Luspatersept: Perbedaan antara revisi
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'''Luspatersept''' adalah obat yang digunakan untuk mengobati [[anemia]] pada [[talasemia]] beta dan sindrom mielodisplastik.<ref name="Reblozyl FDA label">{{cite web | title=Reblozyl- luspatercept injection, powder, lyophilized, for solution | website=DailyMed | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=82f4d266-3f52-41eb-86ba-0abf3cf468e8 | access-date=17 September 2021}}</ref> [[Badan Pengawas Obat dan Makanan Amerika Serikat]] (FDA) menganggapnya sebagai obat
==Sejarah==
Uji coba fase III mengevaluasi kemanjuran luspatersept untuk pengobatan anemia pada gangguan hematologi beta talasemia<ref>{{cite web |title=A Phase 3, Double-Blind, Placebo Controlled Multicenter Study to Determine the Efficacy and Safety of Luspatercept (ACE-536) in Adults With Transfusion Dependent Beta (B)-Thalassemia |url=https://www.clinicaltrials.gov/ct2/show/NCT02604433 |publisher=clinicaltrials.gov |access-date=5 May 2022 |date=21 January 2022}}</ref> dan sindrom mielodisplastik.<ref>{{cite web |title=A Phase 3, Double-blind, Randomized Study to Compare the Efficacy and Safety of Luspatercept (ACE-536) Versus Placebo for the Treatment of Anemia Due to the IPSS-R Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes in Subjects With Ring Sideroblasts Who Require Red Blood Cell Transfusions. |url=https://www.clinicaltrials.gov/ct2/show/NCT02631070 |publisher=clinicaltrials.gov |access-date=5 May 2022 |date=19 November 2021}}</ref>
Obat ini [[pengembangan obat|dikembangkan]] oleh Acceleron Pharma, bekerja sama dengan Celgene.<ref>{{cite web |url=http://www.acceleronpharma.com/products/luspatercept/ |title=Luspatercept: Our Lead Product Candidate |publisher=Acceleron Pharma |date= |access-date=22 May 2017 |archive-date=5 March 2017 |archive-url=https://web.archive.org/web/20170305123310/http://www.acceleronpharma.com/products/luspatercept/ |url-status=dead }}</ref>
Badan Pengawas Obat dan Makanan Amerika Serikat (FDA) memberikan persetujuan untuk luspatersept–aamt pada bulan November 2019, untuk pengobatan anemia (kekurangan sel darah merah) pada pasien dewasa dengan beta talasemia yang memerlukan transfusi sel darah merah (RBC) secara teratur.<ref name="FDA PR">{{cite press release | title=FDA approves first therapy to treat patients with rare blood disorder | website=U.S. [[Food and Drug Administration]] (FDA) | date=8 November 2019 | url=https://www.fda.gov/news-events/press-announcements/fda-approves-first-therapy-treat-patients-rare-blood-disorder | archive-url=https://web.archive.org/web/20191113231630/https://www.fda.gov/news-events/press-announcements/fda-approves-first-therapy-treat-patients-rare-blood-disorder | archive-date=13 November 2019 | url-status=live | access-date=13 November 2019}} {{PD-notice}}</ref><ref>{{cite web | title=Reblozyl (luspatercept-aamt) FDA Approval History | website=Drugs.com | url=https://www.drugs.com/history/reblozyl.html | archive-url=https://web.archive.org/web/20191113233045/https://www.drugs.com/history/reblozyl.html | archive-date=13 November 2019 | url-status=live | access-date=13 November 2019}}</ref><ref>{{cite press release | title=FDA Approves Reblozyl (luspatercept-aamt) for the Treatment of Anemia in Adults With Beta Thalassemia Who Require Regular Red Blood Cell Transfusions | website=Celgene | date=8 November 2019 | url=https://ir.celgene.com/press-releases/press-release-details/2019/FDA-Approves-REBLOZYL-luspatercept-aamt-for-the-Treatment-of-Anemia-in-Adults-With-Beta-Thalassemia-Who-Require-Regular-Red-Blood-Cell-Transfusions/default.aspx | archive-url=https://web.archive.org/web/20191113233542/https://ir.celgene.com/press-releases/press-release-details/2019/FDA-Approves-REBLOZYL-luspatercept-aamt-for-the-Treatment-of-Anemia-in-Adults-With-Beta-Thalassemia-Who-Require-Regular-Red-Blood-Cell-Transfusions/default.aspx | archive-date=13 November 2019 | url-status=live | access-date=13 November 2019}}</ref><ref name="FDA Snapshot">{{cite web | title=Drug Trials Snapshots: Reblozyl | website=U.S. [[Food and Drug Administration]] (FDA) | date=8 November 2019 | url=http://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-reblozyl | access-date=26 January 2020}} {{PD-notice}}</ref> Luspatersept disetujui untuk penggunaan medis di Uni Eropa pada bulan Juni 2020.<ref name="Reblozyl EPAR">{{cite web | title=Reblozyl EPAR | website=[[European Medicines Agency]] (EMA) | date=28 April 2020 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/reblozyl | access-date=26 September 2020}} Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.</ref>
FDA memberikan status [[obat piatu]] pada tahun 2013, dan penetapan jalur cepat pada tahun 2015.<ref>{{cite press release|url=http://www.businesswire.com/news/home/20150518005252/en/FDA-Fast-Track-Designation-Granted-Luspatercept-Treatment |title=FDA Fast Track Designation Granted to Luspatercept for the Treatment of Patients with Beta-Thalassemia |publisher=Acceleron/Celgene|via=Business Wire |date=18 May 2015 |access-date=22 May 2017}}</ref>
==Kegunaan dalam medis==
Luspatersept diindikasikan untuk pengobatan orang dewasa dengan anemia yang bergantung pada transfusi akibat sindrom mielodisplastik (MDS) risiko sangat rendah, rendah, dan menengah dengan sideroblas cincin, yang memiliki respons yang tidak memuaskan atau tidak memenuhi syarat untuk terapi berbasis eritropoietin.<ref name="Reblozyl EPAR" />
Luspatersept diindikasikan untuk pengobatan orang dewasa dengan anemia yang bergantung pada transfusi yang terkait dengan talasemia beta.<ref name="Reblozyl EPAR" />
==Efek samping==
Efek samping yang mungkin terjadi termasuk nyeri tulang sementara, nyeri sendi ([[artralgia]]), [[pusing]], [[tekanan darah tinggi]] (hipertensi) dan kadar [[asam urat]] tinggi ([[hiperurisemia]]). Terdapat pula peningkatan risiko [[trombosis]] (bekuan darah) pada pasien yang memiliki faktor risiko trombosis yang mengonsumsi luspatersept.<ref name="Taher">{{cite journal | vauthors = Taher AT, Musallam KM, Cappellini MD | title = β-Thalassemias | journal = The New England Journal of Medicine | volume = 384 | issue = 8 | pages = 727–743 | date = February 2021 | pmid = 33626255 | doi = 10.1056/NEJMra2021838 | s2cid = 232049825 }}</ref>
==Struktur dan mekanisme==
Luspatersept adalah protein fusi rekombinan yang berasal dari reseptor aktivasi manusia tipe IIb (ActRIIb) yang dikaitkan dengan protein yang berasal dari [[antibodi G|imunoglobulin G]].<ref>{{cite web | url = https://ncit.nci.nih.gov/ncitbrowser/pages/concept_details.jsf?dictionary=NCI%20Thesaurus&code=C104012 | title = Luspatercept | work = NCI Thesaurus | publisher = [[National Cancer Institute]]}}</ref> Luspatersept mengikat [[ligan]] superfamili TGF (''transforming growth factor beta'') untuk mengurangi sinyal SMAD. Pengurangan sinyal SMAD menyebabkan peningkatan pematangan eritroid (darah merah).<ref name="Taher" />
==Penelitian==
Luspatersept sedang dievaluasi untuk digunakan pada orang dewasa dengan beta talasemia yang tidak bergantung transfusi.<ref name="Piga BEYOND TRIAL">{{cite journal | vauthors = Piga A, Perrotta S, Gamberini MR, Voskaridou E, Melpignano A, Filosa A, Caruso V, Pietrangelo A, Longo F, Tartaglione I, Borgna-Pignatti C, Zhang X, Laadem A, Sherman ML, Attie KM | display-authors = 6 | title = Luspatercept improves hemoglobin levels and blood transfusion requirements in a study of patients with β-thalassemia | journal = Blood | volume = 133 | issue = 12 | pages = 1279–1289 | date = March 2019 | pmid = 30617198 | doi = 10.1182/blood-2018-10-879247 | pmc = 6440118 | doi-access = free }}</ref>
== Referensi ==
{{reflist}}
[[Kategori:Obat yang dikembangkan oleh Bristol Myers Squibb]]
[[Kategori:Obat piatu]]
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