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" 뷮 ó ...ľó "
뺴ö 2019-12-21 06:17:00
" 뷮 ó ...ľó "
뺴ö 2019-12-21 06:17:00
[ͺ] ̻(ѱȭ к)



  ̻
[ϸ=뺴ö ] ֱ ̱ FDA Ǿǰû(EMA) ȭ JAK (ĽƼսƮ꿰) 뷮 ó Կ 츮 ľó ִ.

̱ FDA 7 ϳ ˾缺 忰 1 ġ 2 ġ 㰡 , EMA ߼ 츦 ϰ, 輺 ˾缺 忰 ȯڵ鿡 1 2ȸ 10mg ؼ ȴٰ .

뷮 ݵ ؾ ϴ ˾缺忰 , ִ ȯڴ , 豺 ȯ Ÿ ٲٶ ǰ ̴.

ġ ̱ ġ(Conventional therapy) ˾缺 忰 ȯڿ TNF blocker ˾缺 忰ȯڿԸ ִ.

̿ ȭ к ̻ "ش ǰ / ͸ϰ ְ, ľó δ籹 ϰ ϰ ִ. ڷ 㰡 ؼ 籹 䰡 ʿϸ, پ ٰſ Ǹ Ǿ ϹǷ ° ܰ踦 ִ" ߴ.

ƼǼ , ˾缺 忰  ε ۽Ʈ Ŭ Ǿǰ̴. Ƽ 5mg 1 2ȸ ݸ, ˾缺 忰 10mg 1 2 8ְ , ġ 5mg Ǵ 10mg 1 2ȸ Ѵ.

Ⱓ ֻ ָ ̷ Ƽ ˾缺忰 忡 Ӱ 汸 Ǿǰ ġз ȭ 븦 Ҵ ŭ ̹ FDA/EMA ġ óǻ鿡 ū ָ ް ִ.

ѱȭ ๰ ִ  ġ ⼺ кθ ̲ ִ ̻翡 ô.

̻ Ϲϴ.

-̻ ҰŹ帳ϴ.

= а Ƿ, 2012 ȭ кο , ƽþ(ѹα, ȣ, 3 ) 鿪 к ͸ ϰ ֽϴ.

- ߵ?

= Ƽ, Ǽ, ˾缺忰 ġ 鿪ȯ ȯ 䱸 Ű ߵ ġԴϴ. װ ġ῵ ־ ߴ پ 䱸 ϴ ο ġɼ Ѵٴ ǥ Ͽ ߵǾϴ.

2012 11 FDA ߵ Ȱ Ƽ ġ ʷ 㰡 ߴŰ(JAK, Janus Kinase) Դϴ. Ƽ, ˾缺忰, Ǽ 3 ȯ ˾缺忰JAK ۽ƮŬ(First-in-Class) ๰Դϴ.

- ۿ ȿȿ ΰ?

= ۿ Ƽ, ˾缺忰, Ǽ ǥ鿪, ׷Ƽ 汸 ߴŰ (JAK inhibitor)Դϴ. ü ī ȣ ϴµ, ʿ ̻ ī Ƽ ˾缺忰 ȯ ߴ ĥ ֽϴ.

, īΰ īΰ ұ, Ǵ ī ̿ ȯ մϴ. ̷ ī ϴJAK ȣް(JAK Pathway) , ī ϴ ๰Դϴ.

, ī Ʈũ ߽ɿ ϴ ȣްθ ǥ ܺΰ ƴ, ο ۿϴ ο ٹ մϴ. Ư, ַJAK3 Ǵ JAK1 ȣ ϸ, ̷ ȣ پ ī ҽŰ մϴ.

Ⱓ ֻ ָ ̷ Ƽ ˾缺忰忡 Ӱ 汸ġ, ̱Ƽȸ(ACR), Ƽȸ(EULAR) ġᰡ̵ο Ǹ, Ƽ ġз ȭ ϰ ֽϴ.

̱ȭȸ(ACG) 2019 ˾缺忰 ӻħ TNF ġῡ ߵ ˾缺忰 ȯ ġ  Ӱ ǰ߽ϴ.

Ƽ ˾缺忰ġ ̿ ȹ ȭ ̷, ȯ ȯ 鿪 ȿҽ ϴ Խϴ. Ǿǰ 鿪 ߻ϴ ȿ Ұ Ӱ, ȯڵ鿡 ο ġɼ մϴ.

Ƽ 5mg ACR ص޷, , ջȿ Ȯ, ܵ ÿ ȿ Ȯ߽ϴ. ġ 1ֽ ACR20 Ÿ½ϴ. 2 ACR 50 ϴ. 3ϸ Ȱ(PtGA) ȿ ϴ. ˾缺忰 ġ 3 ̳ ȿ , ϰ ð ȭ Ⱓ ޼߽ϴ.

ֻ· ư, 庸 ϸ, ڰֻ翡 ȯںδ ֽϴ. 汸 ȯڵ Ǹ ϰ, ˾· մϴ.

- óǵ ȯڵ ñմϴ.

=óϽô Ե 뺯ؼ ü 帮 ϴ.

-ֱ EMA ȯڱ Է Ѵٴ 幮 ǥ߽ϴ. FDA ̿Ͱ 12ġ ߽ϴ. ѱľó ̿  ?

= ϰ 踦 ϰ ֽϴ. ش ǰ / ͸ ̸, κ ľó δ籹 ϰ ϰ ֽϴ.

ڷ 㰡 ؼ 籹 䰡 ʿϸ, پ ٰſ Ǹ Ǿ ϹǷ ° ܰ踦 ֽϴ.

ٿ ֱ EMA , ๰ȸ(PRAC) ๰ڹȸ(CHMP) ǰ ǥ ֽϴ. ڼ ϴ ȮϽ ֽϴ. (https://www.ema.europa.eu/en/medicines/human/referrals/xeljanz)

EMA ๰ڹȸ(CHMP) ๰ȸ(PRAC) ϴ ǰ ǥ, ̴ 2020 1 EC(ȸ) 並 ĥ Դϴ. EMA "߻ ȯ ؾ Ѵ" Ҿ "ٸ ġ ִ , 豺 ˾缺忰ȯڿ 1 2ȸ 뷮(10mg) ǰ ʴ´" ǰ߽ϴ. "65 ̻ ȯ , ġ  ġ " ǰ߽ϴ.

ǰ ƽð 亸ٴ ǡϿ ϴ ǰϰ ְ, Ư 豺 ȯڱ ϶ ֽϴ. Ƽ/Ǽ/˾缺忰 ȯ ġῡ Ǵ ߿ ġɼ ϳ EU ۷ι 󿡼 㰡 ๰Դϴ. ȭڴ  ش ġ῵ ߿ ġɼ benefit/risk ߰ ִٰ մϴ. ̹ CHMP ǰ Ƿ鿡 ġ ⼺ ǰμ,  ġῡ մϴ.

- ѱȭ ΰ?

= RA ġ 5 Ǿ, UC Ӱ ޿ Ȳ, benefit / risk profile Ƿ ϰ, ȯڿ óϽ ֵ ȸ Դϴ.

Advanced Therapy Ƿ/ȯ unmet needs ϹǷ,  ִ (3ϸ ȿ/ϰ ġӼ /汸 Ǽ ) θ ˸, Ŵ ȹԴϴ.

-ѱȭ ߼۽ ΰ? ƿ﷯ ȸ ϰ߼ Ǵ ǻ鿡 ۺεƴ ߼۹ Ź帳ϴ.

=̱ ȭں ÿ(Tofacitinib A3921133) ο ø  㰡 ó氡ɼ ִ Ƿ ϱ ѹ ֽϴ. ѱȭڵ , غϿ 4 Ƿ鿡 ߼ѹ , ľó Ŀ´̼ Ͽϴ.

̴ ̱ǰǾ౹( FDA) 㰡 䱸Ǵ 򰡿 ӻ迡 ġ̸, ش Tofacitinib ӻ ӻ ȯڵ ̰ ּ 50 ̻ ÿ, ּ 1̻ ڸ ִ Ƽ ȯڿ (CV, Cardiovascular) ϱ Դϴ.

, ̿ܿ ȸ, Ƿ鿡 ϰ ϰ ֽϴ. ͸ ľó Ͽ 㰡 ؼȹ(REMS) Ͽ, ˾缺忰 ؼ ؼ α׷ ߰ , ϰ ֽϴ.

- ϸ ι̷ Ȱȭ() 輺 ٴ ӻ Ȯεȹ ֽϴ. ȭ óǻ鿡 ߺ輺 忡 ĪǸ ذȴٰ ϰ ִ Ȯεǰ ֽϴ. ˾缺忰 50 ȯڰ 50% ѽϴ. Ű 50 ̻ ȯڱ ȿȿ ִµ, ȭ Ϲ ӻٰŰ Ǵܵ˴ϴ. ̿ Ź帳ϴ.

=ѱȭڴ ٰſ ϸϰ , Ÿǰ ó ϸ Եȹ ϴ.

뷮 ִٴ Ƿ鿡 ϰ , ߺ ġ κе Բ ϰ ֽϴ. Ϸʷ 5/8 UC Ī ó Ե ϰ ġϽ ֵ ȳ帰 ֽϴ.

Overall cohort , ˾缺忰 ȯڿ 1157 ȯ 65 ȯڿ 69 herpes zoster(5.65%) ߻Ͽϴ. ߻ HZ¾ 1or 2 adjacent dermatomes ȯڰ κ(n=51) mild ϰ ġ herpes zosterϴ. , HZ ߻ ȯ κ(n=44) Ͽ, 16 ȯڴ  ߴϰų 뷮 ̰, 5 ȯڸ HZϿ ߴϿϴ. (Winthrop et al., 2018 Accepted for publication in IBD: Herpes Zoster Infection in Patients with Ulcerative Colitis Receiving Tofacitinib)

-̱ FDA ޾Ƶ鿩  1 2ġ ȯ߽ϴ. ѱȭڰ 忡 ݿ ʴ Ư ֳ? ѱȭڿ ľó ǰ ؿܻʺ Ⱓ ִ ȲԴϴ. ȯھ ε ŭ ʱ ص ƴ϶ Ǵմϴ. ǰ ǰ ִ ̸, ȭڴ ľó ڷ Ŀ´̼  ؿԴ ˷ֽʽÿ.

=̱ 㰡 FDA ׿ , ѱȭڴ Ǿǰ Ŀ´̼ ľó ϰ ϰ ֽϴ. ȯڸ ġ ؿ 㰡 ǿ Ͽ Ŀ´̼ϰ , ׿ 㰡 ûѹ ֽϴ.

ڷ 㰡 ؼ 籹 䰡 ʿϸ, پ ٰſ Ǹ Ǿ ϹǷ ° ܰ踦 ֽϴ.

ٿ, Ǵ UC ȯڸ ƴϸ, CV risk 50 ̻ Ƽȯ ĽƼ 10mg 1 2ȸ ޾ ȯڵ鿡 ¡(safety signal) ̱ PASS(Post Authorization Safety Study) Դϴ. ƮƮ ʰų ༺ ȯ ߵ Ȱ Ƽ, ׷Ƽ(DMARDs) ʰų, ༺ Ȱ Ǽ ġῡ ؼ 5mg 1 2ȸ ޾ҽϴ.

ڸƼڽ׷̵, Ƽ, 6-޸İǪ(6-MP) ġ Ǵ ʰų, ҽǵǰų Ǵ ༺ ߵ-Ȱ ˾缺忰ġῡ ؼ 5mg Ǵ10mg 1 2ȸ ޾ҽϴ.

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ֽż ݴ
ٺ Ϲݾ ǸŰ (2024 03)
뱸- ౹ 37
ǰ ְ
̰źĸ(100) 35,000 29,000 6,000 31,083
ѽŻ÷(10) 3,500 2,500 1,000 3,144
޾(100) 24,000 22,000 2,000 22,800
Ʒγΰ(100) 30,000 27,000 3,000 28,586
īɾ(10g) 8,000 5,500 2,500 6,773
Ľõ򿬰(5g) 5,500 4,000 1,500 5,104
Ź(4) 5,000 3,500 1,500 4,350
λ絹÷(100) 37,000 30,000 7,000 33,889
ڶ(20) 6,500 6,500 0 6,500
(10) 6,000 4,500 1,500 5,238
Ժ(10) 4,000 3,300 700 3,699
ڱ׸(20) 5,000 4,000 1,000 4,597
ť(10) 3,500 2,500 1,000 3,073
Ȱť(1) 1,200 1,000 200 1,199
Ǯɾ(3.3ml) 27,000 25,000 2,000 26,143
޵𿬰(10g) 7,000 6,000 1,000 6,463
öŸ(34) 13,000 11,000 2,000 12,009
뽺ī(20g) 22,000 18,000 4,000 20,462
ġ(1) 1,000 1,000 0 1,000
ӽ÷(21) 10,000 7,000 3,000 9,121
ͺ(10) 3,500 2,500 1,000 3,126
ݿ(1ڽ) 3,000 2,800 200 2,984
׶÷糪ƮŸ(6) 8,000 7,000 1,000 7,952
߽Ÿ(120) 60,000 55,000 5,000 57,842
Źĸ(10ĸ) 3,000 2,000 1,000 2,992
Ÿ̾(120) 60,000 50,000 10,000 55,000
տ(60ĸ) 30,000 25,000 5,000 27,844
Ÿ̷ER(6) 3,000 2,500 500 2,912
ٿ(30g) 12,000 9,800 2,200 11,515
(120) 25,000 22,000 3,000 24,429
Ʒ(6) 4,000 3,000 1,000 3,498
ǽõĸ(270ĸ) 120,000 105,000 15,000 116,250
B(120) 70,000 60,000 10,000 64,111
׳(10) 3,000 2,500 500 2,810
6̺(10) 3,500 2,100 1,400 3,027
(60) 220,000 200,000 20,000 212,000
Ⱦ 12,000 10,000 2,000 10,967
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