October 21, 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 Hibsago as the first antisense therapy for chronic hepatitis B in adults without cirrhosis. Data from two phase 3 trials showed a functional cure rate of 19% following 6 months of treatment. The FDA approved bepirovirsen as the first antisense oligonucleotide for chronic hepatitis B virus infection, alongside existing antiviral therapy for eligible adults without cirrhosis. Bepirovirsen (Hibsago, GSK) is indicated for adults who have taken HBV antiviral therapy for at least 6 months, have suppressed levels of HBV and have hepatitis B surface antigen levels of 3,000 IU/mL or less. The FDA approved bepirovirsen as the first antisense oligonucleotide for chronic hepatitis B virus infection, alongside existing antiviral therapy for eligible adults without cirrhosis. The FDA based its decision on data from phase 3 B-Well 1 and B-Well 2 trials, which showed that 6 months of bepirovirsen treatment achieved functional cure in 19% of patients, compared with none who received placebo. “This is the start of a new era in treating people living with [chronic hepatitis B],” Norah Terrault, MD, MPH, chief of gastroenterology and hepatology at USC Keck Medical Center, said in a manufacturer press release. “Bepirovirsen offers patients the potential to achieve functional cure after a short period of treatment, a long-standing goal for patients and physicians alike.” In both B-Well 1 and B-Well 2 trials, researchers randomly assigned adults with chronic hepatitis B and a baseline HBsAg level of 3,000 IU/mL or less to receive bepirovirsen (n = 1,220) or placebo (n = 614). Patients received subcutaneous bepirovirsen for up to 24 weeks alongside their existing HBV therapy, which continued for at least 24 weeks after the final bepirovirsen injection. Achieving functional cure served as the primary endpoint in both trials. According to results from both trials, 24% of patients who received bepirovirsen met the criteria to discontinue their existing antiviral therapy compared with none in the placebo groups. At 24 weeks, 19% of patients treated with bepirovirsen had achieved clinically meaningful functional cure, compared with none who received placebo. Among patients with no more than 1,000 IU/mL HBsAg levels, 26% in the bepirovirsen group achieved functional cure vs. none in the placebo group. The FDA also approved Roche’s Elecsys HBsAg II quant II RxDx assay as a companion diagnostic to help identify eligible patients for bepirovirsen treatment. No new safety signals were reported in the B-Well 1 and B-Well 2 trials, and the safety profile for bepirovirsen remained consistent with previous studies. “For many people living with chronic hepatitis B, treatment can mean taking antiviral medication for years to keep the virus suppressed,” Wendy Carter, DO, acting director of the Office of Infectious Diseases at FDA’s Center for Drug Evaluation and Research, said in an FDA release. “Hibsago provides a new treatment approach that gives some patients the possibility of maintaining control of the virus after all chronic HBV treatment has ended. This approval represents an important advance for people living with this serious disease.” The most common adverse events included injection-site erythema and pain, fever, fatigue, headache and a temporary rise in liver enzyme levels. Bepirovirsen carries a boxed warning for serious liver reactions and low platelet counts. The prescribing information also warns of worsening kidney function, serious inflammatory reactions and serious risks linked to improper injection administration. 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

Bacterial vaginosis (BV) is an infection that happens when more “bad” bacteria takes over healthy bacteria in the vagina. About 1 in 3 women will experience BV. Symptoms of BV The most common symptom of BV is abnormal vaginal discharge. White, gray or greenish in color Other BV symptoms include: A fishy smell — especially after sex Pain in and around the vagina Itching in or outside the vagina Burning when peeing New testing technology = more accurate results Nucleic Acid Amplification Tests (NAATs) offer higher accuracy in detecting BV-associated bacteria than traditional tests that use microscopes. CALLOUT: NAATs for BV are performed using a vaginal swab. Other NAAT benefits: Ability to diagnosis multiple infections from one sample Quick results in about 24 hours Self-collection options NAATs for BV are usually covered by insurance — but only if you have symptoms. Ask your clinician about a NAAT for BV and whether it’s the best option for you. BV increases your risk of other STIs, including HIVIf left untreated, BV can also lead to: Pelvic inflammatory disease Premature birth and low birth weight if you’re pregnant BV is not an STI, but it can be passed during sex with a male or female partner BV is common in women, so don’t ignore the symptoms. Talk to your clinician about getting tested for BV. This educational resource was created with support from Hologic, a HealthyWomen Corporate Advisory Council member. Source link

October 21, 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: Antidrug antibodies to IV infliximab can compromise reintroduction after treatment interruption. Favorable outcomes were observed with subcutaneous delivery, regardless of antidrug antibody status. NASHVILLE, Tenn. — Antidrug antibodies did not appear to negatively affect outcomes in patients with inflammatory bowel disease after initiation of subcutaneous infliximab following a “drug holiday,” according to a presenter. Results of a post-hoc analysis presented at ACG Annual Scientific Meeting also showed serum infliximab (Zymfentra, Celltrion) concentrations increased over time after subcutaneous initiation, regardless of antidrug antibody (ADA) status. Marla C. Dubinsky, MD, speaks at the podium during ACG Annual Scientific Meeting. Photo: Heather Biele. Patients with IBD may need to halt treatment — also called a “drug holiday” — for a number of reasons. While the impact of reintroducing IV infliximab is well documented, little is known about the effects of subcutaneous delivery. “A drug holiday for anti-TNF when given IV can be associated with increased immunogenicity and less efficacy after attempted reintroduction, impacting the likelihood of success of this strategy,” Marla C. Dubinsky, MD, chief of pediatric gastroenterology and nutrition at Mount Sinai Kravis Children’s Hospital and codirector of the Susan and Leonard Feinstein Inflammatory Bowel Disease Clinical Center at Icahn School of Medicine, told Healio. “The purpose of this analysis was to explore whether the reintroduction of anti-TNF delivered subcutaneously, not intravenously, improved the likelihood of success and improved efficacy outcomes,” she added. Dubinsky and colleagues analyzed data from LIBERTY-CD and LIBERTY-UC trials, in which patients who responded to IV infliximab induction at 10 weeks were randomly assigned to biweekly subcutaneous infliximab 120 mg or placebo through week 54. Failure to respond at week 22, as well as physician discretion, could prompt escalation to 240 mg subcutaneously through week 102. Detection of ADAs at least once from the start of maintenance at week 10 to initiation of subcutaneous infliximab at weeks 22 to 54 was deemed a positive ADA status. Results showed nearly three-quarters (72.5%) of patients who received placebo and initiated subcutaneous infliximab 240 mg in LIBERTY-CD were ADA positive, as were 92.2% of those in LIBERTY-UC. The median interval from last IV infusion to subcutaneous maintenance initiation was 16 weeks for ADA-positive and ADA-negative individuals in both trials. The researchers reported similar outcomes among patients with CD and UC, regardless of ADA status. Clinical response was achieved by approximately 8 weeks and maintained through weeks 78 to 80 in ADA-positive (93.3%) and ADA-negative (90.3%) patients with CD, as was clinical remission (86.7% and 81.8%, respectively). Partial clinical response was achieved by ADA-positive and ADA-negative participants with UC at the same timepoints (96.2% and 100%), as was partial clinical remission (69.2% and 100%). Clinical response and remission rates were 79.3% and 62.1%, respectively, among ADA-positive patients with UC compared with 100% and 66.7% among ADA-negative ones. “Many people who received subcutaneous infliximab after IV induction recaptured response, and both drug concentrations and efficacy were not impacted by antidrug antibodies pre- or post-reintroduction after a drug holiday,” Dubinsky said. In both trials, C-reactive protein levels fell at approximately week 8 and were sustained through weeks 78 to 80, regardless of ADA status, as did fecal calprotectin levels, which were initially measured at week 32. Serum levels of infliximab increased in ADA-positive and ADA-negative patients. The proportion of ADA-positive individuals declined over time after the introduction of subcutaneous infliximab 240 mg, dropping to 66.7% in CD and 65.5% in UC at weeks 78 to 80. “Infliximab is an excellent therapy,” Dubinsky told Healio. “Patients may have cycled through many other drugs but report they felt the best on infliximab. We now may have a more effective and safer way to reintroduce the drug to patients.” For more information: Marla C. Dubinsky, MD, can be reached at gastroenterology@healio.com. Published by: Sources/Disclosures Source: Dubinsky MC, et al. Impact of prior anti-drug antibody status on clinical outcomes following subcutaneous infliximab initiation after intravenous infliximab interruption: A post hoc analysis of LIBERTY‑CD and ‑UC studies. Presented at: ACG Annual Scientific Meeting; Oct. 12-14, 2026; Nashville, Tenn. (hybrid meeting). Disclosures: Dubinsky reports consulting roles with AbbVie, Abivax, AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Celltrion, Eli Lilly & Co, Janssen, Johnson & Johnson, Merck, Pfizer, Prometheus Labs, Sanofi, Spyre and Takeda Pharmaceuticals; grant or research support from AbbVie and Janssen; and a licensing agreement with Takeda. 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 21, 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: More than half of early childhood HBV exposures may be missed under new CDC guidelines. “It is important that other sources of potential exposure are not ignored,” a researcher said. WASHINGTON — A new retrospective cohort study revealed that more than half of early childhood exposures to hepatitis B virus come from household members other than the birth mother. Researcher Karen B. Jacobson, MD, MPH, said the study’s shows that delaying HBV vaccination based strictly on maternal status puts infants at risk from other household members. Data derived from Jacobson K, et al. Household exposure to hepatitis B virus in children <5 years. Presented at: IDWeek; Oct. 21-24, 2026; Washington. Last year, the CDC’s Advisory Committee on Immunization Practices voted to end a 34-year federal policy recommending universal HBV vaccination for all medically stable newborns within 24 hours of birth and instead recommended the birth dose be given only to infants born to mothers with active HBV infections or unknown status. That recommendation — and all the others made by the new-look ACIP last year — remain blocked by a federal judge, pending appeal. “The most recently proposed guidelines are really focusing on that maternal exposure, and I think it is important that other sources of potential exposure are not ignored,” Jacobson told reporters during a press briefing ahead of IDWeek. For their study, Jacobson and colleagues analyzed the medical records of more than 158,000 children aged younger than 5 years and identified 2,024 living with someone with an active HBV infection. Among them, 58.2% were exposed to the virus not at birth but by a household contact who was not the birth mother, researchers found. Most of the nonmaternal contacts — 76.5% — were male, with a median age of 44. The CDC advises that vaccination as “the best way” to prevent HBV, a contagious viral infection that causes inflammation and damage to the liver and can develop into a chronic lifelong condition. The Infectious Diseases Society of America rebuked last year’s ACIP vote, saying in a statement, “Eliminating the universal birth dose recommendation will end a public health practice that has prevented 95% of new hepatitis B infections and an estimated 90,100 deaths in the United States.” “Our study just highlights the importance of being very comprehensive in how we think of exposures and knowing that the risk is not just limited to that perinatal period,” she said. In terms of overall protection, the study showed 100% of infants born to HBV-positive mothers received a vaccine within 7 days of birth, but the rate dipped to 93.5% for children exposed via other household members and 86.7% for unexposed children. Jacobson pointed out that HBV transmission to children from nonmaternal sources remains “quite rare in the United States” due to the high vaccination rates, but she fears “more infants could be at risk” if vaccination rates begin to fall. Perspective Back to Top These findings highlight an important limitation of relying solely on maternal hepatitis B status to determine whether an infant should receive a birth dose of hepatitis B vaccine. HBV can remain infectious on environmental surfaces for days, and household transmission during childhood outside the perinatal period has been well documented. Universal vaccination of neonates has long served as a safeguard against HBV transmission from both perinatal exposure and infected household contacts. Although the study does not establish that household transmission occurred, it sheds light on “hidden” exposures that may be missed if broader household risks are not carefully considered in vaccination policy. Kengo Inagaki, MD University of Michigan Health Disclosures: Inagaki reports no relevant financial disclosures. Published by: Sources/Disclosures Source: Jacobson K, et al. Household exposure to hepatitis B virus in children <5 years. Presented at: IDWeek; Oct. 21-24, 2026; Washington. References: Disclosures: Jacobson reports receiving grant and research support from Pfizer. 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 21, 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: Icotrokinra 400 mg improved clinical, symptomatic and endoscopic outcomes in UC at week 12. At week 76, 97% of patients in remission remained steroid-free, with favorable tolerability. NASHVILLE, Tenn. — Investigational oral interleukin-23 inhibitor icotrokinra sustained efficacy and favorable tolerability through week 76 in patients with moderately to severely active ulcerative colitis, according to data presented here. Findings from a long-term extension of the phase 2b ANTHEM-UC trial, presented at ACG Annual Scientific Meeting and simultaneously published in The New England Journal of Medicine, indicated that icotrokinra (Johnson & Johnson) — especially the 400 mg dose —bested placebo for clinical remission, symptomatic remission and endoscopic improvement as early as week 12. Maria T. Abreu, MD, speaks at the podium during ACG Annual Scientific Meeting. Photo: Robert Stott. “Icotrokinra is a first-in-class oral peptide and, unlike the currently available IL-23 inhibitors, this actually inhibits the binding of IL-23 to the IL-23 receptor,” Maria T. Abreu, MD, executive director of the F. Widjaja Inflammatory Bowel Disease Institute at Cedars-Sinai Medical Center, told attendees. “Previously, the data from week 12 [showed icotrokinra] met all the endpoints for clinical response at the three doses that were tested, as well as a significant improvement in clinical remission — especially at the highest dose — as well as meaningful responses at week 12 and continued improved response at week 28.” In the long-term extension for ANTHEM-UC, Abreu and colleagues enrolled patients with moderately to severely active UC who had a modified Mayo score of 5 to 9, a Mayo endoscopy subscore of at least 2, and prior inadequate response or intolerance to advanced therapies or conventional treatments, including corticosteroids, azathioprine or 6-mercaptopurine. Patients were randomized 1:1:1:1 to once-daily oral icotrokinra at doses of 100, 200 or 400 mg or placebo, with stratification based on inadequate response or intolerance and baseline endoscopic severity (Mayo endoscopy subscore 2 vs. 3) to ensure balanced comparisons across subgroups. At week 16, patients with an inadequate response underwent a blinded treatment adjustment: Placebo recipients were switched to icotrokinra 400 mg once daily, while icotrokinra recipients received a sham adjustment. The researchers allowed patients who achieved clinical response at week 28 to continue their assigned study treatment in the long-term extension. Dose adjustments and initiation of 5-aminosalicylic acid, corticosteroids or immunomodulators were permitted. After week 28 analyses were completed, treatment was unblinded, and patients receiving placebo discontinued treatment. Abreu and colleagues continued to assess clinical response, clinical remission and endoscopic improvement at week 76, with symptomatic remission evaluated at every visit. According to study results, all three doses of icotrokinra outperformed placebo in achieving a clinical response at week 12. Response rates were 63% with the 400 mg dose, 58% with 200 mg, and 55% with 100 mg vs. 27% for placebo (P < .001 for all comparisons). The 400 mg dose also delivered significantly higher rates of clinical remission than placebo (30% vs. 11%; P = .006), symptomatic remission (46% vs. 19%; P < .001) and endoscopic improvement (37% vs. 14%; P = .002). Clinical remission occurred in 24% of patients receiving 200 mg, but this did not reach statistical significance. Through week 28, adverse event rates were similar across the treatment groups, ranging from 60% to 66%, compared with 62% for placebo. Serious adverse events were less frequent in all three icotrokinra groups: 2% with 400 mg, 5% with 200 mg, and none with 100 mg vs. 10% with placebo. Among 136 patients with UC who entered the long-term extension, the majority achieved clinical response, clinical remission, and endoscopic improvement at week 76. Notably, 97% of patients in clinical remission were still corticosteroid-free at week 76. Symptomatic remission, observed as early as week 4, was also sustained or improved through week 76. “The rates of remission were quite high, about 60% overall, especially among patients not previously on any advanced therapies vs. 52% on those who had previous advanced therapy experience,” Abreu told Healio. “And these patients were also off steroids for all intents and purposes by the end of 76 weeks.” Abreu noted that findings from the long-term extension highlight the potential of icotrokinra as a once-daily oral treatment option for UC, with efficacy and safety being evaluated in ongoing phase 3 trials. “What’s really nice about this is that for the first time we’re going to have an oral medication that patients can start taking once a day and get them on the road to recovery pretty early,” Abreu told Healio. “Many of our patients are still reluctant to go on advanced therapies, especially if they’re injectables or infusions. I imagine that this is going to be an easier sell.” For more information: Maria T. Abreu, MD, can be reached at gastroenterology@healio.com. Published by: Sources/Disclosures Source: Abreu MT, et al. Long-term efficacy and safety of icotrokinra, a first-in-class targeted oral peptide that precisely blocks the IL-23 receptor, in ulcerative colitis: Results from the ANTHEM-UC long-term extension. Presented at: ACG Annual Scientific Meeting; Oct 12-14, 2026; Nashville, Tenn. (hybrid meeting). Reference: Disclosures: Abreu reports consulting relationships with AbbVie, Alimentiv, Bristol Myers Squibb, Eli Lilly & Co., Genentech, Johnson & Johnson and Pfizer. 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

Even if you suspect that you might have Alzheimer’s disease, hearing the diagnosis can be tough. However, you can still take control of certain aspects of your care by knowing as much as you can. This means asking even more questions, which could include: Who will be treating me? What changes might I expect in the future? Are there any treatments that might help slow down the disease? Am I eligible for the treatments? Are there any treatments for my symptoms? Are there any clinical trials I might qualify for? Should I make any lifestyle changes, like diet and exercise, that might support my overall health and possibly help slow down the disease progression at the same time? What resources are there for both me and those who will help care for me? What decisions should I make now, such as advanced directives or power of attorney? Is it safe for me to keep driving? What type of support might I need if I want to keep living at home? What are my next steps? Dementia care can be hard for some people to get because of cost, insurance status, language and location. If you face any barriers, ask your clinician if there are support systems for you, such as low-cost services, transportation options, interpreter services or local support programs. If you are alone and don’t have family or friends who can help care for you, it’s particularly important to ask what types of resources are available and how to access them. This could be a social worker or care manager to start. You may qualify for community services, such as those you can find from the Eldercare Locator, part of the HHS Administration for Community Living. The Alzheimer’s Association’s 24/7 helpline (1-800-272-3900) may also be helpful. Source link

October 20, 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: Studies indicate associations between PPI use and adverse events. There was no difference in all-cause mortality between users and nonusers. Long-term acid suppression may be a modifiable risk factor. PHOENIX — Adults with asthma who used proton pump inhibitors had greater risks for exacerbations and other negative outcomes than those who did not, according to an abstract presented at the CHEST Annual Meeting. However, the difference in mortality between patients who did or did not use proton pump inhibitors (PPIs) was not statistically significant, Joshua P. Le, MD, resident, Allegheny Health Network, and colleagues wrote. Data derived from Le JP, et al. Empiric chronic proton pump inhibitor use is associated with increased exacerbations in biologic-treated difficult-to-treat asthma: A propensity-matched US cohort study. Presented at: CHEST Annual Meeting; Oct. 18-21, 2026; Phoenix. Although some patients with nocturnal symptoms of asthma and coexisting reflux have benefited from PPI treatment, the researchers said, evidence for associations between PPI use and infectious and systemic adverse events has been growing. The retrospective study included adults with asthma treated with biologics between 2014 and 2025 in the TriNetX U.S. Collaborative Network. Treatment included benralizumab (Fasenra, AstraZeneca), dupilumab (Dupixent; Sanofi, Regeneron), mepolizumab (Nucala, GSK), omalizumab (Xolair; Genentech, Novartis), reslizumab (Cinqair, Teva) and tezepelumab (Tezspire; AstraZeneca, Amgen). The researchers defined persistent exposure to PPIs as repeated prescriptions from 3 to 6 months and from 6 to 12 months. Prior to matching, the PPI group vs. no PPI group was older (58.3 years vs. 48.1 years) and had a greater proportion with comorbidities (21.1% vs. 13.9%) and diabetes (10.8% vs. 13.9%). Matching yielded 1,228 patients in each group with “well-balanced baseline characteristics,” according to the researchers. At 1 year, a significantly greater proportion of patients in the PPI group vs. the no PPI group had asthma exacerbations (31.9% vs. 22.6%; OR = 1.6; 95% CI, 1.34-1.92), required rescue systemic corticosteroids (72% vs. 40%; OR = 3.88; 95% CI, 3.27-4.59), had respiratory infections (8.4% vs. 2.3%; OR = 3.83; 95% CI, 2.52-5.82), had ICU admissions (4.3% vs. 1.2%; OR = 3.648; 95% CI, 2.04-6.5) and had ED visits (15.6% vs. 8.4%; OR = 2; 95% CI, 1.56-2.58). The researchers did not note any statistically significant differences in all-cause mortality between patients with vs. without PPI use. Based on these findings, the researchers concluded that patients who used biologics for asthma that was difficult to treat as well as PPIs were at greater risk for negative outcomes with no benefits in mortality rates. The researchers attributed these risks to the impact of long-term acid suppression on the microbiome, making these patients more vulnerable to respiratory pathogens, which would be a modifiable risk factor. “Clinicians should carefully reassess the necessity of chronic PPI therapy in biologic-treated asthma patients without clear ulcer-related indications,” Le said in a press release. Patients often continue PPI use after their symptoms have resolved and there is no longer an objective need for it, he continued. “Proactive medication reconciliation, clear documentation of indication, and structured deprescribing strategies may reduce unnecessary long-term exposure and help mitigate preventable morbidity in this vulnerable population,” Le said. Sources/Disclosures Source: Le JP, et al. Empiric chronic proton pump inhibitor use is associated with increased exacerbations in biologic-treated difficult-to-treat asthma: A propensity-matched US cohort study. Presented at: CHEST Annual Meeting; Oct. 18-21, 2026; Phoenix. Reference: Disclosures: Healio could not confirm relevant financial disclosures at the time of publication. 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 20, 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: About 41% of pediatric patients treated with mirikizumab achieved clinical remission, compared with 15% of adults receiving placebo. Mirikizumab also was associated with endoscopic and symptomatic remission. NASHVILLE, Tenn. — Among children with ulcerative colitis, mirikizumab achieved clinical and endoscopic remission rates exceeding those of historical adult outcomes with placebo at week 12, according to data presented. Researchers also reported associations between mirikizumab (Omvoh, Eli Lilly & Co.) and clinical, symptomatic and endoscopic responses at this time point, as well as a reduction in fecal calprotectin levels. Data derived from Dubinsky MC, et al. Mirikizumab induction therapy achieves early clinical, endoscopic, and biomarker improvement in children and adolescents with moderately to severely active ulcerative colitis: Week 12 results from the SHINE-2 study. Presented at ACG Annual Scientific Meeting; Oct 12-14; Nashville, Tenn. (hybrid meeting). “Simply put, we have very limited advanced therapy options for pediatric patients,” Marla C. Dubinsky, MD, chief of pediatric gastroenterology and nutrition at Mount Sinai Kravis Children’s Hospital and codirector of the Susan and Leonard Feinstein Inflammatory Bowel Disease Clinical Center at Mount Sinai, told attendees at ACG Annual Scientific Meeting. “We just had antiTNF until not too long ago, when we had ustekinumab approved. “So here, we’re excited to talk about — hopefully — the next new advanced therapy for pediatric UC,” she added. The phase 3, open-label SHINE-2 study enrolled 63 children aged 2 to 17 years (58.7% girls; mean age, 13.2 years; mean weight, 48.3 kg) with at least a 3-month diagnosis of moderately to severely active UC, confirmed by endoscopy. Eligible patients had inadequate or lost response or intolerance to at least one conventional or advanced therapy. Participants received three weight-based IV induction doses of mirikizumab at 4-week intervals, followed by subcutaneous maintenance every 4 weeks. Induction doses ranged from 5 mg/kg for patients weighing less than 40 kg to 300 mg for those weighing more than 40 kg. Maintenance doses ranged from 50 mg to 200 mg based on weight. “What differentiates the way we study pediatric IBD is weight and weight matching, exposure response matching and [pharmacokinetic] modeling, so it gets a little bit tricky when we’re trying to ensure that we have the right dose,” Dubinsky said. The primary endpoint was clinical remission at week 52, based on modified Mayo score, among week 12 clinical responders. Other endpoints included change in fecal calprotectin at week 12; pharmacokinetic measures; clinical, endoscopic and symptomatic remission and response, and Pediatric Ulcerative Colitis Activity Index (PUCAI) scores. The researchers compared SHINE-2 outcomes with corresponding results from the phase 3 LUCENT-1 study of mirikizumab in adult patients with UC. “The closer we are to mirroring what we see with adults, the better it is for pediatric patients, and why we use the same inclusion criteria and same outcome measures,” Dubinsky said. The study met its primary endpoint of clinical remission at week 52 (50%), which exceeded the placebo rate (26.6%) and was comparable to the mirikizumab rate (50.7%) among adults in LUCENT-1. At week 12 in SHINE-2, clinical remission rates with mirikizumab induction also exceeded those of adults on placebo in LUCENT-1 (41.3% vs. 14.6%). Similar results were reported for clinical response (81% vs. 43.4%), endoscopic remission (25.4% vs. 4.5%) and endoscopic improvement (50.8% vs. 21%). Overall PUCAI clinical remission and response rates reached 58.7% and 87.3%, respectively, in SHINE-2. More than a third (38.1%) of patients achieved symptomatic remission at week 4, which nearly doubled (69.8%) by week 12. “When you look at symptomatic response, you can also see that we achieved faster, better depth of symptomatic response in children than we did with adults,” Dubinsky said. Change in fecal calprotectin from baseline to week 12 was –1,229.9 µg/g among pediatric patients in SHINE-2 vs. –124 µg/g among placebo recipients in LUCENT-1. The safety profile of induction mirikizumab in SHINE-2 was comparable to established safety data from previous studies. “From a safety perspective, there’s absolutely nothing new to see here,” Dubinsky said. Two serious adverse events occurred, a large intestinal polyp and a UC flare, the latter of which led to discontinuation. Mirikizumab exposures among children in SHINE-2 were generally comparable across weight subgroups, according to the researchers. “Modeled across different age groups … with the exception of a few that fell under the lower limit of quantification, the dose was matched correctly for all weight groups in pediatric patients in this trial,” Dubinsky said. The researchers acknowledged study limitations, including the small sample size of patients in the lowest weight category. “In summary, SHINE-2 met its primary efficacy objective in week 52, supporting its efficacy in pediatric UC,” Dubinsky told attendees. “We saw meaningful endpoints, even endoscopy, as early as week 12, symptomatic response as early as week 4, well tolerated and [pharmacokinetic] exposure. Remember: We got the dose right.” Published by: Sources/Disclosures Source: Dubinsky MC, et al. Mirikizumab induction therapy achieves early clinical, endoscopic, and biomarker improvement in children and adolescents with moderately to severely active ulcerative colitis: Week 12 results from the SHINE-2 study. Presented at ACG Annual Scientific Meeting; Oct 12-14; Nashville, Tenn. (hybrid meeting). Disclosures: Dubinsky reports consulting roles with AbbVie, Arena Pharmaceuticals, Boehringer Ingelheim, Bristol Myers Squibb, Celgene Corp., Eli Lilly & Co., F. Hoffmann-La Roche, Genentech, Gilead Sciences, Janssen, Pfizer, Prometheus Laboratories, Takeda Pharmaceuticals and UCB Inc.; research support from AbbVie, Janssen, Pfizer and Prometheus Laboratories; royalties from Takeda Pharmaceuticals; and stock options in Trellus Health. Ask a clinical question and tap into Healio AI’s knowledge base. PubMed, enrolling/recruiting trials, guidelines Clinical Guidance, Healio

Consideramos que una IU es recurrente si un paciente tiene dos IU en un plazo de seis meses o tres IU en un plazo de un año. Una IU complicada significa que la infección se propagó fuera de la vejiga y eso hace que el paciente tenga riesgo de sepsis, lo cual es una reacción potencialmente letal a una infección. Con IU recurrentes, hablamos sobre su frecuencia y cuán a menudo ocurren. Con IU complicadas, hablamos sobre la propagación de la infección. Afortunadamente las IU complicadas son menos frecuentes. Source link

Slide 1: Hed: ¿Está tu asma bajo control? Dek: Cuando el asma está bajo control, la vida es mejor. Aquí encontrarás lo que debes monitorear y lo que debes hacer luego. Slide 2: El asma no controlada altera la vida El asma es un trastorno crónico. No puede curarse, pero el tratamiento correcto puede mantener los síntomas bajo control. Para la mayoría de personas, un asma bien controlada no interfiere con sus actividades normales. Pero cuando el asma no está bajo control: Altera la vida cotidiana Es difícil de controlar Puede tener efectos a largo plazo en tu salud Slide 3: Señal 1: Síntomas frecuentes a pesar del tratamiento Piensa en cuán frecuentemente tienes síntomas de asma. Si tomas medicamentos tal como lo recetó tu equipo de atención, los síntomas no deberían ser frecuentes. ¿Experimentas síntomas de asma más de dos veces a la semana? ¿Son difíciles de controlar? ¿Te despiertas en la noche por el asma? Estas son señales de un asma no controlada. Slide 4: Hospitalizaciones o crisis graves Un asma no controlada puede causar crisis graves. Dos o más crisis de asma que requieren corticoesteroides orales en un año Requerir hospitalizaciones más de una vez durante el último año debido a una crisis de asma Esas son señales de un asma no controlada. Slide 5: Hazte estas preguntas ¿Tienes síntomas o usas un inhalador más de 2 veces a la semana? ¿Te despiertas con síntomas más de 2 veces al mes? ¿Reabasteces tu inhalador más de 2 veces al año? Si la respuesta de una de estas preguntas es “sí”, habla con tu profesional clínico. Slide 6: Identificación de las crisis Pueden ocurrir crisis incluso con asmas no controladas. El ejercicio, especialmente cuando el aire es seco y frío, es un desencadenante. La exposición a elementos irritantes (tales como polvo, gases o vapores químicos) o alérgenos (tales como polen o caspa de mascotas) puede causar síntomas. Si tienes síntomas de crisis sin un desencadenante, habla con tu profesional clínico. Slide 7: Monitorea tus síntomas Si no estás segura si tu asma está bajo control, monitorea tus síntomas. Registra cuándo ocurren y cuán graves son. Muestra este registro a tu profesional clínico. Slide 8: Identifica períodos de tiempo sin atención Incluso si tienes señales de un asma no controlada, pueden haber periodos de tiempo sin atención, lo cual puede significar que tu trastorno no se trata inmediatamente. Los períodos de tiempo sin atención son peores para pacientes que no son de raza blanca. Y los pacientes de raza negra e hispanos ya tienen un mayor riesgo de tener asmas no controladas. Defiende tus derechos para obtener la mejor atención. Slide 9: ¿Qué es un asma grave? Recibir un mejor tratamiento para un asma no controlada debería reducir los síntomas para que no alteren tu vida cotidiana. Si implementas los cambios que se recomendaron, pero los síntomas no mejoran, podrías tener un asma grave. Necesitarás que te refieran a un especialista, tal como un neumólogo o alergólogo, para que te den un diagnóstico y un plan terapéutico personalizado. Slide 10: Hacer que el asma esté bajo control Si tienes síntomas de un asma no controlada, habla con tu profesional clínico inmediatamente. Después de una evaluación, hablarán sobre opciones tales como un incremento de la dosis, probar o agregar otro medicamento, tal como un biofármaco, etcétera. No esperes: Controla tu asma para que puedas disfrutar la vida nuevamente. Este recurso educativo se preparó con el apoyo de Sanofi y Regeneron. Source link