Effectiveness and Safety of Tacrolimus in Patients with Active Rheumatoid Arthritis with Inadequate Response to Disease-modifying Anti-rheumatic Drugs: The TREASURE Study
DC Field | Value | Language |
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dc.contributor.author | Sheen, Dong Hyuk | - |
dc.contributor.author | Hong, Seung Jae | - |
dc.contributor.author | Lee, Sang Heon | - |
dc.contributor.author | Lee, Hye Soon | - |
dc.contributor.author | Chung, Won Tae | - |
dc.contributor.author | Jiang, Hongsi | - |
dc.contributor.author | Lee, Sungmin | - |
dc.contributor.author | Yoo, Dae Hyun | - |
dc.date.accessioned | 2021-08-02T12:28:37Z | - |
dc.date.available | 2021-08-02T12:28:37Z | - |
dc.date.created | 2021-05-12 | - |
dc.date.issued | 2019-01 | - |
dc.identifier.issn | 2093-940X | - |
dc.identifier.uri | https://scholarworks.bwise.kr/hanyang/handle/2021.sw.hanyang/15148 | - |
dc.description.abstract | Objective Evaluate effectiveness/safety of tacrolimus in patients in Korea with active rheumatoid arthritis (RA) and unsuccessful response to disease-modifying anti-rheumatic drugs (DMARDs). Methods Open-label, single-arm, non-comparative, 24-week, Phase-IV study in patients with active RA who had taken DMARDs for >6 months. Following a washout period, tacrolimus was initiated (baseline-12 weeks; dose 2 mg/day and 1.5 mg/day in patients aged ≤65 and >65 years, respectively). After 12 weeks, dose could be adjusted (remaining between 1~3 mg); treatment continued to 24 weeks. Primary endpoint was American College of Rheumatology 20% improvement (ACR20) (baseline-Week 24). Secondary endpoints included ACR50/ACR70 response, disease-activity score in 28 joints (DAS28) erythrocyte sedimentation rate (ESR), number of tender/swollen joints, and bone mineral density (BMD) loss. Adverse events (AEs) were recorded. Results Overall, 121 patients were analysed. Mean±standard deviation tacrolimus dose baseline-Week 24 was 1.81±0.47 mg/day. After 24 weeks, 64.5%, 39.7%, and 19.0% of patients were ACR20, ACR50, and ACR70 responders, respectively. DAS28-ESR score decreased from 5.5±0.8 (baseline) to 3.7±1.5 (Week 24; p<0.0001); number of tender/swollen joints decreased. Between screening and Week 24, change in BMD-T score in lumbar and femur regions was −0.06±0.38 (p=0.1550) and −0.04±0.28 (p=0.0936), respectively, with no significant change in International Society for Clinical Densitometry classification. Fifty-six (46.3%) patients experienced 93 AEs; 75.3% were mild. No unexpected safety signals identified. Conclusion Tacrolimus therapy was associated with a high proportion of ACR responders, and improved DAS28-ESR score and physical joint function during the study. Tacrolimus may be a suitable therapy for DMARD-resistant patients with RA. | - |
dc.language | 영어 | - |
dc.language.iso | en | - |
dc.publisher | KOREAN COLL RHEUMATOLOGY | - |
dc.title | Effectiveness and Safety of Tacrolimus in Patients with Active Rheumatoid Arthritis with Inadequate Response to Disease-modifying Anti-rheumatic Drugs: The TREASURE Study | - |
dc.type | Article | - |
dc.contributor.affiliatedAuthor | Yoo, Dae Hyun | - |
dc.identifier.doi | 10.4078/jrd.2019.26.1.20 | - |
dc.identifier.wosid | 000523559600004 | - |
dc.identifier.bibliographicCitation | JOURNAL OF RHEUMATIC DISEASES, v.26, no.1, pp.20 - 30 | - |
dc.relation.isPartOf | JOURNAL OF RHEUMATIC DISEASES | - |
dc.citation.title | JOURNAL OF RHEUMATIC DISEASES | - |
dc.citation.volume | 26 | - |
dc.citation.number | 1 | - |
dc.citation.startPage | 20 | - |
dc.citation.endPage | 30 | - |
dc.type.rims | ART | - |
dc.type.docType | Article | - |
dc.identifier.kciid | ART002414038 | - |
dc.description.journalClass | 2 | - |
dc.description.isOpenAccess | Y | - |
dc.description.journalRegisteredClass | kci | - |
dc.relation.journalResearchArea | Rheumatology | - |
dc.relation.journalWebOfScienceCategory | Rheumatology | - |
dc.subject.keywordPlus | ANTITUMOR NECROSIS FACTOR | - |
dc.subject.keywordPlus | DOUBLE-BLIND | - |
dc.subject.keywordPlus | CONCOMITANT METHOTREXATE | - |
dc.subject.keywordPlus | CYCLOSPORINE-A | - |
dc.subject.keywordPlus | EFFICACY | - |
dc.subject.keywordPlus | MONOTHERAPY | - |
dc.subject.keywordPlus | THERAPY | - |
dc.subject.keywordPlus | MANAGEMENT | - |
dc.subject.keywordPlus | 6-MONTH | - |
dc.subject.keywordAuthor | Anti-rheumatic | - |
dc.subject.keywordAuthor | Bone density | - |
dc.subject.keywordAuthor | Osteoporosis | - |
dc.subject.keywordAuthor | Rheumatoid arthritis | - |
dc.subject.keywordAuthor | Tacrolimus | - |
dc.identifier.url | https://synapse.koreamed.org/articles/1122085 | - |
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