Apremilast improves Behçet’s syndrome-related oral ulcers in both sexes

The use of apremilast consistently reduced the number and pain due to oral ulcers in both men and women with active Behçet’s syndrome, according to a subgroup analysis of the RELIEF* study presented at EULAR 2021.

This analysis involved 80 men (mean age 38.7 years) and 127 women (mean age 40.8 years) with ≥2 oral ulcers associated with active Behçet’s syndrome, with no active major organ involvement. Participants were randomized to receive either apremilast 30 mg twice daily (men, n=40; women, n=64) or placebo (men, n=40; women, n=63) during a 12-week double-blind treatment period. The area under the curve for the number of oral ulcers from baseline to week 12 (AUC_Wk0-12) was used to assess the continued efficacy of apremilast. [EULAR 2021, abstract POS0828]

At week 12, a greater reduction in the number of oral ulcers, as shown by a lower AUC_Wk0-12, occurred with apremilast vs placebo in both men (118.9 vs 211.4, treatment difference, -92.5; p<0.001) and women (134.3 vs 229.2, treatment difference, -94.9; p<0.001).

Patients treated with apremilast also experienced a greater reduction in pain scores at week 12, as indicated by a reduction in VAS** score, compared with placebo (least squares [LS] mean change from baseline, -37.6 vs -12.0; p<0.0001 in men and -41.5 vs -17.4; p<0.0001 in women).

Moreover, a higher percentage of patients on apremilast than placebo achieved complete response by week 6 and remained oral ulcer-free for an additional ≥6 weeks (25.0 percent vs 2.5 percent; p=0.0033 in men and 32.8 percent vs 6.3 percent; p=0.0002 in women).

Apremilast recipients also demonstrated lesser disease activity, as shown by a greater reduction in BSAS***, compared with placebo recipients (LS mean change from baseline, -14.4 vs -1.3 [men] and -19.7 vs -7.7 [women]; p≤0.0001 for both).

Those on apremilast, particularly in women, also achieved a better quality of life (QoL) at week 12 than those on placebo (BDQoL⁺ score; -4.4 vs -0.3; p=0.0002).

“[Overall, both men and women showed consistent] improvements in [all] additional efficacy measures … and [had] similar safety profiles and adverse events that were consistent with [the] known safety profile [of apremilast],” said lead author Dr Gülen Hatemi from Istanbul University–Cerrahpaşa, Cerrahpaşa Medical School, and Behçet’s Disease Research Center in Istanbul, Turkey.

“[Our findings showed] consistent treatment effects favour[ing] apremilast … in efficacy outcomes, including [the number and pain due to] oral ulcers, complete response, disease activity measures, and QoL in men and women with Behçet’s syndrome,” Hatemi concluded.

“[The] data support [the use of] apremilast as an effective treatment for men and women with Behçet’s syndrome,” she added.

*RELIEF: A phase 3 randomized, double-blind study to evaluate the efficacy and safety of apremilast (CC-10004) in subjects with active Behçet's disease

**VAS: Visual Analog Scale

***BSAS: Behçet’s Syndrome Activity Score

⁺BDQoL: Behçet’s Disease Quality of Life