Journal of Nihon University Medical Association
Online ISSN : 1884-0779
Print ISSN : 0029-0424
ISSN-L : 0029-0424
Original Articles:
Long-Term Clinical Efficacy, Retention Rate, and Safety of 25 mg/week Etanercept in Patients with Rheumatoid Arthritis
Yasuyuki Tomita
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JOURNALS FREE ACCESS

2018 Volume 77 Issue 4 Pages 229-235

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Abstract

Objectives: To investigate changes in disease activity based on Disease activity score (DAS) 28-CRP measured at the initiation of etanercept (ETN) administration and on evaluation, clinical remission rate, retention rate, progression of bone destruction, and reasons for discontinuation. Methods: The subjects were 105 rheumatoid arthritis (RA) patients treated with ETN at a dose of 25 mg/week for 24 weeks or longer at my clinic. DAS28-CRP was used to evaluate RA activity, the Kaplan-Meier method was used to evaluate retention rate, and the van der Heijde modified total Sharp score (mTSS) was used to evaluate radiographic progression of bone destruction. For multivariate analysis of factors influencing the retention rate and clinical efficacy, the Cox proportional hazards model and binary logistic regression analysis were used, respectively. Results: DAS28-CRP in all 105 patients was 5.17 ± 1.20 at initiation and decreased significantly to 3.13 ± 1.44 on evaluation ( p < 0.01). Remission based on DAS28-CRP was achieved in 34% of the patients on evaluation. The 2-, 5-, 7-, and 10- year retention rates were 71.2, 53.7, 43.9, and 37.7%, respectively. The adherence tended to be shorter in females and patients who had undergone previous treatment with a biological agent. An MMP3 level < 100 ng/ml at initiation was extracted as a factor associated with achievement of low disease activity. An RF level ≤ 100 ng/ml or higher at initiation was extracted as a factor associated with difficulty in achieving low disease activity. On radiographic evaluation of the yearly progression of joint destruction (δmTSS/year), structural remission was maintained in 27.5% of the patients. Administration of the drug was discontinued due to adverse events in 9 patients, and the reason was interstitial pneumonia in 2 and acute appendicitis, aggravation of nontuberculous mycobacteriosis, skin reaction, muscle pain, nausea, and diagnosis of breast cancer during treatment in one each. Conclusion: The long-term clinical improvement and inhibition of joint destruction by 25 mg/week ETN were clarified, along with its safety.

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