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KMID : 1084220190260010020
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Journal of Rheumatic Diseases
2019 Volume.26 No. 1 p.20 ~ p.30
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Effectiveness and Safety of Tacrolimus in Patients with Active Rheumatoid Arthritis with Inadequate Response to Disease-modifying Anti-rheumatic Drugs: The TREASURE Study
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Sheen Dong-Hyuk
Hong Seung-Jae
Lee Sang-Heon
Lee Hye-Soon
Chung Won-Tae
Jiang Hongsi
Lee Sung-Min
Yoo Dae-Hyun
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Abstract
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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.
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KEYWORD
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Anti-rheumatic, Bone density, Osteoporosis, Rheumatoid arthritis, Tacrolimus
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