Remicade Dosing For Ulcerative Colitis

Effect Of Schedule On Risk Of Colectomy

The proportion of patients who required in-hospital colectomy was similar in the accelerated and standard groups . Neither were there any between-group differences in the longer-term risk of colectomy .

Multivariable analysis confirmed the lack of difference between accelerated and standard infliximab induction with respect to in-hospital and longer-term colectomy rates. Low-serum albumin was the only variable that was consistently an independent predictor of colectomy and it remained significant until almost two years after hospitalization.

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.

Remicade Treats Ulcerative Colitis

Better Results Than With Fake Drug, Researchers Report

Dec. 7, 2005 — The rheumatoid arthritis drug Remicade may help treat moderate-to-severe ulcerative colitis, a new study shows.

WebMD first reported the news in May, when findings were presented at a medical conference. Now, more details appear in The New England Journal of Medicine.

The researchers included Paul Rutgeerts, MD. He works in Leuven, Belgium, at the University Hospital Gasthuisberg.

Ulcerative colitis is an inflammatory bowel disease that primarily affects the colon and rectum with inflammation and ulcers leading to bleeding and abdominal pain. The disease generally follows a course of flare-ups that can be difficult to manage. In some circumstances, surgery may be necessary to remove the affected area.

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What Are The Outcomes Of Remicade Infusion

Remicade works differently than other medications by targeting a specific protein in the bodys immune system which helps control inflammation. Remicade can reduce signs and symptoms, induce and maintain remission, promote intestinal healing and reduce or stop the need for steroids. People who take Remicade for their IBD symptoms usually experience a period of remission, an inactive time in the disease process.

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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What Happens During Remicade Infusion

Remicade is given by intravenous infusion. Dosage depends on how severe your ulcerative colitis or Crohns disease is as well as your weight. Your doctor will calculate the dose that is right for you. The nurse will prep your arm by sterilizing the area with rubbing alcohol. The IV needle will be inserted and held in place with tape. Remicade will be infused into your bloodstream. Vital signs will be monitored every 30 minutes during the infusion. During infusion, youll be carefully monitored by a nurse or other healthcare provider. This process usually takes about two hours.

Early Serum Infliximab Levels In Pediatric Ulcerative Colitis

• 1Department of Pediatrics, University of Calgary, Calgary, AB, Canada
• 2Department of Community Health Sciences, University of Calgary, Calgary, AB, Canada
• 3Department of Pediatrics, University of British Columbia, Vancouver, BC, Canada
• 4Department of Pediatrics, University of Manitoba, Winnipeg, MB, Canada
• 5Department of Pediatrics, University of Alberta, Edmonton, AB, Canada
• 6Department of Medicine, University of Calgary, Calgary, AB, Canada

Background: Data on serum infliximab concentrations during induction in pediatric ulcerative colitis are limited. The study aim is to evaluate the relationship between serum infliximab concentrations during induction and short-term clinical remission in children with ulcerative colitis.

Methods: We carried out a prospective, multi-center cohort study in pediatric patients with ulcerative colitis. Serum infliximab concentrations were collected at peak dose #1, week 1, trough pre-dose #2, and trough pre-dose #3. Infliximab dosing was left to investigator discretion. Clinical remission was defined by pediatric ulcerative colitis activity index < 10 at week 8.

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A Multicenter Retrospective Cohort

The study cohort included 213 patients who were hospitalized with steroid-refractory acute severe UC and received infliximab rescue therapy at one of three centers between 2005 and 2017. The average patient age was 31 and 60% were men.

The researchers divided the patients into two groups according to infliximab administration schedule: standard or accelerated . At two centers, the choice of schedule was based on symptoms or endoscopic severity at the other, it was based on the ratio of C-reactive protein to albumin.

How Does Remicade Work

REMICADE® blocks a protein in your child’s immune system called TNF-alpha. TNF-alpha can cause inflammation.

• Children with ulcerative colitis produce too much TNF-alpha, a protein that helps regulate immune cells and inflammation in the body
• Too much TNF-alpha can cause your childâs immune system to mistakenly attack cells in the digestive tract, leading to inflammationâan underlying cause of pediatric ulcerative colitis symptoms

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Tell Your Doctor Or Ibd Team Immediately If You Develop

• Symptoms that may mean you are having a reaction to the injection or an allergic reaction:
• Hives or other skin rashes
• Trouble breathing or swallowing, or shortness of breath
• Pains in your chest or muscles or joints
• Fever or chills
• Swelling of your face, hands or feet
• Headaches or a sore throat

Living with Crohn’s Disease

Infliximab is often taken alongside other medicines safely. See the earlier section Taking infliximab with other Crohns or Colitis treatments.

However, infliximab may interact with other medicines. Speak to your doctor or pharmacist if youre taking, or plan to take any other medicines. This includes over the counter medicines and any herbal, complementary, or alternative medicines or therapies.

Do not take medicines that contain anakinra or abatacept. These medicines are commonly used for Rheumatoid Arthritis.

Talking About The Effectiveness Of Medicines

To see how effective a medicine is, we can look at data from clinical trials. Clinical trials are used to test a medicine. However, this data may not completely represent what happens when medicines are given to you by your IBD team. In clinical trials, people are often removed from the trial if they do not respond quickly to a medicine. This wont happen when you start taking infliximab. Your IBD team may advise you take it for a longer time to see if you respond. Theyll also make sure the dose is right for you before suggesting you stop taking it. This means infliximab may be more effective than the data from clinical trials shows.

The best clinical trials include people who were not taking the medicine. This is known as a placebo or control group. This is important. It allows us to see how many people have got better because of the medicine, as well as people who may have got better anyway .

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Impact 2 Study Design56

IMPACT 2 : a randomized, double-blind, placebo-controlled, multicenter, phase 3, parallel-group study of REMICADE® in 200 adult patients with active PsA for at least 6 months who had an inadequate response to disease-modifying antirheumatic drugs or nonsteroidal anti-inflammatory drugs . Patients had active articular disease , psoriatic target skin lesion , and either C-reactive protein â¥1.5 mg/dL or morning stiffness lasting â¥45 minutes. Stable methotrexate doses of â¤25 mg/week at study entry and stable oral corticosteroid doses equivalent to â¤10 mg/day of prednisone were permitted. During the 24-week, double-blind phase, patients received either REMICADE® 5 mg/kg IV or placebo at Weeks 0, 2, 6, 14, and 22. At Week 16, placebo patients with < 10% improvement in swollen and tender joint counts were switched to active treatment and received REMICADE® 5 mg/kg IV at Weeks 16, 18, 22, 30, 38, and 46. At Week 24, all patients receiving placebo crossed over to active treatment and received REMICADE® 5 mg/kg IV at Weeks 24, 26, 30, 38, and 46. Primary endpoints included the proportion of patients with ACR20 response at Week 14 and the change from baseline in total modified van der Heijde-Sharp score at Week 24. Improvement in Psoriasis Area and Severity Index was evaluated in psoriatic arthritis patients with baseline body surface area â¥3% .

Is Remicade Used Long Term

Yes, Remicade is typically used as a long-term treatment. If you and your doctor determine that Remicade is safe and effective for you, its likely that youll use it long term.

However, if youre an adult with Crohns disease that doesnt respond to Remicade by week 14, your doctor may switch you to a different medication.

Read Also: How Do You Get Ulcers In Your Stomach

Pediatric Ulcerative Colitis Trial Study Design

The REMICADE® Pediatric Ulcerative Colitis trial was a multicenter, phase 3, randomized, open-label, parallel-group trial to evaluate the safety and efficacy of REMICADE® in pediatric patients aged 6 to 17 years with moderately to severely active UC and an inadequate response to conventional therapies. The primary objectives of the study were to evaluate clinical response after a 3-dose induction regimen of REMICADE® 5 mg/kg IV and the safety of REMICADE® during induction and maintenance regimens. Secondary objectives included the evaluation of 2 REMICADE® maintenance dosing regimens in maintaining remission, as measured on the Pediatric Ulcerative Colitis Activity Index the efficacy of a 3-dose regimen of REMICADE® in the induction of clinical remission, as measured by the Mayo score and the induction of remission, as measured on the PUCAI.1,5

All patients received induction dosing of REMICADE® 5 mg/kg IV at Weeks 0, 2, and 6. Patients who did not respond to REMICADE® at Week 8 received no further REMICADE® and returned for safety follow-up. At Week 8, 45 patients were randomized to a maintenance regimen of REMICADE® 5 mg/kg IV given either every 8 weeks through Week 46 or every 12 weeks through Week 42.1,5

Note: REMICADE® 5 mg/kg IV every 12 weeks is not an FDA-approved maintenance dosing regimen for REMICADE® in the treatment of pediatric patients with moderately to severely active UC.1

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.

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Whats The Dosage Of Remicade For Children

Remicade is prescribed to treat ulcerative colitis and Crohns disease in children ages 6 years and older. The dosage of Remicade for children is the same dosage thats used for these conditions in adults. For more information, see Dosage for psoriatic arthritis, Crohns disease, plaque psoriasis, and ulcerative colitis above.

Preparing For A Remicade Infusion

You will need to talk with your doctor or gastroenterologist to see if Remicade is right for you. Make sure you tell your doctor about your familys medical history as well as any medications you are taking. Tell your doctor if you suffer from:

• Tuberculosis
• Allergic reactions to ingredients in Remicade
• Nervous system disorders including seizures, multiple sclerosis

Before a Remicade infusion, it is recommended that you get a good nights sleep, consume ample fluids and eat breakfast or lunch before your treatment. A nurse will perform general assessment tests of your health and record your blood pressure, temperature, respiration, pulse and weight.

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Telling Other Health Professionals

Tell any doctor, dentist or health professional treating you that you are taking infliximab. Always carry the alert card that comes with the medicine while you are taking it and for up to six months after your last dose.

Its not safe to have live vaccines while taking infliximab. It can take up to six months after your last dose for infliximab to completely leave your body. However, its safe to have live vaccines 3 months after your last dose of infliximab. Ask your IBD team to make sure your vaccinations are up to date before you start infliximab, or if youre planning to travel. If youve recently had a live vaccine you may have to wait 4 weeks before starting infliximab.

In the UK, live vaccines include:

• BCG
• Rotavirus
• Flu nasal spray

Everyone with Crohns or Colitis taking a biologic medicine should have the yearly flu jab. This is not a live vaccine and is safe to have while taking infliximab.

If someone you live with is due to have a live vaccine, ask your IBD team if you need to take any precautions.

Infliximab does not affect fertility. If you dont want to get pregnant you should use contraception.

You must tell your babys healthcare team you were taking infliximab while pregnant. It is advised that if you take infliximab during your pregnancy your baby should avoid live vaccines until they are at least six months old. This includes the BCG for tuberculosis and the rotavirus vaccine. It should not affect the rest of your babys vaccination schedule.

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.

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Ifx Concentrations And Week 8 Outcomes

Serum IFX concentrations are shown in Table 2 and Figure 1. Comparing subjects in clinical remission at week 8 with non-remitters, there was no statistically significant difference in IFX concentrations at peak or week 1. There was a trend for higher IFX concentrations at pre-dose #2 and #3 for those in clinical remission at week 8 vs. non-remitters . There was a trend, but no statistically significant difference in IFX concentrations at pre-dose #2 and #3 for those in clinical response and/or remission at week 8 vs. non-responders/remitters

Figure 1. Serum infliximab concentrations by time. Box plot values include: lower adjacent value, first quartile, median, third quartile, and upper adjacent value . Lower and upper adjacent values are the most extreme values within the first quartile minus 1.5 × interquartile range and the third quartile plus 1.5 × interquartile range, respectively.

Figure 2. Serum infliximab concentrations at week 1, pre-dose #2, and pre-dose #3 by clinical remission status at Week 8. Box plot values include: lower adjacent value, first quartile, median, third quartile, and upper adjacent value . Lower and upper adjacent values are the most extreme values within the first quartile minus 1.5 × interquartile range and the third quartile plus 1.5 × interquartile range, respectively.

Accent I Study Design

ACCENT I is a 1-year, multicenter, randomized, double-blind trial of REMICADE® in 545 patients with moderately to severely active CD . All patients received an initial dose of REMICADE® 5 mg/kg IV. Patients were then randomized based on clinical response at Week 2 to 1 of 3 treatment groups through Week 541,6:

• The placebo maintenance group received placebo infusion at Weeks 2, 6, and every 8 weeks thereafter
• The 5 mg/kg IV maintenance group received REMICADE® 5 mg/kg IV at Weeks 2, 6, and every 8 weeks thereafter
• The REMICADE® 10 mg/kg IV maintenance group received REMICADE® 5 mg/kg IV at Weeks 2 and 6, followed by REMICADE® 10 mg/kg IV every 8 weeks thereafter

The coprimary endpoints of the trial were the proportion of patients responding at Week 2 who were in remission at Week 30 and time to loss of response through Week 54.1,6

Note: The recommended dose of REMICADE® is 5 mg/kg given as an IV induction regimen at 0, 2, and 6 weeks followed by a maintenance regimen of 5 mg/kg IV every 8 weeks thereafter for the treatment of adults with moderately to severely active Crohnâs disease.1

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Infusion Dosing Schedule In Adults And Children

Even if you will be taking infliximab by injection, youll have your first two doses by infusion in hospital. See the previous sections on infusions.

Youll usually have your first injection in hospital or by a trained nurse at home. Youll then be trained to inject it yourself. If you prefer, it may be possible for someone else, such as a family member, to be trained to give you the injections.

Infliximab comes ready to use in either a pre-filled syringe or a pre-filled injection pen. You may not see the needle in the injection pen, as its inside. The syringes or pens come in a pack. The pack contains an alcohol pad to clean your skin before injecting.