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Tumor Necrosis Factor (TNF) blockers, Azathioprine and/or Mercaptopurine: Update on Reports of Hepatosplenic T-Cell Lymphoma in Adolescents and Young Adults
AUDIENCE: Rheumatology, Gastroenterology, Oncology, Dermatology
FDA continues to receive reports of a rare cancer of white blood cells (known as Hepatosplenic T-Cell Lymphoma or HSTCL, primarily in adolescents and young adults being treated for Crohn’s disease and ulcerative colitis with medicines known as tumor necrosis factors (TNF) blockers, as well as with azathioprine, and/or mercaptopurine.? TNF blockers include Remicade (infliximab), Enbrel (etancercept), Humira (adalimumab), Cimzia (certolizumab pegol) and Simponi (golimumab).
BACKGROUND: HSTCL is an aggressive (fast-growing) cancer and is usually fatal. The majority of cases reported were in patients being treated for Crohn’s disease or ulcerative colitis, but also included a patient being treated for psoriasis and two patients being treated for rheumatoid arthritis. FDA is now updating the number of reported cases of HSTCL.
Although most reported cases of HSTCL occurred in patients treated with a combination of medicines known to suppress the immune system, including the TNF blockers, azathioprine, and/or mercaptopurine, there have been cases reported in patients receiving azathioprine or mercaptopurine alone.
RECOMMENDATIONS:
* Educate patients and caregivers about the signs and symptoms of malignancies such as HSTCL so that they are aware of and can seek evaluation and treatment of any signs or symptoms. These may include splenomegaly, hepatomegaly, abdominal pain, persistent fever, night sweats, and weight loss.
* Monitor for the emergence of malignancies when a patient has been treated with TNF blockers, azathioprine, and/or mercaptopurine.
* Know that people with rheumatoid arthritis, Crohn's disease, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis may be more likely to develop lymphoma than the general U.S. population. Therefore, it may be difficult to measure the added risk of TNF blockers, azathioprine, and/or meracaptopurine.
Read the Drug Safety Communications for other specific recommendations for Healthcare Professionals and Patients and the Data Summary for additional information.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
* Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
* Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Read the MedWatch safety alert, including a link to the FDA Drug Safety Communication, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHuma...
FDA陸續收到一種罕見的白血球癌症( Hepatosplenic T-cell Lymphoma，簡稱HSTCL)的通報，發生在因為克隆氏症(Crohn's diease)或潰瘍性大腸炎(ulcerative colitis)，接受腫瘤壞死因子(TNF)阻斷劑合併azathioprine及/或mercaptopurine治療的青少年或年輕人身上；TNF 阻斷劑包括Remicade (infliximab)、Enbrel (etancercept)、Humira (adalimumab)、Cimzia (certolizumab pegol)及Simponi (golimumab)。
HSTCL是一種極具侵略性(生長快速)的癌症，通常會致命。被通報的案例中，大多數的病人是因為患有克隆氏病或潰瘍性結腸炎，但有一位病人是患有牛皮 癬，而有兩位病人是患有類風濕性關節炎(rheumatoid arthritis)。FDA已經更新了HSTCL的通報案例數目。雖然大多數被通報的HSTCL案例是發生在併用免疫抑制藥物治療的病人身上，包括 TNF阻斷劑合併azathioprine及/或mercaptopurine治療，但也有案例為單獨接受azathioprine或 mercaptopurine的病人。
建議：
* 教育病人及其照護者學會辨認如HSTCL等惡性腫瘤的徵兆，例如：肝脾腫大、腹痛、持續發燒、夜間盜汗、體重下降等，以便能有所警覺或尋求症狀的評估及治療。
*當病人有被給予TNF阻斷劑合併azathioprine及/或mercaptopurine治療時，要監測是否有惡性腫瘤產生。
* 要瞭解患有類風濕性關節炎、克隆氏症、僵直性脊椎炎（ankylosing spondylitis）、乾癬性關節炎（psoriatic arthritiis）、斑塊性乾癬（plaque psoriasis）的病人比美國的一般族群更容易有淋巴瘤產生，因此會較難衡量加入TNF阻斷劑合併azathioprine及/或 mercaptopurine治療的風險。
相關訊息與連結請參考FDA網址：
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm251443.htm
[Posted 04/14/2011]
資料來源：美國FDA之藥物安全警訊
資料提供：台大醫院藥劑部
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資料來源：藥師週刊（第1731期）
