FDA Approves Stelara for Young Children with Crohn’s; New Blood Test Detects Liver Cancer Early; Experts Weigh In on MASLD Treatments

The U.S. Food and Drug Administration (FDA) has expanded the approval of the drug ustekinumab, sold under the brand name Stelara, to now treat children as young as 2 years old who have Crohn’s disease. This announcement, made by drugmaker Johnson & Johnson, marks a significant step forward for pediatric patients and their families who have long faced limited treatment options for this chronic inflammatory bowel condition.

Crohn’s disease causes inflammation in the digestive tract, leading to symptoms like severe diarrhea, fatigue, abdominal pain, and weight loss. For young children, managing this condition can be especially challenging because many existing treatments are only approved for older kids or adults. Experts generally agree that expanding treatment options to younger age groups gives doctors more tools to control inflammation early, potentially preventing long-term damage to the intestines and improving a child’s quality of life. If you or someone you know has a young child with Crohn’s, this new approval means that a biologic therapy—which targets specific parts of the immune system—is now an option for children as young as 2, not just those over 6 or adults.

What the Latest Research Shows: Long-Term Success with Guselkumab (Tremfya)

In other encouraging news for people with inflammatory bowel diseases, new long-term data on the drug guselkumab (brand name Tremfya) shows high rates of clinical remission in both Crohn’s disease and ulcerative colitis. Clinical remission means patients have few or no symptoms and their disease is considered inactive.

– For Crohn’s disease: Long-term follow-up from the phase II GALAXI-1 trial, published in the journal Inflammatory Bowel Diseases, reported that 98% of patients who continued maintenance therapy with guselkumab achieved clinical remission at approximately 5 years. This is a remarkably high rate that suggests the drug remains effective for many years.

• For ulcerative colitis: According to long-term extension findings from the QUASAR study, published in the American Journal of Gastroenterology, upwards of 70% of patients achieved corticosteroid-free clinical remission at roughly 2 years. Being corticosteroid-free is a key goal because long-term steroid use can lead to serious side effects like bone thinning, weight gain, and increased infection risk.

For readers managing Crohn’s or ulcerative colitis, these findings reinforce that newer biologic drugs like guselkumab may offer durable, long-lasting control of disease activity without relying on steroids. However, experts caution that every patient responds differently, and treatment decisions should always be made in consultation with a gastroenterologist.

Microscopic Colitis on the Rise: Is It Better Awareness or More Disease?

A study from Sweden, published in Clinical Gastroenterology and Hepatology, looked at data spanning the past 25 years and found that both the incidence (new cases) and prevalence (total cases) of microscopic colitis are increasing. Microscopic colitis is a type of inflammatory bowel disease that causes chronic, watery diarrhea but can only be seen under a microscope during a colonoscopy.

Researchers suggest that this rise may be partly due to broader awareness of the condition among doctors and patients. As more healthcare providers learn to look for it, more cases are being diagnosed. For readers, this is a reminder that if you have persistent, watery diarrhea that doesn’t go away, microscopic colitis could be the cause—even if standard tests come back normal. Experts emphasize that it is a treatable condition, often managed with medications like budesonide.

Celiac Disease: Sick Leave May Start Years Before Diagnosis

A study published in Gastro Hep Advances found that people may start taking more sick time from work years before they are formally diagnosed with celiac disease. Celiac disease is an autoimmune disorder where eating gluten (a protein found in wheat, barley, and rye) damages the small intestine.

This finding suggests that the symptoms of celiac disease—such as fatigue, brain fog, abdominal pain, and nutrient deficiencies—can be present long before the disease is recognized. For anyone who has unexplained fatigue or digestive issues, this study highlights the importance of getting tested for celiac disease, especially if you have a family history or other autoimmune conditions. Early diagnosis and a strict gluten-free diet can prevent complications like osteoporosis, infertility, and certain cancers.

New Blood Test Shows Promise for Early Liver Cancer Detection

In a major advance for liver cancer screening, a multi-analyte cell-free DNA-based blood test called HelioLiver Dx has shown superior sensitivity compared to ultrasound for detecting liver cancer early, including small lesions. The findings were reported in the Journal of Hepatology.

Sensitivity refers to how well a test catches true cases of cancer, while specificity refers to how well it avoids false alarms. The study found that HelioLiver Dx was more sensitive than standard ultrasound and was noninferior (meaning not worse) in specificity. For readers at high risk of liver cancer—such as those with cirrhosis, chronic hepatitis B or C, or fatty liver disease—a simple blood test could eventually become a routine screening tool. Currently, ultrasound is the standard, but it can miss small tumors. Experts say that if this test gains FDA approval, it could help catch liver cancer at an earlier, more treatable stage.

FDA Priority Voucher for a New Cholangiocarcinoma Drug

The FDA has issued a priority review voucher for the drug zenocutuzumab (brand name Bizengri), which is being developed for a rare type of bile duct cancer called cholangiocarcinoma. The drug is intended for patients whose tumors harbor a specific genetic mutation called NRG1 gene fusion, and who have already tried other treatments without success.

A priority review means the FDA will make a decision on whether to approve the drug within 6 months instead of the standard 10 months. For patients with this rare and aggressive cancer, this expedited review offers hope for a targeted therapy. Drugmaker Partner Therapeutics announced the news. While this drug is not yet approved, experts note that genetic testing of tumors is becoming increasingly important to identify which patients might benefit from such precision medicines.

Normal Weight with Fatty Liver? Cardiovascular Risk May Be Higher

A study from Japan, published in Gastro Hep Advances, found that normal-weight people with steatotic liver disease (SLD)—commonly known as fatty liver—had a higher prevalence of cardiovascular disease compared to healthy controls and even compared to people with obesity and SLD.

This is a surprising and important finding. Fatty liver disease is often associated with obesity, but this study shows that even people at a healthy weight can have the condition, and they may actually be at greater risk for heart problems. For readers who are normal weight but have risk factors like high cholesterol, high blood pressure, or diabetes, it may be worth asking your doctor about screening for fatty liver. Experts stress that fatty liver is not just a “fat person’s disease,” and that lifestyle changes—like reducing sugar and processed foods—can help manage it regardless of body weight.

HIV and Liver Fibrosis: Standard Test May Miss Many Cases

The Fibrosis-4 (FIB-4) index is a simple blood test used to estimate liver scarring (fibrosis). However, a large multinational screening study published in Hepatology found that FIB-4 misses significant fibrosis in many people living with HIV, especially those who also have metabolic dysfunction-associated steatotic liver disease (MASLD).

For the estimated 38 million people living with HIV worldwide, liver disease is a growing concern. This study suggests that relying solely on FIB-4 could lead to underdiagnosis of advanced liver damage. Experts recommend that people with HIV, particularly those with fatty liver, should undergo more advanced imaging tests like transient elastography (FibroScan) to get an accurate picture of liver health.

Can MASLD Care Move into Primary Care?

A discussion in Gastro Hep Advances asks whether care pathways for metabolic dysfunction-associated steatotic liver disease (MASLD) can be effectively implemented in primary care settings. MASLD is the new name for what was previously called non-alcoholic fatty liver disease (NAFLD), and it affects about 25% of adults worldwide.

Currently, most MASLD care is managed by specialists like gastroenterologists and hepatologists. But with the condition so common, experts argue that primary care doctors—who already manage risk factors like diabetes, obesity, and high cholesterol—are well-positioned to screen for and manage early-stage MASLD. For readers, this could mean more convenient access to care, as your family doctor may soon be able to help you monitor liver health during routine checkups.

Pharmacotherapy for Non-Cirrhotic MASLD: A UK Expert Review

U.K. experts published a review in The Lancet Gastroenterology & Hepatology on the use of pharmacotherapies (medications) for non-cirrhotic MASLD. Currently, there are no FDA-approved drugs specifically for MASLD, though several are in development. The review looked at existing options like vitamin E and pioglitazone, as well as newer agents being tested in clinical trials.

For readers, this review underscores that while lifestyle changes (diet and exercise) remain the cornerstone of MASLD treatment, the field is moving toward having effective medications soon. If you have MASLD, it’s worth staying informed about new drug approvals and discussing any clinical trial opportunities with your doctor.

Hepatitis B: A Broad Review in JAMA

Meanwhile, JAMA published a comprehensive review on hepatitis B, a viral infection that affects the liver and can lead to cirrhosis and liver cancer. The review covered prevention (vaccination), screening, and treatment options. For readers, this is a reminder that hepatitis B is preventable with a vaccine, and that anyone born in regions where the virus is common—or anyone with risk factors—should get tested.

Metabolic Dysfunction and Severe Alcohol-Associated Hepatitis: No Link to Higher Mortality

Finally, a multinational prospective study published in Hepatology found that metabolic dysfunction was not linked with a higher mortality risk in patients with severe alcohol-associated hepatitis. This is a type of liver inflammation caused by heavy drinking. While metabolic issues like obesity and diabetes are known to worsen many liver diseases, this study suggests they do not independently increase the risk of death in this specific condition. For patients and families dealing with alcohol-associated hepatitis, this finding may help doctors focus treatment on the underlying alcohol use and liver injury rather than metabolic factors alone.

Practical Takeaways for Readers

– For parents of young children with Crohn’s: Ask your pediatric gastroenterologist if Stelara (ustekinumab) is an option for your child now that it’s approved for ages 2 and up.

• For anyone with chronic diarrhea: If standard tests are normal, ask about microscopic colitis—it’s treatable and increasingly recognized.
• For those at risk of liver cancer: A new blood test (HelioLiver Dx) may soon offer a more sensitive alternative to ultrasound for early detection.
• For people with fatty liver: Even if you are normal weight, you can still have the condition and may be at higher risk for heart disease. Get screened.
• For people with HIV: Don’t rely solely on the FIB-4 test for liver health; ask your doctor about advanced imaging if you have fatty liver.
• For everyone: Stay up to date on hepatitis B vaccination and consider screening if you have risk factors.

Source: MedPage Today