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出典(authority):フリー百科事典『ウィキペディア（Wikipedia）』「2015/09/05 01:24:28」(JST)

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Daclizumab (trade name Zenapax) is a therapeutic humanized monoclonal antibody. It is used to prevent rejection in organ transplantation, especially in kidney transplants. The drug is also under investigation for the treatment of multiple sclerosis.

Daclizumab works by binding to CD25, the alpha subunit of the IL-2 receptor of T cells. The drug is marketed in the US, but not in Europe.

Uses

Prevention of organ transplant rejection

Daclizumab is given in multiple doses, the first 1 hour before the transplant operation and 5 further doses given at two week intervals after the transplant. These saturate the receptors and prevent T cell activation and thus prevent formation of antibodies against the transplant.

Like the similar drug basiliximab, daclizumab reduces the incidence and severity of acute rejection in kidney transplantation without increasing the incidence of opportunistic infections.

Daclizumab usage may also be indicated in place of a calcineurin-inhibitor (ciclosporin or tacrolimus) during the early phase after kidney transplantation, when the kidney is recovering and vulnerable to calcineurin-inhibitor toxicity. This has been shown to be beneficial in non-heart beating donor kidney transplantation.

In the United Kingdom, the National Institute for Health and Clinical Excellence (NICE) has recommended its use be considered for all kidney transplant recipients.^{[citation needed]}

Multiple sclerosis

In 2006 it began a Phase II clinical trial that finished in 2007 as a possible multiple sclerosis (MS) treatment. Participants were nine patients with multiple sclerosis not controlled with interferon. Daclizumab was effective in reducing lesions and improving clinical scores.^[1] As of September 2013^[update], the drug is in Phase III trials for this indication.^[2]^[3]

Autoimmune diseases

Daclizumab has also been used to slow the progression of autoimmune diseases, particularly that of birdshot chorioretinopathy.^[4]

Adverse effects

Common side effects with a frequency of at least 10% include sleeplessness, tremor, headache, arterial hypertension, dyspnoea, gastrointestinal side effects and oedema. In rare cases, the drug can cause severe anaphylaxis.^[5]

History

Daclizumab was developed by PDL Biopharma, building on research at the National Institutes of Health (NIH).^[6] Since December 1997, it is marketed by Hoffmann-La Roche in the US.

In April 2008, Hoffmann-La Roche submitted an application to have its marketing authorisation withdrawn in the EU for commercial reasons. The drug faced diminishing market demand, according to the company. There were no safety concerns with its use. As of January 2009, its marketing authorisation has been withdrawn and the product discontinued completely.^[7]^[8]

References

^ Rose JW, Burns JB, Bjorklund J, Klein J, Watt HE, Carlson NG (2007). "Daclizumab phase II trial in relapsing and remitting multiple sclerosis: MRI and clinical results". Neurology 69 (8): 785–789. doi:10.1212/01.wnl.0000267662.41734.1f. PMID 17709711.
^ Clinical trial number NCT01064401 for "Efficacy and Safety of Daclizumab High Yield Process Versus Interferon β 1a in Patients With Relapsing-Remitting Multiple Sclerosis ((DECIDE))" at ClinicalTrials.gov
^ Clinical trial number NCT01462318 for "An Immunogenicity and Pharmacokinetics (PK) Study of DAC HYP Prefilled Syringe in Relapsing Remitting Multiple Sclerosis (RRMS) (OBSERVE)" at ClinicalTrials.gov
^ Sobrin L, Huang JJ, Christen W, Kafkala C, Choopong P, Foster CS (2008). "Daclizumab for treatment of birdshot chorioretinopathy". Arch Ophthalmol. 126 (2): 186–191. doi:10.1001/archophthalmol.2007.49. PMID 18268208.
^ "EPAR for Zenapax" (PDF). European Medicines Agency. 2007.
^ Tsurushita, N.; Hinton, P. R.; Kumar, S. (2005). "Design of humanized antibodies: From anti-Tac to Zenapax". Methods 36 (1): 69–83. doi:10.1016/j.ymeth.2005.01.007. PMID 15848076.
^ British National Formulary, Edition 57
^ EMEA: Withdrawal of the marketing authorisation in the European Union

UpToDate Contents

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1. Disease-modifying treatment of relapsing-remitting multiple sclerosis in adults
2. 成人の腎移植における免疫抑制誘導療法 induction immunosuppressive therapy in renal transplantation in adults
3. 成人における肝移植：免疫抑制の概要 liver transplantation in adults overview of immunosuppression
4. 急性移植片対宿主病の治療 treatment of acute graft versus host disease
5. 心臓移植における免疫抑制療法の導入および維持 induction and maintenance of immunosuppressive therapy in cardiac transplantation

English Journal

The Use of Biologic Therapies in Uveitis.

Schwartzman S1, Schwartzman M2.
Clinical reviews in allergy & immunology.Clin Rev Allergy Immunol.2015 Dec;49(3):307-16. doi: 10.1007/s12016-014-8455-6.
Therapy for autoimmune ophthalmic disease is currently evolving. The improved understanding of the abnormal immune response in the various forms of uveitis has resulted in targeted therapy. The aberrations of the immune system have been characterized by atypical cell populations, cytokine expression
PMID 25431348

Neuroimmunotherapies Targeting T Cells: From Pathophysiology to Therapeutic Applications.

Bittner S1,2, Wiendl H3.
Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics.Neurotherapeutics.2015 Nov 12. [Epub ahead of print]
Therapeutic options for multiple sclerosis (MS) have significantly increased over the last few years. T lymphocytes are considered to play a central role in initiating and perpetuating the pathological immune response. Currently approved therapies for MS target T lymphocytes, either in an unspecific
PMID 26563391

Long-Term Immunosuppression After Solitary Islet Transplantation Is Associated With Preserved C-Peptide Secretion for More Than a Decade.

Blau JE1, Abegg MR1, Flegel WA2, Zhao X1, Harlan DM3, Rother KI1.
American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons.Am J Transplant.2015 Nov;15(11):2995-3001. doi: 10.1111/ajt.13383. Epub 2015 Jul 16.
We report on two patients with type 1 diabetes (T1D) after solitary islet transplantation in 2001. They received steroid-sparing immunosuppression (daclizumab, sirolimus, and tacrolimus according to the Edmonton protocol). Both patients became insulin independent for 2 years: Patient A, a 42-year-ol
PMID 26184712

Japanese Journal

5.小腸移植(<特集>小児藏器移植の現状)

古川博之,鈴木友己,藤堂省
日本外科学会雑誌 111(5), 294-298, 2010-09-01
NAID 110007701000

イタリアにおける成人小腸単独移植 : 28例29移植の経験から

木村拓也,Lauro Augusto,Cescon Matteo,Zanfi Chiara,Pinna Antonio Daniele,福澤正洋
日本消化器外科学会雑誌 41(11), 1883-1891, 2008-11-01
… 移植(93%)で,移植の適応としては中心静脈アクセスの確保不能,中心静脈栄養に関連した合併症(繰り返す感染症,肝機能障害)が20例(69%)を占めた.免疫抑制剤はdaclizumab,alemtuzumab,antithymocyte globulinのいずれかをinductionに用い,tacrolimusを維持に用いた.Daclizumab投与例ではプレドニゾロンも併用した.結果:患者/グラフトの5年生存率は74%/71%であった.拒絶反応は13例に認め,全例にステロイドパルス療法を,2例にはOKT3 …
NAID 110006980567

Related Pictures

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★リンクテーブル★

リンク元	「mab」「ダクリズマブ」

「mab」

Daclizumab^?
Monoclonal antibody
Type	Whole antibody
Source	Humanized (from mouse)
Target	CD25
Clinical data
Trade names	Zenapax
AHFS/Drugs.com	monograph
Pregnancy; category	C;
Legal status	US: ℞-only; European marketing authorisation withdrawn;
Routes of; administration	Intravenous
Pharmacokinetic data
Biological half-life	20 days (11–38 days)
Identifiers
CAS Registry Number	152923-56-3
ATC code	L04AC01
DrugBank	DB00111
UNII	CUJ2MVI71Y
ChEMBL	CHEMBL1201605
Chemical data
Formula	C6332H9808N1678O1989S42
Molecular mass	142,612.1 g/mol
(what is this?) (verify)

　　[★]

関: モノクローナル抗体

mab

abciximab
adahmumab
adalimumab
afelimomab
alemtuzumab
apolizumab
arcitumomab
basiliximab
bevacizumab
cantuzumab
certolizumab
cetolizumab
cetuximab
clenoliximab
daclizumab
デノスマブ denosumab 抗RANKL抗体
eculizumab
edrecolomab
efalizumab
epratuzumab
galiximab
gemtuzumab
ibritumomab
インフリキシマブ infliximab 抗TNF-α抗体クローン病 Ph⁺ALL
inotuzumab
keliximab
natalizumab
nebacumab
omalilzumab
omalizumab
oregovomab
palivizumab
panitumumab
pertuzumab
pexelizumab
リツキシマブ rituximab：抗CD20抗体：慢性リンパ性白血病、B細胞リンパ腫

「ダクリズマブ」

　　[★]

英: daclizumab
同: Zenapax

[pmid17709711-1] Rose JW, Burns JB, Bjorklund J, Klein J, Watt HE, Carlson NG (2007). "Daclizumab phase II trial in relapsing and remitting multiple sclerosis: MRI and clinical results". Neurology 69 (8): 785–789. doi:10.1212/01.wnl.0000267662.41734.1f. PMID 17709711.

[2] Clinical trial number NCT01064401 for "Efficacy and Safety of Daclizumab High Yield Process Versus Interferon β 1a in Patients With Relapsing-Remitting Multiple Sclerosis ((DECIDE))" at ClinicalTrials.gov

[3] Clinical trial number NCT01462318 for "An Immunogenicity and Pharmacokinetics (PK) Study of DAC HYP Prefilled Syringe in Relapsing Remitting Multiple Sclerosis (RRMS) (OBSERVE)" at ClinicalTrials.gov

[pmid18268208-4] Sobrin L, Huang JJ, Christen W, Kafkala C, Choopong P, Foster CS (2008). "Daclizumab for treatment of birdshot chorioretinopathy". Arch Ophthalmol. 126 (2): 186–191. doi:10.1001/archophthalmol.2007.49. PMID 18268208.

[EPAR-5] "EPAR for Zenapax" (PDF). European Medicines Agency. 2007.

[6] Tsurushita, N.; Hinton, P. R.; Kumar, S. (2005). "Design of humanized antibodies: From anti-Tac to Zenapax". Methods 36 (1): 69–83. doi:10.1016/j.ymeth.2005.01.007. PMID 15848076.

[7] British National Formulary, Edition 57

[8] EMEA: Withdrawal of the marketing authorisation in the European Union

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daclizumab