TNF抑制劑似乎不會增加淋巴瘤風險


  【24drs.com】根據發表於ACR 2012的大型研究,對於類風濕性關節炎(RA)病患,使用腫瘤壞死因子(TNF)抑制劑治療,與淋巴瘤風險增加並無關聯。
  
  英國曼徹斯特大學、英國流行病學關節炎研究Louise K. Mercer博士表示,在有RA的背景風險下,並無證據顯示使用抗TNF治療會增加淋巴瘤風險,但需要後續追蹤,以確認是否會隨時間而有所變化。
  
  這次的研究確認了之前三篇大型觀察型研究的結果。Mercer博士解釋,第一篇研究發現,1,152名使用TNF抑制劑的病患有4例淋巴瘤;第二篇在19,591名病患(其中55%使用TNF抑制劑)發現95例淋巴瘤;第三篇發現6,604名使用TNF抑制劑的病患有26例淋巴瘤。
  
  Mercer博士等人進行前瞻研究比較在2001-2009年間期間納入「British Society for Rheumatology Biologics Register」的兩組活性RA病患,這些病患被追蹤到2010年;開始時,3,465名病患接受非生物性疾病調節抗風濕藥物(DMARDs),11,987人使用TNF抑制劑。
  
  DMARD組的病患比較年長且多數為男性;TNF抑制劑組的患病期間比較久、且開始時的健康評量問卷分數較高;追蹤方式包括醫師問卷、病患問卷與日記,使用全國健康服務部之癌症與死亡登記資料確認這些病患的癌症診斷。
  
  這篇研究追蹤了DMARD組的13,186病患-年以及TNF組的66,353病患-年;在DMARD組,確認20例淋巴瘤;TNF抑制劑組,確認64例淋巴瘤(比率分別為152/100,000 人-年以及96/1000,000 人-年)。
  
  校正年齡、性別、疾病特徵、使用類固醇/ cyclophosphamide、抽菸等干擾因素之後,使用和未使用TNF抑制劑治療之病患間並未發現淋巴瘤風險差異。
  
  Mercer博士向與會聽眾表示,RA本身有關的淋巴瘤風險率為130/100,000人-年。
  
  DMARD組發現5例何杰金氏淋巴瘤,TNF抑制劑組有9例;DMARD組發現16例非何杰金氏淋巴瘤,TNF抑制劑組有55例。
  
  研究強度包括,樣本數夠多、詳盡的病患資料、確認癌症案例、使用適當模式校正干擾因素。
  
  Mercer博士解釋,因為全國癌症登記資料庫的時間差,無法及時獲得完整的追蹤資料,還需要後續追蹤。
  
  伊利諾州芝加哥西北大學Feinberg醫學院Eric Ruderman醫師表示,要記住的是,淋巴瘤的初級風險是疾病相關的,而非藥物相關的。不過,所有TNF抑制劑的標示都有記載淋巴瘤風險,回想起來,所有認為風險增加的資料幾乎都是因為疾病而非藥物。風濕科醫師和病患應可安心的是,風險主要是疾病相關的。
  
  資料來源:http://www.24drs.com/professional/list/content.asp?x_idno=6960&x_classno=0&x_chkdelpoint=Y
  
  

TNF Inhibitors Do Not Appear to Increase Risk for Lymphoma

By Alice Goodman
Medscape Medical News

WASHINGTON — In patients with rheumatoid arthritis (RA), no association was found between treatment with a tumor necrosis factor (TNF) inhibitor and increased risk for lymphoma, according to a large study presented here at ACR 2012.

"There is no evidence that anti-TNF therapy increases the risk of lymphoma over the background risk associated with RA, but further follow-up is needed to establish if the picture changes with time," said Louise K. Mercer, PhD, from the arthritis research UK epidemiology unit at The University of Manchester in the United Kingdom.

This finding confirms results found previously in 3 large observational studies. The first study found 4 lymphomas in 1152 patients taking TNF inhibitors. The second found 95 lymphomas in 19,591 patients, 55% of whom were on TNF inhibitors. The third found 26 lymphomas in 6604 patients treated with TNF inhibitors, Dr. Mercer explained.

Strengthens Existing Body of Evidence

Dr. Mercer and colleagues conducted a prospective study comparing 2 cohorts of patients with active RA enrolled in the British Society for Rheumatology Biologics Register from 2001 to 2009. Patients were followed until 2010.

At baseline, 3465 patients were receiving nonbiologic disease modifying anti-rheumatic drugs (DMARDs) and 11,987 were receiving TNF inhibitors. Patients in the DMARD group were older and were mostly male; those in the TNF inhibitor group had a longer disease duration and higher Health Assessment Questionnaires scores at baseline. Patients were followed with physician questionnaires, patient questionnaires, and diaries, and the National Health Service Cancer and Death Registries were used to confirm the diagnosis of cancer in these patients.

The study was based on 13,186 patient-years of follow-up for DMARDs and 66,353 patient-years of follow-up for TNF inhibitors. In the DMARD group, 20 lymphomas were identified; in the TNF inhibitor group, 64 lymphomas were identified (rates of 152/100,000 person-years and 96/1000,000 person-years, respectively).

After adjustment for confounding factors such as age, sex, disease characteristics, use of steroids/cyclophosphamide, and smoking, no difference in risk for lymphoma was found between patients treated with a TNF inhibitor and those who were not.

RA itself is associated with a risk for lymphoma that is 130/100,000 person-years, Dr. Mercer told meeting attendees.

Five cases of Hodgkin's lymphoma were identified in the DMARD group and 9 were identified in the TNF inhibitor group; 16 cases of non-Hodgkin's lymphoma were identified in the DMARD group and 55 were identified in the TNF inhibitor group.

The strengths of the study are the size, the detailed patient data, the confirmation of cancer cases, and the use of a propensity model to adjust for confounding factors.

Because of the lag in reporting from the national cancer registry, the complete follow-up data are not available in real time, Dr. Mercer explained. Further follow-up is required, she added.

Primary Lymphoma Risk Related to Disease, Not Drug

"The message is that the primary risk for lymphoma is disease-related, not drug-related," said Eric Ruderman, MD, from the Northwestern University Feinberg School of Medicine in Chicago, Illinois.

Nevertheless, the risk for lymphoma is included in the labeling of all TNF inhibitors, he noted. "In retrospect, all the data suggest that the increased risk is almost completely attributable to disease, not to the drug. Rheumatologists and patients should be comfortable that the majority of the risk is disease-related," Dr. Ruderman said.

Dr. Mercer has disclosed no relevant financial relationships. Dr. Ruderman reports receiving grants for clinical research from Abbott, Amgen, Bristol-Myers Squibb, and Biogen Idec; and serving as an advisor or consultant for Abbott, Amgen, Bristol-Myers Squibb, and Biogen Idec, and Genentech.

ACR 2012: Abstract 1593. Presented November 12, 2012.

    
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