The U-EXCEL (NCT03345849) and U-EXCEED (NCT03345836) phase 3 studies investigated the efficacy and safety of upadacitinib, an oral, selective JAK inhibitor in patients with moderate-to-severe Crohn’s disease. touchIMMUNOLOGY were delighted to speak with Dr. Jean-Frederic Colombel (Icahn School of Medicine, Mount Sinai, New York, NY, USA) to discuss his sub-analysis of the data from U-EXCEL and U-EXCEED looking at rapid symptom relief in Crohn’s disease in patients receiving upadacitinib.
The abstract ‘Upadacitinib Therapy Reduces Crohn’s Disease Symptoms Within the First Week of Induction Therapy.’ (Abstract number: DOP38) was presented at ECCO 2023, March 1-4, 2023.
Questions
- Why is rapid symptom relief so important in Crohn’s disease (CD) and what are the unmet needs in this area? (0:16)
- What have we learned from the U-EXCEL and U-EXCEED studies on the efficacy and safety of upadacitinib in patients with moderate-to-severe CD? (0:57)
- What were the aims and methodology of this sub-analysis? (1:42)
- What were the findings in terms of rapid symptom relief? (2:20)
Disclosures: Jean-Frederic Colombel discloses consulting for: AbbVie, Amgen, Arena Pharmaceuticals, Boehringer Ingelheim, BMS, Celgene Corporation, Eli Lilly, Ferring Pharmaceuticals, Galmed Research, Genentech, Glaxo Smith Kline, Janssen Pharmaceuticals, Kaleido Biosciences, Imedex, Immunic, Iterative Scopes, Merck, Microbia, Novartis, PBM Capital, Pfizer, Protagonist Therapeutics, Sanofi, Takeda, TiGenix, and Vifor; receiving grant/research support from: AbbVie, Janssen Pharmaceuticals and Takeda; serving on advisory boards for: AbbVie, Amgen, Arena Pharmaceuticals, Boehringer Ingelheim, BMS, Celgene Corporation, Eli Lilly, Ferring Pharmaceuticals, Galmed Research, Genentech, Glaxo Smith Kline, Janssen Pharmaceuticals, Kaleido Biosciences, Imedex, Immunic, Iterative Scopes, Merck, Microbia, Novartis, PBM Capital, Pfizer, Protagonist Therapeutics, Sanofi, Takeda, TiGenix, and Vifor; receiving honoraria from: AbbVie, Amgen, Arena Pharmaceuticals, Boehringer Ingelheim, BMS, Celgene Corporation, Eli Lilly, Ferring Pharmaceuticals, Galmed Research, Genentech, Glaxo Smith Kline, Janssen Pharmaceuticals, Kaleido Biosciences, Imedex, Immunic, Iterative Scopes, Merck, Microbia, Novartis, PBM Capital, Pfizer, Protagonist Therapeutics, Sanofi, Takeda, TiGenix, and Vifor and is a major stock shareholder in: Intestinal Biotech Development.
Support: Interview and filming supported by Touch Medical Media Ltd. Interview conducted by Victoria Jones.
Filmed in coverage of the European Crohn´s and Colitis Organisation Annual Meeting 2023.
Click here for more content from Jean-Frederic Colombel.
Transcript
Why is rapid symptom relief so important in Crohn’s disease (CD) and what are the unmet needs in this area? (0:16)
When you have abdominal pain and diarrhoea. I’m asking you the question. Does it matter? Yes, it matters because, of course, if you can get rid of your symptoms, abdominal pain and diarrhoea within one week instead of waiting two weeks or four weeks, I think it’s much better. So, with the medications that we have now, we are trying to bring to patients not, of course, full clinical remission, but at least to relieve symptoms as soon as possible, because this has a big impact on the quality of life.
What have we learned from the U-EXCEL and U-EXCEED studies on the efficacy and safety of upadacitinib in patients with moderate-to-severe CD? (0:57)
U-EXCEL and U-EXCEED were the two phase 3 induction trials using upadacitinib for the treatment of Crohn’s disease with a dose of 45 milligrams daily and basically these studies, which are not yet fully published, are showing that the medication was superior to placebo. So, in other words, upadacitinib is effective for induction of clinical remission and endoscopic response in patients with Crohn’s disease and this was the primary endpoint, was actually for the induction was 12 weeks.
What were the aims and methodology of this sub-analysis? (1:42)
This was a sub analysis where we looked at the efficacy of 45 milligrams daily of upadacitinib on early symptomatic response. What we call early are basically the first 15 days and we pull the data from U-EXCEL and U-EXCEED. So basically, we had data about symptoms, mostly abdominal pain and stool frequency every day until two weeks.
What were the findings in terms of rapid symptom relief? (2:20)
Basically, the studies show that upadacitinib was acting very quickly. It was a very fast improvement of both stool frequency score and abdominal pain score, which are the two scores which are used to monitor clinical activity, in Crohn’s disease. For instance, when you are looking at stool frequency as soon as day five, there was a significant difference with placebo and the same for pain it was after day six. So basically, within one week there was already a difference, a significant difference between the placebo and the upadacitinib arm, showing that actually this drug is working pretty fast within a week, even better.
Subtitles and transcript are autogenerated.
