Since the recent launch of secukinumab in Canada, I have been hearing grumblings of whether or not there may be an issue with IBD flares or de novo cases of IBD. It was on my mind as I recently started my first two AS patients on the drug. This paper therefore caught my eye and I hoped it might put the issue to rest especially with its title: "No Increased Risk of IBD among Secukinumab-Treated Patients with Moderate to Severe Psoriasis, PsA or AS" presented by Dr. Deodhar.
We know there is an association between IBD and PsO, PsA and AS. CD has been reported in PsO patients at a rate of 0.25 cases per 100 pt-years; 0.06 cases per 100 pt-years in PsA patients; and 0.7 cases per 100 pt-years in AS. IL-17 is needed for gut mucosal integrity thus raising some concern about the potential effects of IL-17 inhibition on the GI health of our patients.
This trial looked at pooled data from Phase 2 and 3 studies across all indications, which included 14 studies in total and around 5000 patients who received at least one dose of secukinumab. The study did not exclude patients with a history of prior IBD but whose disease was currently not active. There was variability in dosing as well as duration of exposure.
The results showed a low number of new cases of IBD (7) and flares of existing disease (5). There was no temporal pattern or dose response, and no pattern in time to onset. The authors concluded that there was no increase in new cases or exacerbations above the baseline risk in this population.
I think this is an important trial and overall very reassuring. There may be an issue with selection bias in a RCT setting (i.e. selection of patients with lower risk of IBD) and therefore we really need post-marketing surveillance to know what the risk might be in the real-world setting.
Dr. Shelley Dunne is a graduate of Memorial University of Newfoundland School of Medicine. She completed her training in Internal Medicine and a fellowship in Rheumatology at the University of Toronto. She has been in private practice since 1998 and is currently a consulting rheumatologist at the Toronto East General Hospital.View Full Bio