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¯u©Ê¬õ¦å²y¼W¦h¯g«Y¬°¦­´Á¦åÀù¡A¤]¬OÄÝ©ó°©Åè°ò¦]¯fÅܪº¨u¨£¯e¯f¤§¤@¡CRopeginterferon alfa-2b¬O¥þ²y²Ä¤@­Ó®Ö­ã¥Î©óPVªº²Ä¤@½uªø®Ä«¬¤zÂZ¯ÀªvÀø¥ÎÃÄ ¡A¨Ã¤w¦bªñ¥b¼Æ¼Ú·ù°ê®a¤Î¨ä¥L¼Ú¬w°ê®a¤W¥«¾P°â¡A¥]¬A¼w°ê¡B¶ø¦a§Q¡B­^°ê¡Bªk°ê¡B¤¦³Á¡B±¶§J¡B·ç¨åµ¥°ê¡A²{¤]©ó«D¼Ú·ù°ê¤§·ç¤h¤W¥«¡CÀHµÛ¼Ú¬wªº¤W¥«°ê¼W¥[»PÃÄ»ù®Ö­ã¡A¥¼¨Ó±N³v¨BÂX¤jRopeginterferon alfa-2b ¦b¼Ú¬wªº¥«³õ¡C

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Anderson : §Ú³o­Ó¤H¥u¬ÝªÑ»ù¡A´Nºâ§A¶K¦A¦h¥¦´N¬O¨SÀ禬¡A¥¦ªº»ù­È§Ú¨S¥²­nÀ´¤]¤£·Qª¾¹D~

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ÁÙ¦³¤@­Ó¸ê°T´£¨Ñ¡A«Y¥ÑCancer Research & Treatment Fund (CR&T)©ó2020¦~9¤ë15¤é¡A¨ä¤¤¤@­ÓÁ¿ªÌGhaith Abu-Zeinah, MD¡A¥L¤]¬O³o¦¸ET¤T´Áªº¥D«ù¤H¤§¤@¡A¥L©ó²Ä27¤À¦Ü34¤ÀÄÁ¦³´£¨ì¹ï©óPV¦Ó¨¥(¯S§O¬OLow PV)¡AINF Alpha¬Û¹ï©óHU¤§ªvÀø¦¨®Ä§ó¦n¡C¥u¤£¹L¥L¨S¦³¯S§O´£¨ìRopeg´N¬O¤F¡C

www.youtube.com/watch?v=SDU5fUwB-go&feature=youtu.be

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°£¤F¼Ú¬wÂå¾Ç±M®aªºÃöª`¥~¡A¬ü°êÂåÀø±M®a¤]¦³³\¦h¼v¤ù¤Î·s»D³ø¾ÉRopeg³á¡C

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1. Clinical Opportunities for Novel MPN Therapies(Thursday, September 10, 2020)

www.sohotv.org/Articles/ArtMID/4036/ArticleID/84/Clinical-Opportunities-for-Novel-MPN-Therapies

¦b«e¥b¬q³ø¾É(6¤ÀÄÁ«e)¡A´£¨ì«Ü´Á«ÝRopeg¦b¬ü°êÀòPV®Ö­ã¡A¹w­p2021¦~¡A¥H¤Î¤¶²Ð©ó¸q¤j§Q¶i¦æLow PVªº´Á¤¤Á{§Éµ²ªG¡C

2. Promising ET, PV & Myelofibrosis Therapies in Development (2020¦~9¤ë3¤é)

www.youtube.com/watch?v=HNpE6vCsGaE&feature=youtu.be

MPN specialist, Dr. Srdan Verstovsek discusses the latest research and progress for the treatment of patients with essential thrombocythemia (ET), polycythemia vera (PV) and myelofibrosis (MF).

Dr. Srdan Verstovsek ¦b²Ä1¤ÀÄÁ¤º´£¨ì«Ü´Á«ÝRopeg¦b¬ü°ê2021¦~ÀòPV®Ö­ã¥ÎÃÄ¡A¥H¤ÎETªºÁ{§É¸ÕÅç¡C

3. The MPN Education Foundation and MPN-NET present - MPN Awareness Day 2020 (2020¦~9¤ë11¤é)

www.youtube.com/watch?v=uCjn1LBKje4&feature=youtu.be

The MPN EDUCATION FOUNDATION and MPN-NET present a patient event hosted by Dr. Ruben

¦b²Ä29~32¤ÀÄÁ¤¶²ÐProud PV¤ÎConti PVªºµ²ªG¡B¦b34~36.5¤ÀÄÁ¸q¤j§Q¶i¦æLow PVªº´Á¤¤Á{§Éµ²ªG¡C

4. Expert Reviews the Current State of the Essential Thrombocythemia Treatment Paradigm(September 15, 2020)

www.targetedonc.com/view/expert-evaluates-the-current-state-of-the-essential-thrombocythemia-treatment-paradigm

Ropeginterferon alfa-2b (P1101) also appears promising in this setting, considering its approval in Europe for the treatment of polycythemia vera (PV) and the FDA¡¦s recent acceptance of a Biologics License Application for this agent as treatment of patients with PV in the absence of splenomegaly.

5. ¦bUS¤§clinicaltrials.gov¤º¡A©óSeptember 15, 2020¦³§ó·sET¤T´Áªº¸ê°T¡A¥]§t©ó¬ü°êªº¶i¦æÁ{§ÉªºÂå°|¡C

clinicaltrials.gov/ct2/show/NCT04285086?term=PharmaEssentia&draw=2&rank=1

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youtu.be/8J0iNvWakv0

What is the news about ropeginterferon?

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~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

­«ÂIºK­n: 2020 Ropeg Á`µ²¦Ü¥Ø«e¬°¤î¹ïPVªº·s®ø®§ (°^Äm) ¦p¤U

1 Ropeg 4¦~°lÂܦ¨ªG:

1.1 Complete hematologic response§¹¥þ¦å²G¾ÇÅܤÆ: Ropeg vs. control arm: 60% vs. 40%

1.2 molecular response¤À¤l¤ÏÀ³: Ropeg 60%, ¤×¨ä­«­nªº¬O¨ä¤¤13% ¯f¤H¥i¥H¹F¨ì§¹¥þ§¹¾ãªº¤À¤l¤ÏÀ³ (·N¨ýµÛ§¹¥þ°»´ú¤£¨ìJak2¬ðÅÜ) .....¦³¤@©w¤ñ²v¯f±w¥i¥H§¹¥þ©MJak2 ¬ðÅÜ »¡bye-Bye!!!

2 ¤§«e¦bEHAµoªíªº¸q¤j§Q¦å²G¾Ç±M®aTijanno Babui ¬ã¨sµoªí: (¦Û¦æ°Ñ¦Ò¤½¥q©xºô6/15 P1101ªvÀø§C­·ÀIPV¯f±w±Ú¸s¦¨ªG¨ô¶V ½Ķ)

µ²½×: 2020 ·sªº°T®§¬ORopeg ¤£½×¦bLow risk or high risk PV ±Ú¸sªº¬ã¨s³£¦³¦n®ø®§ ¡V ¤×¨ä¹ïlow risk PV (¸q¤j§QDr. Babui study result) ªºªvÀø«ü¾É¤è°w, ©Î³\¸Ó­«·sµû¦ô!

Video 0:45~ end¡K

After 4 years treatments, the response we see this drug in particular in complete hematologic response are durable with more than 60% of patients or is still in complete hematologic response after 4 years treatments compared to less than 40%of in the control arm.

The second new information with this long-term follow-up is that we see now a huge difference in terms of molecular response with more than 60% of patients achieving molecular response in the Ropeg(interferon) arm and importantly for the first time 13% of these patients achieved complete molecular response meaning that their jak2 mutation is no longer detectable (vs.) none of the patients in the control arm could achieve such a response

The second new information with ropeg comes from the professor Tijanno Babui and the low PV trial in Italy indeed they perform a clinical study ramdomizing ropeg compared to conventional therapy meaning phlebotomy and low dose aspirin for patients with PV at low risk meaning that they are younger than 60 age and also never had any vascular events this trial was a plan for interim analysis that was performed and presented at the EHA meeting with very good results including that this interim analysis allow to close inclusions because the primary endpoint was already met. The primary endpoints was a composite endpoint with combing the control of the hematocrit below 45% without phlebotomy and no disease progression indeed 84% of patients in the ropeg arm achieve the primary endpoint compared to 60% only in the conventional treatment arm. In addition, there was a also significant benefit in term of symptom for the patients receiving ropeg compared to those treated with only phlebotomy and low dose aspirin. So, altogether we have now this year interesting info in both high risk and low risk PV patients that should maybe prompt the reassessment of the management guideline for low risk PV patients

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2020 8¤ë©³µoªí¦b¥xÆWÂå¾Ç·|´Á¥ZJournal of the Formosan Medical Association(IF=3.)

Real-world experience with Ropeginterferon-alpha 2b (Besremi) in

Philadelphia-negative myeloproliferative neoplasms

Cih-En Huang a,b, Yu-Ying Wu a, Chia-Chen Hsu a,

Ying-Ju Chen a, Hsing-Yi Tsou a, Chian-Pei Li a, Yi-Hua Lai a,b,

Chang-Hsien Lu a,b, Ping-Tsung Chen a,b, Chih-Cheng Chen a,b,*

a Division of Hematology and Oncology, Department of Medicine, Chang Gung Memorial Hospital,

Chiayi, Taiwan

b College of Medicine, Chang Gung University, Tao-Yuan, Taiwan

Received 22 June 2020; received in revised form 7 August 2020; accepted 12 August 2020

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Ropeginterferon alpha-2b (Ropeg)¬°·s£¸¥Nªº©µªø«¬¤zÂZ¯À¡Aªñ¦~¨ú±o¼Ú·ù¯u©Ê¬õ¦å²y¼W¥ÍÃÄÃÒ¡A¦ý¯u¹êÁ{§ÉªvÀø¤W¤´¨ã¸û¤Ö¨Ï¥Î¸gÅç¡C

Background/purpose: Ropeginterferon alpha-2b (Ropeg) is a novel pegylated interferon-alpha recently approved for the treatment of polycythemia vera (PV) in Europe. However, other than data from clinical trials, little is known about this agent in real world practice

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¦b2017¦~¶}©l¶i¦æ¥xÆW®¦·OªvÀø¡A§Ú­Ì¹Î¶¤¦Ü¤µÁ`¦@ªvÀø¤F9¦ì¶O«°¬V¦âÅé³±©Ê°©Åè¼W¥Í¯g(MPN)¯f¤H¡A³o¨Ç¯f±w¥H·í®É²{¦³ªºÀøªk¤wµLªkº¡¨¬¨äÂåÀø»Ý¨D¡A¬G¦V¤HÅé¸ÕÅç©e­û·|¤Î½Ã¥ÍºÖ§Q³¡¥Ó½Ð¨Ï¥ÎP1101®¦·OªvÀø

Methods: A compassionate use program employing Ropeg for treating patients with unmet medical need was initiated in Taiwan in 2017. Herein, we collected clinical data and assessed the safety as well as efficacy of Ropeg in nine patients treated in this program.

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Ropeg¤]Åã²{¯gª¬§ïµ½¤ÎµÊŦÅé¿nÁY¤pªºÀø®Ä¡C (¦bµu®É¶¡¤º¥i§ïµ½µÊŦÅé¿n¬O­Ó¦³½ìªºµ²ªG)

¦å¤¤ÅK½Õ¯ÀHepcidinÅܤƳ¡¤À¡G

¦³3¤À¤§2ªº¯f±w¦³¦^¤É±¡ªp¡AÅã¥ÜRopegªºªvÀø¨ã¦³¨Ï¦å²y¼W¥Í¦^´_¨ì¥¿±`ª¬ºAªº¼ç¤O

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¦b1¦ì¯f¤H¤¤Æ[¹î¨ì¾ãÅé¦å¤¤µoª¢¬ÛÃö²Ó­M¿E¯ÀÅãµÛ³Q§í¨îªº±¡ªp¡AµLÆ[¹î¨ì¯S©w¼Ò¦¡¡C¨Ï¥ÎRNA©w§Ç¨ÓÆ[¹î1¦ì¯f±wªº¦å²G¼Ë¥»ªvÀø«e¤ÎªvÀø«áªº±¡ªp¡AÃÒ¹êRopeg¦b¤zÂZ¯À¤ÏÀ³¡Aµoª¢¤ÏÀ³¡A²Ó­M­ä¤`¤Î²Ó­M¤À¤Æ¬ÛÃö°ò¦]ªí²{¤¤°_¨ìÅãµÛ§@¥Î¡C¦¹¦ì¯f¤HªºµÊŦ¦^´_¥¿±`¡Ajak2°ò¦]­t¾á¤]¦³³ÌÅãµÛªº¤U­°¡AÅã¥Ü

³oºØ§ïµ½¬O¥þ­±©Êªº¡C

Results: Collectively, among evaluable patients, both the molecular response and complete blood count remission rates were 62.5%. Most therapy-related side effects were mild, and there was no treatment discontinuation attributable to intolerable adverse events. The agent also showed efficacy in symptom amelioration and spleen size reduction. Although no specific patterns of cytokine level alteration could be identified, significantly attenuated plasma levels of inflammation markers were observed in one particular patient who happened to have normalized spleen size and most remarkable reduction in JAK2 mutant allele burden, indicating all-around improvement in every aspect of this case

µ²½×¡GÁ`Åé¨Ó»¡¡A¦b¦¹¯u¹êÁ{§É®¦·OªvÀø¤¤Æ[¹î¨ìªº¦w¥þ©Ê¤Î¦³®Ä©Ê¼Æ¾Ú¡AÃÒ¹ê¤FRopeg¬°¦³§Æ±æ¤Î¥¼¨Ó¤§MPNªvÀø¿ï¾Ü

Conclusion: Conclusively, observed signs of efficacy and safety in our real-world experience

prove Ropeg as a promising option for the treatment of MPN.

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====================================================================================

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science.sciencemag.org/content/369/6504/718

Abstract ºK­n

Coronavirus disease 2019 (COVID-19) is characterized by distinct patterns of disease progression that suggest diverse host immune responses. We performed an integrated immune analysis on a cohort of 50 COVID-19 patients with various disease severity. A distinct phenotype was observed in severe and critical patients, consisting of a highly impaired interferon (IFN) type I response (characterized by no IFN-£] and low IFN-£\ production and activity), which was associated with a persistent blood viral load and an exacerbated inflammatory response. Inflammation was partially driven by the transcriptional factor nuclear factor¡V£eB and characterized by increased tumor necrosis factor¡V£\ and interleukin-6 production and signaling. These data suggest that type I IFN deficiency in the blood could be a hallmark of severe COVID-19 and provide a rationale for combined therapeutic approaches

«aª¬¯f¬r¯e¯f (COVID-19) ªº¯SÂI¬O¯e¯f¶i®iªº¤£¦P¼Ò¦¡,ªí©ú¤£¦Pªº±J¥D§K¬Ì¤ÏÀ³¡C§Ú­Ì¹ï50¦W¤£¦P¯e¯fÄY­«µ{«×ªºCOVID-19±wªÌ¶i¦æ¤Fºî¦X§K¬Ì¤ÀªR¡C¦b­«¯g©M¦M­«±wªÌ¤¤Æ[¹î¨ì©úÅ㪺ªí«¬,¥]¬A°ª«×¨ü·lªº¤zÂZ¯À(IFN)I«¬¤ÏÀ³(µL IFN-£\ ©M§C IFN-£\ ªº¥Í²£©M¬¡©Ê),»P«ùÄò¦å²y©Mª¢¯g¤ÏÀ³¦³Ãö¡Cª¢¯g³¡¤À¥ÑÂà¿ý¦]¼Æ®Ö¦]¼Æ-£gBÅX°Ê,¨ä¯S¼x¬O¸~½FÃa¦º¦]¼Æ¼W¥[-©M¥Õ²Ó­M¶¡-6ªº²£¥Í©M«H¸¹¡C³o¨Ç¼Æ¾Úªí©ú, ¦å²G¤¤ªºI«¬IFN¯Ê¥F¥i¯à¬OÄY­«COVID-19ªº¼Ð»x,¨Ö¬°Áp¦XªvÀø¤èªk´£¨Ñ¤F²z¥Ñ¡C

Conclusion: ¤pµ²:

On the basis of our study, we propose that type I IFN deficiency is a hallmark of severe COVID-19 and infer that severe COVID-19 patients might be potentially relieved from the IFN deficiency through IFN administration and from exacerbated inflammation through adapted antiinflammatory therapies that target IL-6 or TNF-£\ ~ a hypothesis worth cautious testing.

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