's psoriasis new drug phase 3 clinically regained important positive results
Aberdeen's psoriasis new drug phase 3 clinically regained important positive results December 05, 2017 Source: WuXi PharmaTech AbbVie, a biopharmaceutical company, today announced the positive results of its Phase III clinical trial (IMMhance) for the treatment of psoriasis with its IL-23 monoclonal antibody, risankizumab. This is the fourth and final important phase 3 clinical trial to evaluate risankizumab in the treatment of psoriasis. Psoriasis is a chronic autoimmune inflammatory disease that causes excessive proliferation of skin cells, which can cause skin bulging, inflammation, redness, or plaque formation. Plaque psoriasis is the most common type of psoriasis, and its typical symptoms are the formation of thick red skin flaky, silvery white scaly structures. According to the literature, as many as 125 million people worldwide suffer from psoriasis, and patients have long-term physical and mental pain. Risankizumab is a researching compound designed to selectively block the binding of IL-23 to its p19 subunit. IL-23 is a key cytokine involved in the progression of inflammation and is thought to be involved in many chronic immune-mediated diseases. Not long ago, this new drug just announced the results of the third phase 3 clinical trial, the data is equally gratifying. â–² Risankizumab is expected to treat a variety of indications (Source: AbbVie official website) The clinical trials that announced the results today are divided into two phases in design. In the first phase, patients were randomly assigned to the risankizumab (150 mg) group or placebo group at a 4:1 ratio and received subcutaneous injection treatment every 12 weeks on the start day, 4 weeks, and after. The primary end point was the proportion of patients who achieved a 90% improvement in the Psoriasis Severity Index (PASI) score (PASI 90) and a physician overall assessment (sPGA) score at the 16th week to achieve a clearance or almost clearance (sPGA 0/1) level. Patients who initially received placebo were randomized to receive raniskizumab treatment at week 16. In the second phase of the study (week 28 to week 104), patients who were initially randomized to the risankizumab treatment group were re-randomized to risankizumab (maintenance group) or comforted at week 28 who achieved sPGA 0/1 Agent (withdrawal group). From week 32, any patient who experienced relapse (defined as moderate to severe sPGA [ > 3]) was immediately treated with risankizumab and continued to receive resankizumab treatment every 12 weeks after 4 weeks. This phase of the trial design evaluated the efficacy and safety of continuous treatment with risankizumab and randomized discontinuation, as well as the effect of recovery therapy. The primary endpoint from week 28 to week 104 was the sPGA 0/1 ratio at one year. Results from the first phase showed that after 16 weeks of treatment, the proportion of risankizumab treatment reached the primary end point - the proportion of patients achieving PASI 90, and the proportion of patients with sPGA 0/1 were significantly higher than the placebo control group. At 16 weeks, nearly half (47%) of patients taking risankizumab achieved complete clearance (PASI 100), compared with 1% in the placebo group. 73% of patients who received risankizumab achieved PASI 90, compared with 2% in the placebo group. 84% of patients receiving risankizumab achieved sPGA 0/1, while 7% of placebo patients achieved sPGA 0/1. The results of the second phase reached the primary endpoint of sPGA 0/1 at week 52 (one year). In patients who achieved clearance or nearly clearance (sPGA 0/1) results at week 28, 87% of patients in the maintenance group maintained sPGA 0/1 for one year, while patients in the withdrawal group maintained sPGA 0/1 at 61%. % (p < 0.001). The safety in IMMhance is consistent with previously reported Phase 3 clinical trials, and no new safety risks have been identified in Phase 3 clinical trials. â–² Dr. Michael Severino, Executive Vice President and Chief Scientific Officer of AbbVie R&D (Source: The Field Museum) Dr. Michael Severino, Executive Vice President and Chief Scientific Officer of AbbVie, said: "These positive results are consistent with our data throughout the key Phase 3 clinical trials. A significant proportion of patients receiving risankizumab achieve high levels. Skin clearance rates, these results increase data supporting the potential of risankizumab for effective new treatment options for patients with psoriasis, and we look forward to sharing more follow-up key trial data with the scientific community and regulatory authorities to prepare for the drug listing application." Dr. Andrew Blauvelt, a dermatologist who is the lead researcher at the Oregon Medical Research Center and the dermatologist, said: "It is very encouraging to see such high skin clearance rates in patients with moderate to severe plaque psoriasis. It has also been shown that continuous treatment may provide patients with better disease improvement than patients who withdraw from treatment after initial response." We congratulate Abbie on the good news of clinical trials again, and look forward to the successful launch of this new drug for the benefit of patients! Reference materials: [1] Risankizumab Meets All Primary Endpoints Reporting Positive Results in it's Fourth Pivotal Phase III Psoriasis Study [2] Abbvie official website
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