Inflammatory bowel disease events, including Crohn’s disease and ulcerative colitis, are uncommon in patients with psoriatic arthritis, psoriasis and ankylosing spondylitis who were treated with secukinumab, according to data published in the Annals of the Rheumatic Diseases.
“Patients with [psoriasis], PsA and AS have a 1–4-fold increased risk, relative to the background population, of developing IBD,” Stefan Schreiber, MD, PhD, of University Hospital Schleswig Holstein, Christian-Alrechts-University in Germany, and colleagues wrote. “Secukinumab, a fully human monoclonal antibody that inhibits IL-17A, has shown significant efficacy in the treatment of [psoriasis], PsA and AS demonstrating rapid onset of action. Detection of IBD has been reported in patients being treated with IL-17 inhibition.”
To analyze the incidence rates of IBD — including Crohn’s disease and ulcerative colitis — among patients treated with secukinumab (Cosentyx, Novartis) for PsA, AS and psoriasis, Schreiber and colleagues pooled data from 21 randomized controlled clinical trials. The trials included 14 phase 3 studies and one phase 4 study in psoriasis, three phase 3 studies in PsA and three phase 3 studies in AS.
IBD events, including Crohn’s disease and ulcerative colitis, are uncommon in patients with PsA, psoriasis and AS who were treated with secukinumab, according to data.
The researchers included data from all patients who had been treated with at least one dose of secukinumab. In all, 7,355 patients representing 16,226.9 patient-years were included in the pooled analysis. Schreiber and colleagues completed safety analyses to determine cumulative incidence and per-year rates of IBD. Cases of Crohn’s disease, ulcerative colitis and unclassified IBD were evaluated using exposure-adjusted incidence rates, defined as patient incidence rates per 100 patient-years.
According to the researchers, there were 14 cases of ulcerative colitis, five cases of Crohn’s disease and one unclassified event among the 5,181 patients with psoriasis. This resulted in exposure adjusted incidence rates (EAIRs) of 0.13, 0.05 and 0.01, respectively. In addition, of these 20 cases of IBD events, 14 were new-onset. Among the 1,380 patients with PsA, the researchers found three cases of ulcerative colitis (EAIR = 0.08), three cases of Crohn’s disease (EAIR = 0.08) and two unclassified events (EAIR = 0.05). Of these, seven were new-onset. Finally, the 794 patients with AS included four cases of ulcerative colitis (EAIR = 0.2), eight cases of Crohn’s disease (EAIR = 0.4) and one unclassified event (EAIR = 0.1), of which nine were new-onset. EAIRs did not increase over time in the per-year analysis.
“The strength of this report is the fact that the analysis is undertaken in a large patient population pooled from 21 clinical trials across multiple indications and is complemented with substantial post-marketing surveillance data,” Schreiber and colleagues wrote. “The use of exposure-adjusted incidence rates also enhances the robustness of the results by adjusting for disease duration. Long-term comparative registry data are needed to further examine the role of IL-17 inhibition on the incidence of IBD.” – by Jason Laday
Disclosure: Schreiber reports consulting fees from Abbvie, AstraZeneca/Medimmune, Boehringer, Celltrion, Ferring, Jansen, Novartis, MSD, Pfizer, Sanofi, Takeda and UCB, as well as speaking fees from Abbvie, Celltrion, Ferring, MSD and Takeda. Please see the study for all other authors’ relevant financial disclosures.