Helminth Characteristics Required For Use In Therapy
For use as a therapeutic agent, the specific helminth should meet all the following minimum requirements:
Pfizers Promising Ulcerative Colitis Treatment Could Generate $19 Billion In Sales By 2030 Lillys Got A Drug In Development Too
Pfizer has a promising ulcerative colitis drug in development.
+0.87% promising ulcerative colitis treatment could generate $1.9 billion in sales by 2030 if its approved by U.S. regulators next year.
Thats according to SVB Securities analyst David Risinger, who told investors this week that he remains bullish on the drug.
Pfizer obtained etrasimod through its $6.7 billion acquisition of Arena Pharmaceuticals Inc., which closed in March. The data that Pfizer shared earlier this week from two pivotal late-stage clinical trials further makes the case for the deal.
One study found patients taking etrasimod reported clinical remission of 32.1% compared with 6.7% taking placebo after 52 weeks. A second study reported clinical remission of 24.8% for patients taking etrasimod compared with 15.2% for placebo after 12 weeks.
These Phase 3 results support the positioning of etrasimod as the first-in-line oral therapy after conventional treatments fail, Mike Gladstone, Pfizers global president of inflammation and immunology, said Thursday at Digestive Disease Week, according to a FactSet transcript of the presentation.
The experimental therapy is part of a wave of new ulcerative colitis treatments that aim to better treat an inflammatory bowel disease that is estimated to affect about 1 million people in the U.S.
An increasingly crowded market
Its expected to bring in $619 million in revenue this year and $1.8 billion in 2026, according to a FactSet consensus.
Bristol Myers Squibb Presents Interim Results From Long
The percentage of patients achieving clinical remission, clinical response, endoscopic improvement and corticosteroid-free remission was maintained through Week 142
Zeposia is the first and only oral sphingosine 1-phosphate receptor modulator approved to treat patients with ulcerative colitis
PRINCETON, N.J.â-Bristol Myers Squibb today announced interim results from the True North open-label extension study evaluating the long-term efficacy and safety profile of Zeposia in patients with moderately to severely active ulcerative colitis . Findings show that the percentage of patients achieving clinical remission, clinical response, endoscopic improvement and corticosteroid-free remission was maintained through Week 142. No new safety signals emerged in the study. These data will be presented at the 17th Congress of the European Crohnâs and Colitis Organisation , taking place February 16-19, 2022.
Additional Bristol Myers Squibb-sponsored abstracts presented at the ECCO 2022 Congress can be accessed online here.
Visit this page on BMS.com for more information on Bristol Myers Squibbs scientific approach and resources on gastrointestinal immune-mediated diseases.
About True North
Bristol Myers Squibb thanks the patients and investigators involved in the True North clinical trial.
About Ulcerative Colitis
ZEPOSIA is indicated for the treatment of:
IMPORTANT SAFETY INFORMATION
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The Positive Side Of Biosimilars: More Ibd Treatment Choices
No one doubts that biosimilars are here to stay and that theyll take over a growing share of the biologic drug market in coming years.
Afzali hopes the influx of new drugs will prompt more research on their effects in people with IBD. We still need a lot more human and research testing, she says, to really evaluate the safety and efficacy of biosimilars for individual diseases.
Gerich is cautiously optimistic about the potential benefits of biosimilars. Hopefully, safety wont be a concern, he says, and it will be interesting to see what the financial outcomes are.
As Afzali notes, as long as choices arent taken away from doctors and patients, the availability of biosimilars can only be a good thing. I think having more treatment options in our medicine cabinet is always appealing, she says.
Additional reporting by Quinn Phillips
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New Treatment Option For Ulcerative Colitis
The U.S. Food and Drug Administration has approved ustekinumab for the treatment of adults with moderately to severely active ulcerative colitis, a condition that affects approximately 910,000 adults in the U.S.
The U.S. Food and Drug Administration has approved ustekinumab for the treatment of adults with moderately to severely active ulcerative colitis, a condition that affects approximately 910,000 adults in the U.S.
Ustekinumab, an interleukin-12/23 inhibitor, is the first approved ulcerative colitis treatment to provide improvement of the intestinal lining as assessed by a novel histologic-endoscopic mucosal improvement endpoint.
“Ulcerative colitis is a chronic and progressive disease that can have a significant impact on patients, often disrupting their day-to-day lives with frequent and urgent needs for bowel movements that can be accompanied by pain and cramping,” said William J. Sandborn, M.D., UC San Diego School of Medicine in California.
Additionally, more patients treated with ustekinumab achieved endoscopic improvement and mucosal healing, with 17 percent of patients on ustekinumab achieving improvement of the intestinal lining at week eight, while 44 percent did so at one year.
The overall safety profile of ustekinumab in ulcerative colitis was consistent with what has been observed across all approved indications of the drug.
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Comparison With Acg Guidelines
Unlike the updated American College of Gastroenterology ulcerative colitis guidelines released in 2019, as reported by Medscape Medical News, the AGA clinical practice guidelines are not intended to cover all aspects of UC. Rather, explains Feuerstein, the guidelines are focused on providing the most thorough evidence-based answers to specific PICO questions based only on the GRADE assessment of the evidence.
The ACG guidelines, on the other hand, include recommendations for the diagnosis, medical management of the disease at all levels of severity, and quality of life, according to David T. Rubin, MD, FACG, from the University of Chicago, Illinois, who was lead author on the ACG guidelines. The two guidelines overlap around the use of biologic therapies and the choice of severity-based maintenance therapies in patients with moderate to severe disease to reduce the likelihood of future complications, he told Medscape Medical News. And although the ACG guidance does not specifically recommend early use of biologic agents over gradual step up after failure of 5-ASA therapy, Rubin acknowledges that large gaps in care with 5-ASA therapies indicate a clear need for better therapies.
Gastroenterology. Published online January 13, 2020. Full text
Worms The Natural Cure
In nature, whipworm infections usually spread areas with poor sanitation, when fecal matter gets back into the soil. Mild infections can be asymptomatic, but more severe cases usually result in bloody diarrhea, and in rare cases, a prolapsed rectum, said Loke. More than 20 percent of patients end up having a colectomy in which a portion of the colon must be removed.
While whipworm infection is endemic in Asia, Africa and Latin America, it is rare in North America and northern Europe, where sewage systems generally interrupt transmission. Colitis, on the other hand, is generally nonexistent in those regions with widespread exposure, leading researchers to hypothesize that childhood exposure to these parasites might offer gastrointestinal protection against inflammatory bowel disease.
So far, the research has supported this theory, though the long-term safety of actively infecting patients with the worm is still unknown.
Because current medications for colitis and other bowel disorders are harsh, expensive and can come with negative side effects, people may see whipworms as a more natural, gentle solution, Mullin said, but these parasites carry their own risks.
So while this patients case study serves as a valuable educational tool for researchers, a whipworm cocktail is not advised for people living with colitis, doctors warned.
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The Advantages Of Biologics For Ulcerative Colitis
Biologics can improve gut symptoms, bringing about and maintaining remission in people with moderate to severe ulcerative colitis. They can also reduce the need for hospitalization and surgery, says the British organization Crohns & Colitis UK.
One key advantage of biologic therapies over other types of treatment for ulcerative colitis is that their mechanisms of action are more precisely targeted to the factors responsible for the condition, notes the Crohns & Colitis Foundation.
Unlike corticosteroids, for example, which affect the whole body and may produce major side effects, biologic agents act more selectively. These therapies are targeted to particular proteins that have already been proven to be involved in ulcerative colitis.
Patients are often nervous about biologics, says Laura Raffals, MD, a gastroenterologist at the Mayo Clinic in Rochester, Minnesota. But theyre not as scared about taking a corticosteroid, and thats an important conversation to have because the data shows that patients on biologics are much safer and stay in remission longer. The serious side effects we see are from steroids or narcotics, not biologics.
The Future Of Biosimilars
As of December 2019, a total of 26 biosimilars have been approved in the United States. But that number could grow quickly, according to Anita Afzali, MD, a gastroenterologist and the medical director of The Ohio State University Inflammatory Bowel Disease Center in Columbus.
There are more than 650 biosimilars under development, Dr. Afzali notes, adding that most are in the early stages of development. Whats to come in the United States will certainly be a hot topic of discussion.
So far in the United States, biosimilars for IBD have been approved for all the same uses as their originator drugs but have not been ruled interchangeable with those drugs. In practice, this means that pharmacists cant substitute a biosimilar for a biologic, as they could with a generic for a brand-name drug.
Afzali worries that this may become a distinction without a difference. Its easy to imagine, she says, that an insurance company or hospital system could simply cover only the biosimilar equivalent of an original biologic. In this imagined scenario, she says, the state or the insurance or the pharmacist is saying, You have to try the biosimilar, even when a person has already experienced side effects from the biologic that might become worse with the biosimilar.
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Drugs For Ulcerative Colitis
Therapy of ulcerative colitis intends to lower the swelling in the colon. The inflammation-reducing medications with one of the most considerable experience are the aminosalicylates, medications that belong to pain killers. If aminosalicylates are inefficient, corticosteroids are utilized. A 3rd sort of medicine that is utilized is immunomodulators, medications that lower the immune reaction and also thus the swelling. It might take numerous weeks to months for the medications to come to be maximally efficient. Biologics like adalimumab and also others target healthy proteins generated by the body immune system.
Work Closely With Your Doctor
If your doctor prescribes a biologic, theyâll want to see you often to make sure the treatment works safely and effectively. So be sure to go to all of your appointments.
Tell your doctor about all prescription and over-the-counter drugs, supplements, or natural remedies you take. Any of those can affect the way other medications or supplements work. Talk to your doctor before you take anything new. Also tell your doctor about all of your medical conditions. Let them know if your symptoms get worse or if you notice any new ones.
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The Potential Downsides Of Biologics
While biologics may be a promising option for treating your ulcerative colitis, not every drug is suited to every patient.
We will work with patients for a while to tailor a treatment plan that is right for them, says Dr. Raffals. That may mean trying different biologics and small-molecule drugs, and, of course, taking into account what the patients insurance will cover.
A persons lifestyle, demographic factors, and the severity of the disease are all considerations in the choice of whether or not to use biologics, and which of them is the best option.
Some potential downsides of taking biologics include:
If youre considering biologics for treatment, speak to your doctor to find out whats best for you. As Tsynman says, At the heart of the decision is the relationship between the patient and the physician and specifically exploring what works best for each individual.
Additional reporting by Jordan M. Davidson.
Ulcerative Colitis Treatment: Surgery
If you did not respond to a medication regimen or you developed complications of colitis, you may be a candidate for surgery to treat ulcerative colitis.
Colectomy may be used in children with ulcerative colitis who experienced growth retardation. In all patients, elective colectomy can be a cure for ulcerative colitis. Almost always, the procedure is a total colectomy, meaning the entire colon is removed.
Surgical procedures include:
-
Total proctocolectomy with Brooke ileostomy. Removal of your entire colon and rectum. Your doctor will perform an ileostomy, which brings out your small intestine through the abdominal wall. Waste collects in an ileostomy bag. An ileostomy can be temporary or permanent.
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Ulcerative Colitis Treatment: Medication
The most common medication option is anti-inflammatory drugs. These can be used orally or topically to reduce inflammation of the colon and rectum.
Treating ulcerative colitis is a highly individualized process. At Johns Hopkins, we tailor your treatment to your specific needs and alter the medication as necessary. Your specific medication regimen will depend largely on the severity of your condition.
Other medications include:
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Immunosuppressive medications: These drugs slow your immune system to stop the immune response that is causing the colon and rectum to swell.
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Biologics: Like immunosuppressive medications, biologics target the immune system, but biologics act on specific immune system proteins that encourage inflammation.
Study Design And Setting
This was a randomised, double-blind, placebo-controlled, multicentre Phase II study undertaken to evaluate the efficacy and safety of three different dosages of TSO versus placebo in mildly-to-moderately active CD patients. The study was performed during November 2010 to February 2014 at 53 hospitals or private practices in Austria , Czech Republic , Denmark , Germany , and Switzerland . The study was conducted in accordance with the International Conference on Harmonisation Guideline for Good Clinical Practice and was approved by independent ethics committees for each centre.
The study comprised a 710-day screening phase, a 12-week double-blind treatment phase with eight visits: Weeks 0 , 1, 2, 4, 6, 8, 10, and 12 , and a follow-up visit, which took place 4 weeks after the EoT visit.
The study was conducted with four treatment groups in the form of a parallel group comparison. The primary objective was to demonstrate the superiority of any of the three TSO dosing groups compared with placebo for the induction of clinical remission in CD.
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Living With Ulcerative Colitis
With careful management, most people with UC are able to enjoy life, including work, travel, recreation, sex and having children.
To keep healthy, consider:
- eating a nutritious diet to help with healing and reduce fatigue
- keeping a food diary to check if there are any foods that make your symptoms worse during a flare-up
- asking your doctor about supplements if you think you may be malnourished
- exercising regularly to lift your mood and help relieve stress
- learning some relaxation techniques to help manage stress
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