medwireNews: Findings from an Italian real-world study provide support for the phosphodiesterase-4 inhibitor apremilast as a treatment option for people with Behçet’s disease.
The study involved 12 individuals with recurrent or relapsing oral ulcers who had an inadequate response or intolerance to conventional treatment with corticosteroids and colchicine. All patients were treated with oral apremilast at doses currently approved for the treatment of psoriatic arthritis (10 mg once daily–30 mg twice daily).
Giacomo De Luca (Vita-Salute San Raffaele University, Milan, Italy) and co-researchers found that the average number of oral ulcers per person decreased significantly, from 3.33 at baseline to 0.58 after 12 weeks of apremilast treatment. This was accompanied by a significant reduction in disease activity, with average Behçet’s Syndrome Activity Scores decreasing from 45.90 to 16.80 points.
Patient-reported outcomes including Behçet’s Disease Current Activity Form and VAS pain scores for oral ulcers also improved significantly over the treatment period, with average scores decreasing from 2.45 to 0.72 points and from 67.9 to 23.3 points, respectively. Average Behçet’s Disease Quality of Life scores improved from 14.07 to 10.15 points.
Among the six patients who had symptomatic genital ulcers at baseline, there was a numerical decrease in the average number of oral ulcers from baseline to week 12, from 1.50 to 0.17, but De Luca et al say that the difference did not reach statistical significance due to the small number of patients in this subgroup.
Eight patients had cutaneous involvement (pustulosis, folliculitis, or erythema nodosum) at baseline, which resolved with apremilast treatment in all patients, and there was a significant reduction in corticosteroid and colchicine use over the study period.
In all, four patients (33%) experienced treatment-related adverse events, all of which led to discontinuation of apremilast. The most commonly reported event was diarrhea (n=3), which the researchers note occurred in two patients receiving colchicine, with one having Behçet’s disease-related gastrointestinal involvement.
“It is thus plausible that concomitant treatment or underlying pathophysiology contributed to apremilast-induced diarrhoea in these patients,” they write in Rheumatology.
De Luca et al caution that their study was limited by “[t]he small number of patients enrolled,” but point out that this is “in line with the rarity of the condition.”
They conclude that their “encouraging” data, although preliminary, are “in keeping with those from clinical trials and support the use of apremilast, either as monotherapy or combined with DMARDs,” for the treatment of Behçet’s disease.
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