How much does a Remicade infusion cost. What factors influence the price of Remicade treatments. How can patients reduce their out-of-pocket expenses for Remicade infusions. What insurance considerations should patients be aware of when receiving Remicade therapy.

Understanding Remicade: A Powerful Biologic Treatment

Remicade, known generically as infliximab, is a monoclonal biologic antibody used to treat various autoimmune diseases. This powerful medication works by inhibiting tumor necrosis factor-alpha (TNF-alpha), a protein produced by the immune system that can cause it to attack healthy body parts in certain conditions.

Remicade is prescribed for several conditions, including:

• Crohn’s disease
• Ulcerative colitis
• Rheumatoid arthritis (in combination with methotrexate)
• Ankylosing spondylitis
• Psoriatic arthritis
• Plaque psoriasis

The Cost of Remicade Infusions: Breaking Down the Numbers

One of the most pressing questions for patients prescribed Remicade is: How much does a Remicade infusion cost? The answer can be quite substantial, with treatment costs ranging from $3,000 to $12,000 per infusion. Over the course of a year, this can total between $50,000 and $150,000.

Why is Remicade so expensive? There are several factors contributing to its high cost:

1. Complex production process: As a biologic medication, Remicade is expensive to manufacture.
2. Research and development costs: Significant investment goes into developing and testing new biologics.
3. Ongoing treatment requirements: Most patients need regular infusions over extended periods, increasing overall costs.
4. Limited competition: As a brand-name medication, Remicade faces less competition than generic drugs.

Insurance Coverage and Its Impact on Remicade Costs

The amount a patient pays out-of-pocket for Remicade infusions largely depends on their insurance coverage. Understanding key insurance terms is crucial for patients navigating treatment costs:

• Copay: A fixed amount paid for each healthcare service, typically ranging from $0 to $50 per visit.
• Coinsurance: A percentage of the total cost of a healthcare service that the patient is responsible for paying.
• Deductible: The amount a patient must pay before their health insurance begins to share costs.

Due to the high cost of Remicade infusion therapy, many patients will meet their deductible with the first infusion of the year. This often results in lower out-of-pocket expenses for subsequent treatments within the same calendar year.

What options do patients have if they lack insurance or are out-of-network?

Patients without insurance or those whose infusion centers are out-of-network may have several options:

1. Billing insurance for out-of-network medication costs
2. Exploring self-pay options
3. Investigating manufacturer assistance programs
4. Discussing alternative treatment locations with their healthcare provider

The Impact of Treatment Location on Remicade Infusion Costs

Where a patient receives their Remicade infusion can significantly affect the overall cost. There are three primary options for receiving infusion therapy:

1. Hospital outpatient departments
2. Home infusion services
3. Office settings (Ambulatory Infusion Centers or Specialty Doctor’s Offices)

Hospital outpatient departments, where 50-60% of infusions take place nationally, are generally the most expensive option, costing approximately twice as much as home or office-based infusions. While home infusion has gained popularity, it tends to be about 50% more expensive than receiving treatment in a healthcare provider’s office.

Which infusion setting is most cost-effective for patients?

For patients seeking the most affordable care setting, an office-based infusion center or specialty doctor’s office is often the best choice. These locations typically offer lower costs than hospitals while providing professional medical supervision during treatment.

Strategies for Lowering Remicade Infusion Costs

Despite the high cost of Remicade, there are several strategies patients can employ to reduce their out-of-pocket expenses:

1. Utilize manufacturer assistance programs: Janssen, the maker of Remicade, offers the Janssen Carepath Savings Program to help eligible patients offset costs.
2. Explore copay assistance: These programs can cover up to $20,000 per year for eligible patients, significantly reducing or eliminating financial burdens.
3. Investigate patient assistance programs: Some organizations offer financial aid to patients who meet specific criteria.
4. Discuss biosimilars with your doctor: Cheaper alternatives like Inflectra may be suitable for some patients.
5. Choose cost-effective infusion locations: Opting for office-based infusions over hospital settings can lead to substantial savings.

How effective are manufacturer assistance programs in reducing Remicade costs?

Manufacturer assistance programs can be highly effective in reducing patient costs. For example, the Janssen Carepath Savings Program can cover up to $20,000 per year for eligible patients, which can significantly lower or even eliminate out-of-pocket expenses for many individuals.

Understanding Remicade Treatment: Beyond the Cost

While cost is a crucial factor, patients should also be aware of other important aspects of Remicade treatment:

• Treatment schedule: Remicade is typically administered via intravenous infusion every 4-8 weeks, depending on the condition being treated.
• Side effects: Common side effects may include infusion reactions, increased risk of infections, and potential liver problems.
• Efficacy: Remicade can be highly effective in managing symptoms of various autoimmune diseases, but response varies among individuals.
• Monitoring: Regular blood tests and check-ups are necessary to ensure the medication is working properly and to watch for potential side effects.

How long does it take for Remicade to start working?

The time it takes for Remicade to show effectiveness can vary depending on the condition being treated and the individual patient. Some patients may notice improvements within a few weeks, while others may take several months to experience significant benefits. It’s important for patients to maintain open communication with their healthcare providers about their response to treatment.

Comparing Remicade to Other Biologic Treatments

Remicade is not the only biologic treatment available for autoimmune conditions. Understanding how it compares to other options can help patients and healthcare providers make informed decisions:

• Inflectra: A biosimilar to Remicade, often offered at a lower cost
• Humira: Another TNF inhibitor, administered via subcutaneous injection
• Enbrel: Also a TNF inhibitor, given as a subcutaneous injection
• Stelara: Works by targeting different inflammatory proteins, administered as an injection

How does Remicade compare to its biosimilar, Inflectra?

Inflectra is a biosimilar to Remicade, meaning it is highly similar in terms of safety, purity, and potency. The main differences lie in the manufacturing process and cost. Inflectra is often less expensive than Remicade, potentially offering a more affordable option for some patients. However, the choice between Remicade and Inflectra should be made in consultation with a healthcare provider, considering factors such as individual patient needs, insurance coverage, and potential cost savings.

Navigating Insurance Approval for Remicade Treatment

Obtaining insurance approval for Remicade can be a complex process. Many insurance companies require prior authorization before covering the medication. This process typically involves:

1. Submission of clinical documentation by the healthcare provider
2. Review of the patient’s medical history and previous treatments
3. Evaluation of the necessity of Remicade for the patient’s condition
4. Consideration of alternative, potentially less expensive treatments

What is the typical timeline for obtaining insurance approval for Remicade?

The timeline for insurance approval can vary widely depending on the insurance company and the complexity of the case. Some approvals may be granted within a few days, while others could take several weeks. Patients and healthcare providers should be prepared to follow up regularly with the insurance company to ensure the process moves forward efficiently.

Long-Term Considerations for Remicade Therapy

When considering Remicade therapy, patients should be aware of long-term factors that may impact their treatment and its associated costs:

• Potential for drug holidays: Some patients may be able to take breaks from treatment under medical supervision.
• Development of antibodies: Over time, some patients may develop antibodies to Remicade, potentially reducing its effectiveness.
• Combination therapy: Some conditions may require Remicade to be used in combination with other medications, potentially affecting overall treatment costs.
• Monitoring for long-term side effects: Regular check-ups and tests are necessary to ensure ongoing safety and efficacy.

Can patients eventually stop taking Remicade?

The possibility of discontinuing Remicade treatment depends on various factors, including the specific condition being treated, the patient’s response to therapy, and individual health considerations. Some patients may be able to reduce the frequency of infusions or stop treatment entirely if their condition remains well-controlled for an extended period. However, this decision should always be made under the close supervision of a healthcare provider, as abrupt discontinuation can lead to symptom flares or other complications.

Understanding the costs associated with Remicade infusions is crucial for patients considering this treatment. While the expense can be substantial, various strategies exist to help manage and reduce out-of-pocket costs. By exploring insurance options, utilizing assistance programs, and choosing cost-effective infusion locations, many patients can access this powerful biologic treatment without overwhelming financial burden. As with any medical decision, it’s essential to work closely with healthcare providers to determine the most appropriate and affordable treatment plan for individual needs and circumstances.

How Much Does Remicade Infusion Cost?

Find out how much Remicade infusions cost (with & without insurance) and how patients can lower costs.

Remicade is the brand name for a monoclonal biologic antibody (infliximab) used to treat several autoimmune diseases, including Crohn’s disease, ulcerative colitis, rheumatoid arthritis (in combination with methotrexate), Ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis.

It works by inhibiting the action of a protein produced by the immune system known as tumor necrosis factor-alpha (TNF-alpha), which causes the immune system to attack healthy parts of the body. Those suffering from certain diseases may have too much TNF-alpha.

As with any FDA-approved IV treatment, Remicade can be expensive for a few reasons. First and foremost, it’s a prescription medication that’s expensive to produce. But most eligible patients also need regular infusions over long periods of time, which can contribute to higher costs.

Below, we break down how much Remicade infusions cost (with and without insurance), along with how patients can lower the cost of their infusions.

How much does Remicade cost?

The cost of Remicade can range between $3k-$12k per treatment, totaling upwards of $50k-150k per year.

How does insurance coverage impact the cost of Remicade?

How much the patient pays (aka out-of-pocket costs) is ultimately a function of the insurance plan. Every plan is different, but there are a few concepts that are important to remember:

• Copay: a fixed amount of money that you pay for a healthcare service, which generally totals $0-$50 per visit
• Coinsurance: a percentage of the total cost of a healthcare service
• Deductible: an amount of money you must pay before your health insurance plan starts to share costs
• Or a combination of these options

Because of the high cost of Remicade infusion therapy, a patient will generally meet their deductible in the first infusion of the year, thus he/she would have limited out-of-pocket expenses for treatment costs the rest of the calendar year.

Don’t have insurance or aren’t in-network with your infusion center? It may be possible to bill your insurance company for the medication costs out-of-network. If out-of-network benefits aren’t available, you may be able to be seen as a Self Pay patient.

READ MORE: Prior Authorization: What It Is & How Long It Takes 

How does site of care impact the cost of Remicade?

The only decision a patient can make to influence the cost of their infusion is to decide where to receive treatment. Generally, there are three options where a patient may receive prescription drug infusion therapy from a healthcare professional:

1. Hospital outpatient
2. Home
3. Office setting (Ambulatory Infusion Center or Specialty Doctor’s Office)

Hospital outpatient is where 50-60% of infusions take place nationally. The cost is generally ~2x what it costs in the home or office. Home infusion has received a lot of press recently, but according to the National Infusion Center Association, it tends to be 50% more expensive than a healthcare provider’s office. The office setting will be the most affordable care setting for patients who have received a referral from their physician for infusion therapy.

READ MORE: How Much Does Infusion Therapy Cost?

How can I lower the cost of Remicade infusions?

Manufacturers have copay assistance and financial assistance programs to help offset the cost to patients, such as the Janssen Carepath Savings Program. Based on eligibility requirements, these programs may cover up to $20,000 per year per patient and significantly reduce, or remove, any financial burden a patient may face for the drug’s administration.

Interested in learning more about Remicade IV infusion (including side effects/allergic reactions, FAQs, enrollment qualifications, and more)? Here’s a full guide on what to expect, how long it takes to work, and a run-down of the differences between Remicade and its similar biologic drug/TNF blocker, Inflectra.

Paying for REMICADE® – Cost Support

Paying for REMICADE® – Cost Support | Janssen CarePath

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Summary of resources to help you pay for REMICADE® [PDF]

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• I have commercial or private insurance coverage
• I have government insurance coverage
• I have no insurance coverage

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The following program is affiliated with Janssen.

Janssen CarePath Savings Program for REMICADE®

Eligible patients using commercial or private insurance can save on out-of-pocket medication costs for REMICADE®. Depending on the health insurance plan, savings may apply toward co-pay, co-insurance, or deductible. Eligible patients pay $5 for each infusion, with a $20,000 maximum program benefit per calendar year. Not valid for patients using Medicare, Medicaid, or other government-funded programs to pay for their medications. Terms expire at the end of each calendar year and may change. There is no income requirement. Program does not cover the cost to give you your infusion.

We provide cost support directly to patients through the Janssen CarePath Savings Program. This benefit is intended to help eligible patients afford their out-of-pocket obligations as set by their health plans. The cost support is meant solely for patients—not health plans and/or their partners. If you are having any difficulty accessing cost support through the Janssen CarePath Savings Program, please contact us at 877-CarePath (877-227-3728).

See program requirements

To determine if you are eligible for Janssen CarePath Savings Program and get a Savings Program card, if you don’t have one:

Enroll Online

Complete and send a Patient Enrollment Form [PDF]

Already enrolled? Create your online account at MyJanssenCarePath. com to manage your program benefits and submit rebate requests.

How to obtain a rebate if you have not created an online account:

• If you use medical/primary insurance to pay for your medication, you are responsible for submitting a rebate request including an explanation of benefits (EOB) in order to receive payment under the Savings Program. At your direction, your provider may submit the rebate request and explanation of benefits on your behalf. Please ensure you and your provider coordinate who will submit the rebate request. Please note that the rebate form must be signed, and may be signed by your provider if you request your provider to do so.
• If you use your pharmacy/prescription insurance to pay for your medication, and the pharmacy is unable to process your card for instant savings, you will need to submit a rebate request.

Click here for rebate form. Complete, sign and return the rebate form (instructions on form), with required proof of purchase, to receive your rebate benefit.

Or call a Janssen CarePath Care Coordinator at
877-CarePath (877-227-3728) for help getting started.

The following programs are not affiliated with Janssen.

Be sure to contact the programs directly to get details on eligibility and application requirements, and to see if they have funding available to help you.

State-Sponsored Programs

Some states sponsor prescription financial assistance programs, each with its own eligibility requirements. Find out if your state has a program that can help you.

Visit this program site

Independent co-pay assistance foundations

Independent co-pay assistance foundations have their own rules for eligibility, which are subject to change. We cannot guarantee a foundation will help you. We only can refer you to a foundation that supports your disease state. This information is provided as a resource for you. We do not endorse any particular foundation. The foundations on this list are not the only ones that might be able to help you.

Accessia Health

800-366-7741

Visit this program site

Patient Advocate Foundation

866-512-3861

Visit this program site

The Assistance Fund

855-845-3663

Visit this program site

The following programs are not affiliated with Janssen.

Be sure to contact the programs directly to get details on eligibility and application requirements, and to see if they have funding available to help you.

State-Sponsored Programs

Some states sponsor prescription financial assistance programs, each with its own eligibility requirements. Find out if your state has a program that can help you.

Visit this program site

Medicare Savings Program

Many states have programs for people with limited income and resources that pay some or all of Medicare’s premiums and may pay Medicare deductibles and co-insurance. Find out if your state has a program that can help you.

Visit this program site

Medicaid

Medicaid and the Children’s Health Insurance Program (CHIP) provide free or low-cost health coverage to millions of Americans, including some low-income people, families and children, pregnant women, the elderly, and people with disabilities.

Some states have expanded their Medicaid programs to cover all people below certain income levels.

Visit this program site

Independent co-pay assistance foundations

Independent co-pay assistance foundations have their own rules for eligibility, which are subject to change. We cannot guarantee a foundation will help you. We only can refer you to a foundation that supports your disease state. This information is provided as a resource for you. We do not endorse any particular foundation. The foundations on this list are not the only ones that might be able to help you.

Accessia Health

800-366-7741

Visit this program site

HealthWell Foundation

^®

800-675-8416

Visit this program site

PAN Foundation

866-316-7263

Visit this program site

Patient Advocate Foundation

866-512-3861

Visit this program site

The Assistance Fund

855-845-3663

Visit this program site

The following programs are not affiliated with Janssen.

Be sure to contact the programs directly to get details on eligibility and application requirements, and to see if they have funding available to help you.

State-Sponsored Programs

Some states sponsor prescription financial assistance programs, each with its own eligibility requirements. Find out if your state has a program that can help you.

Visit this program site

Medicaid

Medicaid and the Children’s Health Insurance Program (CHIP) provide free or low-cost health coverage to millions of Americans, including some low-income people, families and children, pregnant women, the elderly, and people with disabilities.

Some states have expanded their Medicaid programs to cover all people below certain income levels.

Visit this program site

No health insurance?

Check the Health Insurance Marketplace at www.HealthCare.gov to see if you can enroll in a plan.

Visit this program site

Independent co-pay assistance foundations

Independent co-pay assistance foundations have their own rules for eligibility, which are subject to change. We cannot guarantee a foundation will help you. We only can refer you to a foundation that supports your disease state. This information is provided as a resource for you. We do not endorse any particular foundation. The foundations on this list are not the only ones that might be able to help you.

Johnson & Johnson Patient Assistance Foundation, Inc. (JJPAF)

The following program is affiliated with Janssen.

Janssen CarePath Savings Program for REMICADE®

Eligible patients using commercial or private insurance can save on out-of-pocket medication costs for REMICADE®. Depending on the health insurance plan, savings may apply toward co-pay, co-insurance, or deductible. Eligible patients pay $5 for each infusion, with a $20,000 maximum program benefit per calendar year. Not valid for patients using Medicare, Medicaid, or other government-funded programs to pay for their medications. Terms expire at the end of each calendar year and may change. There is no income requirement. Program does not cover the cost to give you your infusion.

We provide cost support directly to patients through the Janssen CarePath Savings Program. This benefit is intended to help eligible patients afford their out-of-pocket obligations as set by their health plans. The cost support is meant solely for patients—not health plans and/or their partners. If you are having any difficulty accessing cost support through the Janssen CarePath Savings Program, please contact us at 877-CarePath (877-227-3728).

See program requirements

To determine if you are eligible for Janssen CarePath Savings Program and get a Savings Program card, if you don’t have one:

Enroll Online

Complete and send a Patient Enrollment Form [PDF]

Already enrolled? Create your online account at MyJanssenCarePath.com to manage your program benefits and submit rebate requests.

How to obtain a rebate if you have not created an online account:

• If you use medical/primary insurance to pay for your medication, you are responsible for submitting a rebate request including an explanation of benefits (EOB) in order to receive payment under the Savings Program. At your direction, your provider may submit the rebate request and explanation of benefits on your behalf. Please ensure you and your provider coordinate who will submit the rebate request. Please note that the rebate form must be signed, and may be signed by your provider if you request your provider to do so.
• If you use your pharmacy/prescription insurance to pay for your medication, and the pharmacy is unable to process your card for instant savings, you will need to submit a rebate request.

Click here for rebate form. Complete, sign and return the rebate form (instructions on form), with required proof of purchase, to receive your rebate benefit.

Or call a Janssen CarePath Care Coordinator at
877-CarePath (877-227-3728) for help getting started.

The following programs are not affiliated with Janssen.

Be sure to contact the programs directly to get details on eligibility and application requirements, and to see if they have funding available to help you.

State-Sponsored Programs

Some states sponsor prescription financial assistance programs, each with its own eligibility requirements. Find out if your state has a program that can help you.

Visit this program site

Medicare Savings Program

Many states have programs for people with limited income and resources that pay some or all of Medicare’s premiums and may pay Medicare deductibles and co-insurance. Find out if your state has a program that can help you.

Visit this program site

Medicaid

Medicaid and the Children’s Health Insurance Program (CHIP) provide free or low-cost health coverage to millions of Americans, including some low-income people, families and children, pregnant women, the elderly, and people with disabilities.

Some states have expanded their Medicaid programs to cover all people below certain income levels.

Visit this program site

No health insurance?

Check the Health Insurance Marketplace at www. HealthCare.gov to see if you can enroll in a plan.

Visit this program site

Independent co-pay assistance foundations

Independent co-pay assistance foundations have their own rules for eligibility, which are subject to change. We cannot guarantee a foundation will help you. We only can refer you to a foundation that supports your disease state. This information is provided as a resource for you. We do not endorse any particular foundation. The foundations on this list are not the only ones that might be able to help you.

Accessia Health

800-366-7741

Visit this program site

HealthWell Foundation

^®

800-675-8416

Visit this program site

PAN Foundation

866-316-7263

Visit this program site

Patient Advocate Foundation

866-512-3861

Visit this program site

The Assistance Fund

855-845-3663

Visit this program site

Johnson & Johnson Patient Assistance Foundation, Inc.

(JJPAF)

X

To view programs that are best suited for you, select your coverage status for REMICADE^®

• I have commercial or private insurance coverage
• I have government insurance coverage
• I have no insurance coverage

View all programs

Remicade, search in Chelyabinsk pharmacies

Composition and form of release

Lyophilisate for solution for infusion

1 vial. contains infliximab 100 mg

Pharmacological action

Remicade is an immunosuppressive agent with a high affinity for TNF-alpha, which is a cytokine with a wide biological effect; is a mediator of the inflammatory response and is involved in the modulation of the immune system. TNF-alpha plays a role in the development of autoimmune and inflammatory diseases. The drug quickly binds and forms a stable compound with soluble and transmembrane forms of human TNF-alpha, thereby reducing the functional activity of the latter. The specificity of infliximab for TNF-alpha was confirmed by its inability to neutralize the cytotoxic effect of a lymphotoxin-cytokine using the same receptors as TNF-alpha.

Indications

Rheumatoid arthritis (with the ineffectiveness of previous therapy, including methotrexate). Crohn’s disease (severe course, including with the formation of fistulas; with the ineffectiveness of standard therapy, including corticosteroids and / or immunosuppressants).

Contraindications

Hypersensitivity (including to mouse proteins), abscess, sepsis, tuberculosis, severe infections.

Caution. Pregnancy, lactation, age up to 17 years.

Method of administration and doses

Remicade is administered intravenously over 2 hours at a rate of not more than 2 ml/min, using an infusion system with a built-in sterile pyrogen-free filter with low protein-binding activity. In rheumatoid arthritis, treatment is carried out in combination with methotrexate. The initial single dose of infliximab is 3 mg/kg; after 2 and 6 weeks, they are administered again at the same dose, then every 8 weeks (the total number of injections is 5-6). In Crohn’s disease (severe course) – once 5 microns / kg. In Crohn’s disease with the formation of fistulas – a single dose of 5 mg / kg, re-administered 2 and 6 weeks after the first injection. In the event of a recurrence of the disease, the drug can be prescribed again within 14 weeks after the last dose. To prepare the infusion solution, the contents of the vial are dissolved in 10 ml of water for injection and the total volume is adjusted to 250 ml 0.9% NaCl solution. The resulting solution should be colorless or light yellow and opalescent; it may contain a small amount of small translucent particles (a solution in which dark particles are present or with a changed color is not used). Due to the absence of a preservative in the preparation, the administration of the infusion solution should be started as soon as possible and no later than 3 hours after its preparation. The unused part of the infusion solution is not subject to further use.

Side effects

From the nervous system: headache, dizziness, fainting, depression, psychosis, anxiety, amnesia, apathy, nervousness, drowsiness. From the side of the cardiovascular system: “flushing” of blood to the skin of the face, an increase or decrease in blood pressure, petechiae, thrombophlebitis, bradycardia, palpitations, vasospasm, cyanosis, peripheral circulatory disorders, arrhythmia. From the digestive system: nausea, diarrhea, abdominal pain, dyspepsia, constipation, gastroesophageal reflux, cheilitis, diverticulitis, liver dysfunction, cholecystitis. From the urinary system: urinary tract infections, pyelonephritis. From the genitourinary system: vaginitis. From the musculoskeletal system: myalgia, arthralgia. On the part of the hematopoietic organs: anemia, leukopenia, lymphadenopathy, lymphocytosis, lymphopenia, neutropenia, thrombocytopenia. From the respiratory system: infections of the upper respiratory tract, bronchitis, pneumonia, shortness of breath, sinusitis, epistaxis, bronchospasm, pleurisy. From the sensory organs: conjunctivitis, keratoconjunctivitis, endophthalmitis. On the part of the skin and subcutaneous fat: urticaria, increased sweating, dry skin, eczema, seborrhea, periorbital edema, hyperkeratosis, skin pigmentation disorders, alopecia, bullous rash. Allergic reactions (delayed type): myalgia and / or arthralgia with fever, urticaria, itching, swelling of the face, lips, hands, dysphagia, headache. Other: the formation of autoantibodies, lupus syndrome, excessive fatigue, chest pain, edema, infusion syndrome; viral infections (flu, herpes), abscess, sepsis, bacterial and fungal infections (erysipelas, warts, furunculosis, onychomycosis, cellulitis).

Drug interactions

In patients with rheumatoid arthritis and Crohn’s disease, the simultaneous use of methotrexate or other immunomodulators reduces the formation of antibodies to Remicade and increases the concentration of the latter in plasma.

GCS practically do not affect the pharmacokinetics of Remicade.

It is not recommended to combine treatment with Remicade and Anakinra.

There are no data on the interaction between infliximab and other medicinal products.

Pharmaceutical interactions

Do not mix Remicade solution with other medicinal products during infusion.

Storage conditions

The drug should be stored out of the reach of children at a temperature of 2° to 8°C; do not freeze.

Shelf life

3 years.

Treatment of ulcerative colitis (page 8)

Page 8 of 10

Treatment of ulcerative colitis

The goals of treating a patient with UC are:

• achieving and maintaining remission (clinical, endoscopic, histological),
• minimization of indications for surgical treatment,
• reduction in the incidence of complications and side effects of drug therapy,
• reduction of hospital stay and cost of treatment,
• improving the patient’s quality of life.

The results of treatment largely depend not only on the efforts and qualifications of the doctor, but also on the willpower of the patient, who clearly follows medical recommendations. The modern medicines available in the doctor’s arsenal allow many patients to return to normal life.

The complex of therapeutic measures includes:

• diet (diet therapy)
• taking medications (drug therapy)
• surgical intervention (operative treatment)
• lifestyle change.

Diet therapy. Usually, patients with UC during an exacerbation are recommended a slag-free (with a sharp restriction of fiber) diet, the purpose of which is to mechanically, thermally and chemically spare the inflamed intestinal mucosa. Fiber is limited by exclusion from the diet of fresh vegetables and fruits, legumes, mushrooms, hard, sinewy meat, nuts, seeds, sesame, poppy. With good tolerance, juices without pulp, canned (preferably at home) vegetables and fruits without seeds, ripe bananas are acceptable. Only bakery products and pastries made from refined flour are allowed. With diarrhea, dishes are served warm, wiped, limit foods with a high sugar content. The use of alcohol, spicy, salty foods, dishes with spices is highly undesirable. In case of intolerance to whole milk and lactic acid products, they are also excluded from the patient’s diet.

In severe course of the disease with weight loss, a decrease in the level of protein in the blood, increase the daily amount of protein in the diet, recommending lean meat of animals and birds (beef, veal, chicken, turkey, rabbit), lean fish (perch, pike, pollock ), buckwheat and oatmeal, chicken egg protein. In order to make up for protein losses, artificial nutrition is also prescribed: special nutrient solutions are injected through a vein (more often in a hospital setting) or special nutritional mixtures are administered through the mouth or probe, in which the main food ingredients have been subjected to special processing for their better digestibility (the body does not need to spend its forces to process these substances). Such solutions or mixtures can complement or replace natural nutrition. At present, special nutritional mixtures have already been created for patients with inflammatory bowel diseases, which also contain anti-inflammatory substances.

Non-compliance with the principles of therapeutic nutrition during an exacerbation can lead to an aggravation of clinical symptoms (diarrhea, abdominal pain, the presence of pathological impurities in the stool) and even provoke the development of complications. In addition, it should be remembered that the reaction to various products in different patients is individual. If you notice a deterioration in well-being after eating any product, then after consulting with your doctor, it should also be eliminated from the diet (at least during the period of exacerbation).

Drug therapy is determined by:

• prevalence of colon lesions;
• the severity of UC, the presence of complications of the disease;
• the effectiveness of the previous course of treatment;
• individual patient tolerance to drugs.

Mild to moderate disease can be treated on an outpatient basis. Patients with severe UC require hospitalization. The choice of the necessary medicines by the attending physician is carried out step by step.

In mild to moderate disease, treatment usually begins with 5-aminosalicylates (5-ASA) . These include sulfasalazine and mesalazine. Depending on the extent of the inflammatory process in UC, these drugs are recommended in the form of suppositories, enemas, foams administered through the anus, tablets, or a combination of topical and tablet forms. The drugs reduce inflammation in the colon during a flare-up, are used to maintain remission, and are proven to prevent colon cancer when taken long-term. Side effects often occur while taking sulfasalazine in the form of nausea, headache, increased diarrhea and abdominal pain, and impaired renal function.

If there is no improvement or the disease has a more severe course, then the patient with UC is prescribed hormonal preparations – systemic glucocorticoids (prednisolone, methylprednisolone, dexamethasone). These drugs quickly and effectively cope with the inflammatory process in the intestines. In severe UC, glucocorticoids are administered intravenously. Due to serious side effects (edema, increased blood pressure, osteoporosis, increased blood glucose levels, etc.), they must be taken according to a certain scheme (with a gradual decrease in the daily dose of the drug to a minimum or up to complete withdrawal) under the strict guidance and control of the attending physician. doctor. In some patients, phenomena of steroid refractoriness (lack of response to glucocorticoid treatment) or steroid dependence (resumption of clinical symptoms of exacerbation of UC when trying to reduce the dose or shortly after hormone withdrawal) are noted. It should be noted that during the period of remission, hormonal drugs are not a means of preventing new exacerbations of UC, so one of the goals should be to maintain remission without glucocorticoids.

With the development of steroid dependence or steroid refractoriness, severe or frequently relapsing course of the disease, the appointment of immunosuppressants (cyclosporine, tacrolimus, methotrexate, azathioprine, 6-mercaptopurine) is indicated. The drugs of this group suppress the activity of the immune system, thereby blocking inflammation. Along with this, affecting the immune system, they reduce the resistance of the human body to various infections, and have a toxic effect on the bone marrow.

Cyclosporine, tacrolimus are fast-acting drugs (results are evident in 1-2 weeks). Their timely use in 40-50% of patients with severe UC avoids surgical treatment (removal of the colon). The drugs are administered intravenously or are prescribed in the form of tablets. However, their use is limited by high cost and significant side effects (convulsions, kidney and liver damage, high blood pressure, gastrointestinal disorders, headache, etc.).

Methotrexate is a drug for intramuscular or subcutaneous administration. Its action unfolds in 8 to 10 weeks. When using methotrexate, one also has to reckon with its high toxicity. The drug is prohibited for use in pregnant women, as it causes malformations and fetal death. The effectiveness of the use in patients with UC is being specified.

Azathioprine, 6-mercaptopurine are slow acting drugs. The effect of their reception develops not earlier than in 2-3 months. Drugs can not only cause, but also maintain remission with prolonged use. In addition, the appointment of azathioprine or 6-mercaptopurine allows you to gradually stop taking hormonal drugs. They have fewer side effects compared to other immunosuppressants, they are well combined with 5-ASA preparations and glucocorticoids. However, due to the fact that thiopurines have a toxic effect on the bone marrow in some patients, patients should definitely perform a clinical blood test to monitor this side effect and take timely therapeutic measures.

At the end of the 20th century, a revolution in the treatment of patients with inflammatory bowel diseases (Crohn’s disease, UC) was the use of fundamentally new drugs – biological (anticytokine) drugs. Biologics are proteins that selectively block certain cytokines, key players in the inflammatory process. This selective action contributes to a faster onset of a positive effect and causes fewer side effects compared to other anti-inflammatory drugs. Currently, active work is underway around the world to create and improve new and existing biological drugs (adalimumab, certolizumab, etc.), and their large-scale clinical trials are being carried out.

In Russia, for the treatment of patients with inflammatory bowel diseases (UC and Crohn’s disease), the only drug of this group is registered so far – infliximab (trade name – Remicade) . Its mechanism of action is to block the multiple effects of the central pro-inflammatory (inflammation-supporting) cytokine, tumor necrosis factor-α. First, in 1998, the drug was licensed in the US and Europe as a reserve drug for the treatment of refractory and fistulous forms of Crohn’s disease. In October 2005, based on the accumulated experience of high clinical efficacy and safety of the use of infliximab in the treatment of patients with UC, a round table devoted to the development of new standards for the treatment of UC and CD in the EU and the USA decided to include infliximab and UC in the list of indications for treatment with infliximab and UC. Since April 2006, infliximab (Remicade) has been recommended for the treatment of patients with severe ulcerative colitis in Russia as well.

Infliximab has become a real breakthrough in modern medicine and is considered the “gold standard”, with which most of the new drugs (adalimumab, certolizumab, etc.) currently under clinical trials are compared.

For UC, infliximab (Remicade) is prescribed:

• for patients who have failed traditional therapy (hormones, immunosuppressants)
• patients dependent on hormonal drugs (cancellation of prednisolone is not possible without the resumption of exacerbation of UC)
• patients with moderate to severe disease, which is accompanied by damage to other organs (extraintestinal manifestations of UC)
• patients who would otherwise require surgical treatment
• patients in whom successful treatment with infliximab caused remission (to maintain it).

Infliximab is given as an intravenous infusion in a treatment room or anticytokine therapy center. Side effects are rare and include fever, joint or muscle pain, and nausea.

Infliximab is faster than prednisolone in terms of symptom relief. So, some patients already feel better within the first 24 hours after the administration of the drug. Abdominal pain, diarrhea, bleeding from the anus are reduced. There is a restoration of physical activity, appetite increases. For some patients, for the first time, hormone withdrawal becomes possible, for others, saving the colon from surgical removal. Due to the positive effect of infliximab on the course of severe forms of UC, the risk of complications and deaths is reduced.

This drug is not only indicated to achieve remission of UC, but can also be administered as an intravenous infusion over a long period of time as maintenance therapy.

Infliximab (Remicade) is currently one of the best studied drugs with an optimal benefit/risk profile. Infliximab (Remicade) is even approved for use in children over 6 years of age.

However, biologics are not without side effects. By suppressing the activity of the immune system, as well as other immunosuppressants, they can lead to an increase in infectious processes, in particular tuberculosis. Therefore, before prescribing infliximab, patients should undergo chest x-ray and other studies for the timely diagnosis of tuberculosis (for example, the quantiferon test is the “gold standard” for detecting latent tuberculosis abroad).

A patient treated with infliximab, as with any new agent, should be monitored closely by their physician or anticytokine specialist.

Prior to the first infliximab (Remicade) infusion, patients undergo the following tests:

• chest X-ray
• Mantoux skin test
• blood test.

Chest x-ray and Mantoux skin test are done to rule out latent TB. A blood test is necessary to assess the general condition of the patient and rule out liver disease. If an active severe infection (eg, sepsis) is suspected, other investigations may be required.

Infliximab (Remicade) is given directly into a vein, by drip, as an intravenous infusion, slowly. The procedure takes approximately 2 hours and requires constant monitoring by medical personnel.

The standard recommended single dose dose of infliximab in patients with UC is 5 mg/kg body weight.

An example of calculating the single dose of infliximab required for a single infusion. For a patient weighing 60 kg, a single dose of infliximab is: 5 mg x 60 kg = 300 mg (3 x 100 mg Remicade vials).

Infliximab (Remicade), in addition to therapeutic efficacy, provides patients with a sparing regimen of therapy. In the first 1.5 months at the initial, so-called induction stage of therapy, the drug is administered intravenously only 3 times with a gradually increasing interval between subsequent injections carried out under the supervision of a physician. At the end of the induction period, the doctor evaluates the effectiveness of treatment in this patient and, if there is a positive effect, recommends continuing therapy with infliximab (Remicade), usually according to the scheme once every 2 months (or every 8 weeks).