Evidence map›Paper›PMID 35798511›Full record

Trial reportRMD open2022

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

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase III
PubMed Full text at PMC Publisher
In one paragraph

Trial report in RMD open, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02307513 (A Phase 3, Multicenter, Randomized, Doubleblind, Placebo-controlled, Parallel Group Study, Followed by an Active-treatment Phase to Evaluate the Efficacy and Safety of Apremilast), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
2.7field-weighted citation impact, top 10% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02307513 phase3completednot on this map

A Phase 3, Multicenter, Randomized, Doubleblind, Placebo-controlled, Parallel Group Study, Followed by an Active-treatment Phase to Evaluate the Efficacy and Safety of Apremilast (CC-10004) in the Treatment of Subjects With Active Behcet's Disease

TypeinterventionalSponsorAmgenRan2014 to 2020Enrolled207ConditionsBehçet's SyndromeArmsApremilast, Placebo
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 15 citations in OpenAlex.

  1. Article
  2. Nasal Mucosal Manifestation of Behçet's Disease.Internal medicine (Tokyo, Japan) · 2026
    Article
  3. Article
  4. Review
  5. Article
  6. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 6 institutions in 5 countries.

Gülen HatemiCerrahpaşa School of Medicine and Behçet's Disease Research Center, Istanbul University, Istanbul, Turkey gulenhatemi@yahoo.com.ORCID 0000-0002-1952-1135
Alfred MahrCantonal Hospital St. Gallen, St. Gallen, Switzerland.
Mitsuhiro TakenoNippon Medical School, Musashi Kosugi Hospital, Kawasaki, Japan.
Doyoung KimYonsei University College of Medicine and Severance Hospital, Seoul, South Korea.
Melike MelikoğluCerrahpaşa School of Medicine and Behçet's Disease Research Center, Istanbul University, Istanbul, Turkey.
Sue ChengAmgen Inc, Thousand Oaks, California, USA.
Shannon McCueCelgene Corporation, Summit, New Jersey, USA.
Maria ParisAmgen Inc, Thousand Oaks, California, USA.
Mindy ChenAmgen Inc, Thousand Oaks, California, USA.
Yusuf YaziciNew York University School of Medicine, New York, New York, USA.ORCID 0000-0002-7605-5759
Amgen (United States) · USIstanbul University · TRNew York University · USNippon Medical School Musashi Kosugi Hospital · JPUniversity of St.Gallen · CHYonsei University · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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<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).

conclusionsApremilast 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.

Indexed as

Behcet SyndromeOral UlcerHumansPainQuality of LifeThalidomideapremilastThalidomideBehcet SyndromePatient Reported Outcome MeasuresSystemic vasculitis

Identifiers

PMID35798511
PMCPMC9263903
OpenAlexW4284705903

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.