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Secukinumab does not increase IBD incidence in patients with psoriasis, spondyloarthropathies
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Reports of Crohn’s disease and ulcerative colitis among patients with psoriasis, psoriatic arthritis or ankylosing spondylitis treated with secukinumab were infrequent and consistent with earlier findings, according to data presented at the American College of Rheumatology Annual Meeting.
“We looked at the onset of inflammatory bowel disease (IBD) in patients with psoriasis, psoriatic arthritis (PsA) and ankylosing spondylitis (AS),” Atul A. Deodhar, MD, MRCP, FACP, FACR, of Oregon Health & Science University, told Healio Rheumatology. “Crohn’s disease [CD] and ulcerative colitis [UC] occur more commonly in patients with AS, PsA and psoriasis.”
Deodhar and colleagues examined the incidence of CD and UC in data from 10 phase 2 and phase 3 studies for moderate to severe psoriasis, two phase 3 studies for active PsA and two Phase 3 studies for active AS that were pooled per indication. Most of the studies utilized short-term, placebo treatment arms, although one study of patients with psoriasis included an active etanercept comparator arm. Participants were eligible for enrollment if they had a prior history of IBD, but they could not have active disease. The length of the trials varied, according to the study results.
Data were included in the analysis for all patients who received one or more doses of secukinumab (Cosentyx, Novartis) by week 52 in the psoriasis studies or by week 112 in the PsA and AS studies. Crude infrequency rates (as a percentage) were used to report data in the short term (week 12 for the psoriasis studies and week 16 for the PsA and AS studies), and exposure-adjusted incidence rates per 100 patient years were used for the entire treatment period.
The greatest amount of data was collected from patients in the psoriasis studies (n = 3,430). Data were also available for 974 patients in the PsA studies and 571 in the AS studies. Reports of adverse events related to the incidence of CD or UC were infrequent among patients who received secukinumab in both the short- and long-term treatment periods.
“We did see patients with Crohn’s and ulcerative colitis,” Deodhar said. “But if you compare these numbers with patients with histologic AS or PsA who were not treated with secukinumab, and the histological rate of new-onset IBD in these patients, there was no difference. The histology of patients with PsA and AS compared with what we found in this study is similar.”
There were no reports of dose dependency with secukinumab regarding the incidence of CD or UC and no pattern in time to symptom onset. In addition, the rate of IBD among patients treated with secukinumab was similar to those reported among patients treated with etanercept.
“This statistical observation should be taken with a grain of salt, mainly because clinical trials do not go long enough to truly determine the safety,” Deodhar told Healio Rheumatology. “There are not enough patients followed for long enough — over several years — to evaluate safety.”
However, reports related to CD and UC events in these trials were “infrequent,” according to the study findings, and Deodhar said the results of this analysis are “reassuring.”
In addition, the exposure-adjusted incidence rates of CD and UC seen among patients treated with secukinumab “are consistent with those reported in the literature in psoriasis, PsA and AS populations,” the researchers wrote. – by Julia Ernst, MS
Reference:
Deodhar AA, et al. Abstract 962. Presented at: American College of Rheumatology Annual Meeting; Nov. 11-16, 2016; Washington.
Disclosures: Deodhar reports associations with AbbVie, Amgen, Eli-Lilly, Janssen, Novartis, Pfizer and UCB. Please see the full study for a list of all other researchers’ relevant financial disclosures.