medwireNews: The small molecule phosphodiesterase 4 inhibitor apremilast reduces the number of oral ulcers and improves quality of life to a greater degree than placebo in people with Behçet’s syndrome, results of the phase III RELIEF study show.
The study included 207 patients with Behçet’s syndrome and at least two active oral ulcers but no major organ involvement who were randomly assigned to receive either oral apremilast 30 mg (n=104) or placebo (n=103) twice daily for 12 weeks, followed by a 52-week extension phase in which all patients were eligible to receive the study drug.
As reported at the 2019 ACR/ARP Annual Meeting in Atlanta, Georgia, USA, and published in The New England Journal of Medicine, the area under the curve for the total number of oral ulcers during the 12-week placebo-controlled period was significantly lower with apremilast than with placebo, at 129.5 versus 222.1. This indicates that patients in the apremilast group had significantly fewer ulcers during this period, Gülen Hatemi (Istanbul University–Cerrahpaşa, Turkey) and co-authors remark.
In addition, significantly more patients receiving apremilast relative to placebo were free from oral ulcers at week 12 (52.9 vs 22.3%), and the mean number of ulcers was significantly lower in the treatment group from week 1 onwards. By week 12 the mean number of ulcers was 1.1 among the patients who received apremilast compared with 2.0 among those who received placebo, from baseline levels of 4.2 and 3.9, respectively.
Furthermore, people in the apremilast group experienced a greater fall in the Behçet’s Disease Quality of Life score, indicating improved quality of life, than those in the placebo group, at a mean of 4.3 versus 1.2 points, as well as clinically meaningful improvements in disease activity and pain.
Hatemi also presented unpublished data at the meeting which showed that the reduction in the number of ulcers was sustained up to week 64 among patients in the apremilast group who continued treatment, and emerged among those who switched from placebo to apremilast at week 12. The mean numbers of ulcers in these two groups at week 64 were 1.4 and 0.8, respectively.
However, during the 4 weeks after patients stopped taking the drug, the number of ulcers began to increase again, as did pain.
The majority of patients in both the apremilast (79%) and placebo (72%) groups experienced at least one adverse event in the placebo-controlled period, but the rates of diarrhea, nausea, headache, upper respiratory tract infection, and viral upper respiratory tract infection were all more common with apremilast than with placebo. However, Hatemi et al note that the gastrointestinal adverse events generally resolved within 15 days of beginning treatment.
The researchers conclude: “This trial showed the efficacy of apremilast as compared with placebo for the treatment of oral ulcers in patients with Behçet’s syndrome.”
They add that trials using an active comparator are now required.
By Laura Cowen
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N Engl J Med 2019; 381: 1918–1928
ACR/ARP 2019; Atlanta, Georgia, USA: 8–13 November