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Category Archives: Ulcerative Colitis

Hundreds to Take Steps for Crohn’s and Ulcerative Colitis – WSYR

Posted: June 19, 2017 at 5:47 pm

LIVERPOOL (WSYR-TV) – According to the Crohn’s and Colitis Foundation, 1.6-million Americans are suffering with one of the painful gastrointestinal diseases they’re trying to fight.

For some patients, medicine does not relieve symptoms including internal bleeding, joint swelling, skin lesions and abdominal cramping.

Researchers haven’t pinpointed a single cause for the diseases, but possibilities include environmental factors, genetic predisposition or abnormalities of the immune system.

Ulcerative Colitis patients suffer from intense inflammation along their colon, while Crohn’s Disease can impact various points along the gastrointestinal tract.

To support ongoing research, the Crohn’s and Colitis Foundation is hosting the 2017 Syracuse Takes Steps walk on June 17 at Onondaga Lake Park.

Families can register now online. Click here for more information.

People who don’t want to form their own team can still walk. NewsChannel 9’s Tammy Palmer, who suffers from ulcerative colitis is welcoming anyone to join her team. Click here to sign up!

You can also play the clip above to hear more about Tammy’s personal struggles with the disease.

She has created a Facebook group called CNY Crohn’s and Colitis Crusaders to offer patients a place to meet and share their experiences.

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Take Steps for Crohn’s and Colitis walk doubles in size and fundraising – WSYR

Posted: June 18, 2017 at 2:47 am

LIVERPOOL (WSYR-TV) – As more people are diagnosed with Crohn’s Disease and ulcerative colitis, the push for a cure is growing.

Saturday morning about 400 people joined the annual Take Steps for Crohn’s and Colitis walk at Onondaga Lake Park in Liverpool.

That’s more than double the turnout just last year.

Volunteers with the Crohn’s and Colitis Foundation say they also doubled their fundraising this year, topping a $30,000 goal.

“Our goal, obviously first and foremost is to get the word out so that people know what those diseases mean, so when they look around and see 300 plus people there to support them, they don’t feel alone and isolated,” says Eric Israel with the Crohn’s and Colitis Foundation.

Organizers say many people don’t understand the diseases because patients may be uncomfortable talking about them.

“I know a lot of people are sensitive to the subject. But here, it is normal. It affects people in different ways and you learn about them,” says Sara Gunther, an ulcerative colitis patient who led a team of supporters in the walk.

Several people from NewsChannel 9 joined Tammy Palmer’s team at the walk. She underwent J-pouch surgery when medication failed to treat her ulcerative colitis.

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Take Steps for Crohn’s and Colitis walk doubles in size and fundraising – WSYR

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Ulcerative Colitis Market and Forecast Analysis Report 2017: Focus on Pipeline, Marketed Drugs, Epidemiology … – GlobeNewswire (press release)

Posted: May 31, 2017 at 7:50 pm

May 30, 2017 05:20 ET | Source: Research and Markets

Dublin, May 30, 2017 (GLOBE NEWSWIRE) — Research and Markets has announced the addition of the “Ulcerative Colitis Market and Forecast Analysis” report to their offering.

Ulcerative colitis is a chronic inflammatory bowel disease that is characterized by inappropriate diffuse inflammation of the rectal and colonic mucosa, which occurs in the innermost layer of the intestinal lining. Ulcerative colitis is a chronic, incurable disease with low mortality that is generally diagnosed in adolescence and early adulthood.

Ulcerative colitis is currently an idiopathic condition, the pathogenesis of which is yet to be fully elucidated. However, it is known to involve an interaction between genetics, the immune system, and environmental factors. Risk factors include ethnicity, family history, antibiotic or non-steroidal anti-inflammatory agent use, and diet. Incidence and prevalence have been increasing over the past two decades in most regions of the world.

It is estimated that in 2015, there were 2.1 million diagnosed prevalent cases of ulcerative colitis in the US, Japan, and five major EU markets (France, Germany, Italy, Spain, and the UK). Over 2015-35, the number of prevalent cases is expected to increase to 2.5 million (16.6% increase).

Key Topics Covered:

1. Treatment: Ulcerative Colitis

2. Epidemiology: Ulcerative Colitis

3. Marketed Drugs: Ulcerative Colitis

4. Pipeline: Ulcerative Colitis

5. Appendix

For more information about this report visit http://www.researchandmarkets.com/research/87k8xs/ulcerative

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Ulcerative Colitis Market and Forecast Analysis Report 2017: Focus on Pipeline, Marketed Drugs, Epidemiology … – GlobeNewswire (press release)

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Celgene Accesses IMIDomics Immune-Mediated Inflammatory … – Genetic Engineering & Biotechnology News

Posted: at 7:50 pm

Celgene established a collaboration with IMIDomics centered on access to the Spanish firm’sclinical and molecularimmune-mediated inflammatory diseases (IMIDs)database to help identify new targets and biomarkers, support drug and companion diagnostic development, and help stratify patients for clinical trials.No financial details were disclosed, except to note that IMIDomics will receive project funding and potential royalties on products resulting from the collaboration.

IMIDomics database provides a powerful window into the clinical and molecular underpinnings of immune-mediated inflammatory diseases, said Douglas E. Bassett, Ph.D., vp informatics and knowledge utilization at Celgene. This collaboration has exciting potential to impact our ongoing efforts to innovate breakthrough therapies for unmet medical needs in this space, and were enthusiastic to team up with IMIDomics to unlock the full potential of this resource for patient benefit.

IMIDomics is a spinout from the Vall d’Hebron Institute of Research (VHIR) at the Vall d’Hebron Hospital Campus in Barcelona. The firm is combining what it claims is one of the largest IMID biobanks with clinical expertise and high-throughput genomic and genetic analysis to identify and develop biomarkers and targets for IMID monitoring and treatment. The organizations focus is on rheumatoid arthritis, Crohns disease, ulcerative colitis, psoriasis, psoriatic arthritis, and systemic lupus erythematosus (SLE).

Celgenes oral phosphodiesterase type 4 (PDE4) inhibitor Otezla (apremilast) is approved in the U.S., Europe, and, most recently, Japan (December 2016) for treating plaque psoriasis and active psoriatic arthritis. Global sales of the drug topped $1 billion in 2016, an increase of 116% year-on-year. Q4 sales of Otezla were $305 million, up 67%. The drug is also in mid-late-stage clinical development for indications, including ulcerative colitis and Crohns disease.

Celgenes inflammatory diseases pipeline includes: CC-220, which is in Phase II development for treating SLE; ozanimod, which is in mid- and late-stage clinical development for indications including ulcerative colitis and Crohns disease; and GED-0301 (mongersen), also in mid- and late-stage development for the ulcerative colitis and Crohns disease indications.

The firm recently stated that data from the Phase III REVOLVE and DEFINE registrational trials with GED-0301 in patients with active Crohns disease are due to report in 2018. The Phase III TRUE NORTH registrational trial evaluating ozanimod in patients with ulcerative colitis is also due to report in 2018. Data from separate proof-of-concept Phase II studies evaluating GED-0301 in ulcerative colitis and ozanimod in Crohns disease are expected this year.

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Uceris Evaluated in Mesalamine-Refractory Ulcerative Colitis – Monthly Prescribing Reference (registration)

Posted: May 24, 2017 at 7:50 pm

May 18, 2017

A total of 510 patients with mild-to-moderate ulcerative colitis took part in the randomized, placebo-controlled trial

Salix announced the publication of study data for budesonide multimatrix (MMX), also known as Uceris extended-release tablets, in theJournal of Crohn’s & Colitis.

In the randomized, double-blind, placebo-controlled, multicenter study, budesonide MMX was evaluated for the induction of remission in 510 patients withmild to moderate ulcerative colitis (UC)refractory to baseline mesalamine therapy. Study patients were randomized to oral budesonide MMX 9mg daily or placebo for 8 weeks. Baseline treatment with oral mesalamine 2.4g daily was continued.

Clinical remission was defined as UC disease activity index rectal bleeding and stool frequency subscale scores of 0. Endoscopic remission was defined as UC disease activity index mucosal appearance subscale score of 0.

At Week 8, combined clinical and endoscopic remission was obtained in 13.0% of budesonide MMX patients vs. 7.5% of placebo patients in the modified intent-to-treat population (P=0.049). Clinical remission was similar for both study arms (P=0.70). More patients in the budesonide MMX group vs. the patients in the placebo group achieved endoscopic remission (20.0% vs. 12.3%;P=0.02) and histological healing (27.0% vs. 17.5%;P=0.02).

Study authors reported that the rates of adverse events were comparable between the budesonide MMX and placebo arms: 31.8% vs. 27.1%. A reduction in mean morning cortisol concentrations was noted at Weeks 2, 4, and 8 with budesonide MMX, but concentrations remained in the normal range.

David T. Rubin, MD, lead author, from the University of Chicago Medicine, added, “The data suggest the efficacy and safety of Uceris in patients experiencing an active flare of UC despite initial oral 5-ASA therapy.”

Uceris, a second-generation extended-release corticosteroid, is currently approved for the induction of remission in patients with active, mild to moderate ulcerative colitis. It is available as 9mg extended-release tablets in 30-count bottles.

For more information visitacademic.oup.com.

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Uceris Evaluated in Mesalamine-Refractory Ulcerative Colitis – Monthly Prescribing Reference (registration)

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Beamer freshman Nate Clow: ‘It’s not really worth hiding’ from his disease, ulcerative colitis – The Seattle Times

Posted: May 12, 2017 at 5:50 pm

Not even through his first year of high-school baseball, Nate Clow has already committed to Washington.

Theres just something about baseball.

At age 2, Nate Clow attended his first Mariners game and sat in the stands without speaking or fidgeting, watching the entire game. By middle school, his bedroom was covered with every MLB teams pennant, photos of legends and an embarrassing amount of Ichiro bobblehead dolls.

Now a freshman at Todd Beamer, Clow turned the passion into a starting spot on the varsity baseball team. Arizona Diamondbacks infielder Jake Lamb is a favorite player, Clow studying the swing of the fellow lefty from Seattle before every game.

Lately, another player has become a favorite of Clows Texas Rangers relief pitcher Jake Diekman. Odd for Clow, a hitter so skilled he verbally committed to the University of Washington just as Lamb did.

But what you cant tell about Clow is he suffers from ulcerative colitis, an inflammatory bowel disease where the bodys own immune system attacks the normal gut bacteria in the large intestine, causing inflammation and ulcerations. In 2015, Diekman publicly acknowledged his 19-year battle with the incurable disease.

When Im in a flare (up), I know hes gone through the same exact thing with the same sport at the highest level, Clow said. It gives me that extra motivation.

Clows most recent flare up was in April, dropping 10 pounds. He had his third colonoscopy of the month on April 24 and proceeded to bat 6 for 7 as the Titans split a doubleheader against Decatur.

Beamer (12-7) plays Emerald Ridge (10-10) at Bellarmine Prep in Tacoma on Tuesday in a loser-out district tournament game.

Doctors have adjusted Clows treatment to regain control of his flare ups, which have subsided. He describes it as an inconvenience that can cause an average of 14 trips to the restroom a day. Hes had to immediately leave baseball games and has been on a strict diet since March 2016 where he doesnt eat dairy, meat, processed sugars or highly processed foods.

Nate handles it extremely well, Todd Beamer coach Shane Elliott said. Hes open about it; its not a secretive thing.

Its poop, Clow says, using humor to ease any uneasiness in the discussion.

Unlike Diekman, Clow immediately became an advocate for the approximate 1.6 million Americans who suffer from Crohns and ulcerative colitis. Clow has been a sufferer since October 2014 at age 12.

The symptoms began that summer. Clow, the youngest of three, dismissed the stomach cramps and diarrhea as stress from baseball tournaments and track and field meets. He didnt even tell his parents much about the discomfort. His mother suspected her son had food poisoning.

But things worsened. The family sought help from the doctors at Seattle Childrens Hospital, undergoing numerous tests.

They werent able to get it under control, Clows father Scott said of the early days. They put him on steroids for several months. Remicade (a common medication for the condition) didnt seem to be working. They referred us to the surgeon to have his colon removed because they thought that was what was going to be where we had to go with this to get it under control. Were very fortunate that the Remicade finally kicked in.

A year later, in November 2015, Clow had to be hospitalized for 10 days because of a severe relapse. He currently gets Remicade infusions every six weeks and coupled with the diet, hes able to manage the disease.

Were trying to buy time, said Scott, noting research is being done to find a cure. When his son turns 20, hell have to have regular colonoscopies to check for colon cancer. A side effect of the Remicade is lymphoma.

But theres no threat to Nate playing baseball.

He met Diekman when the Rangers played at Safeco Field last year. Diekman has given Clow shout-outs on Twitter.

Baseball is where I belong, Clow said. Ill just grab a glove and a tennis ball and throw it against the garage or do some dry hacking and imagine Im playing in the College World Series.

(But) the disease is going to be with me my whole life, so its not really worth hiding.

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Beamer freshman Nate Clow: ‘It’s not really worth hiding’ from his disease, ulcerative colitis – The Seattle Times

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Tofacitinib effective as induction and maintenance therapy for ulcerative colitis – 2 Minute Medicine

Posted: at 5:50 pm

1. Patients with active ulcerative colitis who failed prior treatment achieved significantly greater remission of disease and mucosal healing compared to those treated with placebo.

2. Remission of ulcerative colitis symptoms over 1 year was significantly greater for patients who initially responded to tofacitinib and continued therapy compared to patients who responded and then were treated with a placebo.

Evidence Rating: 1 (Excellent)

Study Rundown: Ulcerative colitis is an inflammatory condition of the colon. The condition is difficult to treat despite an array of therapies available. Janus kinase (JAK) receptors are involved in many intracellular immune pathways associated with inflammatory bowel disease, therefore JAK inhibitors may prove useful in treatment of ulcerative colitis. Prior phase 2 trials indicated tofacitinib, a JAK inhibitor, can induce remission of ulcerative colitis. In three phase 3 trials, tofacitinib was further evaluated as an induction and maintenance treatment for patients with ulcerative colitis.

The studies randomized patients with moderate to severe active ulcerative colitis into treatment and placebo groups. In the first 2 studies (OCTAVE 1 and 2), patients received 10 mg of tofacitinib twice a day or a placebo for 8 weeks. At 8 weeks, treated patients were significantly more likely to have achieved remission and gastrointestinal mucosal healing than those treated with placebo. For the third trial (OCTAVE Sustain), patients who responded to tofacitinib were randomized to receive 5 mg tofacitinib, 10 mg tofacitinib, or a placebo twice a day. At 1 year, patients receiving either treatment dose were significantly more likely than those treated with placebo to still be in remission and have mucosal healing.

Click to read the study, published today in NEJM

Relevant Reading: Modulation of innate and adaptive immune responses by tofacitinib (CP-690,550)

In-Depth [randomized controlled trial]:This work describes the results of three separate, multinational, randomized controlled trials carried out from 2012 to 2016. All trials included adult patients with a confirmed diagnosis of ulcerative colitis defined as moderate to severe as assessed by the Mayo score, which included pre- and post-treatment endoscopy. All patients included had to have failed prior treatment for ulcerative colitis, and were generally not allowed to be on other ulcerative colitis treatments during the trial. The first two trials (OCTAVE 1 and 2) randomly assigned patients to treatment groups of 10 mg tofacitinib twice a day (n = 476 and 439, respectively) or a placebo (n = 122 and 112, respectively) for 8 weeks. Key endpoints were remission and mucosal healing at 8 weeks, both assessed by Mayo scores. At 8 weeks, patients in OCTAVE 1 and 2 trials treated with tofacitinib experienced remission significantly more than those in the placebo groups (OCATVE 1 18.5% vs 8.2%, p = 0.007; OCTAVE 2 16.6% vs 3.6%, p

In the OCTAVE Sustain trail, patients who responded to tofacitinib were randomized to receive maintenance therapy over 52 weeks with 5 mg tofacitinib (n = 198), 10 mg tofacitinib (n = 197), or placebo (n=198) twice a day. Their study endpoints were also remission and mucosal healing. At 52 weeks, patients in either the 5 mg or 10 mg tofacitinib groups were more likely to be in remission (34.3% and 40.6%, respectively) than those treated with placebo (11.1%, p

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20172 Minute Medicine, Inc. All rights reserved. No works may be reproduced without expressed written consent from 2 Minute Medicine, Inc. Inquire about licensing here. No article should be construed as medical advice and is not intended as such by the authors or by 2 Minute Medicine, Inc.

2 Minute Medicines The Classics in Medicine: Summaries of the Landmark Trials is available now in paperback and e-book editions.

This text summarizes the key trials in:General Medicine and Chronic Disease, Cardiology, Critical and Emergent Care, Endocrinology, Gastroenterology, Hematology and Oncology, Imaging, Infectious Disease, Nephrology, Neurology, Pediatrics, Psychiatry, Pulmonology, and Surgery.

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20 Year Ulcerative Colitis Market and Forecast Analysis 2015-2035 … – Business Wire (press release)

Posted: at 5:50 pm

DUBLIN–(BUSINESS WIRE)–Research and Markets has announced the addition of the “Ulcerative Colitis Market and Forecast Analysis” report to their offering.

Ulcerative colitis is a chronic inflammatory bowel disease that is characterized by inappropriate diffuse inflammation of the rectal and colonic mucosa, which occurs in the innermost layer of the intestinal lining. Ulcerative colitis is a chronic, incurable disease with low mortality that is generally diagnosed in adolescence and early adulthood.

Ulcerative colitis is currently an idiopathic condition, the pathogenesis of which is yet to be fully elucidated. However, it is known to involve an interaction between genetics, the immune system, and environmental factors. Risk factors include ethnicity, family history, antibiotic or non-steroidal anti-inflammatory agent use, and diet. Incidence and prevalence have been increasing over the past two decades in most regions of the world.

It is estimated that in 2015, there were 2.1 million diagnosed prevalent cases of ulcerative colitis in the US, Japan, and five major EU markets (France, Germany, Italy, Spain, and the UK). Over 2015-35, the number of prevalent cases is expected to increase to 2.5 million (16.6% increase).

Key Topics Covered:

1. Treatment: Ulcerative Colitis

2. Epidemiology: Ulcerative Colitis

3. Marketed Drugs: Ulcerative Colitis

4. Pipeline: Ulcerative Colitis

5. Appendix

For more information about this report visit http://www.researchandmarkets.com/research/gp4sxb/ulcerative

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20 Year Ulcerative Colitis Market and Forecast Analysis 2015-2035 … – Business Wire (press release)

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Ben Saarel Uses Lessons From Running Community To Battle Ulcerative Colitis – FloTrack

Posted: May 7, 2017 at 8:52 pm

Distance running is, by definition, overcoming physical discomfort with mental strength. But there is a line between running through pain and the body actually needing medical attention. Colorado All-American Ben Saarel was not afraid to speak up when his body failed him. The decision to be proactive has saved his health and, consequently, his running career.

“I think everyone has their own struggles. The best people that I’ve met in the running community ask, ‘What can I do and how much can I get done on this particular day?'” Saarel told FloTrack.

“They’re just tenacious when it comes to taking care of their bodies. The best people find ways to stay positive.”

This Friday, Saarel will be competing in the 800m at the Payton Jordan Invitational. Almost exactly three years earlier, he was diagnosed with ulcerative colitis, a bowel disease that causes long-lasting inflammation and ulcers in the digestive tract. Depending on the case, ulcerative colitis can sometimes lead to life-threatening complications.

“I could tell I was losing a lot of blood, and when I looked in the mirror, I was just pale,” Saarel said. “You wake up, you’re tired. You go to bed, you’re tired. You’re just tired all the time.

Payton Jordan was a turning point where he could no longer ignore the signs that something was wrong. His mother, who works as a cardiologist, was alarmed and encouraged him to see a doctor immediately. Saarel was proactive, setting up appointments in Boulder, CO, and in his hometown at the University of Utah in Salt Lake City. He was fortunate that the diagnosis came early and that the symptoms were manageable.

Fellow Pac-12 standout Collin Jarvis also suffers from ulcerative colitis but didn’t get diagnosed until six months after he started feeling symptoms. In a year-and-a-half-long ordeal in which doctors initially didn’t detect the disease, Jarvis’ body slowly shut down until he was forced to undergo a series of emergency surgeries to have his colon removed. Against all odds and his doctor’s prognosis that he would never run competitively again, Jarvis returned to collegiate running and completed his degree at Cal in 2015. He still runs competitively today, but instead of using the bathroom normally, he uses an ileostomy bag attached to his side that collects bodily waste.

Luckily for Saarel, his symptoms were not as severe, and he was able to receive treatment immediately. That same freshman season, he still managed to compete in the 1500m semifinal of the NCAA Outdoor Championship.

“It’s important to be proactive and say ‘something is wrong, I got to get help’ instead of trying to get through it,” Saarel said, admitting that his only regret is that he wished he had said something sooner.

To treat the disease, his doctors gave him specific medications and instructed him to avoid foods with a lot of fiber. Saarel has been on a gluten-free diet since his sophomore year of high school and was already accustomed to managing dietary restrictions. Still, sometimes managing the diet can be difficult. He can’t eat any foods with seeds and crunchy peanut butter is definitely off-limits. Traveling to meets in locations without gluten-free menus can also be troublesome. But Saarel continues to manage it in ways that work best for him while keeping his stress levels down. It’s an especially impressive feat given the fact that he’s a student-athlete studying engineering physics with a 3.9 grade-point average.

The regimented lifestyle has translated well to Saarel’s running career, ultimately culminating in five All-American honors and two NCAA cross country team titles.

“When he starts to hurt, that’s when he starts to push,” said Blake Theroux, an All-American and former teammate of Saarel.

During his sophomore year, Saarel contributed to the Buffaloes’ national team title in cross country with a seventh-place individual finish. He also managed to qualify for the NCAA Outdoor Championships and finished ninth in his 1500m semifinal heat. But throughout the season, he suffered from sinus problems and had to get surgery during the summer. During the following fall season, he contracted mononucleosis. Because of the sickness, Saarel and his coaches decided to redshirt the 2016 track season.

In his first race since November 2015, Saarel ran a personal best of 3:39 in the 1500m at the Hoka One One Middle Distance Classic in May. He followed the performance with another personal best of 3:38 at the Portland Track Festival. The mark broke the Colorado school record and qualified him for a spot to compete in the 2016 Olympic Trials. He finished eighth in his heat as a result of a collision late in the race.

Watch Saarel’s 3:38 at the 2016Portland Track Festival:

Considering the trio of health scares that Saarel has dealt with, the question had to be asked: Did you ever think about quitting?

“I always wanted to keep running. I always liked it but there were a couple of times where I wondered if I could manage it, especially when the sinus problems happened. But the biggest thing was wondering if I could keep running at this level,” he said.

“I didn’t know if I could. But I think the answer, hopefully this year, is going to be ‘yes, I can run at the level I want to and feel good. It’s just going to take time.'”

In his four years at Colorado, Saarel has trained alongside dozens of fellow national-caliber teammates and several alums who also happen to be Olympic and world medalists. It’s these individuals who inspire Saarel on a daily basis.

“Kara [Goucher], Jenny [Simpson], Emma [Coburn], those are all people who, when things go wrong they take the time to really make sure that their body is healthy and they don’t let it affect them, they keep going,” he said. “I try to tell myself ‘if these pros can do it, there’s no reason I can’t.'”

This weekend’s Payton Jordan Invitational will mark the three-year anniversary of his decision to be proactive about his health. His goal is to improve upon his 800m personal best of 1:51.

“You just have to weather the tough parts and appreciate the good parts because sometimes they don’t happen very often.”

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Arthritis Drug Promising for Ulcerative Colitis – WebMD – WebMD

Posted: at 8:52 pm

By Steven Reinberg

HealthDay Reporter

WEDNESDAY, May 3, 2017 (HealthDay News) — A new study finds that people with moderate to severe ulcerative colitis who haven’t done well on other treatments may find relief with Xeljanz (tofacitinib), a drug currently used to treat arthritis.

Ulcerative colitis is a chronic inflammatory bowel disease. It affects about 700,000 Americans, according to the Crohn’s and Colitis Foundation (CCF).

The illness causes inflammation, irritation, swelling and sores on the lining of the large intestine. Symptoms include diarrhea with blood or pus and abdominal discomfort, according to CCF.

“There is still a substantial unmet need for new treatments for patients with ulcerative colitis,” said study lead author Dr. William Sandborn. He is professor of medicine and chief of the division of gastroenterology at the University of California, San Diego.

Xeljanz targets certain proteins involved in the body’s inflammatory and immune responses that other so-called biologic drugs don’t, the researchers said.

“Treatment with oral tofacitinib is potentially a new treatment option for patients with moderate to severe ulcerative colitis, pending review by the [U.S. Food and Drug Administration],” Sandborn said.

The study was funded by Pfizer, Inc., the maker of Xeljanz. Sandborn said he has received research grants from the company and served as a consultant for Pfizer.

Whether Xeljanz should be used as a first treatment is still not clear, said Dr. Arun Swaminath, director of the inflammatory bowel disease program at Lenox Hill Hospital in New York City.

Because Xeljanz comes as a pill, it could have an advantage for patients, Swaminath said. But so far it has only been tried with patients who have not responded to other treatments, he said.

“How it is used in the real world may be different than how it was used in these studies,” Swaminath said. “I am not going out on a limb and say this should be the first choice, because we don’t have enough data to say that’s the way it should be positioned.”

The researchers randomly assigned more than 1,700 people with ulcerative colitis to one of three phase 3 trials.

The first two trials looked at more than 1,100 patients with moderate to severe ulcerative colitis who had failed with conventional treatment or treatment with newer “tumor necrosis factor antagonist” drugs, such as Remicade (infliximab). They received Xeljanz or a placebo twice a day for eight weeks.

In the third trial, nearly 600 patients who responded to Xeljanz were assigned to a maintenance dose (one group with 5 milligrams [mg] and another group with 10 mg) of the drug, or placebo for a year.

In the first trial, nearly 19 percent of the patients taking Xeljanz experienced a remission of their condition in eight weeks. That compared to just 8 percent of patients receiving placebo.

In the second trial, almost 17 percent of those taking Xeljanz had a remission, compared with nearly 4 percent of those taking placebo, the researchers found.

In the third trial, more than 34 percent of patients taking 5 mg of Xeljanz had disease remission after one year. Forty percent of those taking a 10-mg dose of the drug had remission at a year. Only 11 percent of patients on placebo saw a remission.

However, in all of the trials, more patients taking Xeljanz suffered from infections, such as shingles, than those receiving placebo, researchers found.

In addition, five patients taking Xeljanz developed nonmelanoma skin cancer, compared with one patient receiving placebo. Five patients taking the drug experienced heart problems compared with no one on the placebo.

Also, compared with placebo, Xeljanz was associated with an increase in levels of cholesterol.

The report was published May 4 in the New England Journal of Medicine.

Dr. Sonia Friedman is an associate professor of medicine at Harvard Medical School. She’s also the author of an editorial accompanying the study.

“Tofacitinib is a promising new class of medical therapy that has efficacy in ulcerative colitis. It is an oral, small-molecule drug that is different from current biologic therapies, such as infliximab [Remicade], adalimumab [Humira], golimumab [Simponi] and vedolizumab [Entyvio],” Friedman said.

An advantage of Xeljanz is that it is a pill. Other biologic drugs are given by infusion or injection. In addition, patients cannot develop antibodies to Xeljanz as they can with other biologic drugs, Friedman said.

“Tofacitinib may be used in the future as rescue therapy from failure of biologics,” she said. “Only future studies will determine whether it can be used as initial therapy for ulcerative colitis and what patients it would help the most.”

WebMD News from HealthDay

SOURCES: William Sandborn, M.D., professor, medicine, and chief, division of gastroenterology, University of California, San Diego; Sonia Friedman, M.D., associate professor, medicine, Harvard Medical School, Boston; Arun Swaminath, M.D., director, inflammatory bowel disease program, Lenox Hill Hospital, New York City; May 4, 2017, New England Journal of Medicine

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