First global guidelines for pregnancy and inflammatory bowel disease developed

For women with inflammatory bowel disease (IBD), pregnancy can be an uncertain time due to limited clinical data about how IBD medications impact pregnancy outcomes and infants who have been exposed to IBD medications in utero.

As a matter of policy, pregnant women are excluded from clinical trials of experimental therapies for IBD and when a new therapy achieves regulatory approval, there is only animal safety data, but no human pregnancy safety data.

For patients with IBD, stopping medication leads to an increase in IBD symptoms, which can make their pregnancies high-risk. These women are often young and otherwise healthy, so they are not always recognized as high-risk despite the association of uncontrolled IBD with adverse maternal and obstetric outcomes.

To improve treatment of IBD during pregnancy worldwide, the Helmsley PIANO Expert Global Consensus was convened to provide standardized, evidence-based recommendations to providers caring for women with IBD. The PIANO (Pregnancy Inflammatory Bowel Disease And Neonatal Outcomes) study looked at the safety of IBD medications in pregnancy and short- and long-term outcomes of the children.

Based on reviews of the literature by the consortium experts, final recommendations for the global consensus were published simultaneously on August 28, in six international journals including Clinical Gastroenterology and Hepatology,American Journal of Gastroenterology, GUT, Inflammatory Bowel Diseases, Journal of Crohn’s and Colitis, and Alimentary Pharmacology and Therapeutics.

Hope and comfort for mothers with IBD

The final study results and guidelines include new findings such as continuing all biologics throughout pregnancy and lactation, universal pre-conception counseling, understanding of high-risk maternal status, providing low dose aspirin to prevent preterm preeclampsia, and giving the rotavirus vaccine on schedule.

“Some of the findings were expected, but others were novel,” said Uma Mahadevan, MD, director of the Colitis and Crohn’s Disease Center at UCSF, principal investigator of the PIANO study, and chair of the Global Consensus Conference. “The goal of our study and consortium has been to provide hope, comfort, and the same high-level care to current and future mothers with IBD. The consensus recommendations are the first truly global effort to improve treatment and outcomes for women with IBD and their children.”

Specifically, the consortium recommends women with inflammatory bowel disease receive preconception counseling and ideally be in remission for three to six months prior to considering conception. It also recommends that all women with IBD are followed as high-risk pregnancies.

Also recommended is the continuation of medications that are considered low risk for use during pregnancy, such as 5-ASAs, sulfazalazine, thiopurines, and all monoclonal antibodies during preconception, pregnancy, and lactation. For small molecule drugs, the consortium recommends they be avoided for at least one month, and in some cases for three months prior to attempting conception, unless there is no alternative for the health of the mother. They should also be avoided during lactation.

Another novel recommendation is that women with IBD may breastfeed with all monoclonal antibodies, including newer IL-23s, even though there is not yet clinical trial data. The recommendation to continue them through pregnancy and lactation is based on placental physiology, as well as on the physiology of monoclonal antibody transfer in breast milk.

While biologic medication can cross the placenta and be detected in infants from 1 to 6 months, levels of biologic drugs detected in breast milk in the study were very low and did not adversely affect infant outcomes. The consensus recommends that women with IBD can breastfeed while on biologic therapy. Additionally, there was no increase in infant infections at 4 months or 12 months if they were exposed to a biologic or thiopurine (or both) during pregnancy.

The consortium also recommends that all women with IBD be started on aspirin by 12 to 16 weeks of pregnancy. This is to reduce the risk of preterm preeclampsia. Women with IBD should also be monitored for venous thromboembolism (VTE) risk, both before delivery as well as in the postpartum period. Offspring of women with IBD should also receive a rotavirus vaccine on schedule, even among infants exposed to biologic therapy in utero.

“A unique aspect of this consensus conference was the geographically diverse representation from around the globe,” said Millie D. Long MD, MPH, co-chair of the Global Consensus Conference and chief of the Division of Gastroenterology and Hepatology at the University of North Carolina at Chapel Hill. “Through this international collaboration, we ensured that all recommendations were feasible and appropriate for women with IBD. In addition, we included patient representatives from each continent to maximize the role of the patient voice in determining best practices of care. We hope that this consensus statement will provide a blueprint for evidence-based management of women with IBD, from pre-conception to post-delivery.”

No increase in birth defects or negative impact on brain development

The PIANO research study, a national study of women with IBD and their children around the U.S., enrolled 2,268 pregnant women with IBD who had 1,702 live births. Among the women, 598 IBD mothers were exposed to steroids during pregnancy. Compared to unexposed mothers, those on steroids had higher rates of preterm birth, low birth weight infants, and infants being admitted to the neonatal intensive care unit. However, there was no increase in birth defects, brain deficits, or infant infection based on steroid use. The researchers concluded that steroid use may be a marker of active disease, which is the real driver of these outcomes. Active disease during pregnancy was more common in patients with ulcerative colitis and led to increased miscarriage.

The study found no reduction in brain development or developmental milestones based on maternal IBD medication use. Infants of mothers with IBD who go to daycare were not more likely to get infections than other children based on medication exposure during pregnancy.

The Global Consensus Consortium consisted of 50 experts from around the world, including IBD specialists, teratologists, maternal fetal medicine specialists, patient advocates, and surgeons. The members of the group convened to review and assess current data and come to an agreement on best practices based on these data. They used the GRADE process (Grading of Recommendations Assessment, Assessment, Development, and Evaluation) when appropriate and the RAND process (Research and Development) in those instances where expert opinion was needed to guide consistent practice. 

Reference:

Mahadevan, UmaAbreu, Maria et al., Global Consensus Statement on the Management of Pregnancy in Inflammatory Bowel Disease, Clinical Gastroenterology and Hepatology, DOI: 10.1016/j.cgh.2025.04.005 

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Fake WHO, Abbott Emails Used in Over Rs 1.1 Crore Scam on Pharma Executive, 2 Nabbed

New Delhi: A senior pharmaceutical executive was duped of more than Rs 1.1 crore in a high-profile cyber fraud where two men, posing as representatives of Abbott Pharmaceutical UK and the World Health Organization (WHO), lured him into a fake kola nut trade deal. The case came to light after Kolkata Police arrested the accused from Delhi.

The accused, identified as Ejike Benjamin Nwabunwanne and Believe Onyeacholem, were nabbed from their rented residence in Mahavir Enclave, South West Delhi. According to investigators, the duo used forged WHO and pharma documents, fake email accounts, and WhatsApp communication to convince the victim of the scheme’s legitimacy. Once trust was established, the executive was persuaded to transfer over ₹1.1 crore.

Also Read: Email From ‘Chairman’ Costs Pharma Company Rs 1.9 Crore in Cyber Fraud

During the raid, police recovered a large cache of incriminating material, including 12 Android phones, two keypad mobiles, a laptop, a Wi-Fi router, multiple UK SIM cards, ATM cards, and a pen drive containing fabricated letters and a database of other potential targets.

Authorities noted that this is not the first time pharma executives have been targeted by international cyber fraudsters. Similar scams involving impersonation of reputed global organisations have been reported earlier this year, raising concerns over the sector’s vulnerability to such sophisticated attacks.

As per a report by the Times of India, the arrests are part of a larger crackdown on organised cybercrime networks targeting pharmaceutical professionals across the country. The two accused remain in police custody as further investigations continue to trace their wider network.

Also Read: Rs 180 Crore Ozempic Fraud: LOC Issued Against Pharma Firm CEO

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Pembrolizumab Significantly Improves Event-Free Survival in Head and Neck Cancer: NEJM

According to a recent study adding perioperative pembrolizumab to standard therapy such as surgery and radiotherapy with or without cisplatin consistently improves event-free survival (EFS) in patients with locally advanced head and neck squamous-cell carcinoma (HNSCC), researchers have discovered. Significantly, this increase in EFS was seen in patients with various levels of programmed death ligand 1 (PD-L1) expression, with no adverse effect on surgical completion and with no new safety issues. The study was published in The New England Journal of Medicine by Ravindra U. and colleagues.

HNSCC is a highly recurrant cancer, and outcomes with surgery and adjuvant treatment continue to be suboptimal for most patients. Immunotherapy, such as checkpoint inhibition with agents like pembrolizumab, has been of value in recurrent and metastatic disease, but its place in locally advanced disease treated with curative intent has remained unclear. This large phase 3 trial gives vital proof that the addition of pembrolizumab in both the neoadjuvant and adjuvant environments can enhance long-term outcomes.

This open-label, phase 3 randomized trial included patients with locally advanced HNSCC. The participants were randomly assigned in a 1:1 ratio to receive:

• Pembrolizumab group: 2 cycles of neoadjuvant pembrolizumab and then 15 cycles of adjuvant pembrolizumab (200 mg every 3 weeks) plus standard treatment.

• Control group: Standard treatment alone (surgery and radiotherapy ± cisplatin).

The main endpoint was event-free survival (EFS), which was measured sequentially in patients with CPS ≥10, CPS ≥1, and the overall population.

Key Results

• 714 participants were randomized: 363 to pembrolizumab and 351 to control. Of these, 234 pembrolizumab vs. 231 control patients had CPS ≥10, and 347 pembrolizumab vs. 335 control patients had CPS ≥1.

• Surgical completion rate: ~88% in both groups.

• Median follow-up: 38.3 months.

• Event-free survival at 36 months:

• CPS ≥10 population: 59.8% (pembro) vs. 45.9% (control); HR 0.66; 95% CI 0.49–0.88; P=0.004.

•CPS ≥1 population: 58.2% vs. 44.9%; HR 0.70; 95% CI 0.55–0.89; P=0.003.

• Total population: 57.6% vs. 46.4%; HR 0.73; 95% CI 0.58–0.92; P=0.008.

• Grade ≥3 treatment-related adverse events: 44.6% (pembro) vs. 42.9% (control).

• Deaths due to treatment: 1.1% (pembro) vs. 0.3% (control).

• Immune-mediated grade ≥3 adverse events: 10.0% in the pembro group.

This extensive phase 3 trial reaffirms that perioperative pembrolizumab added to surgery and adjuvant therapy greatly enhances event-free survival in locally advanced HNSCC without sacrificing surgical procedure or adding new safety issues. The trial is a significant advancement in the management of head and neck cancer, with immunotherapy entering earlier stages of disease.

Reference:

Uppaluri, R., Haddad, R. I., Tao, Y., Le Tourneau, C., Lee, N. Y., Westra, W., Chernock, R., Tahara, M., Harrington, K. J., Klochikhin, A. L., Braña, I., Vasconcelos Alves, G., Hughes, B. G. M., Oliva, M., Pinto Figueiredo Lima, I., Ueda, T., Rutkowski, T., Schroeder, U., Mauz, P.-S., … KEYNOTE-689 Investigators. (2025). Neoadjuvant and adjuvant pembrolizumab in locally advanced head and neck cancer. The New England Journal of Medicine, 393(1), 37–50. https://doi.org/10.1056/NEJMoa2415434

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Risk-Based, Centralized Screening may Improve Osteoporosis Care in Men: JAMA

Researchers have found in a new cluster randomized trial that selecting men for osteoporosis screening by fracture risk factors and using a centralized screening model enhanced screening rates, treatment initiation, and medication adherence. The findings, published in JAMA, highlight a potential shift in how osteoporosis prevention and care can be effectively implemented in men, a group often underdiagnosed and undertreated for bone health.

The study included older male participants who were identified through primary care practices. Rather than relying solely on opportunistic screening during clinic visits, the intervention used a centralized process that flagged high-risk individuals based on established fracture risk profiles. These men were then invited for dual-energy X-ray absorptiometry (DXA) testing and, if indicated, were offered treatment and follow-up support.

Compared to usual care, the risk-based centralized strategy led to significantly higher screening completion rates. Importantly, it also increased the number of men who started pharmacologic therapy for osteoporosis, with better persistence and adherence to prescribed medications. This is particularly relevant given that men tend to present later in the course of osteoporosis, often after experiencing a fragility fracture, leading to worse outcomes compared to women.

The authors suggest that integrating centralized screening pathways within health systems may reduce the burden on primary care providers, while ensuring that men at greatest risk are not overlooked. Such approaches could ultimately reduce fracture incidence, health care costs, and disability related to osteoporosis.

Further research is needed to evaluate scalability across diverse populations and health systems, as well as to assess long-term impacts on fracture prevention and mortality. Still, the results add to growing evidence that proactive, risk-based, and system-level interventions can close existing gaps in men’s osteoporosis care.

Reference:

Crandall, C. J., et al. (2025). Effect of risk-based, centralized screening on osteoporosis detection and treatment in men: A cluster randomized clinical trial. JAMA. https://jamanetwork.com/journals/jama/fullarticle/xxxx

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Around 90% of middle-aged and older autistic adults are undiagnosed in the UK, review finds

Some 89–97% of autistic adults aged 40+ years are undiagnosed in the UK, according to the largest review of its kind which was conducted at the Institute of Psychiatry, Psychology & Neuroscience at King’s College London. The review indicated that middle-aged and older autistic adults are facing higher rates of mental and physical health conditions than non-autistic adults of the same age, alongside challenges with employment, relationships and well-being.

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Surgery to treat chronic sinus disease more effective than antibiotics, clinical trial finds

Sinus surgery is more effective than antibiotics at treating chronic rhinosinusitis, according to a major clinical trial led by University College London (UCL) along with academics at the University of East Anglia and Guy’s and St Thomas’ NHS Foundation Trust.

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Blood pressure calculator promises more precise medication choices for millions

A first-of-its-kind Blood Pressure Treatment Efficacy Calculator built on data from nearly 500 randomized clinical trials in over 100,000 people allows doctors to see how much different medications are likely to lower blood pressure.

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Mathematical model sheds light on ovarian aging, offering path toward advances in women’s health

Researchers at Rice University have developed a mathematical model that enhances our understanding of ovarian aging and the timing of menopause, revealing mechanisms that could inform future strategies for women’s health.

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Broad use of psychedelic MDMA could ease devastating psychological trauma in Ukraine, study says

Russia’s invasion of Ukraine has killed tens of thousands of Ukrainian soldiers and civilians, and injured hundreds of thousands more. But the war has also taken a less visible toll, with millions suffering from acute PTSD. Now a study co-authored at UC Berkeley proposes that use of the psychedelic MDMA, under close clinical supervision, could bring relief to millions of patients—with fewer therapists, lower costs and better results than conventional care.

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ATTAIN-2 Trial: Oral GLP-1 Orforglipron Lowers Weight and HbA1c among diabetics with obesity

Topline results from the ATTAIN-2 trial have demonstrated that adults taking 36 mg orforglipron lost an average of 10.5% body weight at 72 weeks, with over half of participants on any dose achieving an HbA1c of 6.5% or lower. The oral GLP-1 demonstrated significant benefits for adults with obesity and type 2 diabetes.

In the trial, all three doses of orforglipron met the primary and all key secondary endpoints, delivering significant weight loss, meaningful A1C reductions, and improvements in cardiometabolic risk factors at 72 weeks. For the primary endpoint, orforglipron 36 mg, taken once per day without food and water restrictions, lowered weight by an average of 10.5% (22.9 lbs) compared to 2.2% (5.1 lbs) with placebo using the efficacy estimand.1 With the completion of ATTAIN-2, Lilly now has the full clinical data package required to initiate global regulatory submissions for orforglipron.

“Based on my experience leading clinical trials in obesity and diabetes, these data show the potential for orforglipron to offer an efficacy, safety, and tolerability profile consistent with the injectable GLP-1 class,” said Louis J. Aronne, MD, FACP, DABOM, founder and Chair Emeritus of the American Board of Obesity Medicine, former president of The Obesity Society, Fellow of the American College of Physicians, and world-renowned obesity specialist. “Orforglipron could help health care providers expand treatment options for patients who prefer oral therapies without compromising clinical results.”

In the ATTAIN-2 trial, orforglipron met the primary endpoint of superior body weight reduction compared to placebo. Participants taking the highest dose of orforglipron lost an average of 22.9 lbs (10.5%) at 72 weeks using the efficacy estimand. In a key secondary endpoint, orforglipron lowered A1C by 1.3% to 1.8% from a baseline of 8.1% across doses. In another key secondary endpoint, 75% of participants taking the highest dose of orforglipron achieved an A1C ≤6.5%, which is at or below the American Diabetes Association’s definition of diabetes. Additionally, orforglipron showed clinically meaningful benefits across key cardiovascular risk factors, including non-HDL cholesterol, systolic blood pressure and triglycerides. In a pre-specified exploratory analysis, the highest dose of orforglipron reduced high-sensitivity C-reactive protein (hsCRP) levels, a marker of inflammation, by 50.6%.

iSuperiority test was adjusted for multiplicity with all three doses.

iiSuperiority test was adjusted for multiplicity with the 12 mg and 36 mg doses.

For the treatment-regimen estimand, each dose of orforglipron led to statistically significant improvements across the primary and all key secondary endpoints, including:

• Percent weight reduction: -5.1% (-5.3 kg; -11.7 lbs; 6 mg), -7.0% (-7.2 kg; -15.9 lbs; 12 mg), -9.6% (-9.6 kg; -21.2 lbs; 36 mg), -2.5% (-2.7 kg; -6.0 lbs; placebo)

• Percentage of participants achieving body weight reductions of ≥10%: 22.6% (6 mg), 31.2% (12 mg), 45.6% (36 mg), 9.0% (placebo)

• Percentage of participants achieving body weight reductions of ≥15%: 6.8% (6 mg), 14.4% (12 mg), 26.0% (36 mg), 3.0% (placebo)

• A1C reduction: -1.2% (6 mg), -1.5% (12 mg), -1.7% (36 mg), -0.5% (placebo)

• Percentage of participants achieving A1C <7%: 64.6% (6 mg), 75.9% (12 mg), 75.5% (36 mg), 30.5% (placebo)

• Percentage of participants achieving A1C ≤6.5%: 52.5% (6 mg), 57.6% (12 mg), 66.6% (36 mg), 15.4% (placebo)

“The ATTAIN-2 results reinforce the potential for orforglipron, as a once-daily oral, to deliver meaningful weight loss and A1C reduction, consistent with similar landmark trials for injectable GLP-1s,” said Kenneth Custer, Ph.D., Lilly executive vice president and president of Lilly Cardiometabolic Health. “With these positive data in hand, we are moving with urgency toward global regulatory submissions to potentially meet the needs of patients who are waiting. If approved, we are ready to offer a convenient, once-daily pill that can be scaled globally-removing barriers and redefining how obesity is treated around the world.”

The overall safety profile of orforglipron in ATTAIN-2 was consistent with the established GLP-1 receptor agonist class. The most commonly reported adverse events were gastrointestinal-related and generally mild-to-moderate in severity. The most common adverse events for participants treated with orforglipron (6 mg, 12 mg and 36 mg, respectively) were nausea (20.1%, 31.1% and 36.4%) vs. 8.4% with placebo, vomiting (12.8%, 20.2% and 23.1%) vs. 3.8% with placebo, diarrhea (21.3%, 24.8% and 27.4%) vs. 15.0% with placebo, constipation (17.7%, 21.1% and 22.4%) vs. 7.8% with placebo, and dyspepsia (9.1%, 15.4% and 10.9%) vs. 3.5% with placebo. Treatment discontinuation rates due to adverse events were 6.1% (6 mg), 10.6% (12 mg) and 10.6% (36 mg) for orforglipron vs. 4.6% with placebo. Overall treatment discontinuation rates were balanced across the treatment groups with 19.1% (6 mg), 22.3% (12 mg) and 20.5% (36 mg) for orforglipron vs. 20.0% with placebo. No hepatic safety signal was observed.

Detailed ATTAIN-2 results will be presented at a future medical meeting and published in a peer-reviewed journal.

About orforglipron

Orforglipron (or-for-GLIP-ron) is an investigational, once-daily small molecule (non-peptide) oral glucagon-like peptide-1 receptor agonist that can be taken any time of the day without restrictions on food and water intake.5 Orforglipron was discovered by Chugai Pharmaceutical Co., Ltd. and licensed by Lilly in 2018. Chugai and Lilly published the preclinical pharmacology data of this molecule together. Lilly is running Phase 3 studies on orforglipron for the treatment of type 2 diabetes and for weight management in adults with obesity or overweight with at least one weight-related medical problem. It is also being studied as a potential treatment for obstructive sleep apnea and hypertension in adults with obesity.

About ATTAIN-2 and ATTAIN clinical trial program

ATTAIN-2 (NCT05872620) is a Phase 3, 72-week, randomized, double-blind, placebo-controlled trial comparing the efficacy and safety of orforglipron 6 mg, 12 mg and 36 mg as monotherapy with placebo in adults with obesity or overweight and type 2 diabetes. The trial randomized over 1,600 participants across the U.S., Argentina, Australia, Brazil, China, Czechia, Germany, Greece, India, South Korea and Puerto Rico in a 1:1:1:2 ratio to receive either 6 mg, 12 mg or 36 mg orforglipron or placebo. The primary objective of the study was to demonstrate that orforglipron (6 mg, 12 mg, 36 mg) is superior to placebo in mean body weight change from baseline at 72 weeks in people with a BMI ≥27.0 kg/m² and type 2 diabetes who are on stable treatment with either diet/exercise alone or up to three oral antihyperglycemic medications. All participants receiving orforglipron started the study at a dose of 1 mg once-daily and then increased the dose in a step-wise approach at four-week intervals to their final randomized maintenance dose of 6 mg (via steps at 1 mg and 3 mg), 12 mg (via steps at 1 mg, 3 mg and 6 mg) or 36 mg (via steps at 1 mg, 3 mg, 6 mg, 12 mg and 24 mg). Dose reduction was only allowed for GI tolerability if other mitigations failed.

The ATTAIN Phase 3 global clinical development program for orforglipron has enrolled more than 4,500 people with obesity or overweight across two global registration trials.

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