Unique ID issued by UMIN | UMIN000044257 |
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Receipt number | R000050547 |
Scientific Title | Treatment effects of apremilast for Behcet's disease: a systematic review and meta-analysis |
Date of disclosure of the study information | 2021/05/19 |
Last modified on | 2021/05/19 15:43:42 |
Treatment effects of apremilast for Behcet's disease: a systematic review and meta-analysis
Treatment effects of apremilast for Behcet's disease: a systematic review and meta-analysis
Treatment effects of apremilast for Behcet's disease: a systematic review and meta-analysis
Treatment effects of apremilast for Behcet's disease: a systematic review and meta-analysis
Japan |
Behcet's disease
Clinical immunology |
Others
NO
Apremilast, an oral phosphodiesterase (PDE)-4 inhibitor, has been shown to be efficacious in controlling oral ulcers of Behcet disease, after successful phase 3 RELIEF trial, in which apremilast 30mg twice daily significantly reduced the area under the curve in the number of oral ulcers for12 weeks compared to placebo (PMID 31722152). However, in this trial, the effects of apremilast for other major organs were not evaluated. Recently, real world data shows that apremilast is effective for genital ulcers and also reduced disease activity scores of Behcet disease. We therefore aimed to perform the systematic literature review and meta-analysis whether apremilast really has an effect on the treatment outcomes of major organ involvements and disease activity scores.
Safety,Efficacy
BDCAF and presence of BD-related symptoms after 12 weeks of apremilast treatment
Others,meta-analysis etc
Not applicable |
Not applicable |
Male and Female
Behcet's disease patients treated with apremilast
Patients not fulfilled Behcet's disease diagnostic criteria
1st name | Kaoru |
Middle name | |
Last name | Minegishi |
Yokohama City University School of Medicine
Department of Stem Cell and Immune Regulation
236-0004
3-9 Fukuura Kanazawaku Yokohama
0457872800
kaoru-t@yokohama-cu.ac.jp
1st name | Kaoru |
Middle name | |
Last name | Minegishi |
Yokohama City University School of Medicine
Department of Stem Cell and Immune Regulation
236-0004
3-9 Fukuura Kanazawaku Yokohama
0457872800
kaoru-t@yokohama-cu.ac.jp
Yokohama City University School of Medicine
Yokohama City University
Local Government
not applicable
not applicable
not applicable
not applicable
NO
2021 | Year | 05 | Month | 19 | Day |
Unpublished
Preinitiation
2021 | Year | 05 | Month | 19 | Day |
2021 | Year | 05 | Month | 19 | Day |
2021 | Year | 05 | Month | 19 | Day |
Study search
We will search for candidate articles using PubMed, Cochrane, EMBASE, and Web of Science Core Collection on May 20th, 2021.
Publication type
Case-control studies, cohort studies, and randomized controlled trials will be included when each study provided data of treatment effects of apremilast for Behcet's disease.
Studies that offered information concerning only the secondary endpoints will be also included.
Non-English language article and conference abstract will be allowed.
Treatment
Apremilast with any type of concomitant medications will be allowed.
Primary outcome
The primary outcome will be relative efficacy for major organ involvements on apremilast in the form of an unadjusted odds ratio (OR) in Behcet's disease patients.
Secondary outcome.
The secondary outcomes includes (i) oral ulcers pain visual analogue scale (VAS) change from the baseline, difference (MD), (ii) Behcet's Disease Current Activity Form (BDCAF) score change from the baseline, difference (MD), and (iii) relative efficacy for arthritis/arthralgia in the form of an unadjusted odds ratio (OR) in Behcet's disease patients.
Quality assessment
The risk of bias of each study will be assessed by Cochrane risk of bias (RoB) tool for randomized trials and Newcastle-Ottawa Scale (NOS) for non-randomized studies.
Subgroup analysis
Subgroup analysis based on study designs will be conducted.
2021 | Year | 05 | Month | 19 | Day |
2021 | Year | 05 | Month | 19 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050547
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