medwireNews: People with entero-Behçet’s disease and active ulcerative lesions who are treated with tumor necrosis factor (TNF) inhibitors, either alone or in combination with corticosteroids, are more likely to experience ulcer cure or improvement than those taking corticosteroids alone, researchers report.
The retrospective study included 71 patients, of whom 20 were treated with TNF inhibitors plus corticosteroids, 29 were given TNF inhibitors alone, and 22 were given corticosteroids alone.
During 1 year of follow-up, rates of ulcer cure – defined as the disappearance and scarring of ulcerative lesions – were 60.0% for patients given the combination treatment, 44.8% for those given TNF inhibitors alone, and 13.6% in the corticosteroid monotherapy group.
These results translate into a significant sixfold increase in the likelihood of achieving ulcer cure among patients who received TNF inhibitors versus those who did not on multivariate analysis, report Yoshiya Tanaka (University of Occupational and Environmental Health, Kitakyushu, Japan) and team. They note that there was no significant difference in ulcer cure rates among individuals treated with TNF inhibitors plus corticosteroids versus TNF inhibitor monotherapy.
Similarly, ulcer improvement rates were significantly higher among patients in the combination therapy and TNF inhibitor monotherapy groups versus the corticosteroid monotherapy group (60.0 and 51.7 vs 27.3%, respectively), but improvement rates were not significantly different between the TNF inhibitor combination therapy and monotherapy groups.
The researchers also found that a significantly higher proportion of patients receiving combination therapy versus corticosteroids alone achieved a corticosteroid dose of 7.5 mg/day or lower, at approximately 90% versus 25%.
“In other words, patients in the [corticosteroids] without TNF [inhibitor] group exhibited [corticosteroid] dependency,” say Tanaka et al, noting that corticosteroid dose “is considered a risk factor for gastrointestinal bleeding and perforation.”
In contrast to these positive findings, the investigators found no significant difference in rates of improvement in disease activity, as measured by disease activity index for intestinal Behçet’s disease score, among patients who received TNF inhibitors versus those who did not.
There was no significant difference in relapse rates among TNF inhibitor-treated patients who did and did not receive concomitant corticosteroids, but a numerically lower proportion of those given both treatments experienced relapses (zero vs four patients), and the proportion of treatment nonresponders was numerically lower in this group (5.0 vs 13.8%).
“Based on these results, although the activity of entero-[Behçet’s disease] was sufficiently controlled and maintained at low levels with TNF [inhibitor] therapy without [corticosteroids] in some patients, there may be other patients for whom concomitant [corticosteroid] use is necessary,” write the study authors.
They conclude in Arthritis Research & Therapy: “In the future, additional studies with a larger sample size may be needed to reveal the features of patients who do or do not require a combination of TNF [inhibitors] and [corticosteroids].”
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