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

Abstract

Objective To assess apremilast&apos;s impact on patient quality of life (QoL) in active Behcet&apos;s syndrome and correlations between improvement in patients&apos; QoL and efficacy measures in the phase 3 RELIEF study. Methods QoL measures included Behcet&apos;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&apos;s correlation coefficients assessed relationships between efficacy endpoints (oral ulcer count, oral ulcer pain, Behcet&apos;s Syndrome Activity Scale (BSAS), Behcet&apos;s Disease Current Activity Form (BDCAF)) and QoL endpoints for apremilast at Week 12. Results Apremilast (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<0.05). Mild correlations were observed in improvements of SF-36v2 measures (PCS, MCS, PF) with oral ulcer count (r=-0.11, PCS), and change in oral ulcer pain from baseline (r=-0.28, PCS; r=-0.10, PF) and BSAS (r=-0.38, PCS; r=-0.20, PF; r=-0.16, MCS). Correlations among BDCAF and SF-36v2 components and BDQoL were variable. BDQoL showed mild/moderate correlations with SF-36v2 components (r=-0.18, PCS; r=-0.13, PF; r=-0.45, MCS). Conclusions Apremilast was associated with significant improvements in QoL measures of SF-36v2 PCS, MCS and PF and BDQoL in patients with Behcet&apos;s syndrome. Correlations of improvement among QoL endpoints support the beneficial clinical effects of apremilast in Behcet&apos;s syndrome.