Background/Purpose: Recurrent, painful oral ulcers (OU) are common symptoms of Behçet’s syndrome that can impact daily activities and impair quality of life (QoL) (Kokturk A. Patholog Res Int. 2012;2012:690390; Hatemi G, et al. Ann Rheum Dis. 2018;67:808-818). Apremilast (APR), an oral phosphodiesterase 4 inhibitor, demonstrated efficacy in the treatment of OU associated with Behçet’s syndrome, including improvements in OU pain, disease activity, and QoL, in the phase III RELIEF study (Hatemi G, et al. N Engl J Med. 2019;381:1918-1928). We describe outcomes in APR-treated patients in the RELIEF study who achieved complete response of OU (ie, OU-free) by Week 6 and remained OU-free for at least an additional 6 weeks compared with those who did not.

Methods: RELIEF was a phase III, multicenter, randomized, double-blind, placebo (PBO)-controlled study (BCT-002; NCT02307513). Adult patients (≥18 years of age) with active Behçet’s syndrome and ≥3 OU at randomization or ≥2 OU at screening and randomization, without active major organ involvement, were randomized (1:1) to APR 30 mg BID or PBO during the 12-week PBO-controlled phase. In patients who received APR, a post hoc analysis compared outcomes in patients who achieved an OU-free response by 6 weeks and remained OU-free for at least 6 weeks thereafter (6+6 achiever) with outcomes in those who did not achieve an OU-free response at any time point, or those who did but were not able to remain OU-free for at least 6 weeks thereafter (non-6+6 achiever). Outcomes assessed at Week 12 included OU pain visual analog scale (VAS; 0-100 mm), disease activity measures (components of the Behçet’s Disease Activity Index Form: Behçet’s Disease Current Activity Index [BDCAI], Patient’s Perception of Disease Activity, Clinician’s Overall Perception of Disease Activity, and Behçet’s Syndrome Activity Scale [BSAS]), and a QoL measure (Behçet’s Disease Quality of Life [BDQoL]). OU pain VAS scores, disease activity measures, and BDQoL scores were analyzed using an analysis of covariance model.

Results: Of the 207 patients who were randomized and received ≥1 dose of study medication, 104 received APR; of these, 31 (29.8%) were 6+6 achievers and 73 (70.2%) were non-6+6 achievers. 6+6 achievers, as defined above, showed greater improvements from baseline in outcomes beyond OU count, such as OU pain VAS score, measures of disease activity, and QoL measures, compared with non-6+6 achievers (Table).

Conclusion: In RELIEF, patients who achieved an OU-free response by Week 6 and remained OU-free for an additional 6 weeks with APR treatment showed greater improvements in clinically relevant outcomes, including OU pain, overall disease activity, and QoL, than those who did not achieve or maintain an OU-free response.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/disease-activity-and-quality-of-life-outcomes-in-patients-with-behcets-syndrome-who-achieved-and-maintained-oral-ulcer-complete-response-with-apremilast-treatment/