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Abstract Number: 0405

Disease Activity and Quality-of-Life Outcomes in Patients with Behçet’s Syndrome Who Achieved and Maintained Oral Ulcer Complete Response with Apremilast Treatment

Gülen Hatemi1, Alfred Mahr2, Mitsuhiro Takeno3, Doyoung Kim4, Melike Melikoğlu1, Sue Cheng5, Sven Richter5, Michele Brunori6, Maria Paris5, Mindy Chen5 and Yusuf Yazici7, 1Istanbul University‒Cerrahpaşa, Cerrahpaşa Medical School and Behçet’s Disease Research Center, Istanbul, Turkey, 2Cantonal Hospital St. Gallen, St. Gallen, Switzerland, 3Nippon Medical School, Graduate School of Medicine, Tokyo, Japan, 4Yonsei University College of Medicine and Severance Hospital, Seoul, Republic of Korea, 5Amgen Inc., Thousand Oaks, 6Amgen Europe GmbH, Rotkreuz, Switzerland, 7New York University School of Medicine, New York

Meeting: ACR Convergence 2020

Keywords: Behçet's Syndrome, pain, quality of life, Ulcers

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Session Information

Date: Friday, November 6, 2020

Session Title: Vasculitis – Non-ANCA-Associated & Related Disorders Poster I

Session Type: Poster Session A

Session Time: 9:00AM-11:00AM

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.


Disclosure: G. Hatemi, BMS, 1, Celgene Corporation, 1, Silk Road Therapeutics, 1, AbbVie, 1, Mustafa Nevzat, 1, Novartis, 1, UCB, 1, Bayer, 1, Eli Lilly, 1; A. Mahr, Roche, 1, Chugai, 1; M. Takeno, Celgene Corporation, 1, Esai, 1, Tanabe-Mitsubishi, 1; D. Kim, None; M. Melikoğlu, None; S. Cheng, Amgen Inc., 1; S. Richter, Amgen Inc., 1; M. Brunori, Amgen Europe GmbH, 1; M. Paris, Amgen Inc., 1; M. Chen, Amgen Inc., 1; Y. Yazici, BMS, 1, Celgene Corporation, 1, Genentech, 1, Sanofi, 1.

To cite this abstract in AMA style:

Hatemi G, Mahr A, Takeno M, Kim D, Melikoğlu M, Cheng S, Richter S, Brunori M, Paris M, Chen M, Yazici Y. Disease Activity and Quality-of-Life Outcomes in Patients with Behçet’s Syndrome Who Achieved and Maintained Oral Ulcer Complete Response with Apremilast Treatment [abstract]. Arthritis Rheumatol. 2020; 72 (suppl 10). 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/. Accessed June 30, 2022.
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