Impact of apremilast on quality of life in Behçet’s syndrome: analysis of the phase 3 RELIEF study

ObjectiveTo assess apremilast’s impact on patient quality of life (QoL) in active Behçet’s syndrome and correlations between improvement in patients’ QoL and efficacy measures in the phase 3 RELIEF study.MethodsQoL measures included Behçet’s Disease QoL (BDQoL), 36-Item Short-Form Health Survey V.2...

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Bibliographic Details
Published in:Rheumatic & musculoskeletal diseases open 2022-07, Vol.8 (2), p.e002235
Main Authors: Hatemi, Gülen, Mahr, Alfred, Takeno, Mitsuhiro, Kim, Doyoung, Melikoğlu, Melike, Cheng, Sue, McCue, Shannon, Paris, Maria, Chen, Mindy, Yazici, Yusuf
Format: Article
Language:English
Subjects:
Behcet Syndrome
Chronic illnesses
Disease
FDA approval
Pain
Patient Reported Outcome Measures
Patients
Quality of life
Review boards
Systemic vasculitis
Ulcers
Vasculitis
Vein & artery diseases
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Summary:ObjectiveTo assess apremilast’s impact on patient quality of life (QoL) in active Behçet’s syndrome and correlations between improvement in patients’ QoL and efficacy measures in the phase 3 RELIEF study.MethodsQoL measures included Behçet’s Disease QoL (BDQoL), 36-Item Short-Form Health Survey V.2 (SF-36v2) Physical/Mental Component Summary (PCS/MCS) and eight subscale scores, focusing on Physical Functioning (PF). Pearson’s correlation coefficients assessed relationships between efficacy endpoints (oral ulcer count, oral ulcer pain, Behçet’s Syndrome Activity Scale (BSAS), Behçet’s Disease Current Activity Form (BDCAF)) and QoL endpoints for apremilast at Week 12.ResultsApremilast (n=104) demonstrated significantly greater improvements versus placebo (n=103) in SF-36v2 PCS (3.1 vs 0.9), MCS (4.6 vs ─0.7) and PF (2.9 vs 0.14), respectively (all p
ISSN:2056-5933
2056-5933
DOI:10.1136/rmdopen-2022-002235