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

Gülen Hatemi, Alfred Mahr, Mitsuhiro Takeno, Doyoung Kim, Melike Melikoğlu, Sue Cheng, Shannon McCue, Maria Paris, Mindy Chen, Yusuf Yazici, Gülen Hatemi, Alfred Mahr, Mitsuhiro Takeno, Doyoung Kim, Melike Melikoğlu, Sue Cheng, Shannon McCue, Maria Paris, Mindy Chen, Yusuf Yazici

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.

Keywords: Behcet Syndrome; Patient Reported Outcome Measures; Systemic vasculitis.

Conflict of interest statement

Competing interests: GH has received grant/research support from Celgene, Amgen and Silk Road Therapeutics, and has served as a speaker for AbbVie, Boehringer Ingelheim, Novartis and UCB Pharma. AM has served as a consultant for Celgene and Amgen, a consultant and speaker for Chugai and a speaker for Roche. MT has served as a consultant for Celgene and Amgen, has received grant/research support from AbbVie, Asahi Kasei, Chugai, Eisai and Tanabe-Mitsubishi, and has served as a speaker for Astellas, Ayumi, Eli Lily, Jansen Pharma, Nippon Shinyaku, Novartis, Ono Pharmaceuticals and Takeda. D-YK has no conflicts to disclose. MM has no conflicts to disclose. SC, MP and MC are employees of and stockholders in Amgen. SM is a former employee of Celgene. YY has served as a consultant for Amgen, Bristol Myers Squibb, Celgene, Genentech and Sanofi.

© 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.

Figures

Figure 1
Figure 1
Improvement in SF-36v2 (A) PCS, (B) MCS and (C) PF subscale scores at Week 12 (modified intent-to-treat population). Scores range from 0 to 100. Higher scores indicate better functioning; positive changes from baseline represent improvement. Missing values were assessed using last-observation-carried-forward analysis. BL, baseline; LS, least squares; MCS, Mental Component Summary; PCS, Physical Component Summary; PF, Physical Functioning; SF-36v2, 36-Item Short-Form Health Survey V.2.
Figure 2
Figure 2
SF-36v2 subscale scores at baseline and improvement at Week 12 (modified intent-to-treat population). Scores range from 0 to 100. Higher scores indicate better functioning; positive changes from baseline represent improvement. Missing values were assessed using last-observation-carried-forward analysis. BID, twice per day; BP, Bodily Pain; GH, General Health; MH, Mental Health; PF, Physical Functioning; RE, Role/Emotional; RP, Role/Physical; SF, Social Functioning; SF-36v2, 36-Item Short-Form Health Survey V.2; VT, Vitality.
Figure 3
Figure 3
Percentages of patients with improvement of ≥2.5 points (MCID) at Week 12 for SF-36v2 subscale scores (modified intent-to-treat population). Missing values were assessed using last-observation-carried-forward analysis. BP, Bodily Pain; GH, General Health; MCID, minimal clinically important difference; MH, Mental Health; PF, Physical Functioning; RE, Role/Emotional; RP, Role/Physical; SF, Social Functioning; SF-36v2, 36-Item Short-Form Health Survey V.2; VT, Vitality.

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Source: PubMed

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