The next phase in the battle between anti-TNF therapies in inflammatory bowel disease began on Friday when the US FDA approved infliximab (Janssen Biotech’s Remicade) to treat moderate to severe ulcerative colitis in children 6 years and older who have failed conventional therapy.
Approval had been long expected and was based on safety and efficacy data from a multicenter, randomized, open-label study in 60 children aged between 6 - 17 years with active disease who did not respond to treatment with corticosteroids or immunomodulators.
Day 3 of DDW was again full of new, potentially practice-changing evidence. The day started with the Clinical Science Plenary session during which data was presented from the first prospective randomized trial comparing the use of cyclosporin and infliximab in patients with severe acute ulcerative colitis that had failed to respond to intravenous corticosteroid treatment. The study was designed to show the superiority of cyclosporin, i.e. that patients failed less frequently on cyclosporin therapy than on infliximab. It was estimated that 60% of patients would fail treatment on infliximab.
Day 2 of DDW 2011 has been as varied and as interesting as Day 1, with some significant new data presented that is likely to alter clinical practice in IBD in the coming months and years.
Disease Disease Week - the world’s largest conference on gastroenterology - kicked off today in Chicago with a full schedule of oral and poster sessions.
Based on our research with KOLs, Sociable Pharma held a preview webinar on Wednesday highlighting the key sessions and ‘must-see’ presentations that contained new evidence that will likely impact clinical practice in the future. A number of these presentations were given on Saturday, and they provoked some heated debate and discussion among the presenters and those attending.
Two articles in the April issue of American Journal of Gastroenterology created more confusion about the practical role of 5-aminosalicylates in treating Crohn’s disease, an issue that featured prominently in our recent research report.
The first journal article featured a systematic review and meta-analysis examining the efficacy of 5-ASAs in Crohn's disease. The main conclusions of the systematic review were that 5-ASA therapy may be more effective than placebo at inducing remission in Crohn's disease patients but that the number needed to treat (NNT) to achieve remission in one patient was no better than 11. In fact, the authors point out that one sizeable failed trial was excluded from the analysis and that would probably have led to no statistically significant difference between 5-ASAs and placebo.
There was more bad news when the role of 5-ASAs in preventing relapses was examined. The analysis showed no statistically significant benefit of these drugs over placebo, while a subgroup analysis showed that mesalazine appeared to be of only modest benefit in preventing relapse, with an NNT of 13.
Apart from some obligatory jokes at each others’ expense, surgeons and gastroenterologists took part in some serious discussions at the ECCO Annual Congress.
Surgery, and more importantly its timing, played a key part in this year’s conference program and interesting viewpoints were point forward. The central message from these discussions was that despite an increased use of immunosuppressive therapy over the last two decades, surgery is still an almost inevitable event in the natural history of ileal and ileocolonic Crohn’s disease.
There were anniversaries galore the ECCO Annual Congress in Dublin, Ireland.
There were events to mark the 10th anniversary of ECCO’s inauguration, presentations showing five years of biologic treatment in ulcerative colitis, and a review of 10 years of biologics use in Crohn’s disease*
* It’s actually been just over 11 years but that ruined the symmetry!
What was learned amid all the balloons and cake?
The official strap-line of the Annual Congress of European Crohn’s & Colitis Organisation (ECCO) was ‘Embracing Diversity in IBD’. After speaking with many delegates at the conference, a more appropriate strap-line may well have been ‘Making the Most of What We’ve Got’.
There were several presentations and symposia that focused heavily on optimizing currently available conventional drugs in Crohn’s disease and ulcerative colitis. Interestingly, a number of presenters voiced the opinion that the excitement about biologic therapy use had meant that valuable options had been overlooked and the time to re-visit these drugs were long overdue.