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
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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Administration Instructions Regarding Infusion Reactions:
Prior to treatment, ensure appropriate personnel and medication are available to treat reactions that occur during infusion and shortly after infusion. Prior to infusion with Infliximab, patients may be premedicated with histamine-1 receptor antagonists, histamine-2 receptor antagonists, acetaminophen, and/or corticosteroids.
For mild to moderate reactions during the infusion, consider slowing or stopping the infusion. Upon resolution of these reactions, may reinitiate at a lower infusion rate and/or with histamine-1 receptor antagonists, histamine-2 receptor antagonists, acetaminophen, and/or corticosteroids. Discontinue the infusion if the mild to moderate reactions reoccur.
Discontinue the infusion if severe hypersensitivity reactions occur during the infusion.
Reference:1. Infliximab . Horsham, PA: Janssen Biotech, Inc.
SERIOUS INFECTIONS
Patients treated with either REMICADE® or Infliximab are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. Discontinue either REMICADE® or Infliximab if a patient develops a serious infection or sepsis.
Reported infections include:
MALIGNANCIES
CONTRAINDICATIONS
HEPATITIS B REACTIVATION
HEPATOTOXICITY
HEART FAILURE
HEMATOLOGIC EVENTS
HYPERSENSITIVITY
CARDIOVASCULAR AND CEREBROVASCULAR REACTIONS DURING AND AFTER INFUSION
NEUROLOGIC EVENTS
AUTOIMMUNITY
cp-253861v1
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Reconstitution Dilutionand Administration Instructions1
Infliximab is intended for use under the guidance and supervision of a healthcare provider. The supplied lyophilized powder must be reconstituted and diluted prior to administration. The infusion solution should be prepared and administered by a trained medical professional using aseptic technique by the following procedure:
Calculate the dose, total volume of reconstituted Infliximab solution required, and the number of Infliximab vials needed. More than 1 vial may be needed for a full dose.
Reconstitute each 100-mg Infliximab vial with 10 mL of Sterile Water for Injection, USP, to obtain a concentration of 10 mg/mL, using a syringe equipped with a 21-gauge or smaller needle as follows:
Dilute the total volume of the reconstituted Infliximab solution to 250 mL* with sterile 0.9% Sodium Chloride Injection USP as follows:
- Withdraw a volume from the 0.9% Sodium Chloride Injection, USP, 250-mL bottle or bag equal to the total volume of reconstituted Infliximab required for a dose. Slowly add the total volume of reconstituted Infliximab solution from the vial to the 250-mL infusion bottle or bag
- Discard any unused portion of the reconstituted Infliximab solution remaining in the vial
- Gently invert the bag to mix the solution. The resulting infusion concentration should range between 0.4 mg/mL and 4 mg/mL of Infliximab
If You Take More Than The Recommended Amount Of Remicade
Call your doctor right away if you believe youve received too much Remicade. Another option is to call the American Association of Poison Control Centers at 800-222-1222 or use its online tool. If you have severe symptoms, immediately call 911 or your local emergency number, or go to the nearest emergency room.
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Reconstitution Dilution And Administration Instructions
REMICADE is intended for use under the guidance and supervision of a healthcare provider. The supplied lyophilized powder must be reconstituted and diluted prior to administration. The infusion solution should be prepared and administered by a trained medical professional using aseptic technique by the following procedure:
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% .
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Key Points About Humira
- Humira is approved for both Crohns 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.
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.
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Dosage In Rheumatoid Arthritis
The recommended dosage of REMICADE is 3 mg/kg given as an intravenous induction regimen at 0, 2 and 6 weeks followed by a maintenance regimen of 3 mg/kg every 8 weeks thereafter for the treatment of moderately to severely active RA. REMICADE should be given in combination with methotrexate. For patients who have an incomplete response, consideration may be given to adjusting the dosage up to 10 mg/kg every 8 weeks or treating as often as every 4 weeks bearing in mind that risk of serious infections is increased at higher doses per infusion or more frequent dosing .
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:
- 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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Dosage In Adult Crohn’s Disease
The recommended dosage of REMICADE is 5 mg/kg given as an intravenous induction regimen at 0, 2 and 6 weeks followed by a maintenance regimen of 5 mg/kg every 8 weeks thereafter for the treatment of adults with moderately to severely active CD or fistulizing CD. For adult patients who respond and then lose their response, consideration may be given to treatment with 10 mg/kg every 8 weeks. Patients who do not respond by Week 14 are unlikely to respond with continued dosing and consideration should be given to discontinue REMICADE in these patients.
Rationale For An Intensified Infliximab Dosing Regimen In Acute Severe Uc
Pharmacokinetic data.
Monoclonal antibodies are large molecules that are cleared by pinocytosis and gradual acidification in endosomes, followed by fusion with lysosomes and proteolysis by the mononuclear cells of the reticuloendothelial system .18, 19 This pathway is mainly regulated through Fc gamma receptors that have been identified to play a role in response to tumour necrosis factor-a antagonist therapy.20 A recycling mechanism exists for immunoglobulin G antibodies, which bind to the neonatal Fc receptor at low pH. This drug-receptor complex is subsequently carried back to the cell surface and dissociates at neutral pH. As a result, the immunoglobulin G antibody escapes degradation in the lysosome and returns to the serum.18 Therapeutic immunoglobulin G1 antibodies such as infliximab participate in this recycling mechanism, resulting in longer drug half-lives. Factors influencing the clearance rate of infliximab in patients with acute severe UC are shown in Figure 2.
Total inflammatory burden:
Faecal loss:
Anti-drug antibodies:
Additional patient factors:
Patient-related factors that influence the clearance rate of infliximab include gender and bodyweight .35, 36.
Clinical data.
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What If I Miss A Dose
Its important to keep all your appointments to receive your Remicade doses. You need to receive consistent doses of the drug to improve your condition. If you do miss an infusion appointment, call your doctors office right away to reschedule.
If you need help remembering your infusion appointments, try setting a reminder on your phone.
Search Strategy And Study Selection
We searched MEDLINE , EMBASE and CENTRAL databases for records from 2000 to 2016, without language restriction. The following search strategy was used: 1. severe*.mp 2. .mp 3. 1 and 2 4. colitis.ti 5. infliximab.ti 6. 3 and 4 and 5. Bibliographies of relevant studies, review articles and meta-analyses were hand-searched to identify additional studies. This search yielded a total of 400 citations of which 66 were identified as duplicates and removed . Randomised controlled trials , cohort, casecontrol and cross-sectional studies were eligible provided they reported on pharmacokinetics of infliximab in adult acute severe UC patients, on prognostic markers for acute severe UC outcome, or on the use of infliximab treatment intensification strategies in acute severe UC patients. Seventy-six citations were eligible for analysis .
Flow diagram. The search strategy identified 400 references of which 66 were duplicates and removed. Two hundred sixty-four of the remaining 334 records were excluded because they did not meet the eligibility criteria or provided insufficient information for analysis. Six supplemental references were manually retrieved, resulting in a total of 76 records included for analysis.
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Does Remicade Have A Loading Dose
Yes, Remicade has a loading dose. A loading dose is a larger dose given at the beginning of treatment. This helps get more medication into your body sooner, allowing the drug to begin working more quickly.
Regardless of the condition youre using Remicade to treat, youll likely receive loading doses. Specifically, youll get a Remicade infusion loading dose at weeks 0, 2, and 6. Then, youll receive maintenance doses of Remicade. For maintenance doses, youll receive an infusion every 8 weeks.
What Are The Typical Dosages Of Remicade
The dosage of Remicade youre prescribed will be based on your weight in kilograms * and the condition youre using Remicade to treat.
Typically, your doctor will start you on the dosage thats recommended to treat your condition. Your doctor may use a dosage calculator to determine this dose. Then theyll monitor your condition over time to make sure the drug is working for you. Your doctor will ultimately prescribe the smallest maintenance dosage that provides the desired effect.
The information below describes dosages that are commonly used or recommended. Your doctor will determine the best dosage to fit your needs.
* One kg is about 2.2 pounds .
Dosage for psoriatic arthritis, Crohns disease, plaque psoriasis, and ulcerative colitis
The recommended dosage level for Remicade is the same when used to treat the following conditions in adults:
For each of these conditions, your starting dose of Remicade is 5 mg per kg of body weight. This is given for your first dose and the doses youll receive at weeks 2 and 6. After that, youll receive 5 mg/kg every 8 weeks.
Over time, Remicade may become less effective at treating Crohns disease in some adults. If this happens, your doctor may increase your Remicade dosage to 10 mg/kg every 8 weeks.
Dosage for ankylosing spondylitis
Dosage for rheumatoid arthritis
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The Above Policy Is Based On The Following References:
Which Coronavirus Vaccine Will I Be Offered
The COVID-19 vaccines currently approved for use in the UK are:
- Moderna vaccine
- Pfizer/BioNTech vaccine
All of the available coronavirus vaccines are considered suitable for people with Crohns or Colitis, as they are not live vaccines. Having Crohns or Colitis, or taking medicine to treat your condition, will not affect which coronavirus vaccine is best for you.
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What Should I Know About Entyvio Vs Remicade
Entyvio and Remicade are both used to manage symptoms of inflammatory bowel disease. Specifically, theyre both used for Crohns disease and ulcerative colitis. Remicade is also used to manage other autoimmune conditions.
Remicade has the active ingredient infliximab and Entyvio has the active ingredient vedolizumab. Both drugs are given by intravenous infusion, which is an injection thats given slowly into your vein.
Talk with your doctor if you have more questions about Entyvio versus Remicade. You can also check out this detailed breakdown of the two medications.
Entyvio and Humira are both used to treat Crohns disease and ulcerative colitis. Humira is used to treat some other autoimmune diseases, too.
Humira has the active ingredient adalimumab, and Entyvio has the active ingredient vedolizumab.
Humira is given as an injection under the skin. You can give the drug to yourself at home.
Entyvio, on the other hand, is given at a doctors office or clinic. Its given by intravenous infusion, which is an injection thats given slowly into your vein.
If youd like to know about the similarities and differences of Entyvio and Humira, see this comparison. And talk with your doctor about which drug is right for you.
If you have a certain autoimmune disease, your doctor may prescribe Entyvio for you. Its a biologic drug that treats inflammatory bowel disease thats causing symptoms.
Specifically, Entyvio is used in adults to treat moderate to severe: