Dr Panaccione reviews the latest trial results for guselkumab in treating Crohn's disease, showing that both IV and subcutaneous induction are superior to placebo.

Remo Panaccione, MD, is professor of medicine and director of the Inflammatory Bowel Disease Clinic at the University of Calgary in Calgary, Canada.

I'm Remo Panaccione, professor of Medicine and director of the Inflammatory Bowel Disease Clinic at the University of Calgary in Calgary, Canada. We're here in Philadelphia at ACG and I just finished presenting the data from the GRAVITI study evaluating sub-q guselkumab in patients with moderate to severe Crohn's disease. We know from the GALAXI 2 and 3 data that was presented at DDW that IV induction with guselkumab followed by sub-q maintenance, was superior to both placebo and in a head -to -head comparison to ustekinumab in those patients with moderate to severe Crohn's disease across a variety of endpoints. GRAVITI is a phase 3 study evaluating sub-q induction followed by sub-q maintenance. So about 347 patients were randomized in this study to either receive guselkumab 400 milligram sub-q at week 0, 4, and 8, followed by either 200 milligram sub-q every 4 weeks, or guselkumab 400 milligram sub-q at 0, 4, and 8, followed by 100 milligram sub-q every 8 weeks, or to placebo.

So what did the study show? Well it showed for the coprimary end points, which were clinical remission and endoscopic response at week 12, that the sub-q induction dosing was superior to placebo for both of those coprimary endpoints. The rates were quite high for both of those endpoints with large placebo-adjusted deltas which were statistically significant, and the results were very similar to the GALAXI 2 and 3 data where there was use of the IV induction. And then following that, both doses, both the 100 every 8 weeks and the 200 every 4 weeks, were statistically significant compared to placebo across a variety of clinical andendoscopic endpoints, and we continue to show excellent safety.

So what does it really mean for us who treat IBD patients? Now we have a highly effective therapy that can be used either as IV induction or sub-q induction over the first 12 weeks. There's rapid response in both the IV and the sub-q. So now we can go to our patients and provide them choice on whether they would prefer sub-q or IV induction, which I think is a great step forward for the field.