Volgens mij gaat dit geen al te grote concurrent worden voor filgotinib:
IL-23 Inhibitor Risankizumab Induces Remission in Phase II Study in Patients with Moderate-to-Severe Crohn's Disease
- After 12 weeks, approximately twice as many patients with moderate-to-severe Crohn's disease, the majority of whom had previously failed treatment with one or more TNF antagonists, achieved clinical remission with risankizumab compared with placebo(1)
- Endoscopic remission was achieved in 15% and 20% of patients receiving 200 mg and 600 mg risankizumab, respectively, compared with three percent of patients receiving placebo after 12 weeks(1)
- These results indicate that the selective blockade of IL-23 with risankizumab may be a promising new therapeutic approach for this serious chronic disease and warrants further investigation
PR Newswire AbbVie
3 hours ago
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INGELHEIM, Germany, and NORTH CHICAGO, Ill., May 24, 2016 /PRNewswire/ -- Results were presented today from a proof-of-concept, Phase II, randomized, placebo-controlled study (NCT02031276) in Crohn's disease with investigational biologic, risankizumab (formerly BI 655066), a compound from Boehringer Ingelheim research and recently licensed by AbbVie (ABBV). Risankizumab was shown to be more effective than placebo in patients with moderately-to-severely active Crohn's disease.1 These interim results are the first to be reported in this indication with risankizumab, which selectively blocks IL-23 through the specific targeting of the IL-23p19 subunit.1 After 12 weeks, 24% and 37% of patients achieved clinical remission (no symptoms or very mild symptoms of disease) with 200 mg and 600 mg risankizumab, respectively, compared with 15% of patients receiving placebo*1. Endoscopic remission (normalization of the lining of bowel as seen during an endoscopy) was achieved by 15% and 20% of patients receiving 200 mg and 600 mg risankizumab, respectively, compared with three percent of patients receiving placebo.1
Dr. Brian G. Feagan, MD, PhD, Director of Robarts Clinical Trials at Robarts Research Institute, Western University, London, Ontario, Canada, and Principal Investigator of this study, presented the findings at the Digestive Disease Week (DDW) conference in San Diego, USA. He said, "These results are particularly encouraging because of the difficult-to-treat population within the study. Our patients had endoscopically confirmed moderate or more severe disease activity at study entry and the majority had previously failed treatment with one or more TNF antagonists."
Risankizumab also achieved higher rates of clinical response (defined by a Crohn's Disease Activity Index of 1 Risankizumab was well tolerated in this clinical trial, with numerically fewer severe or serious adverse events in risankizumab treated patients compared with placebo. Most frequently reported adverse events were gastrointestinal events (nausea, worsening of Crohn`s disease, abdominal pain, vomiting), arthralgia, anemia and headache.1
"Patients with moderate-to-severe Crohn's disease who have failed anti-TNF therapy have very limited choices for treatment," said Theresa Podrebarac, vice president, immunology clinical development, AbbVie. "We are encouraged by the promising results seen in this study with risankizumab and look forward to continuing development of this compound as a potential new treatment option for patients and physicians."
"It's exciting to see such positive results from a compound with a different mechanism of action to currently available treatments. Boehringer Ingelheim is committed to improving the care of patients with difficult-to-treat immune diseases, and the promising results of this study of risankizumab in patients with difficult-to-treat moderate-to-severe Crohn's disease is an encouraging step towards achieving this goal," said Dr. Steven Padula, Therapeutic Area Head Medicine Immunology at Boehringer Ingelheim.
Additional Trial Information
The data discussed in this press release represent results for intravenous risankizumab 200 mg (n=41) and 600 mg (n=41) versus placebo (n=39), administered at weeks zero, four, and eight in patients with moderately-to-severely active Crohn's disease.1
Risankizumab also showed the following results at 12 weeks:
Endoscopic response (>50% improvement in the lining of the bowel from before treatment started, as seen during an endoscopy) was achieved by 37% of patients receiving 600 mg risankizumab, compared with 13% of patients receiving placebo1
Deep remission (patients achieving clinical and endoscopic remission at the same time) was achieved by 12% of patients receiving 600 mg risankizumab, compared with none in the placebo group1
The trial is ongoing and will evaluate patients up to 52 weeks.
About Risankizumab (BI 655066 now ABBV-066)
Risankizumab selectively blocks IL-23, a key protein involved in inflammatory processes that has been linked to a number of chronic immune-mediated diseases. Risankizumab is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading future development and commercialization of risankizumab globally. The therapeutic potential of risankizumab is being evaluated in immunological disorders, including Crohn's disease, psoriasis and psoriatic arthritis.
*Risankizumab is not approved by regulatory authorities, and its safety and efficacy are being investigated.