October 26, 2026 1 min watch Add topic to email alerts Receive an email when new articles are posted on Please provide your email address to receive an email when new articles are posted on . “ data-action=”subscribe”> Subscribe We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com. Back to Healio Key takeaways: Thorough documentation should reflect clinicians’ clinical reasoning, including diagnoses considered and ruled out. Clinicians should also understand the difference between decision-making capacity and consent. LAS VEGAS — Physicians can mitigate their legal risk by documenting their clinical reasoning and staying informed about emerging medical-legal issues, a speaker at OMED said. Medical legal “is always a great topic for people to learn more” about, John R. Casey, DO, MA, FACOEP-D, director of medical education at OhioHealth Doctors Hospital, told Healio. Physicians can mitigate their legal risk by documenting their clinical reasoning and staying informed about emerging medical-legal issues, a speaker at OMED said. Image: Adobe Stock “It’s not meant to be scary. Some people think it’s a bit dry, but I think it’s interesting if you look at it with the same lens that you look at quality review,” Casey said. “If you think about it from the fact that we all do medicine, we’re always going to interact with the legal system. So, it’s important to know what’s changing in the medical legal world.” Healio spoke with Casey about strategies that can lessen the risk for legal action, how AI factors into medical-legal issues and more. Healio: What are the emerging and important areas of legal risk that clinicians should be aware of? Casey: Most physicians are aware of basic legal risk as the legal landscape, much like medicine, is slow to evolve. I think the areas that they need to focus on are good differentials, considering all factors for the patient and documentation that explains their decision-making. There’s a commonly held misconception that if you miss some kind of unicorn diagnosis out there, that you’re practicing bad medicine. That’s not what the data supports. The data really supports that it’s when something is not that rare of a diagnosis, but you didn’t consider it, or you did but you didn’t document very well. That’s what really gets people into legal trouble. Healio: How does emerging AI factor into the legal landscape? Casey: One of the newer areas that people have concerns about — and it’s an underdeveloped area because, again, the legal system moves very slowly — are AI scribes and recording, the use of technology for health system alerts and this technology in electronic medical records. The thing we need to think about in medicine is AI is designed to be a tool to help patients, and they do that by helping the physician do a better job. When you use the AI that’s available to you for the right thing, making sure that the physician is ultimately the person with oversight, that really is the safest way to protect yourself. You can get a lot more done a lot safer with having AI rather than without.  John R. Casey, DO, MA, FACOEP-D, held a talk at OMED about how physicians can mitigate legal risks. Healio: Are there any medical-legal principles you feel need better education and implementation? Casey: One of the biggest areas — and it’s interesting because it goes right to the root of something that we do in medicine all the time — is the difference between capacity and the ability to consent to things, and I think capacity in general is one of those ideas that seems easy to grasp, but it’s not really the same as competence, and that can really cause problems for people. You have the right in this country to make a poor decision, as long as you’re informed about the circumstances around that and are choosing to do that. Sometimes we forget that capacity can fluctuate. Someone can have capacity in certain domains, but not in others, and I think that unless you do a lot of work on this or have had recent education on it, some of the thoughts on it since your time in medical school or training have probably changed a bit, and it’s a topic worth revisiting. Healio: Do you have any basic tips for mitigating legal risk? Casey: The easiest way to mitigate risk is to do good medicine and document what you do. In your medical record, make sure that it’s clear what you thought things were and weren’t, what you considered and what you didn’t. A lot of times we just leave it to assume that everyone would know that’s something we would do, and unless you either ordered a test or documented that you thought about it, it really never makes its way in, and years down the road, you often would have a hard time justifying what you did or didn’t look for, particularly because when you’re playing the game with the final result, it’s a lot easier to question rulings on the play. For more information: John Casey, DO, MA, FACOEP-D, can be reached at primarycare@healio.com. Sources/Disclosures Source: Casey J. Medical legal you need to know. Presented at OMED; Oct. 22-25, 2026; Las Vegas. Disclosures: Casey reports no relevant financial disclosures. Ask a clinical question and tap into Healio AI’s knowledge base. PubMed, enrolling/recruiting trials, guidelines Clinical Guidance, Healio CME, FDA news Healio’s exclusive daily news coverage of clinical data Learn more Add topic to email alerts Receive an email when new articles are posted on Please provide your email address to receive an email when new articles are posted on . “ data-action=”subscribe”> Subscribe We were unable to process your

October is Breast Cancer Awareness Month. Twenty-nine was to be the first year of the rest of my life. I was active and healthy, an avid runner with a well-established career in healthcare. Newly engaged, Ryan and I were searching for our forever home and imagining what our future family may look like. One child? How about two? Yes, two! I’d always wondered what being a mom would be like. In no time, our venue was booked and our lives were on course to merge in the most perfect way. But all of that would come to a halt in January 2016 when I returned to the comfort of my living room couch from an outdoor cold-weather run, just a normal part of a normal day. I crossed my arms to warm up, almost as though I was hugging myself. Almost immediately, I felt something in my left breast that wasn’t there before, something that did not belong. Something … alarming. It was firm and nearly the size of a golf ball, not painful but strangely immovable. Recognizing this to be outside of what I knew to be normal for my body, I contacted my primary care physician’s office the next day, and I would find myself sitting nervously in her office the following morning. “Mindy, I’m concerned,” my PCP said quietly. She looked at me with compassion and paused. She’d been my trusted physician since high school, and I took her words seriously. “Just tell me what we need to do,” I said. She referred me to the breast clinic where I’d eventually receive the diagnostic imaging and biopsy that would confirm our worst fears: stage 2 breast cancer, with involvement of one lymph node. My prayers quickly shifted and I found myself hoping with everything I had that it wouldn’t spread before I could begin treatment. 2016 (Photo/Courtesy Mindy Miller) Over a decade before being of age to qualify for a routine screening mammogram, I found myself learning everything I could about what it meant to have breast cancer. I was the healthiest person — I knew until I wasn’t. As odd as it may sound, my first worries were not for my mortality but instead for my joy. After the initial shock and tears, I vowed that I wouldn’t let cancer steal my joy, nor Ryan’s. And instead of cancelling the dinner reservations we had hoped would be in celebration of good news, we made the decision to dress up and show up — the very same day that we received the news. While we were seated next to each other in the dimly lit Italian restaurant that evening, we revealed not only our fears and worries but also our hopes for how we might be able to move together through this ominous, overwhelming chapter of the unknown. Tears fell here and there, yet somehow, we found ways to smile and even laugh between them. My treatment plan included IV chemotherapy, a mastectomy, radiation, several breast reconstruction surgeries, and a total of nearly six years spent in medically induced menopause. You see, my body’s natural estrogen production was working against me. It was feeding the cancer, and that meant our chances of becoming parents were delayed. We didn’t lose hope, though. I chose to have only one breast removed in case I could still breastfeed someday. Not long after chemotherapy and my mastectomy, I would be declared cancer-free, and Ryan and I would marry just over a year later. We built our home in 2017, and in 2018, we began creating our farm, a place that would eventually become such a meaningful part of the life we were building together. Mindy and Ryan on their wedding day. (Photo/Courtesy Artefact Image Co., 2016) On paper, life looked much as we’d hoped. At the same time, I was lovingly watching my friends begin their families. One baby, then two. Sometimes three. I happily embraced their tiny human snuggles and I took joy in celebrating alongside them at their cutely themed birthday parties. What a gift it was to still be included in those special events even when I didn’t have similar milestones, myself. Even when I couldn’t relate. Instead, I was doing everything I could to manage the side effects of the medications I was receiving to keep my ovaries suppressed and my body in menopause — the hot flashes, extreme fatigue, difficulty sleeping, body aches, weight gain, and thinning hair and bones, with few effective ways to manage them. So, I leaned into gratitude for these options in recurrence risk reduction and I did the best I could to endure the years that would lead up to the day I’d complete my treatment course. The most triumphant milestone! However, even though my menstrual cycle soon returned and my oncologist gave us his blessing to begin our efforts with family planning, that positive pregnancy test never came. Even though we eventually received medical clearance to try, I think we had always carried a quiet feeling that having children might not be in the cards for us. While that did become our reality, we were already in the process of creating something beautiful: our life together. We leaned into a radical acceptance of sorts, a belief that if it was meant to be, it would be, and if it wasn’t, that was okay, too. Because a family doesn’t always have to be made up of the two-legged type. Mindy and one of her lambs. (Photo/Courtesy Mindy Miller, 2020) Our farm became a different kind of labor, a labor of love and a source of great meaning to us. What began as a hobby grew into something much bigger, giving us so many precious little friends to nurture. Today, we’re fortunate to call ourselves parents to numerous sheep, an alpaca, a llama, three miniature cows, three farm cats and one indoor dog. So many cold nights in the barn watching our sheep give birth to their lambs! How beautiful it

October 19, 2026 10 min read Add topic to email alerts Receive an email when new articles are posted on Please provide your email address to receive an email when new articles are posted on . “ data-action=”subscribe”> Subscribe We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com. Back to Healio Key takeaways: Musculoskeletal pain and injuries are common among ophthalmologists. Office layout, exercise and equipment all can improve physician ergonomics. Click here to read the At Issue to this Healio Exclusive, “Practice good ergonomics early in career to avoid work-related injuries.” For ophthalmologists, occupational pain can start early. Image: Courtesy of Sunir J. Garg, MD, FACS, FASRS For Cynthia Matossian, MD, FACS, discomfort arose fewer than 5 years into her career. She said surgeons often find themselves in similar positions over the course of their routine work, and repeated motions can wear people down. “There were two areas that I noticed were bothering me after being hunched over the slit lamp day in, day out, week in, week out, and after being in the OR for long days of surgery,” she said. “Those two areas were my neck and upper back area around my shoulder blades.” The discomfort got so bad that she knew if she did not address it, it could have a significant impact on her career. “I told myself, ‘I can’t go on like this,’” she said. “I need to help my body so that I can be an effective and healthy ophthalmologist for as long as possible.” Musculoskeletal pain and injuries are common among ophthalmologists. A 2025 literature review that included data from more than 3,200 ophthalmologists found that the average prevalence of work-related musculoskeletal disorders was about 63%, with neck, lower back and shoulder disorders most affected. The authors also found that more than 7% of ophthalmologists require spine surgery because of cervical spine disease related to disc herniation. Additionally, these disorders push about 13% of ophthalmologists to early retirement, according to the study. Cynthia Matossian When Matossian looked for solutions for her discomfort about 30 years ago, there was not much to work with because not many people talked about the problem, she said. “I started to do some research about it, and ergonomics was not a common topic back in the day,” she said. “It wasn’t discussed, it wasn’t talked about, and you just slouched over and did what you had to do to examine patients. Nobody paid attention to this area.” Deepinder K. Dhaliwal, MD, LAc, said ergonomic problems trace back to the physician’s mindset to put the patient and their comfort first. “We tell ourselves that the patient has to be comfortable, and we’ll withstand an uncomfortable position,” she said. “The problem is that because we do so many exams and so many surgeries in a career, all that poor posture and habits come back to haunt us.” Matossian agreed, saying physicians are taught to push through tough times, exhaustion and pain. “You’re sleepless, but you get through the night,” she said. “We just try to tough it out and power through whatever aches and pains we may be having. These are signs of your body telling you that it is not happy, and perhaps there are simple adjustments that can be made to alleviate those issues completely if you pay attention to them.” The early career experience of Eric D. Rosenberg, DO, was no different. When he started his internship, his first goals were not to hurt anyone else and to help patients. “From day 1 coming out the gate, we’re always inclined to take care of the person in front of us, never ourselves,” he said. “We frequently do it at the cost of ourselves. We don’t care about ourselves because we’ve been trained not to care about ourselves. All aspects of our lives have been trained and geared toward making sure that the people around us are better off than we are.” Common Mistakes When Dhaliwal works with young physicians, there are a few ergonomic issues that she spots right away, including their posture at the slit lamp, which was an issue early in her career. “I used to crane my neck forward, and it’s such a common thing that I see people do because they try to reach the patient,” she said. “The critical thing I do now is lift the patient’s chair up and slide my stool under the footrest so I can get close. I have the patient move to the edge of their seat so that they are leaning forward into the slit lamp, and I can keep my spine and neck straight. That has changed my life.” Dhaliwal said her goal is to keep her ears over her shoulders and ensure she is properly supporting her head when she is examining patients. “The typical head weighs 10 to 12 pounds, but if we flex forward 30°, which is not a lot, that effective weight on our cervical spine is 40 pounds” she said. “You can understand why even when you’re looking down at your phone for a long time, your neck can start to feel uncomfortable.” Sunir J. Garg, MD, FACS, FASRS, said a lot of ergonomic mistakes are caused by environmental factors, including a poor office setup. “Our profession, including our equipment, is set up for everything besides our ergonomic benefit,” he said. “If you walk into one of my exam rooms, I have the computer parallel to the wall on one side, and I have the patient chair at 90° in front of me; that setup is ergonomically not good. I’m trying to type while I rotate and turn my head toward the patient, which causes unnecessary stress on our neck and our back. That twisting motion is bad for a person’s spine.” Garg said common slit lamp setups are wrong

October 23, 2026 2 min read Add topic to email alerts Receive an email when new articles are posted on Please provide your email address to receive an email when new articles are posted on . “ data-action=”subscribe”> Subscribe We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com. Back to Healio Key takeaways: The FDA approved a subcutaneous induction regimen of risankizumab for adults with moderate to severe Crohn’s disease. Patients can now start induction therapy at home. The FDA has expanded its approval of Skyrizi to include subcutaneous induction for adults with moderately to severely active Crohn’s disease. Risankizumab (Skyrizi, AbbVie) was approved in 2022 for this patient population as an IV induction regimen followed by subcutaneous maintenance. The FDA has expanded its approval of Skyrizi to include subcutaneous induction for adults with moderately to severely active Crohn’s disease. The latest approval allows patients to start treatment from home with an on-body injector induction pack, according to a manufacturer release. Data from the phase 3 AFFIRM trial supported the approval, the release noted. Results showed nearly twice as many patients who received the subcutaneous induction regimen achieved clinical remission at week 12 when compared with placebo. “One of the things that we as gastroenterologists want to do is use the safest, most effective therapy to hopefully treat [inflammatory bowel disease] early, achieve mucosal healing and prevent need for surgery or other complications in our patients,” Millie D. Long, MD, MPH, FACG, professor of medicine at University of North Carolina School of Medicine and lead investigator of the AFFIRM trial, previously told Healio. “One of the things we have learned with this class of medicines — the [interleukin]-23 p19 agents — is they seem to be incredibly safe for advanced therapies and highly effective.” As Healio has reported, the AFFIRM trial investigated efficacy and safety of subcutaneous risankizumab induction in 289 adults with moderate to severe CD. All study participants had a confirmed diagnosis for at least 3 months prior to enrollment and Crohn’s Disease Activity Index scores ranging from 220 to 450 at baseline. Researchers randomly assigned patients 2:1 to receive a 720 mg subcutaneous risankizumab dose at baseline followed by either 720 mg doses at weeks 2, 5 and 8 (n = 191) or placebo (n = 98). At week 12, risankizumab outperformed placebo in clinical remission (55% vs. 29.6%; delta = 26.6; 95% CI, 15.6-37.6) and endoscopic response (44% vs. 14.3%; delta = 29.4; 95% CI, 19.9-38.9). Similar results were reported among patients who had not received prior advanced therapy (clinical remission, 73.1% vs. 27.3%; endoscopic response, 61.2% vs. 15.2%) and those who were intolerant or had inadequate response to other biologic therapies (clinical remission, 45.2% vs. 30.8%; endoscopic response, 34.7% vs. 13.8%). According to the release, the most common adverse events related to risankizumab are upper respiratory infections, headache, joint and abdominal pain, injection-site reactions, anemia, fever, back pain, urinary tract infection and rash. “People living with Crohn’s disease need treatments that can deliver meaningful disease control from the start,” Roopal Thakkar, MD, AbbVie’s chief scientific officer and executive vice president of research and development, said in the release. “With the approval of subcutaneous induction, we are building on the strong efficacy of Skyrizi while giving patients and physicians greater flexibility in how treatment is initiated.” Published by: Ask a clinical question and tap into Healio AI’s knowledge base. PubMed, enrolling/recruiting trials, guidelines Clinical Guidance, Healio CME, FDA news Healio’s exclusive daily news coverage of clinical data Learn more Add topic to email alerts Receive an email when new articles are posted on Please provide your email address to receive an email when new articles are posted on . “ data-action=”subscribe”> Subscribe We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com. Back to Healio Source link

October 19, 2026 3 min read Add topic to email alerts Receive an email when new articles are posted on Please provide your email address to receive an email when new articles are posted on . “ data-action=”subscribe”> Subscribe We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com. Back to Healio Click here to read the Healio Exclusive, “Practice good ergonomics early in career to avoid work-related injuries.” Now that I am in the middle of my career and approaching 51 years old, I feel like my body does not bounce back as well as it used to. I feel more tension in my back and sometimes in my shoulders. I used to be able to see patients all week, operate and feel great. I would not say I feel terrible at the end of the week, but I also know there has been a change over the last couple of years. As I have gotten more established in my career, I have gotten busier. I am doing longer surgery days and more cases, and that certainly plays a role. When I first started out, especially as someone in an academic setting, I was not super busy, and I had more time between cases. Now, I am jumping between rooms and always on the go on a surgical day. I have come to understand that ergonomics cannot be something I think about only during surgery. It has to be something that I am aware of all week long when I am seeing patients at the slit lamp, doing YAG lasers or performing other tasks. That all requires being mindful of ergonomics. Physicians are often making patients comfortable while making ourselves uncomfortable, but it is important to have a happy medium. I often ask patients to meet me in the middle and say, “Let’s make sure you’re as comfortable as you can be and I’m as comfortable as I can be so I can help you.” If they have trouble accommodating you, you can have family or a staff member help them sit up at the slit lamp so you are not overextending your neck and back. I try to be consistent with setup during surgery, including bed height, distance from me to the patient and distance from the oculars, but it can be a challenge. Not every patient can accommodate that. Recently, I had a patient whose cervical spine was completely fused, and in order to get him partially flat, we had to put him into the Trendelenburg position so his feet were up and his head was low. I was sitting low, and it was an awkward surgery to get through. Being more cognizant of my ergonomic habits in routine cases helped me to get through that case. One of the things that has made the biggest difference is finding out where the pain is coming from. A good friend is a physical therapist, and I had the chance to ask him why I was having so much lower back soreness and tightness. He told me it was my hips and gave me tips for stretches I could do. This helped me open up my hips and alleviate some of the tension. I should be doing this every day, and I try to do it at least a few times a week. There are some days that I come home and I will stretch while I am sitting and talking to my wife or watching a ball game. I will get on the floor in front of the TV and just do some stretches. Making that change has made a big difference in my lower back discomfort. I have also been trying to be more mindful as I get a little older by transitioning my exercise routine from more cardio to more strength training. I wanted to see if that helped me be a little more resilient, not just for work but for all aspects of life. As we get a little bit older, incorporating strength training is a way to maintain good health and longevity. When I work with young doctors, I try to impart that they have to develop these habits because it is not easy to fix the damage that can come from repetitive movements. For more information: Sumit “Sam” Garg, MD, a Healio | OSN Cataract Surgery Board Member, can be reached at gargs@hs.uci.edu. Published by: Sources/Disclosures Source: Healio Interviews Disclosures: Garg reports no relevant financial disclosures. Ask a clinical question and tap into Healio AI’s knowledge base. PubMed, enrolling/recruiting trials, guidelines Clinical Guidance, Healio CME, FDA news Healio’s exclusive daily news coverage of clinical data Learn more Add topic to email alerts Receive an email when new articles are posted on Please provide your email address to receive an email when new articles are posted on . “ data-action=”subscribe”> Subscribe We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com. Back to Healio Source link

October 23, 2026 2 min read Add topic to email alerts Receive an email when new articles are posted on Please provide your email address to receive an email when new articles are posted on . “ data-action=”subscribe”> Subscribe We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com. Back to Healio Key takeaways: Rates of clinical remission and endoscopic response and remission were higher with subcutaneous vs. IV infliximab in ileal-dominant CD. Additional prospective studies could confirm results. NASHVILLE, Tenn. — Patients with ileal Crohn’s disease had significantly better clinical and endoscopic outcomes at week 54 with subcutaneous vs. IV infliximab therapy, according to a presenter at ACG Annual Scientific Meeting. “Across every single endpoint, [subcutaneous maintenance] was better than IV maintenance for patients,” Marla C. Dubinsky, MD, codirector of the Susan and Leonard Feinstein Inflammatory Bowel Disease Clinical Center at Icahn School of Medicine, told attendees. Dubinsky emphasized the difficulties clinicians face when treating the ileal CD phenotype. Although surgical rates have decreased among patients with other types of inflammatory bowel disease — like ulcerative colitis — surgical rates for patients with ileal CD have yet to “catch up,” she said. “This is a very difficult-to-treat population, particularly [patients with] isolated ileal disease, just because of the [disease’s] fibrotic nature,” Dubinsky said. “We are typically operating.” Dubinsky and colleagues compared the efficacy of subcutaneous infliximab (Zymfentra, Celltrion) and IV infliximab (Remicade; Janssen, Johnson & Johnson) to determine whether patients with ileal CD “may preferentially respond better to one type of infliximab delivery over the other.” They collected data from four registrational trials for both subcutaneous and IV infliximab. A total of 200 patients across the trials met inclusion criteria, which included ileal or ileocolonic disease and treatment with IV infliximab 5 mg/kg every 8 weeks (n = 104) or subcutaneous infliximab at 120 mg every 2 weeks (n = 96). The pooled dataset was generally balanced by demographics and disease characteristics, although more patients treated with IV infliximab received immunomodulators at baseline (54.8% vs. 33.3%). The dataset remained well balanced after 1:1 propensity-score matching (total, n = 140). Dubinsky and colleagues assessed clinical remission and endoscopic response and remission in both unmatched and matched populations. Week 54 data showed patients in the unmatched population who received subcutaneous infliximab achieved significantly higher rates of clinical remission (76% vs. 55.8%, P = .003), endoscopic response (66.7% vs. 32.7%, P < .001) and endoscopic remission (41.7% vs. 18.3%, P < .001) than those who received IV infliximab. Outcomes were similar in the matched population, with subcutaneous infliximab achieving higher rates of clinical remission (71.4% vs. 51.4%, P = .023), endoscopic response (65.7% vs. 27.1%, P < .001) and endoscopic remission (41.4% vs. 17.1%, P = .003). Subgroup analysis of patients with ileal disease in the matched population showed subcutaneous infliximab outperformed IV infliximab in endoscopic response (52.2% vs. 18.2%, P = .029) and endoscopic remission (47.8% vs. 18.2%, P = .057). Rates of clinical remission also were higher with subcutaneous delivery, but did not meet statistical significance. Serum concentrations of infliximab were significantly higher among endoscopic responders than nonresponders with both subcutaneous and IV delivery. “This requires a lot more exploration and bigger [study populations],” Dubinsky said. “It was nice to see that we may have something that may have improved efficacy in isolated ileal disease when it comes to endoscopy, which is our most objective endpoint.” Additional prospective studies are needed to validate these results, the researchers noted. “As we think about how to position therapies, we need to think about phenotypes that may drive which treatment you should choose first or second based on [patients’] disease characteristics,” Dubinsky told attendees. Published by: Sources/Disclosures Source: Colombel J, et al. Comparative efficacy of subcutaneous vs intravenous infliximab in Crohn’s disease with ileal involvement: A pooled analysis and propensity score-matched analysis of infliximab registrational studies. Presented at: ACG Annual Scientific Meeting; Oct. 12-14, 2026; Nashville, Tenn. (hybrid meeting). Disclosures: Dubinsky reports advisory or consulting roles with AbbVie, Abivax, Amgen, AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Celltrion, Eli Lilly & Co, Genentech, Janssen, Johnson & Johnson, Merck, Novartis, Pfizer, Prometheus Labs, Sanofi, Spyre Therapeutics, Takeda Pharmaceuticals and Tentarix Biotherapeutics. Please see the study for all other authors’ relevant financial disclosures. Ask a clinical question and tap into Healio AI’s knowledge base. PubMed, enrolling/recruiting trials, guidelines Clinical Guidance, Healio CME, FDA news Healio’s exclusive daily news coverage of clinical data Learn more Add topic to email alerts Receive an email when new articles are posted on Please provide your email address to receive an email when new articles are posted on . “ data-action=”subscribe”> Subscribe We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com. Back to Healio Source link

October 23, 2026 4 min read Add topic to email alerts Receive an email when new articles are posted on Please provide your email address to receive an email when new articles are posted on . “ data-action=”subscribe”> Subscribe We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com. Back to Healio Key takeaways: ASH released new guidelines to improve iron deficiency diagnosis. Higher serum ferritin thresholds for multiple at-risk groups are intended to overcome variations in testing and diagnostic criteria. ASH has released new clinical practice guidelines designed to improve diagnosis of iron deficiency, the most common nutritional deficiency in the world. The guidelines recommend higher thresholds of serum ferritin — a protein that stores iron in cells — to improve diagnosis in multiple at-risk populations. Data derived from Powers J, et al. Blood Adv. 2026;doi:10.1182/bloodadvances.2025015950. The goal is to overcome variations in testing practices and diagnostic criteria to increase the likelihood that iron deficiency is identified earlier and more accurately, regardless of whether anemia is present. Angela C. Weyand “This condition affects billions of people worldwide. We know it can cause debilitating symptoms, and there are inexpensive, readily available medications to treat it, yet we’re not really doing anything about it,” guideline co-author Angela C. Weyand, MD, pediatric hematologist and clinical professor of pediatrics at University of Michigan Medical School, told Healio. “It is underdiagnosed, undertreated and understudied. In that sense, these guidelines are a huge step forward.” A problem before anemia Iron plays an essential role in hemoglobin production. It also regulates the immune system and supports brain function, according to background information provided in the guideline. About 14% of U.S. adults have absolute iron deficiency, meaning the body has run out of stored iron, according to a study by Tawfik and colleagues. Another 15% have functional iron deficiency, meaning sufficient iron is stored but it is trapped by inflammation, reducing the body’s ability to use it, the researchers continued. Guideline study background also specified that children and individuals who are pregnant or menstruating are at elevated risk, as are people with dietary restrictions, blood loss, or chronic conditions such as heart failure, kidney disease, inflammatory bowel disease or cancer. However, the majority of cases in high-risk populations go undiagnosed, Weyand said. If untreated, it can progress to iron deficiency anemia, which impairs oxygen transport in the body and can lead to life-threatening complications. “In medical school, most physicians learned about iron deficiency in the context of anemia,” Weyand said. “But iron plays so many other important roles in the body, and people don’t become anemic until they are severely iron deficient. There hasn’t been enough focus on the problems this can cause long before patients become anemic.” Several factors may contribute to underdiagnosis, Weyand said. Symptoms of iron deficiency — which include extreme fatigue, rapid heartbeat, shortness of breath, pale skin or headaches — can overlap with other conditions or may be attributed to psychosocial causes. Lack of consensus recommendations also has a role, Weyand said, noting neither the U.S. Preventive Services Task Force nor American College of Obstetricians and Gynecologists recommend iron screening during pregnancy. Higher ferritin thresholds Even when screening is performed, the ferritin thresholds used to diagnose iron deficiency vary widely. CDC and WHO use 15 ng/mL as the diagnostic threshold, but some physiologic studies of iron status and metabolism demonstrated thresholds of 25 ng/mL to 30 ng/mL — and possibly as high as 50 ng/mL — offer greater sensitivity. The ASH guidelines aim to provide some clarity by issuing conditional recommendations that suggest higher diagnostic serum ferritin thresholds for high-risk groups, including: 20 ng/mL or lower for children ages 9 months to 4 years, instead of 12 ng/mL or lower; 30 ng/mL or lower for adults and pregnant/menstruating individuals, instead of 15 ng/mL or lower; 50 ng/mL or lower for high-risk groups, such as those with heavy menstrual bleeding or pregnant individuals with anemia. Adults with inflammation — including those with infectious disease, cancer or inflammatory bowel disease — also are at risk. However, because inflammation is on a continuum, establishing a serum ferritin threshold for iron deficiency diagnosis has proved challenging. The guidelines recommend using a serum ferritin threshold of 100 ng/mL or lower, or a transferrin saturation below 20% for this group. Guideline authors emphasized the need for more evidence to strengthen the current conditional recommendations. Ideally, they would have found evidence to support thresholds of 50 ng/mL for all at-risk groups, Weyand said. “Because this topic has been underfunded and understudied for so long, we did not have the quality of evidence or caliber of studies needed to support that,” she said. “Another challenge is that we are relying on ferritin. It is the best option we have but, like most of our markers, it is imperfect. We are measuring what we can in the blood, but iron is important in so many different tissues and organs in our body. We don’t know anything about what iron is getting to our brain or to our muscles.” ‘No downside to checking’ An important next step will be spreading awareness in the clinical community about the ASH guidelines, as well as American Academy of Pediatrics guidelines issued earlier this year that recommend universal iron deficiency and iron deficiency anemia screening for all menstruating adolescent females who are at least 1 year post menarche, with screening to be done by age 14 years. “The biggest takeaway for the clinical community is how prevalent this is, and remembering iron is important to consider before anemia develops,” Weyand said. Clinicians should be mindful that widely used reference levels are “suboptimal,” Weyand said. This means some patients who previously underwent ferritin tests that did not identify them as iron deficient now may meet the more stringent criteria. She also emphasized ferritin is not a standard component of complete blood count (CBC),

HealthyWomen welcomes the Administration’s recent announcement of an Executive Order that would establish a new women’s health division within the National Institutes of Health, create a White House Women’s Health Task Force and coordinate a comprehensive approach to women’s health across all stages of life. Meaningfully advancing women’s health will take sustained commitment and collaboration across government, the healthcare community and the organizations that serve women. This order is an important step in mobilizing federal agencies around women’s health, and it builds on longstanding bipartisan efforts. As the White House Women’s Health Task Force convenes, we look forward to it translating the Order’s priorities into meaningful action, fostering collaboration, and identifying opportunities to strengthen research, innovation, education and access to care. For nearly 40 years, HealthyWomen has been a trusted voice in advancing women’s health, and we stand ready to work with the Administration to further our shared priority to improving women’s health across the lifespan. Source link

October 22, 2026 3 min read Add topic to email alerts Receive an email when new articles are posted on Please provide your email address to receive an email when new articles are posted on . “ data-action=”subscribe”> Subscribe We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com. Back to Healio Key takeaways: Tegoprazan 50 mg and 100 mg outperformed placebo in 24-hour and nighttime heartburn frequency, as well as in days without regurgitation. Results persisted through 20 weeks. NASHVILLE, Tenn. — Tegoprazan demonstrated significant improvements in 24-hour and nighttime heartburn among patients with nonerosive reflux disease, with numerical differences from placebo as early as day 1, according to a presenter. Study results presented at ACG Annual Scientific Meeting also showed once-daily tegoprazan — a rapid-onset potassium-competitive acid blocker, or P-CAB, with sustained acid control —improved regurgitation over the 4-week treatment period. Ronnie Fass, MD, MACG, speaks at the podium at ACG Annual Scientific Meeting. Photo: Heather Biele. Nearly 70% of patients with GERD present with nonerosive reflux disease (NERD), according to study background. However, symptom relief reaches only about 50% with standard-dose proton pump inhibitors, the researchers wrote. “NERD can be particularly challenging because many patients continue to experience symptoms despite available therapy, and those symptoms aren’t limited to daytime heartburn,” Ronnie Fass, MD, MACG, medical director of the Digestive Health Center at MetroHealth in Cleveland, told Healio regarding the presentation. “Regurgitation and overnight heartburn can also be major contributors to symptom burden.” Fass and colleagues conducted a phase 3, multicenter trial to evaluate the efficacy and safety of tegoprazan vs. placebo among adults with symptomatic NERD. Eligible participants had at least a 6-month history of heartburn, normal esophageal mucosa on endoscopy and heartburn duration on at least 4 of 7 consecutive days. The researchers enrolled 783 patients who were randomly assigned to tegoprazan 50 mg (n = 259), 100 mg (n = 262) or placebo (n = 262) for weeks 1 to 4. An extension phase followed from weeks 5 to 24, in which patients assigned tegoprazan 50 mg (n = 231) or 100 mg (n = 228) continued treatment, and those assigned placebo switched to tegoprazan 50 mg (n = 115) or 100 mg (n = 123). Demographics were balanced across groups (mean age, 51-52.7 years; women, 65%-74%), as was heartburn severity score (mean, 1.5-1.6). The percentage of 24-hour days without heartburn through week 4 served as the primary endpoint. Other endpoints included percentage of days without overnight heartburn, regurgitation or both. Tegoprazan outperformed placebo in percentage of 24-hour heartburn-free days at both 50 mg (26.2% vs. 17.3%, P = .0006) and 100 mg doses (30.1% vs. 17.3%, P < .0001), for improvements over placebo of 51% and 74%, respectively. Results for percentage of regurgitation-free days were similar, with tegoprazan 50 mg besting placebo by 35% (31.9% vs. 23.6%, P = .0012) and tegoprazan 100 mg outperforming placebo by 43% (33.8% vs. 23.6%, P < . 0001). Both 50 mg and 100 mg tegoprazan doses also increased the percentage of days without daytime heartburn (36% and 38.4% vs. 27.4%) and nighttime heartburn (36.1% and 39.9% vs. 27%), as well as days without both heartburn and regurgitation (24.5% and 27% vs. 15.3%). “Numerical differences from placebo were apparent from day 1, and symptom control continued through the 20-week extension phase,” Fass said. “That provides a more complete picture of symptom control and better reflects what we see in clinical practice than looking at heartburn alone.” The percentage of 24-hour heartburn-free days increased among patients who continued tegoprazan 50 mg (47.8%) and 100 mg (50.4%) in the extension phase, as did those of patients who switched from placebo to 50 mg (40.2%) or 100 mg (48.3%). The researchers noted that mean gastric levels increased during both trial phases but remained within normal limits and returned to baseline levels with 2 weeks of treatment discontinuation. Treatment-emergent adverse events during the first 4 weeks were similar across groups, ranging from 22.9% with placebo and tegoprazan 100 mg to 27% with tegoprazan 50 mg. Fass emphasized that these patients had frequent NERD symptoms —6% to 8% 24-hour heartburn-free days at baseline — which should be considered when reviewing these results and comparing outcomes across other NERD trials. Still, “these data add to the evidence for tegoprazan across both erosive and nonerosive manifestations of GERD,” Fass told Healio. “If approved, tegoprazan could provide another option for clinicians seeking rapid and more comprehensive symptom control in patients with NERD.” For more information: Ronnie Fass, MD, MACG, is director of gastroenterology and hepatology at MetroHealth and professor of medicine at Case Western Reserve University School of Medicine. He can be reached at gastroenterology@healio.com. Published by: Sources/Disclosures Source: Fass R, et al. Tegoprazan significantly improves heartburn and regurgitation in a randomized, double-blind, placebo-controlled phase 3 study in patients with nonerosive reflux disease. Presented at: ACG Annual Scientific Meeting; Oct. 12-14, 2026; Nashville, Tenn. (hybrid meeting). Disclosures: Fass reports an advisory or review panel role with Braintree Laboratories/Sebela Pharmaceuticals. Please see the study for all other authors’ relevant financial disclosures. Ask a clinical question and tap into Healio AI’s knowledge base. PubMed, enrolling/recruiting trials, guidelines Clinical Guidance, Healio CME, FDA news Healio’s exclusive daily news coverage of clinical data Learn more Add topic to email alerts Receive an email when new articles are posted on Please provide your email address to receive an email when new articles are posted on . “ data-action=”subscribe”> Subscribe We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com. Back to Healio Source link

October 22, 2026 3 min read Add topic to email alerts Receive an email when new articles are posted on Please provide your email address to receive an email when new articles are posted on . “ data-action=”subscribe”> Subscribe We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com. Back to Healio Key takeaways: Tezepelumab outperformed placebo in histologic and endoscopic outcomes at weeks 24 and 52. Improvement in dysphagia symptoms also was higher through week 52 in the treatment group. NASHVILLE, Tenn. — Tezepelumab significantly improved histologic remission and dysphagia symptoms at 24 and 52 weeks compared with placebo among individuals with eosinophilic esophagitis, according to a presenter. Thymic stromal lymphopoietin (TSLP), an antibody, is associated with EoE pathogenesis. Evan S. Dellon, MD, MPH, FACG, discusses study results at ACG Annual Scientific Meeting. Photo by: Octavia Feliciano. “Food allergens and environmental factors interact with the epithelium of the esophagus and release alarmins, of which TSLP is one,” Evan S. Dellon, MD, MPH, FACG, director of the Center for Esophageal Diseases and Swallowing at University of North Carolina at Chapel Hill, told attendees at ACG Annual Scientific Meeting. “TSLP then polarizes T cells and other new cells to start the typical T2 inflammatory cascade with cytokines like [interleukin]-4 and IL-13, that ultimately lead to the downstream effector cells that cause the clinical manifestations and esophageal changes. “Elevated expression of TSLP has been observed in patients with EoE,” Dellon added. “Tezepelumab is a human monoclonal antibody that blocks the activity of TSLP and is approved for treatment of asthma and chronic rhinosinusitis with nasal polyposis, but it’s never been studied for EoE.” Dellon and colleagues enrolled 365 individuals aged 12 to 80 years (mean age, 35.3 years; 68.8% male) with symptomatic and histologically active EoE in a multicenter, randomized, double-blind, placebo-controlled phase 3 study to evaluate efficacy and safety of tezepelumab (Tezspire; AstraZeneca, Amgen) in this patient population. All participants had documentation of previous standard of care therapy. “This was a highly inflamed group,” Dellon said. “They were highly symptomatic by the [Dysphagia Symptom Questionnaire], and they had high degrees of endoscopic and histologic severity.” The researchers randomly assigned patients to receive placebo (n = 121) or tezepelumab 210 mg (n = 122) or 420 mg (n = 122) subcutaneously every 4 weeks for 52 weeks. Histologic remission and change from baseline in Dysphagia Symptom Questionnaire (DSQ) score at week 24 served as primary endpoints, while change from baseline in EoE Endoscopic Reference Score (EREFS) at week 24 was a key secondary endpoint. Prior treatments and baseline characteristics were balanced between groups, with DSQ scores ranging from 37.2 to 37.9, and EREFS from 7.5 to 7.6. Tezepelumab outperformed placebo at week 24, with more patients achieving histologic remission in the 210 mg (64.8% vs 3.5%; difference = 60.5; 95% CI, 51.1-69.8) and 420 mg groups (68.9% vs 3.5%; difference = 65.8; 95% CI, 56.8-74.7). Results were sustained through week 52 (tezepelumab 210 mg: 67.8% vs. 5.4%; tezepelumab 420 mg: 63.3% vs. 5.4%). Tezepelumab also improved dysphagia symptoms compared with placebo at week 24, with a difference of –4.1 (95% CI, –8.12 to 0) in the 210 mg group and –7.3 (95% CI, –11.3 to –3.3) in the 420 mg group. These results were sustained through week 52 (210 mg: difference, –8.9; 420 mg: difference, –10.8). “There was a significant, statistically and clinically meaningful improvement in dysphagia symptoms for both doses compared to the placebo,” Dellon said. “And as we continue on through the 52-week double-blind phase, there is ongoing improvement in symptoms.” Tezepelumab significantly improved EREFS compared with placebo at week 24, as well, with differences of –3.4 (95% CI, –4 to –2.7) in the 210 mg group and –3.4 (95% CI, –4.1 to –2.8) in the 420 mg group. Data presented the following week at United European Gastroenterology Week showed that these benefits were sustained through week 52. Tezepelumab also appeared well tolerated, with similar incidences of adverse events between treatment and placebo groups. “Tezepelumab provides clinical benefit in adults and adolescents with active EoE,” Dellon told attendees. “Specifically, the CROSSING trial met both coprimary endpoints, with tezepelumab every 4 weeks demonstrating statistically significant and clinically meaningful improvements in histologic remission and dysphagia symptom scores vs. placebo at weeks 24 and 52.” Published by: Sources/Disclosures Source: Dellon ES, et al. Efficacy and safety of tezepelumab in adults and adolescents with eosinophilic esophagitis: Results from the phase 3 CROSSING study. Presented at: ACG Annual Scientific Meeting; Oct. 12-14; Nashville, Tenn. (hybrid meeting). Reference: Disclosures: Dellon reports consulting roles with and/or research support from AbbVie, Adare Pharma Solutions, Alfasigma, Alimentiv, ALK, Allakos, Amgen, AnaptysBio, Apogee Therapeutics, Apollo, Aqilion, Arena Pharmaceuticals, AstraZeneca, Bethanamist, BioCryst, Bristol Myers Squibb, Bryn, Calypso, Calyx, Celgene, Celldex, Cyted, Domain, Dr. Falk Pharma, Eli Lilly & Co., Ellodi Pharmaceuticals, EsoCap Biotech, Eupraxia, Ferring Pharmaceuticals, First Tracks Biotherapeutics, GI Reviewers, GSK, Holoclara, Immunology Uniquity, Johnson & Johnson, Knightpoint, Kymera, Lucid Diagnostics, Meritage, Miraca Life Sciences, NexStone Innovation, Noa, Nutricia, Parexel, Pfizer, Phathom Pharmaceuticals, Receptos, Regeneron Pharmaceuticals, Revolo, Robarts, Roivant, Sanofi Pharmaceuticals, Shire, Takeda Pharmaceuticals, Target RWE, Third Harmonic Bio and Uniquity Bio. He also reports educational grants from Allakos, Aqilion, Holoclara and Invea. Please see the study for all other authors’ relevant financial disclosures. Ask a clinical question and tap into Healio AI’s knowledge base. PubMed, enrolling/recruiting trials, guidelines Clinical Guidance, Healio CME, FDA news Healio’s exclusive daily news coverage of clinical data Learn more Add topic to email alerts Receive an email when new articles are posted on Please provide your email address to receive an email when new articles are posted on . “ data-action=”subscribe”> Subscribe We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com. Back to Healio Source link