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

Abstract

OBJECTIVE:

To 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.

METHODS:

QoL 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.

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 Behçet's syndrome. Correlations of improvement among QoL endpoints support the beneficial clinical effects of apremilast in Behçet's syndrome.

TRIAL REGISTRATION NUMBER:

NCT02307513.

• Authors: Gülen Hatemi, Alfred Mahr, Mitsuhiro Takeno, Doyoung Kim, Melike Melikoğlu, Sue Cheng, Shannon McCue, Maria Paris, Mindy Chen, Yusuf Yazici
• Journal: RMD open (RMD Open) Vol. 8 Issue 2 (07 2022) ISSN: 2056-5933 [Electronic] England
• PMID: 35798511 (Publication Type: Clinical Trial, Phase III, Journal Article, Research Support, Non-U.S. Gov't)
• Copyright: © Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Chemical References

• Thalidomide
• apremilast

Topics

• Behcet Syndrome (complications, drug therapy)
• Humans
• Oral Ulcer (complications, drug therapy)
• Pain
• Quality of Life
• Thalidomide (analogs & derivatives)