WordNet

pierce with a wooden pin or knock or thrust a wooden pin into
stabilize (the price of a commodity or an exchange rate) by legislation or market operations; "The weak currency was pegged to the US Dollar"
a wooden pin pushed or driven into a surface (同)nog
a holder attached to the gunwale of a boat that holds the oar in place and acts as a fulcrum for rowing (同)pin, thole, tholepin, rowlock, oarlock
a prosthesis that replaces a missing leg (同)wooden leg, leg, pegleg
regulator that can be turned to regulate the pitch of the strings of a stringed instrument
small markers inserted into a surface to mark scores or define locations etc. (同)pin
fasten or secure with a wooden pin; "peg a tent" (同)peg down

PrepTutorEJDIC

(木などの,おもに木工に用いる)『くぎ』,掛けくぎ;(たるなどの)『せん』;(テントなどの)『くい』 / (弦楽器の弦をしめる)ねじ / 《話》(評価などの)段階)degree) / (議論などの)きっかけ,口実 / 《話》(おもに野球で)送球 / …‘を'『木くぎ』(『くい』)『でとめる』,‘に'木くぎ(木くい)を打つ《+『名』+『down』,+『down』+『名』》 / 〈物価・賃金など〉‘を'仰える,安定させる / 《話》(おもに野球で)〈ボール〉‘を'投げる / 《話》…‘を'認める,見定める

Wikipedia preview

出典(authority):フリー百科事典『ウィキペディア（Wikipedia）』「2015/06/16 07:42:15」(JST)

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Certolizumab pegol ^[1] (CDP870, tradename Cimzia) is a therapeutic monoclonal antibody to tumor necrosis factor alpha (TNF-α), for the treatment of Crohn's disease^[2] and rheumatoid arthritis, manufactured by UCB.^[3]^[4]^[5]

Medical uses

Certolizumab appears beneficial in those with rheumatoid arthritis.^[6]

Positive results have been demonstrated in two phase III trials (PRECiSE 1 and 2) of certolizumab pegol versus placebo in moderate to severe active Crohn's disease.^[2]^[7]^[8]^[9]

In 2013, a phase 3 double blind randomized placebo-controlled study found significantly positive results in patient self-reported questionnaires, with rapid improvement of function and pain reduction, in patients with axial spondyloarthritis.^[10]

Side effects

Significant side effects occur in 2% of people who take the medication.^[6]

Method of action

Certolizumab pegol is a monoclonal antibody directed against tumor necrosis factor alpha. More precisely, it is a PEGylated Fab' fragment of a humanized TNF inhibitor monoclonal antibody.^[7]

Legal status

On April 22, 2008, the U.S. Food and Drug Administration (FDA) approved Cimzia for use in the United States for the treatment of Crohn's disease in people who did not respond sufficiently or adequately to standard therapy.^[4]^[11]^[12]

On June 26, 2009, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) issued a positive opinion recommending that the European Commission grant a marketing authorisation for Cimzia for the treatment of rheumatoid arthritis only - the CHMP refused approval for the treatment of Crohn's disease. The marketing authorisation was granted to UCB Pharma SA on October 1, 2009.^[13]

On September 27, 2013, the U.S. Food and Drug Administration (FDA) approved Cimzia for use in the United States for the treatment of adult patients with active psoriatic arthritis.^[14]

References

^ Goel, Niti; Sue Stephens (2010). "Certolizumab pegol". MAbs 2 (2): 137–147. doi:10.4161/mabs.2.2.11271. PMC 2840232. PMID 20190560.
^ ^a ^b Sandborn WJ, Feagan BG, Stoinov S et al. (July 2007). "Certolizumab pegol for the treatment of Crohn's disease". N. Engl. J. Med. 357 (3): 228–38. doi:10.1056/NEJMoa067594. PMID 17634458.
^ Kaushik VV, Moots RJ (April 2005). "CDP-870 (certolizumab) in rheumatoid arthritis". Expert opinion on biological therapy 5 (4): 601–6. doi:10.1517/14712598.5.4.601. PMID 15934837.
^ ^a ^b index.cfm?fuseaction=Search.Label_ApprovalHistory "Cimzia Label and Approval History". Drugs@FDA. U.S. Food and Drug Administration (FDA). Retrieved 2009-11-15.
^ "Cimzia Medication Guide" (PDF). U.S. Food and Drug Administration (FDA). May 2009. Retrieved 2009-11-15.
^ ^a ^b Ruiz Garcia, V; Jobanputra, P; Burls, A; Cabello, JB; Vela Casasempere, P; Bort-Marti, S; Kynaston-Pearson, FJ (Sep 18, 2014). "Certolizumab pegol (CDP870) for rheumatoid arthritis in adults.". The Cochrane database of systematic reviews 9: CD007649. doi:10.1002/14651858.CD007649.pub3. PMID 25231904.
^ ^a ^b Schreiber S. et al.,Certolizumab pegol, a humanised anti-TNF pegylated FAb' fragment, is safe and effective in the maintenance of response and remission following induction in active Crohn's disease: a phase 3 study (precise),Gut,2005,54,suppl7,A82
^ Sandborn et al., Certolizumab pegol administered subcutaneously is effective and well tolerated in patients with active Crohn's disease: results from a 26-week, placebo-controlled Phase 3 study (PRECiSE 1),Gastroenterology, 2006,130,A107
^ "New Analysis Shows Cimzia (Certolizumab Pegol) Maintained Remission and Response in Recent Onset Crohn’s Disease" (Press release). UCB. October 23, 2006. Retrieved 2009-11-15.
^ Sieper J, Tubergen A, Coteur G, Woltering F, Landewe R (May 2013). "PMS50 – Rapid Improvements In Patient-Reported Outcomes With Certolizumab Pegol In Patients With Axial Spondyloarthritis, Including Ankylosing Spondylitis And Non-Radiographic Axial Spondyloarthritis: 24-Week Results Of A Phase 3 Double Blind Randomized Placebo-Controlled Study". Value in Health 16 (3): A227. doi:10.1016/j.jval.2013.03.1150. Retrieved 2013-05-18.
^ UCB press release - Cimzia Approved in the US for the Treatment of Moderate to Severe Crohn's Disease. Retrieved April 22, 2008.
^ Waknine, Yael (May 1, 2008). "FDA Approvals: Patanase, Actonel, Cimzia". Medscape. Retrieved 2008-05-01.
^ "Cimzia European Public Assessment Report". European Medicines Agency. Retrieved November 15, 2009.
^ "Cimzia (certolizumab pegol) approved by the U.S. FDA for treatment of adult patients with active psoriatic arthritis". Retrieved October 1, 2013.

External links

certolizumab pegol at the US National Library of Medicine Medical Subject Headings (MeSH)
Cimzia Website

UpToDate Contents

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1. 成人におけるクローン病治療のためのセルトリズマブペゴール certolizumab pegol for treatment of crohn disease in adults
2. 成人における重症または難治性クローン病の内科的マネージメントの概要 overview of the medical management of severe or refractory crohn disease in adults
3. リウマチ性疾患における生物学的製剤の概要 overview of biologic agents in the rheumatic diseases
4. 腫瘍壊死因子α（TNF-α）阻害剤：副作用の概要 tumor necrosis factor alpha inhibitors an overview of adverse effects
5. 慢性関節リウマチにおける腫瘍壊死因子阻害剤（TNF）のランダム化臨床試験 randomized clinical trials of tumor necrosis factor inhibitors in rheumatoid arthritis

English Journal

Development of psoriasis in IBD patients under TNF-antagonist therapy is associated neither with anti-TNF-antagonist antibodies nor trough levels.

Protic M1, Schoepfer A2, Yawalkar N3, Vavricka S4, Seibold F5.
Scandinavian journal of gastroenterology.Scand J Gastroenterol.2016 Dec;51(12):1482-1488. Epub 2016 Aug 18.
BACKGROUND: The cause of anti-TNF-induced psoriasis is still unknown.OBJECTIVE: We aimed to evaluate if the appearance of psoriasis under anti-TNF therapy is associated with anti-TNF antibody levels and TNF-antagonist trough levels.METHODS: In this case-control study we identified 23 patients (21 wi
PMID 27534974

Comparison of the clinical effectiveness of tumour necrosis factor inhibitors and abatacept after insufficient response to tocilizumab in patients with rheumatoid arthritis.

Akiyama M1, Kaneko Y2, Kondo H1, Takeuchi T1.
Clinical rheumatology.Clin Rheumatol.2016 Nov;35(11):2829-2834. Epub 2016 Mar 12.
The aim of this study is to compare the clinical effectiveness of tumour necrosis factor inhibitors (TNFi) and abatacept (ABT) after insufficient response to tocilizumab (TCZ) in patients with rheumatoid arthritis (RA). Among 527 RA patients treated with TCZ, 63 patients were enrolled who switched T
PMID 26971256

Biology of anti-TNF agents in immune-mediated inflammatory diseases: therapeutic implications.

Levy RA1, Guzman R2, Castañeda-Hernández G3, Martinez-Vazquez M4, Damian G5, Cara C6.
Immunotherapy.Immunotherapy.2016 Oct 14. [Epub ahead of print]
Biologics are increasingly being used to modify the course of immune-mediated inflammatory diseases. Some main agents are monoclonal antibodies and a fusion-protein that target TNF. This group includes adalimumab, infliximab, certolizumab pegol, golimumab and etanercept. Although the efficacy of ant
PMID 27737604

Japanese Journal

臨床新薬レビューセルトリズマブペゴル(遺伝子組換え) Certolizumab Pegol (Genetical Recombination) シムジア皮下注ユーシービージャパン株式会社アステラス製薬株式会社

上野耕司
MD : medical doctor : 明日を創る医療総合誌 10(8), 50-52, 2013-08
NAID 40019771348

海外の新薬審査情報を読み解く(第16回)セルトリズマブペゴル(Certolizumab pegol)

野村香織
月刊薬事 = The pharmaceuticals monthly 55(4), 632-635, 2013-04
NAID 40019667127

Industrial Info. ペグ化抗TNFα阻害薬セルトリズマブペゴル

金子祐子
細胞 43(14), 578-581, 2011-12
NAID 40019336367

「セルトリズマブ」

Certolizumab pegol^?
Monoclonal antibody
Type	Fab' fragment
Source	Humanized (from mouse)
Target	TNF alpha
Clinical data
Trade names	Cimzia
AHFS/Drugs.com	Consumer Drug Information
MedlinePlus	a608041
Pregnancy; category	US: B (No risk in non-human studies);
Legal status	US: ℞-only;
Routes of; administration	Subcutaneous
Identifiers
CAS Registry Number	428863-50-7
ATC code	L04AB05
UNII	UMD07X179E
KEGG	D03441
ChEMBL	CHEMBL1201831
Chemical data
Formula	C2115H3252N556O673S16
Molecular mass	47.75 kDa
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