POPULARITY
Welcome to The HCPFive, your go-to roundup for the latest healthcare news and breakthroughs, curated specifically for busy healthcare professionals. Each week, we highlight 5 key developments or headlines from healthcare that you need to know—whether it's a cutting-edge treatment, regulatory updates, or innovations shaping the future of medicine. This week's top stories included the US Food and Drug Administration's (FDA) acceptance of a Biologics License Application (BLA) for a cholesterol-lowering drug, long-term data on a dermatologic treatment for hidradenitis suppurativa, an expanded dosing label for a blinding eye disease treatment, and more! With The HCPFive, you'll get the essential takeaways to stay informed and ahead of the curve. Here's your quick dive into the top stories for the week of February 09, 2025—let's jump in! Interested in oncology news? Check out The OncFive, from our sister publication OncLive. Top News for Healthcare Providers from the Week of 02/09 1. FDA Accepts Lerodalcibep BLA for LDL-C Reduction in High-Risk Patients The FDA accepted the BLA for lerodalcibep, targeting reductions in low-density lipoprotein cholesterol (LDL-C) levels in patients with or at high risk for atherosclerotic cardiovascular disease (ASCVD) and primary hyperlipidemia. The agency set a Prescription Drug User Fee Act (PDUFA) action date of December 12, 2025, and announced no plans to hold an advisory committee meeting. 2. Travere Therapeutics Plans FSGS Submission for Sparsentan Travere Therapeutics announced its intent to submit a supplemental New Drug Application (sNDA) for sparsentan (Filspari) with the FDA for the treatment of focal segmental glomerulosclerosis (FSGS) at the end of Q1. The announcement arrived soon after the completion of a Type C meeting with the FDA, with the sNDA based on existing data from the Phase 3 DUPLEX and Phase 2 DUET studies. 3. Bimekizumab Long-Term Hidradenitis Suppurativa Data Support Efficacy, Safety Profile Bimekizumab (Bimzelx) was associated with sustained disease control for up to 2 years in patients with hidradenitis suppurativa (HS), according to presentation of long-term data from the BE HEARD trials. Presented at the 14th Conference of the European Hidradenitis Suppurativa Foundation (EHSF), bimekizumab reduced the symptoms of HS, achieved a low rate of flares, and improved health-related quality of life. 4. Rosnilimab Demonstrates Historic Responses for Rheumatoid Arthritis Rosnilimab achieved historic American College of Rheumatology (ACR) and clinical disease activity index (CDAI) low disease activity (LDA) responses in patients with rheumatoid arthritis (RA), according to new Phase 2b findings. A depleter and agonist of PD-1+ T cells, rosnilimab was evaluated in the global 424-patient RENOIR trial for efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics in patients with moderate-to-severe RA on background conventional disease-modifying antirheumatic drugs (cDMARDs). 5. FDA Expands Dosing Label for Avacincaptad Pegol for Geographic Atrophy The FDA approved an expanded label for avacincaptad pegol intravitreal solution (IZERVAY) for geographic atrophy (GA), extending the approved dosing beyond 12 months. Announced by Astellas Pharma, the decision comes after the company resubmitted its supplemental New Drug Application (nDA) in December 2024, based on feedback received from the FDA. The company received a Complete Response Letter (CRL) the month prior. See you next week! Editor's note: this was created with the assistance of AI tools.
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Grapes could help protect against cognitive decline University of California, Los Angeles - February 06 2022. The January issue of Experimental Gerontology published the finding of researchers at the University of California, Los Angeles of a protective effect for powdered grape against a decline in brain metabolism in older adults. The results of the investigation suggest that eating grapes might contribute to the prevention of Alzheimer's disease. The study included ten men and women with mild cognitive decline. Participants were given freeze-dried grape powder or a placebo similar in flavor and appearance but lacking beneficial grape polyphenols. The grape powders, which provided the equivalent of three servings of grapes per day, were mixed with water and consumed in divided daily doses for six months. Cognitive performance and changes in brain metabolism as assessed by PET scans were evaluated before and after the treatment period. (NEXT) Loneliness associated with increased risk of dementia in older adults New York University, February 7, 2022 As social isolation in the United States has been increasing among older adults, a new study shows a notable link between loneliness and dementia risk, and one that is most striking for Americans who represent a large part of the population. In the study publishing February 7 in Neurology, the medical journal of the American Academy of Neurology,researchers found a three-fold increase in risk of subsequent dementia among lonely Americans younger than 80 years old who would otherwise be expected to have a relatively low risk based on age and genetic risk factors. The study also found that loneliness was associated with poorer executive function (i.e., a group of cognitive processes including decision-making, planning, cognitive flexibility, and control of attention) and changes in the brain that indicate vulnerability to Alzheimer's disease and related dementias (ADRD). (NEXT) Dietary total antioxidant capacity and mortality outcomes: the Singapore Chinese Health Study Huazhong University of Science and Technology (China), February 1, 2022 To evaluate the relations of dietary total antioxidant capacity (DTAC) with mortality outcomes in a Chinese population. The study included 62,063 participants from the Singapore Chinese Health Study. The participants were 45–74 years at baseline (1993–1998) when dietary data were collected with a validated 165-item food frequency questionnaire. During 1,212,318 person-years of follow-up, 23,397 deaths [cardiovascular diseases (CVD): 7523; respiratory diseases: 4696; and cancer: 7713] occurred. In multivariable models, the HR (95% CI) comparing participants in the highest vs. lowest quartile of CDAI was 0.85 for all-cause mortality, 0.82 for CVD mortality, 0.76 for respiratory disease mortality and 0.94 for cancer mortality Similar associations were found with the VCEAC index. Higher intakes of the DTAC components, i.e., vitamin C, vitamin E, carotenoids, and flavonoids, were all associated with lower mortality risk. (NEXT) Healthy lifestyle equals bigger brain Yale University School of Medicine, February 4 2022. Research findings scheduled to be reported at the American Stroke Association's International Stroke Conference 2022 demonstrated that adherence to Life's Simple 7 lifestyle behaviors is associated with greater brain volume and fewer indicators of damage among middle-aged men and women. The study included 35,914 participants enrolled in the UK Biobank. Magnetic resonance imaging (MRI) of the brain measured brain volume and white matter hyperintensity volume. (NEXT) No time to exercise? What about three seconds a day? Edith Cowan University (Australia) and Niigata University (Japan), February 7, 2022 Lifting weights for as little as three seconds a day can have a positive impact on muscle strength, a new study from Edith Cowan University (ECU) has discovered. A collaboration with researchers from Niigata University of Health and Welfare (NUHW) in Japan had 39 healthy university students perform one muscle contraction at maximum effort for three seconds per day, for five days a week over four weeks. The participants performed either an isometric, concentric or eccentric bicep curl (see definitions below) at maximum effort, while researchers measured the muscles' maximum voluntary contraction strengthbefore and after the four-week period. Another 13 students performed no exercise over the same period and were also measured before and after the four weeks. Muscle strength increased more than 10 percent for the group who performed the eccentric bicep curl after the four weeks, but less increase in muscle strength was found for the other two exercise groups. The no exercise group saw no increase. The study shows all three lifting methods had some benefit to muscle strength, however eccentric contraction easily produced the best results. (OTHER NEWS) Dystopia Disguised as Democracy: All the Ways in Which Freedom Is an Illusion John W. Whitehead & Nisha Whitehead, February 8, 2022 We are no longer free. We are living in a world carefully crafted to resemble a representative democracy, but it's an illusion. We think we have the freedom to elect our leaders, but we're only allowed to participate in the reassurance ritual of voting. There can be no true electoral choice or real representation when we're limited in our options to one of two candidates culled from two parties that both march in lockstep with the Deep State and answer to an oligarchic elite. We think we have freedom of speech, but we're only as free to speak as the government and its corporate partners allow. We think we have the right to freely exercise our religious beliefs, but those rights are quickly overruled if and when they conflict with the government's priorities, whether it's COVID-19 mandates or societal values about gender equality, sex and marriage. We think we have the freedom to go where we want and move about freely, but at every turn, we're hemmed in by laws, fines and penalties that regulate and restrict our autonomy, and surveillance cameras that monitor our movements. Punitive programs strip citizens of their passports and right to travel over unpaid taxes. We think we have property interests in our homes and our bodies, but there can be no such freedom when the government can seize your property, raid your home, and dictate what you do with your bodies. We think we have the freedom to defend ourselves against outside threats, but there is no right to self-defense against militarized police who are authorized to probe, poke, pinch, taser, search, seize, strip and generally manhandle anyone they see fit in almost any circumstance, and granted immunity from accountability with the general blessing of the courts. Certainly, there can be no right to gun ownership in the face of red flag gun laws which allow the police to remove guns from people merely suspected of being threats. We think we have the right to an assumption of innocence until we are proven guilty, but that burden of proof has been turned on its head by a surveillance state that renders us all suspects and overcriminalization which renders us all lawbreakers. Police-run facial recognition software that mistakenly labels law-abiding citizens as criminals. A social credit system (similar to China's) that rewards behavior deemed “acceptable” and punishes behavior the government and its corporate allies find offensive, illegal or inappropriate. We think we have the right to due process, but that assurance of justice has been stripped of its power by a judicial system hardwired to act as judge, jury and jailer, leaving us with little recourse for appeal. A perfect example of this rush to judgment can be found in the proliferation of profit-driven speed and red light cameras that do little for safety while padding the pockets of government agencies. By gradually whittling away at our freedoms—free speech, assembly, due process, privacy, etc.—the government has, in effect, liberated itself from its contractual agreement to respect the constitutional rights of the citizenry while resetting the calendar back to a time when we had no Bill of Rights to protect us from the long arm of the government. We've bartered away our right to self-governance, self-defense, privacy, autonomy and that most important right of all: the right to tell the government to “leave me the hell alone.” In exchange for the promise of safe streets, safe schools, blight-free neighborhoods, lower taxes, lower crime rates, and readily accessible technology, health care, water, food and power, we've opened the door to militarized police, government surveillance, asset forfeiture, school zero tolerance policies, license plate readers, red light cameras, SWAT team raids, health care mandates, overcriminalization and government corruption. In the end, such bargains always turn sour. We can no longer maintain the illusion of freedom. (NEXT) Preventive Use of Ivermectin Reduced COVID Mortality by 90%, Study Found A peer-reviewed study published last month found the prophylactic use of ivermectin reduced COVID mortality by 90% among more than 223,000 study participants in a town in Southern Brazil. David Charbonneau, Ph.D., February 7, 2022 A peer-reviewed study published last month found the prophylactic use of ivermectin reduced COVID mortality by 90% among more than 223,000 study participants in a town in Southern Brazil. The study, published in the Cureus Journal of Medical Science, also found a 44% reduction in COVID cases among those who took the re-purposed drug. Between July 7, 2020, and Dec. 2, 2020, all residents of Itajaí were offered ivermectin. Approximately 3.7% of ivermectin users contracted COVID during the trial period, compared with 6.6% of residents who didn't take the drug. Based on the results, Dr. Flavio Cadegiani, one of the study's lead authors, said, “Ivermectin must be considered as an option, particularly during outbreaks.” Dr Pierre Kory said: “You would think this would lead to major headlines everywhere. And yet, nothing. And this is not new, this censorship of this highly effective science and evidence around repurposed drugs. The censoring of it, it's not new, it's just getting more and more absurd. And it has to stop.” Kory said it's not even about ivermectin, “it's about the pharmaceutical industry's capture of our agencies and how our policies are all directed at suppressing and avoiding use of re-purposed drugs” in favor of high-profit medicines.
On the new CDA pod we've got a blockbuster interview with Gustavo Dudamel that was only possible thanks to AI technology. Plus we try out a long list of marketing ideas ensembles can use — Orchestra Roulette! Quartet Fight Club! good old reverse psychology! and …… weed? — to win back recalcitrant audiences. And our AI hosts try and fail to read some advertisements. The CDA podcast is the only classical music pod hosted entirely by AI, without the intervention of human producers, human engineers, or humans, period.
Guest: Xiaohong Wang, MD, PhD Association of Biomarker Cutoffs and Endoscopic Outcomes in Crohn's Disease: A Post Hoc Analysis From the CALM Study Walter Reinisch, Remo Panaccione, Peter Bossuyt, Filip Baert, Alessandro Armuzzi, Xavier Hébuterne, Simon Travis, Silvio Danese, William J Sandborn, Stefan Schreiber, Sofie Berg, Qian Zhou, Kristina Kligys, Ezequiel Neimark, Ahmed A Suleiman, Geert D'Haens, Jean-Frederic Colombel Background: CALM was a randomized phase 3 trial in patients with Crohn's disease (CD) that demonstrated improved endoscopic outcomes when treatment was escalated based on cutoffs for inflammatory biomarkers, fecal calprotectin (FC), C-reactive protein (CRP), and CD Activity Index (CDAI) remission vs CDAI response alone. The purpose of this post hoc analysis of CALM was to identify drivers of treatment escalation and evaluate the association between biomarker cutoff concentrations and endoscopic end points. Methods: The proportion of patients achieving CD Endoscopic Index of Severity (CDEIS)
Guest: Xiaohong Wang, MD, PhD Association of Biomarker Cutoffs and Endoscopic Outcomes in Crohn's Disease: A Post Hoc Analysis From the CALM Study Walter Reinisch, Remo Panaccione, Peter Bossuyt, Filip Baert, Alessandro Armuzzi, Xavier Hébuterne, Simon Travis, Silvio Danese, William J Sandborn, Stefan Schreiber, Sofie Berg, Qian Zhou, Kristina Kligys, Ezequiel Neimark, Ahmed A Suleiman, Geert D'Haens, Jean-Frederic Colombel Background: CALM was a randomized phase 3 trial in patients with Crohn's disease (CD) that demonstrated improved endoscopic outcomes when treatment was escalated based on cutoffs for inflammatory biomarkers, fecal calprotectin (FC), C-reactive protein (CRP), and CD Activity Index (CDAI) remission vs CDAI response alone. The purpose of this post hoc analysis of CALM was to identify drivers of treatment escalation and evaluate the association between biomarker cutoff concentrations and endoscopic end points. Methods: The proportion of patients achieving CD Endoscopic Index of Severity (CDEIS)
The CDA pod returns after a six-year hiatus! Now AI-hosted and DMCA-compliant. What could go wrong.
Episode: #25 August 10, 2020 ----- Tools from our sponsors to go bankless: Loopring - trade & pay on Ethereum w/ near-0 gas fees! (use "Bankless" for VIP4 status & trades at 6bps!) Monolith - holy grail of bankless Visa cards Aave - money lego for lending & borrowing Rocket Dollar - tax shelter your crypto ($50 w/ "BANKLESS") (Read this on IRAs and 401ks) ---- Andre Cronje calls himself just another DeFi dev, but you can't help but wonder, is he's underselling himself with that title? In a few short months he single-handedly created a fleet of DeFi yield farming money robots that locked up over $400m in assets in his yearn protocol. He launched a YFI token that grew in value by over 1,000% in its first week, one of the most explosive price charts crypto has ever seen. No pre-mine, no VC, no founders reward. Maybe a better title is King of the Yield Farmers. DeFi's Satoshi. Who is this guy? What did he build and why is it brilliant? Why did YFI go from $3 on July 17th to $5000 on August 8th? This is everything you need to know about yearn, YFI, and Andre. We cover: How Andre's really feeling What's up with "I test in prod" Why high YFI price can be bad How Yearn automates yield farming Andre's money robots Incenting strategy writers Risks of yearn Launching YFI to scale Why people buy YFI Organic governance Is Andre The Joker? What's coming next Join us next Monday for a fresh episode! ----- Resources discussed: yearn protocol yearn governance yfi price chart Acronym helper: LP = liquidity provider yearn (or "Y-earn") = Andre's protocol cUSD, cDAI = stablecoins in Compound TLV = total locked valued in a DeFi protocol Look up other assets on DeFiMarketCap ----- Episode Actions: Try yearn protocol - "tested in prod" you could lose it all Get involved in yearn governance Listen to SOTN#7 - YFI Token Magic w/ Daryl Lau Also...subscribe to Bankless YouTube to watch State of the Nation every Tuesday. ----- Subscribe to podcast on iTunes | Spotify | YouTube | RSS Feed Leave a review on iTunes Share the episode with someone you know! ----- Don't stop at the podcast! Subscribe to the Bankless newsletter program Watch Bankless shows and tutorials on YouTube Visit official Bankless website for resources Follow Bankless on Twitter Follow Ryan on Twitter Follow David on Twitter ----- Not financial or tax advice. This podcast is strictly educational and is not investment advice or a solicitation to buy or sell any assets or to make any financial decisions. Do your own research.
In this Episode we will take an in-depth look at he new cDai Cryptocurrency as well as an introductory look at the also newly added xDai
On the EthHub Weekly Recap we cover topics from the EthHub Weekly Newsletter. In this episode we discuss EIP-2025 and thoughts on block reward funding, Anthony and Eric going to Berlin for DappCon and ETHBerlin, Circle moving to Bermuda for Poloniex, Microsoft to use Ethereum for machine learning, pooling cDai to earn interest with ERC-2212, Coinbase starts to educate users about DeFi with Maker CDPs and Chris Burniske’s new metic “Network Value to Token Value” in an attempt to value smart contract platforms. Support our show! Buy EthHub Merch Get on the email list at ethhub.substack.com
Host: Louis J Cohen, MD Impact of Obesity on Short- and Intermediate-Term Outcomes in Inflammatory Bowel Disease: Pooled Analysis of Placebo Arms of Infliximab Clinical Trials. Siddharth Singh, MD, MS James Proudfoot, MS Ronghui Xu, PhDWilliam J Sandborn, MD Background: To assess whether obesity may affect natural history of inflammatory bowel diseases (IBD), we conducted an individual participant data (IPD) pooled analysis of placebo arms, using data from clinical trials of infliximab in IBD and using the Yale Open Data Access (YODA) Project. Methods: We obtained IPD from 4 placebo-controlled trials of infliximab in adults with IBD (ACCENT-I and ACCENT-II; ACT-1 and ACT-2). Patients were categorized into quartiles based on body mass index (BMI) or weight at time of trial entry. Primary outcome was clinical remission (Crohn’s disease activity index [CDAI]
Host: Louis J Cohen, MD Impact of Obesity on Short- and Intermediate-Term Outcomes in Inflammatory Bowel Disease: Pooled Analysis of Placebo Arms of Infliximab Clinical Trials. Siddharth Singh, MD, MS James Proudfoot, MS Ronghui Xu, PhDWilliam J Sandborn, MD Background: To assess whether obesity may affect natural history of inflammatory bowel diseases (IBD), we conducted an individual participant data (IPD) pooled analysis of placebo arms, using data from clinical trials of infliximab in IBD and using the Yale Open Data Access (YODA) Project. Methods: We obtained IPD from 4 placebo-controlled trials of infliximab in adults with IBD (ACCENT-I and ACCENT-II; ACT-1 and ACT-2). Patients were categorized into quartiles based on body mass index (BMI) or weight at time of trial entry. Primary outcome was clinical remission (Crohn’s disease activity index [CDAI]
Host: Louis J Cohen, MD Impact of Obesity on Short- and Intermediate-Term Outcomes in Inflammatory Bowel Disease: Pooled Analysis of Placebo Arms of Infliximab Clinical Trials. Siddharth Singh, MD, MS James Proudfoot, MS Ronghui Xu, PhDWilliam J Sandborn, MD Background: To assess whether obesity may affect natural history of inflammatory bowel diseases (IBD), we conducted an individual participant data (IPD) pooled analysis of placebo arms, using data from clinical trials of infliximab in IBD and using the Yale Open Data Access (YODA) Project. Methods: We obtained IPD from 4 placebo-controlled trials of infliximab in adults with IBD (ACCENT-I and ACCENT-II; ACT-1 and ACT-2). Patients were categorized into quartiles based on body mass index (BMI) or weight at time of trial entry. Primary outcome was clinical remission (Crohn’s disease activity index [CDAI]
Host: Louis J Cohen, MD Impact of Obesity on Short- and Intermediate-Term Outcomes in Inflammatory Bowel Disease: Pooled Analysis of Placebo Arms of Infliximab Clinical Trials. Siddharth Singh, MD, MS James Proudfoot, MS Ronghui Xu, PhDWilliam J Sandborn, MD Background: To assess whether obesity may affect natural history of inflammatory bowel diseases (IBD), we conducted an individual participant data (IPD) pooled analysis of placebo arms, using data from clinical trials of infliximab in IBD and using the Yale Open Data Access (YODA) Project. Methods: We obtained IPD from 4 placebo-controlled trials of infliximab in adults with IBD (ACCENT-I and ACCENT-II; ACT-1 and ACT-2). Patients were categorized into quartiles based on body mass index (BMI) or weight at time of trial entry. Primary outcome was clinical remission (Crohn’s disease activity index [CDAI]
Host: Louis J Cohen, MD Impact of Obesity on Short- and Intermediate-Term Outcomes in Inflammatory Bowel Disease: Pooled Analysis of Placebo Arms of Infliximab Clinical Trials. Siddharth Singh, MD, MS James Proudfoot, MS Ronghui Xu, PhDWilliam J Sandborn, MD Background: To assess whether obesity may affect natural history of inflammatory bowel diseases (IBD), we conducted an individual participant data (IPD) pooled analysis of placebo arms, using data from clinical trials of infliximab in IBD and using the Yale Open Data Access (YODA) Project. Methods: We obtained IPD from 4 placebo-controlled trials of infliximab in adults with IBD (ACCENT-I and ACCENT-II; ACT-1 and ACT-2). Patients were categorized into quartiles based on body mass index (BMI) or weight at time of trial entry. Primary outcome was clinical remission (Crohn’s disease activity index [CDAI]
Host: Louis J Cohen, MD Impact of Obesity on Short- and Intermediate-Term Outcomes in Inflammatory Bowel Disease: Pooled Analysis of Placebo Arms of Infliximab Clinical Trials. Siddharth Singh, MD, MS James Proudfoot, MS Ronghui Xu, PhDWilliam J Sandborn, MD Background: To assess whether obesity may affect natural history of inflammatory bowel diseases (IBD), we conducted an individual participant data (IPD) pooled analysis of placebo arms, using data from clinical trials of infliximab in IBD and using the Yale Open Data Access (YODA) Project. Methods: We obtained IPD from 4 placebo-controlled trials of infliximab in adults with IBD (ACCENT-I and ACCENT-II; ACT-1 and ACT-2). Patients were categorized into quartiles based on body mass index (BMI) or weight at time of trial entry. Primary outcome was clinical remission (Crohn’s disease activity index [CDAI]
All For The Culture Show Episode 5-ZackTV Interview We got the pleasure to sit down and chat with interviewer ZackTV, ZackTV is youtube interviewer who goes to some of the most dangerous in hoods in Chicago and America to interview rappers and artist. We sat down and got to chat about how he started interviewing and making videos, growing up and life in Chicago, what made Chicago so bad and violent, is it more overrated then what people think, and Zack attended college. He also spoke on his legendary interview with LA Capone (RIP) and Rondo Numba Nine (Free Rondo) and his phone call interview with Rondo and Cdai in Jail, his belief of the reason why Rondo did not want to say whether Tay600 snitched, the Tay600 snitching allegations, his most scariest dangerous interview, drama that has occurred during interviews, and Momma Capone calls in ! plus much more Check it out!!! Watch the interview on also! www.Youtube.com/Allforthecultureshow IG- @allforthecultureshow IG/Twitter/Snapchat-HipHopHandicap Check out the website to see the interviews and purchase our All For The Culture Logo TShirts www.all4theculture.com #allfortheculture #allforthecultureshow #allfortheculturepodcast #podcast #Zacktv #hiphopodcast #rappodcast #hiphopculture #rapculture #rapmusic #interviews #chicago #chiraq #drillmusic #lacapone #rondonumbanine #tay600 #edai600
Edai600 speaks on everything from his early life growing up, the violence in Chicago, community service, what Chicago needs to help stop the violence, Tay600 "allegedly snitching, the internet paperwork, Tay600s VLAD TV Interview, Meeting Rondo Numba Nine, Cdai and Rondos controversial Zack TV1 interview, whether Rondo believes Tay600 snitched, meeting LA Capone, what type of person he was, the night he passed, if there is a beef with Tray Savage, his relationship with Chief Keef, Lil Reese, and Fredo Santana, plus much more Watch the interview on also! www.Youtube.com/Allforthecultureshow IG- @allforthecultureshow IG/Twitter/Snapchat-HipHopHandicap Check out the website to see the interviews and purchase our All For The Culture Logo TShirts www.all4theculture.com #allfortheculture #allforthecultureshow #allfortheculturepodcast #edai600 #hiphop #hiphoppodcast #chicago #drillrap #rappodcast #rapculture #rapmusic #interview #drillmusic
Vedolizumab as Induction and Maintenance Therapy for Crohn's Disease in Patients Naïve to or Who Have Failed Tumor Necrosis Factor Antagonist Therapy. Sands BE1, Sandborn WJ, Van Assche G, Lukas M, Xu J, James A, Abhyankar B, Lasch K. BACKGROUND: Vedolizumab is a gut-selective α4β7 integrin antagonist for the treatment of moderately to severely active Crohn's disease (CD). Aims of this study were to characterize the efficacy and safety of vedolizumab induction and maintenance therapy in patients who were naïve to tumor necrosis factor-alpha (TNF-α) antagonist therapy (TNF-naïve) or who had discontinued TNF-α antagonist therapy because of inadequate response (i.e., primary nonresponse), loss of response, or intolerance (collectively classified as the TNF-failure population). METHODS: Post hoc analyses of the efficacy data for 516 TNF-naïve and 960 TNF-failure patients from the GEMINI 2 and GEMINI 3 trials were evaluated at weeks 6, 10, and 52 and included clinical remission (CD Activity Index [CDAI] score ≤150), enhanced clinical response (≥100-point decrease from baseline in CDAI score), durable clinical remission (remission at ≥80% of visits), and corticosteroid-free remission. Adverse events were summarized for the TNF-naïve and TNF-failure subgroups by treatment received. RESULTS: Among patients who responded to vedolizumab induction at week 6, 48.9% ...
Vedolizumab as Induction and Maintenance Therapy for Crohn's Disease in Patients Naïve to or Who Have Failed Tumor Necrosis Factor Antagonist Therapy. Sands BE1, Sandborn WJ, Van Assche G, Lukas M, Xu J, James A, Abhyankar B, Lasch K. BACKGROUND: Vedolizumab is a gut-selective α4β7 integrin antagonist for the treatment of moderately to severely active Crohn's disease (CD). Aims of this study were to characterize the efficacy and safety of vedolizumab induction and maintenance therapy in patients who were naïve to tumor necrosis factor-alpha (TNF-α) antagonist therapy (TNF-naïve) or who had discontinued TNF-α antagonist therapy because of inadequate response (i.e., primary nonresponse), loss of response, or intolerance (collectively classified as the TNF-failure population). METHODS: Post hoc analyses of the efficacy data for 516 TNF-naïve and 960 TNF-failure patients from the GEMINI 2 and GEMINI 3 trials were evaluated at weeks 6, 10, and 52 and included clinical remission (CD Activity Index [CDAI] score ≤150), enhanced clinical response (≥100-point decrease from baseline in CDAI score), durable clinical remission (remission at ≥80% of visits), and corticosteroid-free remission. Adverse events were summarized for the TNF-naïve and TNF-failure subgroups by treatment received. RESULTS: Among patients who responded to vedolizumab induction at week 6, 48.9% ...
Vedolizumab as Induction and Maintenance Therapy for Crohn's Disease in Patients Naïve to or Who Have Failed Tumor Necrosis Factor Antagonist Therapy. Sands BE1, Sandborn WJ, Van Assche G, Lukas M, Xu J, James A, Abhyankar B, Lasch K. BACKGROUND: Vedolizumab is a gut-selective α4β7 integrin antagonist for the treatment of moderately to severely active Crohn's disease (CD). Aims of this study were to characterize the efficacy and safety of vedolizumab induction and maintenance therapy in patients who were naïve to tumor necrosis factor-alpha (TNF-α) antagonist therapy (TNF-naïve) or who had discontinued TNF-α antagonist therapy because of inadequate response (i.e., primary nonresponse), loss of response, or intolerance (collectively classified as the TNF-failure population). METHODS: Post hoc analyses of the efficacy data for 516 TNF-naïve and 960 TNF-failure patients from the GEMINI 2 and GEMINI 3 trials were evaluated at weeks 6, 10, and 52 and included clinical remission (CD Activity Index [CDAI] score ≤150), enhanced clinical response (≥100-point decrease from baseline in CDAI score), durable clinical remission (remission at ≥80% of visits), and corticosteroid-free remission. Adverse events were summarized for the TNF-naïve and TNF-failure subgroups by treatment received. RESULTS: Among patients who responded to vedolizumab induction at week 6, 48.9% ...
Vedolizumab as Induction and Maintenance Therapy for Crohn's Disease in Patients Naïve to or Who Have Failed Tumor Necrosis Factor Antagonist Therapy. Sands BE1, Sandborn WJ, Van Assche G, Lukas M, Xu J, James A, Abhyankar B, Lasch K. BACKGROUND: Vedolizumab is a gut-selective α4β7 integrin antagonist for the treatment of moderately to severely active Crohn's disease (CD). Aims of this study were to characterize the efficacy and safety of vedolizumab induction and maintenance therapy in patients who were naïve to tumor necrosis factor-alpha (TNF-α) antagonist therapy (TNF-naïve) or who had discontinued TNF-α antagonist therapy because of inadequate response (i.e., primary nonresponse), loss of response, or intolerance (collectively classified as the TNF-failure population). METHODS: Post hoc analyses of the efficacy data for 516 TNF-naïve and 960 TNF-failure patients from the GEMINI 2 and GEMINI 3 trials were evaluated at weeks 6, 10, and 52 and included clinical remission (CD Activity Index [CDAI] score ≤150), enhanced clinical response (≥100-point decrease from baseline in CDAI score), durable clinical remission (remission at ≥80% of visits), and corticosteroid-free remission. Adverse events were summarized for the TNF-naïve and TNF-failure subgroups by treatment received. RESULTS: Among patients who responded to vedolizumab induction at week 6, 48.9% ...
Vedolizumab as Induction and Maintenance Therapy for Crohn's Disease in Patients Naïve to or Who Have Failed Tumor Necrosis Factor Antagonist Therapy. Sands BE1, Sandborn WJ, Van Assche G, Lukas M, Xu J, James A, Abhyankar B, Lasch K. BACKGROUND: Vedolizumab is a gut-selective α4β7 integrin antagonist for the treatment of moderately to severely active Crohn's disease (CD). Aims of this study were to characterize the efficacy and safety of vedolizumab induction and maintenance therapy in patients who were naïve to tumor necrosis factor-alpha (TNF-α) antagonist therapy (TNF-naïve) or who had discontinued TNF-α antagonist therapy because of inadequate response (i.e., primary nonresponse), loss of response, or intolerance (collectively classified as the TNF-failure population). METHODS: Post hoc analyses of the efficacy data for 516 TNF-naïve and 960 TNF-failure patients from the GEMINI 2 and GEMINI 3 trials were evaluated at weeks 6, 10, and 52 and included clinical remission (CD Activity Index [CDAI] score ≤150), enhanced clinical response (≥100-point decrease from baseline in CDAI score), durable clinical remission (remission at ≥80% of visits), and corticosteroid-free remission. Adverse events were summarized for the TNF-naïve and TNF-failure subgroups by treatment received. RESULTS: Among patients who responded to vedolizumab induction at week 6, 48.9% ...
Dr. Clifton Bingham from the Johns Hopkins Arthritis Center begins with a review of current best practices, including the issues related to diagnosis. Dr. George Lawry will follow with an overview of the risks and benefits of biologic therapy for patients with RA before Dr. Bingham presents on emerging DMARDs.The second half of the nearly 2 hour presentation covers the subject of comorbidities, presented by Dr. Lawry, on how to recognize comorbidities and how to best manage them. Dr. Bingham will follow up with the presentation of two cases to offer a clinical perspective to recognizing and treating comorbidities.
Background: Crohn's disease (CD) patients with increased disease activity may reveal an increased risk for perioperative complications. The `Crohn's disease activity index' (CDAI) and the `Vienna classification' (VC) were developed for standardized disease activity estimations. The significance of these scores to predict extent, type and early outcome of surgery in CD patients was analyzed. Methods: In 179 surgically treated CD patients, the CDAI and VC were assessed from a prospective database. Relations of the scores with CD risk factors, type, number, location and complications of surgery were analyzed. Results: VC behavior and location subtypes were associated with distinct types of surgery (i.e. `strictureplasty' in `stricturing disease', `colon surgery' in `colon involvement'), but not with surgery type and extent or outcome. Surgery extent (i.e. with 5 vs. 3 `surgical sites' 425 +/- 25 vs. 223.3 +/- 25) and complications (357.1 +/- 36.9 (with) vs. 244.4 +/- 13 (without)) were associated with elevated CDAI levels; however, nicotine abuse remained the only significant risk factor for perioperative complications after multiple logistic regression. Conclusion: The significance of VC or CDAI for predicting the extent of surgery or complications is limited. None of the tested variables except preoperative nicotine abuse influenced the likelihood for perioperative complications. Copyright (c) 2006 S. Karger AG, Basel