Remicade Is Top Among Biologic
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Remicade ranked highest for induction of remission and endoscopic improvement among biologic-naive patients, according to a meta-analysis of treatments for moderately to severely active ulcerative colitis.
In the same study, Stelara and Xeljanz had the best results among patients who had been previously exposed to anti-TNF therapy.
Several treatment options are now available for the management of moderate-severe ulcerative colitis, with variable efficacy and safety profiles, and positioning different agents in treatment course, as first-line and second-line is a key knowledge gap,Siddharth Singh, MD, MS, of the division of gastroenterology at the University of California, San Diego, and colleagues wrote. With the recent labeling and dosing change for tofacitinib in light of safety considerations, recent publication of the first head-to-head trial comparing vs. in patients with moderate-severe ulcerative colitis and recent regulatory approval of ustekinumab for these patients, the results of these analyses warrant updating.
Among biologic naive patients, Remicade was ranked highest for induction of remission and endoscopic improvement.
For patients who had previously been exposed to anti-TNF, ustekinumab and tofacitinib were superior to vedolizumab and adalimumab .
Key Points About Remicade
- Remicade is given by IV.
- Remicade is approved for Crohn’s disease and ulcerative colitis.
- Three starting doses are given .
- After the starting doses, it’s given about every eight weeks .
- Common side effects are abdominal pain, nausea, fatigue, and vomiting.
- If you are pregnant or plan to become pregnant, you and your doctor should decide if you should take Remicade.
Comparing Administration Efficacy And Side Effects Of Different Drugs For Ibd
Inflammatory bowel disease medications are often used to help treat the inflammation of the condition. These medications may include biologics, a newer class of drugs.
Biologics work in slightly different ways with different standards of administration and dosing. Some are approved to treat just one form of IBD, while others are used to treat both Crohn’s disease and ulcerative colitis.
Because biologic drugs temper the immune response, people taking them are prone to certain infections. It’s important, therefore, to take steps to reduce your vulnerability. People with IBD should receive vaccinations, ideally before starting a biologic, although many immunizations can also be given while taking a biologic.
According to 2020 guidelines, a biologic drug should be used first-line for treatment in people with moderate to severe ulcerative colitis.
There are different types of biologics for IBD: anti-tumor necrosis factor drugs, integrin receptor antagonists, and interleukin-12/interleukin-23 antagonists. If you’ve never taken a biologic, your healthcare provider is likely to prescribe an anti-TNF drug first.
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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 Crohn’s & 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.
More Options Means More Questions
“Looking back almost 25 years ago, the struggle was how to work with just one biologic and how to make it last for patients who have already failed all the available therapies. All these years later, we have such riches that the question we most often deal with is ‘What’s my first treatment?’ for patients with inflammatory bowel disease,” Arun Swaminath, MD, told Medscape Medical News, when asked to comment on both studies.
“Increasingly, we are seeing industry do head-to-head trials of drugs, but this is a time-consuming and expensive process,” added Swaminath, chief of gastroenterology and director of the inflammatory bowel diseases program at Lenox Hill Hospital in New York City.
The study from Buisson and colleagues in UC approaches the design of a head-to-head trial, Swaminath said. “In the end, their primary endpoint was a statistical dead heat between the two options.”
In the VERSUS-CD study, vedolizumab was compared with ustekinumab “with more patients not discontinuing ustekinumab therapy compared to vedolizumab,” he said. “This study also seems to favor sicker patients being treated with ustekinumab.”
“In both cases, we are starting to see the ‘order’ of treatments take shape, even before the benefit of head-to-head trials,” Swaminath said.
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What Is The Safest Biologic For Ulcerative Colitis
The benefits of biologics may outweigh the potential risks in people with moderate-to-severe IBD.
However, biologics can affect how the immune system works. Specifically, they may impact the immune systemâs ability to ward off certain infections.
The risk of infection tends to be higher with anti-TNF agents than with other types of biologics.
The 2020 review of research found that the overall rate of serious infections in people using biologics was low. Entyvio was the safest biologic for treating ulcerative colitis. It was linked to the lowest number of infections.
The authors ranked Stelara as the next safest biologic for treating ulcerative colitis.
Biologics may carry other risks of side effects. A person should speak with a doctor about the potential risks of biologics before they use them.
However, biologics are relatively new medications. For this reason, long-term safety data are limited.
Scientists have completed fewer long-term studies on Entyvio or Stelara. The available data suggest that these biologics are safer than anti-TNF agents.
People with moderate-to-severe ulcerative colitis may need to use biologics on an ongoing basis to keep the condition in remission. Stopping treatment with biologics may cause a relapse, during which symptoms return.
More research is necessary to confirm if and when people can stop using biologics without experiencing a relapse.
Some research has linked biologics to modest weight gain in people with ulcerative colitis.
Tofacitinib In Special Circumstances
Use in acute severe UC
The rapid onset of action and short half-life have raised the prospect of using tofacitinib in the management of acute severe UC . Data remain limited to a few case reports.30,6064 In three case series, 14 of 15 patients received 3 days high-dose intravenous steroids prior to rescue tofacitinib with a history of anti-TNF failure.30 Eleven patients received standard induction dosing 10 mg BD, whereas the Michigan group used a higher dose of 10 mg three times daily.30,60 Following tofacitinib rescue therapy, 13% required colectomy during that index admission and 20% within 6 months, with no difference in colectomy rates according to tofacitinib dose.30 At the last follow-up, 47% remained in CFCR on maintenance therapy.30 Kotwani et al. reported endoscopic remission in addition to CFCR at last follow-up in 2 of the 4 patients included in their small case series.63 Overall, no major AEs were reported and notably no new thromboembolic events.30,61,64
More recently, a retrospective casecontrol study evaluated the efficacy of tofacitinib induction therapy in hospitalized patients with biologic-experienced ASUC.65 Compared to matched controls, there was a lower 90-day colectomy rate in the 40 patients who received tofacitinib with intravenous corticosteroids . The benefit was only statistically significant at tofacitinib 10 mg three times daily and not at 10 mg BD dosing.65
Post-operative surgical outcomes
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Key Points About Cimzia
- Cimzia is approved to treat Crohn’s disease.
- Cimzia is usually given at home by injection.
- Cimzia is given initially three times in a series of two injections, two weeks apart, followed by two injections every four weeks.
- Common side effects include respiratory infections, viral infections, rashes, and urinary tract infections.
- If you are pregnant or plan to become pregnant, you and your doctor should decide if you should take Cimzia.
- A low amount of Cimzia may pass into the breastmilk.
- Cimzia needs to be refrigerated.
Quicker Remission With Tofacitinib Vs Vedolizumab In Ulcerative Colitis: Study
When antitumor necrosis factor-alpha treatment fails to achieve remission for patients with ulcerative colitis , tofacitinib appears more effective sooner than vedolizumab , suggests a Dutch registry study.
Data on nearly 150 patients with UC who had already undergone treatment with anti-TNF drugs showed that combined clinical and biochemical remission was about five times more likely with tofacitinib vs vedolizumab within 12 weeks of starting therapy.
However, the differences tailed off over subsequent weeks, such that there was no significant difference in combined remission rates at 52 weeks. There were also no notable differences in safety between the two drugs.
“These results may help in guiding clinical decision-making after anti-TNF failure in patients with UC,” the authors write.
The research was by Clinical Gastroenterology and Hepatology.
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Key Points About Stelara
- Stelara is approved to treat Crohn’s disease.
- The loading dose of Stelara is given by infusion and thereafter is given by injections at home.
- People taking shots for allergies should talk to their doctor about possible allergic reactions and Stelara.
- Common side effects include infections, injection site reactions, and vomiting.
- If you are pregnant or plan to become pregnant, you and your doctor should decide if you should take Stelara.
- It’s thought that Stelara does pass into breastmilk.
- Stelara must be refrigerated.
Key Points About Simponi
- Simponi is approved to treat ulcerative colitis.
- Simponi is given by injection at home.
- Simponi is started with two injections, followed by one injection two weeks later, and one injection every four weeks thereafter.
- Common side effects include pain or irritation at the injection site and upper respiratory or viral infections.
- If you are pregnant or plan to become pregnant, you and your doctor should decide if you should take Simponi.
- It’s not currently known how Simponi will affect a nursing infant.
- Simponi must be refrigerated.
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Key Points About Entyvio
- Entyvio is approved for ulcerative colitis and Crohn’s disease.
- Entyvio is given by infusion in three starting doses, and then every eight weeks.
- Common side effects include infections pain in the joints, back, throat or extremities symptoms of nausea, fever, fatigue, cough, or itching and a rash.
- If you are pregnant or plan to become pregnant, you and your doctor should decide if you should take Entyvio.
- It’s not currently known if Entyvio passes into breastmilk.
Key Points About Humira
- Humira is approved for both Crohn’s disease and ulcerative colitis.
- Humira is given at home by self-injection.
- Humira is started with 4 injections, followed by 2 injections 2 weeks later, and then 1 injection every other week.
- Common side effects include pain or irritation at the injection site and headache, rash, and nausea.
- If you are pregnant or plan to become pregnant, you and your doctor should decide if you should take Humira.
- Infants born to mothers receiving Humira should not receive live vaccines for six months.
- Humira needs to be refrigerated.
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Side Effects And Special Concerns
According to Xeljanz prescribing information, care should be taken when prescribing this medication to anyone who:
- Currently has a serious infection
- Is at risk for perforation of the intestines
- Has a low count of neutrophils or lymphocytes, both types of white blood cells
- Has a low hemoglobin level
From the results of clinical trials in ulcerative colitis patients receiving 10 mg of Xeljanz twice a day, the most common side effects and the percentage of patients in which they occurred included:
- High blood pressure
Key Points About Skyrizi
- Skyrizi is approved to treat moderate to severe Crohn’s disease.
- Three starting doses of Skyrizi are given by infusion at four week intervals, followed by injections at home every other month.
- Side effects may include upper respiratory infections, feeling tired, fungal skin infections, headache, and injection site reactions.
- Avoid Skyrizi if you are pregnant, have a persistent infection, liver cirrhosis, or have recently received a live vaccine.
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Talking To Your Doctor
No matter how long youâve had UC, talking about it can feel difficult. Use our quiz to help you take a fresh look at life with UC, then talk to your GI about your disease and the different opportunities available to you for your treatment plan.
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XELJANZ & Pregnancy
The Science From Spain
In another study presented at ECCO ’22 Virtual, investigators from Spain compared vedolizumab to ustekinumab after at least one anti-TNF treatment failure, this time among people with Crohn’s disease.
Finding effective treatments after an anti-TNF failure is essential, Maria Jose Garcia, MD, said when presenting the results of the VERSUS-CD trial. “Over 20% to 30% of Crohn’s disease patients are nonresponders or develop intolerance to anti-TNF therapies. Also, anti-TNF responders can experience a loss of response over time.”
Both vedolizumab and ustekinumab are effective for Crohn’s, she said. “But no clinical trial has compared both treatments, and limited data exist in real life.”
To remedy this situation, Garcia and colleagues studied 755 people from 30 medical centers in a national database in Spain who failed a previous anti-TNF agent, including 195 people switched to vedolizumab and 560 switched to ustekinumab. Luminal activity, perianal disease, or postoperative recurrence of Crohn’s were the indications for treatment.
The study’s main objective was to compare the short- and long-term treatment survival rate of vedolizumab and ustekinumab after anti-TNF therapy failure in clinical practice. Evaluating efficacy and safety were secondary aims.
Just less than half of the 327 patients discontinued treatment over time, including 142 in the vedolizumab group and 185 in the ustekinumab group. The most frequent cause was primarily non-response.
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How Effective Are Biologics For Ulcerative Colitis
Biologics can help bring ulcerative colitis into remission. Remission occurs when the symptoms of ulcerative colitis are gone.
A 2020 review of research found that Remicade was the most effective biologic for reducing the signs and symptoms of ulcerative colitis in people who had never used biologics before.
The same review found that Stelara was the most effective biologic for treating ulcerative colitis in people who had used anti-TNF agents in the past without satisfying results.
Tofacitinib was also highly effective for treating ulcerative colitis in people who had previously used anti-TNF agents. Xeljanz is a JAK inhibitor, which is not a biologic.
These results reflect average trends. Different medications may affect different individuals in different ways. People may need to try multiple medications to find one that works for them.
The authors of one 2019 review reported that up to 30% of people with ulcerative colitis eventually need surgery to treat it. Some evidence has suggested that using biologics may delay the need for surgery.
The Pros And Cons Of Biologics For Ulcerative Colitis
The introduction of biologics has changed treatment for many people with ulcerative colitis. Heres what you need to know about the risks and benefits.
Andrew Brookes/Getty Images
Over the past 15 years, treatment options for ulcerative colitis have expanded quite a bit. Among the newer options is a class of drugs called biologics.
Biologics are derived from natural sources, such as human or animal genes or microorganisms, and are designed to act on the immune system, specifically the parts that play key roles in fueling inflammation.
As inflammation is thought to be a cornerstone of the process involved in the manifestation of inflammatory bowel diseases, like Crohns disease and ulcerative colitis, they have proved to be very effective as treatment for certain patients, says Donald Tsynman, MD, a gastroenterologist at NewYork-Presbyterian Hospital in New York City.
The fact that biologics target the activity of the patients own immune system is what sets them apart from some other medications for ulcerative colitis, Dr. Tsynman says.
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Study Design And Patients
This was a single-centre retrospective study conducted between November 2005 and December 2020. Patients diagnosed with CD or UC aged> 18 years and managed at Severance Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea, were eligible . Patients had moderately to severely active disease, defined by a Mayo score of 612 for UC and a Crohns disease activity index of 220 or higher for CD. They had also received at least one injection of infliximab, adalimumab, or golimumab as induction treatment, and anti-TNF therapy had been discontinued as the first-line treatment due to a primary non-response, secondary loss of response, occurrence of side effects or malignant tumours, or pregnancy. Those who had not previously used an anti-TNF agent or had been followed-up for< 16 weeks were excluded.