Latest news with #adverseevents
Medscape
23-05-2025
- Health
- Medscape
Can Nivolumab Maintain AML Remission?
In a randomized phase 2 study of 79 patients with acute myeloid leukemia (AML) in first complete remission, nivolumab maintenance therapy did not improve progression-free survival (13.2 vs 10.9 months) or overall survival (53.9 vs 30.9 months) compared with observation. Adverse events were more frequent in the nivolumab arm, with 71% experiencing grade ≥ 3 events vs 12% in the observation arm. METHODOLOGY: A multicenter, open-label, randomized phase 2 trial enrolled 79 patients with AML in first complete remission or complete remission with incomplete hematologic recovery who were not candidates for stem cell transplant. Participants were randomized to either observation or nivolumab arm (3 mg/kg intravenously every 2 weeks for 46 doses), with a median follow-up duration of 24 months. Primary endpoint was progression-free survival, defined as time to disease relapse or death, while secondary endpoints included overall survival and evaluation of adverse events. Analysis included measurement of measurable residual disease (MRD) through ultrasensitive duplex DNA sequencing in 55 patients and targeted RNA sequencing in two patients before randomization. TAKEAWAY: Median progression-free survival duration was 13.2 months (95% CI, 8.5-21.8) in the nivolumab arm vs 10.9 months (95% CI, 5.4-14.9) in the observation arm (hazard ratio [HR], 0.92; 95% CI, 0.54-1.56; P = .38). = .38). Overall survival analysis showed median survival duration of 53.9 months (95% CI, 23.4 to not estimable) in the nivolumab arm vs 30.9 months (95% CI, 14.4 to not estimable) in the observation arm (HR, 0.78; 95% CI, 0.40-1.51; P = .23). = .23). Adverse events of grade ≥ 3 occurred in 71% of nivolumab-treated patients compared with 12% of patients in the observation arm ( P < .001), with fatigue (42%), hypertension (37%), and diarrhea (34%) being most common. < .001), with fatigue (42%), hypertension (37%), and diarrhea (34%) being most common. MRD positive patients showed significantly higher relapse rates at 2 years (74% vs 37%; P = .046) and decreased progression-free survival (21% vs 63%; P = .032) than MRD negative patients. IN PRACTICE: 'With negative results using checkpoint inhibitors alone (or in combination with HMA [hypomethylating agent]), now in both the MRD setting and in the front line, the utility of targeting the PD1-PDL1 [programmed cell death 1–programmed death ligand 1] pathway in unselected AML appears limited…. It remains possible that further correlatives studies might identify a subset of patients with AML who may responses to immune checkpoint inhibition,' wrote the authors of the study. SOURCE: The study was led by Athalia Pyzer and Hongtao Liu, The University of Chicago in Chicago. It was published online on May 13 in Blood Advances . LIMITATIONS: According to the authors, subgroup analysis in the cohort of MRD positive patients did not demonstrate any effect of nivolumab on clinical outcomes, but these comparisons were underpowered. The researchers noted that other immune escape mechanisms, even beyond checkpoint pathways, likely contribute to the persistence of this disease. DISCLOSURES: The study was supported by the Intramural Research Program of the National Heart, Lung, and Blood Institute, a University of Chicago Comprehensive Cancer Center pilot grant, the Ullman Scholar Award, and the Elsa U. Pardee Foundation. Additional disclosures are noted in the original article.
Washington Post
12-05-2025
- Health
- Washington Post
Digging into the math of a study attacking the safety of the abortion pill
The Ethics and Public Policy Center, a think tank that says it opposes 'the extreme progressive agenda while building consensus of conservatives,' recently issued a report on a key abortion medication, mifepristone, that it says raises questions about its safety. After analyzing insurance claims for more than 865,000 prescribed mifepristone abortions, the group said it had determined that almost 11 percent of women experienced a 'serious adverse event,' much higher than an overall 0.5 percent rate found in clinical studies.
Fox News
06-05-2025
- Health
- Fox News
Experts sound the alarm over 'shocking' study showing significant risks to women who take abortion pills
A new study exposing a significant number of "serious adverse events" occurring among women who have taken mifepristone, also known as the "abortion pill," has sparked an outcry from the pro-life community, including experts who spoke to Fox News Digital about what the study means for women in the United States. "The biggest thing that will shock most readers of this report is just how different the findings in this study are from what the FDA claims on the abortion drug label," Katie Glenn Daniel, SBA Pro Life America director of legal affairs, told Fox News Digital about the recently released study. "What they found is that more than one in ten women will go to the emergency room seeking follow-up care after taking the abortion drugs. The FDA claims that's more like one in 20 women, which is still concerning, right? If you've got a one in twenty chance of something happening, you might take that seriously, but one in 10. It is shocking," she continued. "This means hundreds of thousands of American women have gone to the hospital for complications from abortions through these abortion drugs and the FDA was not collecting information about those situations. So this study shines a light on what has been happening, what ER doctors certainly know is happening. But what our public health institutions have turned a blind eye to." Mifepristone is a "pregnancy blocker" that is used in combination with another medication, misoprostol, to terminate pregnancies, according to Mayo Clinic. It is also used to manage early miscarriages, as it helps prepare the body to empty the uterus. ROE V. WADE IS GONE, BUT ABORTION STILL THE NUMBER 1 KILLER WORLDWIDE Research by the Ethics & Public Policy Center in Washington, D.C., has revealed that the rate of serious side effects is 22 times higher than what is indicated on the FDA-approved drug label. After going through an abortion assisted by mifepristone, nearly 11% of women — more than one in 10 — reported experiencing "infection, hemorrhaging, or another serious or life-threatening adverse event," according to the study summary. "These reports, which analyzed the largest known data set of real-world mifepristone use, confirm what physicians like me and our members are seeing in our clinical practice: that abortion drugs pose significant dangers to women," Dr. Christina Francis, a board-certified OB/GYN, told Fox News Digital. "I have had patients face life-threatening hemorrhage, infection, and more after taking these drugs, which are now available to order online without an in-person physician visit to confirm the age of the pregnancy and rule out risk factors. The fact that these data show a serious complication rate that is 22 times higher than what the FDA states reveals the urgent need for further investigation into complications of drug-induced abortions and for policymakers and agencies to reprioritize women's safety over the interests of the abortion industry. Women and their children deserve better care than these dangerous drugs." SCOOP: REPUBLICANS DISCUSS DEFUNDING 'BIG ABORTION' LIKE PLANNED PARENTHOOD IN TRUMP AGENDA BILL Mifepristone, which the Biden administration took steps to ensure was made available to women through the mail, is the most well-known abortion pill in the United States, and approximately 63% of all abortions in the U.S. in 2023 were medication abortions, according to the Guttmacher Institute. This was an increase from 53% in 2020. "We knew that the Biden administration's changes to the abortion drug prescribing, which included allowing these drugs to be sent through to mail. We knew that that was harmful for women and girls because there is no medical oversight," Daniel told Fox News Digital. "You don't even know if a pregnant woman's getting these drugs. There have been cases where men order these drugs, to slip them to somebody. The state of Louisiana has a case right now where a mother ordered them and forced her daughter to take them, even though the pregnancy was wanted. So you really lose a lot of the safeguards that are in place when somebody actually physically goes to a doctor's office." Daniel told Fox News Digital she hopes this report will encourage the Trump administration's FDA to take action to ensure that women and unborn children are protected. CLICK HERE TO GET THE FOX NEWS APP "A drug that puts one in ten women in the hospital is certainly not a drug that is quote unquote good for women or caring for women and I think we need to be realistic about that," Daniel said. Daniel also explained that the true harm from the pill is likely even worse than the study only includes certain years and only women who used insurance. "So there are tons of women, including those who are the most vulnerable, who are left out of this data," Daniel pointed out. "There is a lot more to look out here," Daniel continued. "We see this as the starting point of what the FDA, the CDC, our public health institutions, and our physicians need to be looking at. And we need to have an honest conversation about the fact that 20 years of data shows that these drugs are deadly for children, but they're also very dangerous for in girls." Fox News Digital's Melissa Rudy contributed to this report
