Discover and read the best of Twitter Threads about #aducanumab
Most recents (15)
📢Hoy se adelantan los resultados del estudio con nuevo tratamiento anti-amiloide (#Donanemab) con ensayo clínico Fas 3 aparentemente exitoso para fases precoces del #Alzheimer 🧠.
👇
investor.lilly.com/news-releases/…
Resultados interesantes, pero todavía con cautela!
#neurologia #Salud
👇
investor.lilly.com/news-releases/…
Resultados interesantes, pero todavía con cautela!
#neurologia #Salud
En julio en el congreso de la Alzheimer's Association en Amsterdam tendremos más información.
Lo interesante de los resultados es que:
👉 #Donanemab va en la misma línea que #Lecanemab y #Aducanumab (otros anti-amiloide).
👉 Importancia del diagnóstico precoz (pre-demencia).
Lo interesante de los resultados es que:
👉 #Donanemab va en la misma línea que #Lecanemab y #Aducanumab (otros anti-amiloide).
👉 Importancia del diagnóstico precoz (pre-demencia).
Estos estudios van a favor de:
👉 La necesidad de #diagnóstico temprano del #Alzheimer pre-demencia y confirmación diagnóstica mediante #biomarcadores .
👉 Necesidad de apostar por una política de #SaludPública diferente en el campo del #deteriorocognitivo
#Sociedad
👉 La necesidad de #diagnóstico temprano del #Alzheimer pre-demencia y confirmación diagnóstica mediante #biomarcadores .
👉 Necesidad de apostar por una política de #SaludPública diferente en el campo del #deteriorocognitivo
#Sociedad
1/n Good point, Mike. I can use #solanezumab as a case study in selective reporting of RCT trial results which does not serve patient’s interests. Sola was discontinued despite pooled results from 2 ph-3 trials suggesting that ‘mild’ (but not ‘moderate’) stage #Alzheimer patients
2/n may benefit. But a 3rd ph-3 trial in only ‘mild’ AD was clearly negative. Presumed reason was that the Rx did not lower brain amyloid levels enough. Lilly published the MRI findings from these studies looking at brain volume changes. They considered these results important to
3/n report because they noted that “Rates of whole brain volume & ventricular volume changes are sensitive markers of neurodegeneration & used as biomarker outcome measures in trials of potential disease‐modifying therapies.” tinyurl.com/33a7dkh3 They also reported on the
1/n Thoughts on Neurofilament Light (NfL) as a neurodegeneration biomarker. I expect to hear a lot on it in the upcoming #Tofersen Adcom. @US_FDA refers to it as a promising biomarker of neurodegeneration in several diseases at the Relyvrio #ALS approval👇@ProfRobHoward @pash22 
2/n This raises an important question- if decreasing NfL levels are associated with clinical benefit outcomes in #ALS, wouldn’t increasing levels associated with worsening clinical outcomes and/or adverse events in #Alzheimer’s be similarly meaningful? Unfortunately these results
3/n have not been published for #aducanumab or #lecanemab. But they have for #donanemab by @LillyPad in phase-2 where accelerated loss of brain volume seen relative to placebo is associated with Increase in NfL levels. Increase in NFL is also significantly associated with faster
🛑🛑Tras la repercusión del tuit de abajo sobre un artículo resumen de los ensayos clínicos más prometedores de 2023 publicado en @Nature y un sondeo positivo sobre resumir o no su contenido, me dispongo a ello.
pd. Aportaré info adicional y actualizando en estos días
Vamos🧵
pd. Aportaré info adicional y actualizando en estos días
Vamos🧵
1º varias notas aclaratorias:
-En la pieza de @Nature le preguntan a 11 investigadores sobre ensayos, de su área de estudio, prometedores o esperados en 2023. Yo resumiré lo que dicen y aportaré información adicional
-En la pieza de @Nature le preguntan a 11 investigadores sobre ensayos, de su área de estudio, prometedores o esperados en 2023. Yo resumiré lo que dicen y aportaré información adicional
- Clinicaltrials.gov es una web donde se registran los ensayos clínicos, se informa de todo lo relacionado con su diseño, objetivos, resultados que se esperan, equipos implicados, fármacos que se van a usar y en qué enfermedad y otras cosas más
We have tested the antibody in various doses on 856 patients on 3 continents. After only 6 months we observed positive results, and after 18 months 81% of the group receiving the highest dosage showed lower levels of amyloid beta than the level we measure in Alzheimer’s-Lannfelt
“The idea for the antibody originated back in the 1990s, when the team identified a change in the genetic material of a Swedish family that had been severely afflicted by Alzheimer's disease. The mutation indicated that the cause seemed to be protofibrils”
medicalxpress.com/news/2018-10-a…
medicalxpress.com/news/2018-10-a…
Overnight a Swedish professor made $350 million. The lucky man, Lars Lannfelt, was not particularly famous. He had done pioneering work on Alzheimer’s, but it was in the 90s and belonged to a sub-field that, after a litany of failures had fallen from grace
statnews.com/2022/10/11/for…
statnews.com/2022/10/11/for…
1- Detailed & persuasive critique by Dr. @LonSchneiderMD of the #aducanumab esults recently published in the J of Prevention of #Alzheimers Disease.
#GeriTwitter
link.springer.com/article/10.142…
#GeriTwitter
link.springer.com/article/10.142…
@LonSchneiderMD 2- Note that the assn. between amyloid reduction & cognition goes in opposite directions in the 2 studies:
"High dose aducanumab was about as cognitively impairing in ENGAGE as it was beneficial in EMERGE [despite] both trials showing similar, substantial reductions in plaque."
"High dose aducanumab was about as cognitively impairing in ENGAGE as it was beneficial in EMERGE [despite] both trials showing similar, substantial reductions in plaque."
3- It's also possible that the slight cognitive improvement found with high-dose aducanumab in EMERGE was due in part to the greater worsening of cognition in the placebo group of EMERGE compared with the placebo group of ENGAGE.
1/ BLAMING THE PATHWAY?
tinyurl.com/dp5t5njh
@AlzResearchUK tries to explain why EMA didn't approve #aducanumab as @US_FDA did. It seems to suggest that the lack of an accelerated approval pathway at EMA is the problem @ProfRobHoward @pash22
tinyurl.com/dp5t5njh
@AlzResearchUK tries to explain why EMA didn't approve #aducanumab as @US_FDA did. It seems to suggest that the lack of an accelerated approval pathway at EMA is the problem @ProfRobHoward @pash22
2/ "The FDA approved aducanumab via its Accelerated Approval Pathway. This means a licence can be granted based on a drug’s effect on a biological marker of disease, rather than its proven ability to improve people’s day-to-day lives. This meant the FDA was able to consider
3/ #aducanumab’s effect on amyloid levels in the brain, rather than how it affected people’s memory and thinking. The EMA does not have a similar pathway to approval. Under its pathway, its committee considered whether the trial results showed evidence that the drug
@joannamoncrieff and I reply to critics’ letters bit.ly/3wNOuwB regarding our analysis of esketamine bit.ly/3niISHH. There are now 6 short-terms studies published for esketamine vs pbo, 5 of which are negative, 1/8
and one which does not reach clinical significance from pbo.The FDA, which has shown itself not to have the distance from companies to make objective decision about #aducanumab, dropped the bar very low for Janssen on esketamine, re-writing the rules of what they would accept 2/8
Although the suicides in the study (3 in esk, 0 in placebo) were not purely from randomised sections of the trial so causal attributions cannot be established, it does fit with real world analysis finding disproportionately high suicides attributed to esketamine in the US 3/8
Thread about @manlyepic & my @jamaneuro commentary re one especially shameful aspect of the FDA approval of #aduhelm. Before working w/ @manlyepic on this, I knew it was bad, but I didn’t know how bad. doi:10.1001/jamaneurol.2021.3404 1/27
In @Biogen’s FDA filing, only 0.6% (ie 19 people) of 3285 trial participants identified as Black, 3% as Hispanic, 0.03% (1 person) American Indian or Alaska Native, and 0.03% as Native Hawaiian or Pacific Islander. Of 9% identified as Asian, 94% were recruited in Asia. 2/n
But it gets even worse: of those 19 Black participants, most were randomly assigned to control or low-dose treatment arms. FDA approved a medication with known increases in risk for brain bleeding after only 6 Black people had received the approve dose. How is that okay? 3/n
Účinná léčba Alzheimerovy choroby je Svatý grál.
7. června schválila Americká FDA lék #Aduhelm (aducanumab) - první lék na toto onemocnění po 17 letech.
Pojďme se podívat trochu blíž celé této situaci, která bude přepisovat nejen učebnice, ale možná i regulační přístupy.
7. června schválila Americká FDA lék #Aduhelm (aducanumab) - první lék na toto onemocnění po 17 letech.
Pojďme se podívat trochu blíž celé této situaci, která bude přepisovat nejen učebnice, ale možná i regulační přístupy.
⚠️FDA tento lék schválila, čímž ignorovala názor své vlastní komise, která hlasovala 10:0 PROTI SCHVÁLENÍ (1 se zdržel).
⚠️Následně již 3. člen této expertní komise rezignoval.
cnbc.com/2021/06/10/thi…
⚠️Následně již 3. člen této expertní komise rezignoval.
cnbc.com/2021/06/10/thi…
⚠️Léčba #aducanumabem bude stát přibližně 56 000$ (1,17 mil. Kč)
⚠️FDA dala výrobci bianco šek na jakoukoliv léčbu Alzheimera - indikační omezení jsou poměrně široká
⚠️Za to musí výrobce provést postautorizační studii, jejíž výsledky mají být známé do 2030
accessdata.fda.gov/drugsatfda_doc…
⚠️FDA dala výrobci bianco šek na jakoukoliv léčbu Alzheimera - indikační omezení jsou poměrně široká
⚠️Za to musí výrobce provést postautorizační studii, jejíž výsledky mají být známé do 2030
accessdata.fda.gov/drugsatfda_doc…
Been digging into #aducanumab data, thinking about how to advise my patients & their caregivers when they ask me, keeping in mind shared decision-making and that these are individual decisions. Would be grateful for feedback/corrections: 1/7
“Some colleagues I respect say they won’t prescribe this drug. I haven’t made that decision, but as of now I don’t recommend it to anyone. I do want you to make the choice that is right for you, so if you still want to try after we talk then we can discuss how to do that.” 2/7
“When @US_FDA considers approving a drug, they ask a panel of outside experts for recommendations. In this case, none of the 11 experts thought the company has shown that the drug works. It was very strange for FDA to approve the drug despite such strong criticism.” 3/7
ALERTA DE NOVO MEDICAMENTO APROVADO PARA O ALZHEIMER. 🚨 O #aducanumab acaba de ser aprovado pelo @US_FDA para o tratamento da doença de #Alzheimer. Eu, o @wagnersbrum e o @jpfsouza33 resolvemos fazer um resumo dessa história cheia de controvérsias. Segue o 🧶 1/n
A demência é um dos maiores desafios do século XXI na área da saúde, acometendo 50 milhões de pessoas ao redor do 🗺️ (a projeção é de 152 milhões em 2050). O #Alzheimer é a principal causa de demência, sendo responsável por 60-70% dos casos. 2/n
Muito debate-se sobre a causa do #Alzheimer. Mesmo que não seja consenso, a teoria dominante é a da cascata da proteína beta-amiloide (descrita nos anos 90), a qual propõe que o acúmulo dessa proteína no 🧠 funcionaria como um gatilho para a morte progressiva dos neurônios. 3/n
Sobre el #Aducanumab, de la serie #TurraFármacosAlzheimer (miniturra). Como os decía en mi hilo de noviembre del 2020 los dos grandes estudios fase 3 no fueron coincidentes, y por esa razón no se aprobó su uso (del comité evaluador 10 expertos votaron en contra y uno se abstuvo)
Los ensayos clínicos se diseñan definiendo a priori cuál será el parámetro que permitirá decidir si el estudio ha funcionado o no (el primary outcome), aunque también se aprovecha para estudiar parámetros secundarios que nos den pistas de si podría llegar a funcionar el fármaco
En noviembre el Aducanumab no se aprobó porque no había suficientes evidencias de mejora clínica en los pacientes tratados (a excepción de un pequeño grupo de uno de los estudios). Desde entonces hasta ahora esto no ha cambiado
Tohle bude velmi zajímavé sledovat: rozhodnutí by mělo proběhnout 7. června.
Pokud by bylo pozitivní, #aducanumab bude první novou léčbu cca po 17 letech a jedinou, která snižuje kognitivní snížení jedním z mechanismů této choroby (snížení amyloidu), nikoliv jen symptomy.
Pokud by bylo pozitivní, #aducanumab bude první novou léčbu cca po 17 letech a jedinou, která snižuje kognitivní snížení jedním z mechanismů této choroby (snížení amyloidu), nikoliv jen symptomy.
Jenže, v loňském roce poradní komise FDA vyjádřila pochybnosti ohledně dat o účinnosti této látky. fda.gov/advisory-commi…
Velmi podrobně se k tomuto vloni vyjádřil expert na farmaceutický vývoj @Dereklowe a dodal: "Pokud něco takového rozpoutáte, mělo by to být dobré. Léčba Alzheimeru má potenciál naprosto změnit výdaje na zdravotnictví v USA a proto potřebujete jasné důkazy
blogs.sciencemag.org/pipeline/archi…
blogs.sciencemag.org/pipeline/archi…
👇 #Aducanumab declaraciones de los panelistas (un poco molestos con la FDA): statnews.com/2020/11/06/exp…
👇#Aducanumab la nota de prensa de Biogen (en donde su CEO dice: “we will continue to work with the FDA as it completes its review of our application”) investors.biogen.com/news-releases/…
#Aducanumab la FDA todavía no ha colgado nada en su web, pero Biogen dice que “FDA will continue the review process with a decision on whether to approve the aducanumab Biologics License Application by March 7, 2021”
