Latest news with #ulcerativeColitis
Medscape
15 hours ago
- Health
- Medscape
Obefazimod Shows Long-Term Benefits in Ulcerative Colitis
Obefazimod 50 mg once daily demonstrated efficacy in patients with moderate to severely active ulcerative colitis (UC), with 52.5% achieved clinical remission at 96 weeks of open-label maintenance treatment with improvement in endoscopy scores and faecal calprotectin levels. METHODOLOGY: Obefazimod is an investigational oral small molecule that enhances the expression of a single micro-RNA regulating the inflammatory response. In a phase 2b, randomised placebo-controlled 8-week induction trial, obefazimod at three different doses achieved the primary endpoint in patients with moderate to severely active UC. This 96-week open-label maintenance study was conducted including 217 patients (mean age, 42.1 years; 61.3% men) with moderate to severely active UC who were recruited at 69 study centres in 14 countries. All participants received 50 mg obefazimod once daily, regardless of their previous treatment and irrespective of their clinical response at the end of the induction trial. After week 48, patients who showed clinical response, defined as a decrease in the modified Mayo score ≥ 2 points and ≥ 30% from baseline plus a decrease in the rectal bleeding subscore ≥ 1 or absolute rectal bleeding subscore ≤ 1, continued the treatment up to week 96. Efficacy endpoints included rates of clinical remission, clinical response, endoscopic improvement, and endoscopic remission, along with the change in the stool frequency and faecal calprotectin levels from baseline of the maintenance study, assessed using non-responder imputation for missing data. Safety measures comprised the incidence of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (TESAEs), discontinuations due to TEAEs, drug-related SAEs, and clinically significant laboratory abnormalities. TAKEAWAY: Of the 217 patients, 164 completed the study at week 96. By weeks 48 and 96, 81.6% and 72.8% of patients achieved a clinical response and 54.8% and 52.5% achieved clinical remission, respectively; endoscopic improvement was seen in 59.0% of patients and endoscopic remission seen in 35.9% at week 96. Faecal calprotectin levels decreased from a median of 204.7 µg/g at baseline in the maintenance study to 89.6 µg/g at week 96, and 61.9% of patients achieved levels below 150 µg/g at week 96. At both weeks 48 and 96, the proportion of patients who achieved the efficacy endpoints was numerically higher among those who showed a clinical response at week 8 than among those who did not. A proportion of patients also achieved corticosteroid-free endoscopic improvement and remission. Overall, 68.2% of patients experienced at least one TEAE, with the most common being COVID-19 infection (14.3%) and headache (11.5%). TESAEs occurred in 8.3% of patients, and 7.8% discontinued because of TEAEs. No new safety signals or clinically meaningful changes in laboratory parameters were noted. IN PRACTICE: "[The study] findings suggest that long-term treatment with obefazimod provides continued improvement of clinical symptoms of the disease," the authors of the study wrote. "Although the central evaluation of endoscopy data reduced the risk of bias in this open-label study, the results must be interpreted with caution due to the absence of a control group," they added. SOURCE: This study was led by Severine Vermeire, University Hospitals Leuven, Leuven, Belgium. It was published online on May 26, 2025, in the Journal of Crohn's and Colitis . LIMITATIONS: Steroid cycling was not considered in the non-responder imputation method, which may have limited the interpretation of corticosteroid-free outcomes. DISCLOSURES: This study was supported by Abivax S.A. Seven authors reported being employees of Abivax. One author reported owning stocks in Abivax. Several authors reported receiving consultancy and/or speaking fees and grants and being consultants and advisory board members for various pharmaceutical companies.
Daily Mail
24-05-2025
- Health
- Daily Mail
New once-a-month jab can eliminate distressing symptoms for patients with severe bowel diseases like Crohn's and ulcerative colitis in only three months
Patients with severe bowel disease are set to benefit from a new drug that can eliminate their distressing symptoms in only three months. The once-a-month jab, guselkumab, treats Crohn's and ulcerative colitis, two debilitating conditions which occur when the immune system mistakenly attacks healthy tissue in the gut and other parts of the body. The medicine binds to immune cells that cause this damage, significantly reducing symptoms. Studies show that more than half of patients with Crohn's – an aggressive condition which can damage the gut as well as the mouth, stomach, and anus – were symptom-free within 12 weeks of starting guselkumab. About a quarter of patients with ulcerative colitis, where the damage is limited to the gut, experienced a similar benefit after beginning the treatment. Earlier this month, the drug safety watchdog, the Medicines and Healthcare products Regulatory Agency, gave the green light for guselkumab to be prescribed in the UK to patients who have failed to respond to other treatments. It is likely to be rolled out on the NHS within the next year. About half-a-million people in the UK suffer with Crohn's, which causes severe pain, diarrhoea, exhaustion and weight loss. It can also trigger pain in the joints, anus and eyes. About a third of patients living with the condition, where the gut lining becomes inflamed, will require surgery. Ulcerative colitis affects roughly 146,000 people in the UK. Symptoms include diarrhoea, blood in the poo, and regularly needing to go to the toilet. Both conditions can be controlled by drugs called biologics. These injections limit the damage caused by the immune system to the body. However, not all patients respond to them. The NHS spending watchdog, the National Institute for Health and Care Excellence, is currently deciding whether to fund guselkumab. Experts say the £2,250-a-month jab will be a lifeline and crucial addition to the Health Service's bowel disease treatments.
Medical News Today
24-05-2025
- Health
- Medical News Today
Omvoh side effects: Common, mild, and serious
As with other drugs, Omvoh (mirikizumab-mrkz) can cause side effects, such as herpes viral infection. If you are not able to tolerate side effects of Omvoh, talk with your doctor or pharmacist. Omvoh (mirikizumab-mrkz) is a brand-name drug that's prescribed for adults to treat moderately to severely active ulcerative colitis and moderately to severely active Crohn's disease. 'Active' means the condition is currently causing symptoms. The side effects you experience may vary depending on the condition being treated. If you have problems with side effects from Omvoh, talk with your doctor or pharmacist. They can discuss ways to manage side effects or other available treatment options. Do not stop Omvoh treatment without consulting your doctor first. Omvoh can cause certain side effects, some of which are more common than others. These side effects may be temporary, lasting a few days to weeks. However, if the side effects persist, bother you, or become severe, be sure to talk with your doctor or pharmacist. The following are just a few of the more common side effects reported by people who took Omvoh in studies. These side effects can vary depending on the condition being treated. More common side effects in people taking Omvoh for Crohn's disease include: upper respiratory infection, such as a sinus infection injection site reactions elevated liver enzyme tests headache joint pain For more information about some of these side effects, see the 'Side effect specifics' section. Mild side effects can occur with Omvoh use. This list does not include all possible mild side effects of the drug. For more information, you can refer to Omvoh's prescribing information. Mild side effects that have been reported with Omvoh include: upper respiratory infection, such as a sinus infection injection site reactions elevated liver enzyme tests headache joint pain skin rash or hives herpes viral infection These side effects may be temporary, lasting a few days to weeks. However, if the side effects continue, worsen, or become too difficult to tolerate, be sure to talk with your doctor or pharmacist. Note: After the Food and Drug Administration (FDA) approves a drug, it tracks and reviews side effects of the medication. Sharing your experience helps make medications safer for everyone by giving doctors and researchers more information about how the drug works in real life. If you develop a side effect during treatment with Omvoh and want to tell the FDA about it, visit MedWatch or call 800-FDA-1088. For more information about some of these side effects, see the 'Side effect specifics' section. Omvoh may cause serious side effects. The following list may not include all possible serious side effects of the drug. For more information, you can refer to Omvoh's prescribing information. If you develop serious side effects during Omvoh treatment, call your doctor right away. If the side effects seem life threatening or you think you're having a medical emergency, immediately call 911 or your local emergency number. Serious side effects that have been reported and their symptoms include: increased risk of serious infections, such as pneumonia; symptoms will vary based on the specific infection but may include: fever, chills, and sweating cough fatigue liver problems Allergic reaction For some people, Omvoh can cause an allergic reaction. In general, symptoms of allergic reaction can be mild or serious. Ways to manage For mild allergic reaction symptoms, such as a mild rash, call your doctor right away. They may recommend treatments to help manage your symptoms. They'll also let you know whether you should continue taking the medication. For severe allergic reaction symptoms, such as swelling or trouble breathing, call 911 or your local emergency number right away. These symptoms require immediate medical care because they can become life threatening. If you've had a serious allergic reaction to a drug, your doctor may recommend taking a different medication instead. Learn more about some of the side effects that Omvoh may cause. To find out how often side effects occurred in clinical trials, see the prescribing information for Omvoh. Herpes viral infection was a rare side effect reported in studies of Omvoh for treating ulcerative colitis. This side effect was not reported in studies where Omvoh was used to treat Crohn's disease. It's important to note that Omvoh doesn't 'give' you herpes. Treatment with Omvoh can raise your risk of any infection, including infections caused by the herpes virus. And if you've already been exposed to the herpes simplex virus, treatment with Omvoh could trigger an outbreak that causes symptoms to appear. Herpes zoster (shingles) may cause symptoms such as: a skin rash that's similar to chickenpox but appears in only certain areas, such as on your waist, chest, back, or abdomen, and typically affects one side of your body fluid-filled blisters that are part of the rash a constant burning, dull, or gnawing pain or an on-and-off sharp, stabbing pain Oral herpes simplex may cause symptoms including cold sores (also called fever blisters) that develop in or around your mouth or lips. In rare cases, the sores can also appear on your tongue, your face, or other areas of your skin. If you've previously been exposed to the herpes virus, treatment with Omvoh could cause a symptom outbreak. If you have symptoms of a herpes infection while taking Omvoh, talk with your doctor. They'll likely recommend treatment with an antiviral drug such as acyclovir or valacyclovir (Valtrex). They may also recommend other treatments for managing symptoms, which will vary based on your specific symptoms and the type of infection. Liver problems were a very rare side effect in studies of Omvoh. Symptoms of this side effect include: elevated liver enzymes, which your doctor may notice on a liver function test yellowing of your skin or the whites of your eyes abdominal pain If you have an existing liver condition, such as cirrhosis, you may be at higher risk of developing this side effect from Omvoh treatment. For at least the first 24 weeks of treatment, your doctor will order blood tests to check your liver function. Based on the results of these tests, your doctor may temporarily or permanently stop your Omvoh treatment. If you notice symptoms of liver damage while taking Omvoh, let your doctor know right away. Your doctor may temporarily or permanently stop your Omvoh treatment. In studies, liver function tests returned to normal after stopping Omvoh. Injection site reactions were commonly reported in studies of Omvoh. These are side effects that appear at or around the site where Omvoh is injected. Injection site reactions reported with Omvoh include: pain skin redness or discoloration hives In most cases, Omvoh injection site reactions are temporary and go away on their own in a few hours or days. But if you have symptoms that bother you or don't go away, talk with your doctor. They can recommend ways to relieve your symptoms. Omvoh may cause several side effects. Here are some frequently asked questions about the drug's side effects and their answers. Possibly. Omvoh treatment begins with three doses given by intravenous (IV) infusion. In studies of Omvoh, infusion-related reactions included itchiness, skin redness or discoloration, and anaphylaxis. These side effects occur during or shortly after the infusion. While similar side effects can happen with subcutaneous injections of Omvoh, it's not clear whether anaphylaxis occurred after subcutaneous injections in studies. During Omvoh infusions, a healthcare professional will be available to immediately treat any infusion reaction that develops. Talk with your doctor if you have additional questions about what you might expect from Omvoh infusions. Possibly, but it isn't clear whether long-term side effects happened in studies of Omvoh. For example, liver problems, including liver injury, are rare but did happen in these studies. However, liver function appears to return to normal once Omvoh is stopped. Omvoh can raise your risk of infections, including tuberculosis (TB). In rare cases, certain infections can cause long-term complications. Omvoh's prescribing information doesn't detail whether any long-term infections occurred. Your doctor or pharmacist can answer questions you may have about Omvoh treatment and your risk of long-term side effects. Before starting treatment with Omvoh, discuss your health history with your doctor. Omvoh may not be right for you if you have certain medical conditions or other factors affecting your health. Be sure to talk with your doctor if any of the following apply to you: active infection latent tuberculosis (TB) liver condition, such as cirrhosis recent or upcoming vaccinations previous allergic reaction to this or a similar drug pregnancy breastfeeding alcohol consumption Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses. Ulcerative Colitis Pharmacy / Pharmacist Drugs Medical News Today has strict sourcing guidelines and relies on peer-reviewed studies, academic research institutions, and medical journals and associations. We only use quality, credible sources to ensure content accuracy and integrity. You can learn more about how we ensure our content is accurate and current by reading our editorial policy.
Medscape
23-05-2025
- Health
- Medscape
Does Family IBD History Affect Outcomes in Paediatric IBD?
In patients with paediatric-onset inflammatory bowel disease (IBD), a familial history of IBD did not exhibit an increased use of immunomodulators or biologic agents compared with sporadic forms of the disease, but those with Crohn's disease (CD) had a higher need for perianal surgery. METHODOLOGY: This observational retrospective case-control study was conducted using a prospectively maintained registry since 2006, focusing on adults diagnosed with paediatric-onset IBD. This study included patients diagnosed with IBD at the age of 17 years or younger, all of Caucasian ethnicity and born in Spain. Patients with familial forms of IBD were defined as those having at least one first-degree relative with IBD, and those with sporadic forms of IBD had no family history. Each patient with a paediatric-onset familial form of IBD was propensity score matched with four patients with paediatric-onset sporadic forms of IBD, and 655 patients with CD and 440 with ulcerative colitis (UC) comprising familial and sporadic forms were included. Data collected included demographics, IBD diagnosis details, the use of immunomodulators and biologic therapies, and surgery timelines, with a median follow-up duration of 100 and 102 months for patients with CD and UC, respectively. TAKEAWAY: Among patients with CD or UC, no significant differences in the percentage of patients exposed to immunomodulators were found between those with familial and sporadic forms of the disease, nor in the median time to the introduction of immunomodulators. The use of biologic agents did not differ between patients with familial and sporadic forms, with no significant differences in the median time to the initiation of treatment. Patients with familial forms of CD showed a higher requirement for perianal surgery than those with sporadic forms of CD (18.3% vs 10.5%; odds ratio, 1.91; P = .014). = .014). No significant differences in the proportion of patients who underwent intestinal resections and total or segmentary colectomies were observed between familial and sporadic forms in those with CD and UC, respectively. IN PRACTICE: "Having a family history of IBD in children with IBD should not be a criterion for changing the treatment algorithm or for anticipating a worse prognosis," the authors wrote. SOURCE: This study was led by Carlos González-Muñoza, Hospital Santa Creu i Sant Pau, Barcelona, Spain. It was published online on May 12, 2025, in the Journal of Clinical Medicine . LIMITATIONS: The registry primarily included adult patients, potentially underrepresenting paediatric-onset IBD cases. The findings may not be generalisable to non-Caucasian populations owing to the homogeneous genetic background of the cohort. The absence of data on genetic polymorphism further limited the study's conclusions. DISCLOSURES: This study did not receive any external funding. Some authors reported receiving educational or research funding, travel grants, and advisory fees and serving as consultants and/or speakers for several pharmaceutical companies.
The Independent
23-05-2025
- Sport
- The Independent
Fighter Georgia O'Connor dies at just 25
British fighter Georgia O'Connor has unfortunately passed away at the age of just 25. O'Connor, 3-0 (0), was diagnosed with a rare and aggressive cancer last year, according to her family. She had recently changed her name to Georgia Cardinali after marrying partner Adriano just two weeks ago. She had recently been hospitalised with sepsis, narrowly escaping death. On Instagram last February, O'Connor said that she had fought professionally three times while suffering from symptoms that were later diagnosed to be an incurable cancer. She wrote: 'Ulcerative colitis is an autoimmune disease, which means that the immune system is confused and can't tell the difference between your own cells and foreign cells, causing the body to mistakenly attack normal cells. I was upset to find out I have this disease as I've already been unlucky in the past with my health when I nearly lost my life from blood clots in my lungs.' She added: 'I recovered from that but sadly there is no cure for ulcerative colitis. However, since being diagnosed I've been on medication and feel the best I have in a long time during training, work and every other part of my life. My family and boyfriend have been absolutely amazing and I could never be able repay them for what they have done for me.' It is understood that O'Connor's ulcerative colitis developed into cancer. 'The last few months,' she wrote sadly towards the beginning of the year, 'have been a rollercoaster. I've been pregnant with a beautiful baby, suffered a miscarriage, then got diagnosed with 'incurable' cancer. But I still feel on top of the world!' O'Connor's boxing career was a short-but-successful one. She turned professional in 2021 with a points decision over Ester Konecna in Newcastle. She followed this with fights in 2022 against Erica Juana Gabriela Alvarez and Joyce Van Ee, winning both on points. The team at The Independent send our condolences to her family, friends, and loved ones. May her memory be a blessing to them.
