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

Hatemi, Gülen; Mahr, Alfred; Takeno, Mitsuhiro; Kim, Doyoung; Melikoğlu, Melike; Cheng, Sue; McCue, Shannon; Paris, Maria; Chen, Mindy; Yazici, Yusuf
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.
PMID: 35798511
ISSN: 2056-5933
CID: 5268912

A methodological problem and a conceptual issue related to the new 2022 ANCA related vasculitis criteria sets [Letter]

Yazici, Hasan; Yazici, Yusuf
PMID: 35714043
ISSN: 2326-5205
CID: 5282822

Effect size, the misnomer [Letter]

Yazici, Hasan; Yazici, Yusuf
PMID: 34494960
ISSN: 0392-856x
CID: 5178232

The OMERACT Core Set of Domains for Outcome Measures in Behçet Syndrome

Hatemi, Gülen; Meara, Alexa; Ozguler, Yesim; Direskeneli, Haner; Mahr, Alfred; Shea, Beverly; Cam, Esen; Gul, Ahmet; Yazici, Yusuf; Tugwell, Peter; Yazici, Hasan; Merkel, Peter A
OBJECTIVE:There is an unmet need for reliable, validated, and widely-accepted outcome measures for randomized clinical trials in Behçet syndrome (BS). The Outcome Measures in Rheumatology Clinical Trials (OMERACT) BS Working Group, a large, multi-disciplinary group of experts in BS and patients with BS, worked to develop a Core Set of data-driven outcome measures for use in all clinical trials of BS. METHODS:The Core Domain Set was developed through a comprehensive, iterative, multi-stage project which included a systematic review, a focus group meeting and qualitative patient interviews, a survey among experts in BS, a Delphi exercise involving both patients and physician-experts in BS, and utilization of the data, insight, and feedback generated by these processes to develop a final Core Domain Set. RESULTS:All steps were completed and domains were delineated across the organ systems involved in this disease. Since trials in BS often focus on specific manifestations and not the disease in its entirety, the final proposed Core Set includes 5 domains mandatory for study in all trials in BS (disease activity, new organ involvement, quality of life, adverse events, and death) with additional sub-domains mandatory for study of specific organ-systems. The final Core Set was endorsed at the 2018 OMERACT meeting. CONCLUSION/CONCLUSIONS:The Core Set of Domains in BS provides the foundation through which the international research community, including clinical investigators, patients, biopharmaceutical industry, and government regulatory bodies can harmonize the study of this complex disease, compare findings across studies, and advance development of effective therapies.
PMID: 33202101
ISSN: 2151-4658
CID: 4672612

Should Quantitative Measures and Management of Rheumatoid Arthritis Include More Than Control of Inflammatory Activity? [Letter]

Pincus, Theodore; Bergman, Martin J; Yazici, Yusuf
PMID: 34654734
ISSN: 0315-162x
CID: 5171542

Comparing Patient-Reported Outcomes From Sham and Saline-Based Placebo Injections for Knee Osteoarthritis: Data From a Randomized Clinical Trial of Lorecivivint

Tambiah, Jeyanesh R S; Simsek, Ismail; Swearingen, Christopher J; Kennedy, Sarah; Cole, Brian J; McAlindon, Timothy E; Yazici, Yusuf
BACKGROUND/UNASSIGNED:Durable, meaningful symptom responses to intra-articular saline placebo injections are observed in knee osteoarthritis (OA) trials, but it is unclear if these are due to physiological effects. PURPOSE/UNASSIGNED:To perform a prospective comparison of patient-reported outcome responses among participants with knee OA who underwent intra-articular injection of saline-based placebo or sham (dry needle). STUDY DESIGN/UNASSIGNED:Randomized controlled trial; Level of evidence, 2. METHODS/UNASSIGNED:From a 24-week randomized double-blind trial, participants with moderate to severe knee OA received 2-mL intra-articular injections of saline-based placebo (PBO; 99.45% PBS) or sham (dry needle) to the target knee. Least squares mean differences of changes from baseline to week 24 were compared between the PBO and sham groups for the following: pain Numeric Rating Scale; Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain, stiffness, and function; and patient global assessment. Bang Blinding Index was used to evaluate all-group blinding on day 1 and week 24. RESULTS/UNASSIGNED:= .68). Bang Blinding Index indicated that blinding was maintained. CONCLUSION/UNASSIGNED:PBO and sham groups demonstrated equivalent patient-reported outcomes at all time points through week 24, suggesting that responses attributed to saline were contextual (ie, to the procedure) and not physiological. REGISTRATION/UNASSIGNED:NCT03122860 (ClinicalTrials.gov identifier).
PMID: 35005990
ISSN: 1552-3365
CID: 5152982

Editorial: Introduction, Vasculitis 2021

Yazici, Hasan; Yazici, Yusuf
PMID: 34819486
ISSN: 1531-6963
CID: 5063732

Behcet syndrome [Note]

Yazici, Y; Hatemi, G; Bodaghi, B; Cheon, J H; Suzuki, N; Ambrose, N; Yazici, H
Behcet syndrome is a systemic vasculitis with an unknown aetiology affecting the small and large vessels of the venous and arterial systems. The presence of symptom clusters, regional differences in disease expression and similarities with, for example, Crohn's disease suggest that multiple pathological pathways are involved in Behcet syndrome. These disease features also make formulating disease criteria difficult. Genetic studies have identified HLA-B*51 as a genetic risk factor. However, the low prevalence of HLA-B*51 in many patients with bona fide disease, especially in non-endemic regions, suggests that other factors must also be operative in Behcet syndrome. Despite lacking a clear aetiological mechanism and definition, management of manifestations that include major vascular disease, eye disease and central nervous system involvement has improved with the help of new technology. Furthermore, even with our incomplete understanding of disease mechanisms, the prognoses of patients with Behcet syndrome, including those with eye disease, continue to improve. New treatment options and a better understanding of the underlying pathogenesis for various manifestations of this condition are required to further improve the management of the disease, which will improve patient quality of life.
Copyright
EMBASE:2013714798
ISSN: 2056-676x
CID: 5026042

Faulty analysis of a Takayasu arteritis cohort: Comment on the Article by Goel et al [Letter]

Yazici, Hasan; Oztas, Mert; Yazici, Yusuf
There are important problems with the data analyses, interpretation, and the cited references in the recently reported retrospective cohort study of Takayasu arteritis (TAK) (1).
PMID: 33982898
ISSN: 2326-5205
CID: 4867632

Behçet syndrome

Yazici, Yusuf; Hatemi, Gulen; Bodaghi, Bahram; Cheon, Jae Hee; Suzuki, Noburu; Ambrose, Nicola; Yazici, Hasan
Behçet syndrome is a systemic vasculitis with an unknown aetiology affecting the small and large vessels of the venous and arterial systems. The presence of symptom clusters, regional differences in disease expression and similarities with, for example, Crohn's disease suggest that multiple pathological pathways are involved in Behçet syndrome. These disease features also make formulating disease criteria difficult. Genetic studies have identified HLA-B*51 as a genetic risk factor. However, the low prevalence of HLA-B*51 in many patients with bona fide disease, especially in non-endemic regions, suggests that other factors must also be operative in Behçet syndrome. Despite lacking a clear aetiological mechanism and definition, management of manifestations that include major vascular disease, eye disease and central nervous system involvement has improved with the help of new technology. Furthermore, even with our incomplete understanding of disease mechanisms, the prognoses of patients with Behçet syndrome, including those with eye disease, continue to improve. New treatment options and a better understanding of the underlying pathogenesis for various manifestations of this condition are required to further improve the management of the disease, which will improve patient quality of life.
PMID: 34531393
ISSN: 2056-676x
CID: 5012422