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
Tezepelumab sustains EoE remission, dysphagia relief at 52 weeks
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
New Women’s Health Documentaries – HealthyWomen
“Remember last summer when I was so crazy?” a woman asks her husband, dabbing tears from her eyes. For many women, perimenopause causes emotional, mental and physical changes that can be severe. And for a long time, women had no clue what was happening or that perimenopause was even a thing. The M Factor 2: Before the Pause shines a light on perimenopause and the very real effects it can have on relationships, careers, health — basically everything in life. Through interviews with perimenopausal women and testimonials from experts, producer Tamsen Fadal offers a sharp and unfiltered look at the menopausal transition and nothing is off limits. Topics range from hot flashes to flash periods to sex and consequences of not being proactive about your health during perimenopause. Or as one expert puts it: “It’s about making decisions today for the life you want in the future.” Before the Pause serves as a reminder that you’re not alone or the only one up at 3 a.m. sweating through your nightshirt. But you don’t have to suffer. Every woman should know her options for reducing symptoms of menopause and ways you can stay as healthy as possible — mentally and physically — before, during and after menopause. Watch: PBS Source link
Young adults often not counseled on colorectal cancer screening
October 22, 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: Adults ages 45-49 years are less likely to have discussed colorectal cancer screening with a healthcare professional than older adults. Communication about different screening options also lags in this group. Clinician counseling may be inadequate for younger adults newly eligible for colorectal cancer screening, according to study findings presented at this year’s AACR Conference on The Science of Cancer Health Disparities. A survey of screening-eligible individuals in the U.S. showed those aged 45 to 49 years were approximately three times more likely than older adults to report that they have never discussed colorectal cancer screening tests with a healthcare professional. Data derived from Baeker Bispo J, et al. Age-related differences in clinician communication about colorectal cancer screening in the US. Presented at: AACR Conference on The Science of Cancer Health Disparities; Oct. 18-21, 2026; Atlanta. In addition, a considerably lower percentage of younger adults reported that a clinician had spoken with them about the multiple screening modalities available, including alternatives to colonoscopy. “We expected there would be differences by age, but the magnitude of those differences was quite large,” lead author Jordan Baeker Bispo, PhD, MPH, principal scientist of cancer disparity research at American Cancer Society, told Healio. “The high proportion of adults in the younger age group who reported they had never discussed colorectal cancer screening tests with their healthcare professional certainly was alarming, and it should be a wake-up call given the increasing burden of early-onset colorectal cancer.” ‘One piece to this puzzle’ Approximately 10% to 12% of colorectal cancers in the U.S. are classified as early onset, meaning they occur among individuals aged younger than 50 years. Incidence of early-onset colorectal cancer rose by 2.9% per year from 2013 to 2022, according to American Cancer Society statistics, a stark contrast to the approximate 1% annual decline in new diagnoses overall. Meanwhile, the mortality rate is increasing among people aged younger than 65 years. The U.S. Preventive Services Task Force updated its colorectal cancer screening guidance in 2021, lowering the age at which average-risk adults are recommended to begin screening from 50 to 45 years. However, only about 37% of adults ages 45 to 49 are up-to-date with colorectal cancer screening, Baeker Bispo said. “There has been a lot of interest in screening in that younger age group as a way to offset the burden of early-onset colorectal cancer, but uptake has been slow,” she said. “Part of that is expected because there is lag time between guideline updates, dissemination of the changes to clinicians and integration into clinical care. However, we wanted to understand to what extent adults in that age group are getting information about colorectal cancer screening because that might be one piece to this puzzle.” Communication ‘essential’ Baeker Bispo and colleagues examined data from the 2024 Health Information National Trends Survey (HINTS), a nationally representative survey that assesses the public’s knowledge of and attitudes toward cancer and other health topics. The survey included this question: “Has a doctor or other health professional ever told you there are a few different tests to detect colorectal cancer?” Response options included “Yes,” “No” or “I have never discussed these tests with a doctor or other health professional.” The researchers analyzed responses from 3,626 colorectal cancer screening-eligible adults aged 45 to 75 years with no history of the disease. Respondents aged 45 to 49 appeared more than three times as likely as those aged 65 to 75 to report never having discussed colorectal cancer screening with a clinician (23.2% vs. 7%; adjusted prevalence ratio [aPR] = 2.71; 95% CI, 1.64-4.46). A significantly lower percentage of respondents in the younger vs. older age group reported that a clinician had told them about different colorectal screening tests (50.3% vs. 72.5%; aPR = 0.73; 95% CI, 0.63-0.85). Because the survey asked respondents if they “ever” had been told about different screening tests, older individuals understandably would have had more opportunities to discuss the topic with healthcare professionals, Baeker Bispo said. However, the gaps in the younger age group are concerning for multiple reasons. “A doctor’s recommendation is one of the strongest determinants of a patient’s decision to get screened, so making sure healthcare professionals are talking with their patients about it is essential,” Baeker Bispo said. “Discussions about different screening options is an important piece, too, given people have different preferences. A person averse to colonoscopy who is not aware of other modalities may not get screened. We want to be sure that they are aware of the options that are available so they can choose the test that works for them.” Age-stratified analyses showed non-Hispanic Black individuals aged 45 to 49 years were significantly less likely than non-Hispanic white individuals in the same age group to report receiving information about different screening options from a healthcare professional (33.2% vs. 60.7%; aPR = 0.58; 95% CI, 0.37-0.91). Differences by race or ethnicity did not reach statistical significance in older age groups, a finding Baeker Bispo said may indicate race-associated barriers to screening or other aspects of healthcare access become less pronounced as patients age and become eligible for Medicare. A patient-centered approach The researchers acknowledged study limitations, such as the small sample size and use of self-reported survey data. However, the findings highlight “a major opportunity” to improve screening uptake in this age group, Baeker Bispo said. Strategies at the clinician and practice levels may help, she said. For example, automated prompts that appear in the electronic health record during clinical encounters could ensure screening recommendations are delivered in a more routine —
Tipos de asma – HealthyWomen
El asma puede clasificarse en varias categorías. Las categorías dependen de: La gravedad de los síntomas La frecuencia de los síntomas El tratamiento para tu asma dependerá de su categoría. CALL OUT: Síntomas del asma Sibilancia Tos Dificultad para respirar Sensación de opresión torácica 1. Asma leve intermitente Síntomas diurnos menos de 2 veces a la semana Síntomas nocturnos menos de 2 veces al mes Crisis que duran entre unas horas y unos días No hay síntomas entre las crisis Tratamiento Inhalador de rescate ocasional 2. Asma leve persistente Síntomas diurnos más de 2 veces a la semana, pero no más de 1 vez al día Síntomas nocturnos menos de 2 veces al mes Las crisis podrían afectar las actividades normales Tratamiento Podría tratarse con medicamentos de mantenimiento de dosis bajas e inhaladores de rescate tal como sea necesario 3. Asma moderada Síntomas diurnos todos los días Síntomas nocturnos más de 1 vez a la semana Las crisis afectan las actividades normales Crisis más de 2 veces a la semana Las crisis duran días Se necesita un inhalador de rescate todos los días Tratamientos Medicamento de mantenimiento de dosis mediana Inhalador de rescate tal como sea necesario Biofármacos (inyecciones) 4. Asma grave Síntomas diurnos constantes Síntomas nocturnos frecuentes Crisis frecuentes Las crisis interfieren con actividades físicas Tratamientos Medicamentos de mantenimiento de dosis altas Biofármacos (inyecciones) Termoplastia bronquial Tratamientos del asma La prevención es clave para evitar desencadenantes de síntomas y crisis asmáticas, pero, frecuentemente, se necesitan medicamentos para mantener el asma bajo control o para aliviar los síntomas durante una crisis. Los tratamientos varían dependiendo de la frecuencia o la gravedad de los síntomas: Los medicamentos de “rescate”, tales como un inhalador, para un alivio rápido durante una crisis Medicamentos a largo plazo para controlar los síntomas del asma que usualmente se toman a diario Antialérgicos para prevenir crisis si alergias causan tus síntomas Biofármacos como tratamiento adicional para asmas moderadas o graves Termoplastia bronquial para asmas graves que no mejoran Tu profesional clínico podría recetar una combinación de tratamientos. CALLOUT: Crisis de asma A veces denominados episodios o agravamientos Cuando síntomas frecuentes, tales como sibilancia o dificultad para respirar, empeoran y a veces repentinamente Pueden ser leves, graves o incluso letales CALLOUT: Asma no controlada Síntomas o crisis frecuentes que podrían interferir con actividades cotidianas Podría hacer que necesites un inhalador de rescate frecuentemente Podría requerir que acudas a departamentos de emergencia o a hospitales Puede ocurrir cuando el asma no se controla suficientemente bien, incluso con tratamientos Habla con tu profesional clínico si los síntomas persisten o empeoran o si el tratamiento no parece funcionar Elementos clave para controlar el asma Independientemente del nivel de asma que tengas, puedes implementar medidas para controlarla. Identifica y evita tus desencadenantes Ejercicio Irritantes químicos Alérgenos tales como pelo de mascotas, moho y contaminación Prepara un plan de acción para el asma para que estés lista para enfrentar una crisis Monitorea tus síntomas y obtén atención médica si empeoran Sigue tu plan terapéutico Pide ayuda para pagar los medicamentos si fuese necesario Asegúrate de entender cómo tomar tus medicamentos Vacúnate contra infecciones que pueden empeorar el asma Gripe Neumonía VRS Covid-19 Haz ejercicio en forma segura y controla el estrés Este recurso educativo se preparó con el apoyo de Sanofi y Regeneron. Source link
FDA OKs Hibsago as first antisense for chronic hepatitis B
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
What Is Bacterial Vaginosis? – HealthyWomen
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
Subcutaneous infliximab may be ‘more effective’ after drug holiday
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. 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Most early childhood HBV exposures come from nonmaternal contacts
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
Oral icotrokinra sustains UC response through 76 weeks
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
