What are the key differences between Remicade and its biosimilars. How do Inflectra, Renflexis, and Avsola compare to the original biologic medication. What should patients know about switching from Remicade to a biosimilar alternative.

Understanding Biologic Medications and Their Role in Treatment

Biologic medications have revolutionized the treatment of many chronic inflammatory autoimmune conditions. These complex drugs are derived from living organisms and offer targeted therapeutic approaches for diseases that previously had limited treatment options.

What exactly are biologic medications?

Biologic medications are pharmaceutical products created using biotechnology. They are composed of components derived from living sources, including:

• Human cells or tissues
• Animal cells or tissues
• Microorganisms
• Proteins
• DNA
• Sugars

The complexity of biologics stems from their diverse origins and the intricate processes involved in their production. Unlike conventional drugs, biologics can be more unpredictable in their effects and are typically more sensitive to environmental factors such as light and temperature.

How do biologic medications work in the body?

Biologic medications can have various mechanisms of action, depending on the specific drug and the condition it’s designed to treat. Some common ways biologics work include:

1. Modulating immune system signals involved in inflammatory processes
2. Targeting specific proteins that promote inflammation or contribute to disease progression
3. Stimulating the immune system to enhance its ability to fight infections

By targeting specific pathways and molecules in the body, biologics can offer more precise and effective treatments for complex diseases.

Remicade: A Pioneering Biologic Medication

Remicade, with its active ingredient infliximab, has been a game-changer in the treatment of various chronic inflammatory autoimmune diseases. As one of the earlier biologic medications to enter the market, it has paved the way for advancements in treating conditions that were previously challenging to manage.

What conditions does Remicade treat?

Remicade is FDA-approved for the treatment of several chronic inflammatory conditions, including:

• Rheumatoid arthritis
• Psoriatic arthritis
• Ankylosing spondylitis
• Plaque psoriasis (severe or disabling cases in adults)
• Ulcerative colitis (for patients aged 6 and older)
• Crohn’s disease (for patients aged 6 and older)

How is Remicade administered?

Remicade is administered through intravenous (IV) infusions. The dosage and frequency of infusions can vary depending on factors such as:

• The patient’s medical condition
• Body weight
• Individual response to treatment

Typically, patients receive infusions every few weeks, with the exact schedule determined by their healthcare provider based on their specific needs and treatment response.

Biosimilars: The Next Generation of Biologic Treatments

As patents for original biologic medications expire, biosimilars have emerged as alternatives that offer comparable efficacy and safety profiles. Understanding the concept of biosimilars is crucial for patients and healthcare providers alike.

What defines a biosimilar medication?

Biosimilars are medications designed to be highly similar to existing FDA-approved biologic drugs, known as reference products. Key characteristics of biosimilars include:

• Use of the same amino acid materials as the reference drug
• Following similar manufacturing processes
• Demonstrating no clinically meaningful differences in safety or efficacy
• Requiring a prescription from a healthcare professional

The development and approval of biosimilars are guided by the Biologics Price Competition and Innovation Act (BPCI Act) of 2009, which aims to increase treatment options, improve access to life-saving medications, and potentially reduce healthcare costs through competition.

How do biosimilars differ from generic drugs?

While biosimilars may seem similar to generic drugs, there are important distinctions:

• Biosimilars are not identical copies of their reference drugs, unlike generic medications
• The manufacturing process for biosimilars is more complex and can result in slight variations between batches
• Despite these variations, biosimilars must meet rigorous FDA standards for purity, safety, and efficacy

These differences stem from the inherent complexity of biologic medications and the living cells used in their production.

Remicade Biosimilars: Inflectra, Renflexis, and Avsola

As Remicade’s patent protection has expired, several biosimilar alternatives have been developed and approved by the FDA. These medications offer additional options for patients and healthcare providers in managing chronic inflammatory conditions.

What are the current FDA-approved biosimilars to Remicade?

There are currently three FDA-approved biosimilars to Remicade available in the United States:

1. Inflectra: Manufactured by Pfizer and approved in April 2016
2. Renflexis: Approved in April 2017
3. Avsola: Approved in December 2019 (though not yet commercially available)

How do these biosimilars compare to Remicade?

All three biosimilars share several key characteristics with Remicade:

• They belong to the class of drugs called tumor necrosis factor (TNF) alpha inhibitors
• They work by blocking TNF-alpha proteins that cause inflammation and swelling
• They are administered through intravenous (IV) injections
• They are approved to treat the same conditions as Remicade

While these biosimilars are highly similar to Remicade, they may offer potential cost savings for patients and healthcare systems.

Comparing Efficacy and Safety: Remicade vs. Biosimilars

One of the primary concerns for patients and healthcare providers when considering biosimilars is how they compare to the original biologic in terms of efficacy and safety. Extensive research and clinical trials have been conducted to address these concerns.

Are biosimilars as effective as Remicade?

Clinical studies have shown that FDA-approved biosimilars to Remicade demonstrate comparable efficacy to the original medication. Key findings include:

• Similar improvements in disease activity scores across various conditions
• Comparable rates of clinical remission in inflammatory bowel diseases
• Equivalent improvements in quality of life measures

These results suggest that patients can expect similar therapeutic benefits from biosimilars as they would from Remicade.

Do biosimilars have the same safety profile as Remicade?

Safety is a crucial consideration when evaluating biosimilars. Research has shown that:

• The incidence and types of adverse events are generally similar between Remicade and its biosimilars
• Immunogenicity rates (development of antibodies against the medication) are comparable
• Long-term safety profiles appear to be consistent with those of Remicade

However, as with any medication, individual patient responses may vary, and close monitoring by healthcare providers is essential.

Switching from Remicade to a Biosimilar: What Patients Should Know

For patients currently receiving Remicade treatment, the possibility of switching to a biosimilar may arise. Understanding the implications and process of such a switch is crucial for informed decision-making.

Can patients switch between Remicade and its biosimilars?

While switching between Remicade and its biosimilars is possible, there are important considerations:

• The decision to switch should be made in consultation with the patient’s healthcare provider
• Switching is typically considered when a patient is stable on their current treatment
• Some patients may switch due to cost considerations or insurance coverage changes

It’s important to note that at present, the FDA does not consider Inflectra, Renflexis, and Avsola to be “interchangeable” with Remicade. This means that pharmacists cannot automatically substitute a biosimilar for Remicade without the prescribing physician’s approval.

What should patients expect when switching to a biosimilar?

When transitioning from Remicade to a biosimilar, patients can generally expect:

• Similar efficacy in managing their condition
• Comparable side effect profiles
• Potential cost savings, depending on insurance coverage

However, close monitoring by healthcare providers is essential during and after the switch to ensure the new medication is working effectively and to address any concerns that may arise.

Cost Considerations: Remicade vs. Biosimilars

One of the primary motivations behind the development of biosimilars is the potential for cost savings in healthcare. Understanding the financial implications of choosing between Remicade and its biosimilars is important for patients and healthcare systems alike.

Are biosimilars less expensive than Remicade?

In general, biosimilars are designed to offer a more cost-effective alternative to their reference products. However, the actual cost difference can vary depending on several factors:

• Individual insurance coverage and formularies
• Negotiated prices between manufacturers and healthcare providers
• Patient assistance programs offered by pharmaceutical companies
• Geographic location and local market conditions

While biosimilars typically have a lower list price than Remicade, the out-of-pocket cost for patients may not always reflect this difference due to complex insurance and pricing structures.

How do cost savings from biosimilars impact healthcare systems?

The introduction of biosimilars has the potential to generate significant cost savings for healthcare systems:

• Increased competition can lead to lower prices for both biosimilars and reference products
• Healthcare providers and insurers may be able to negotiate better rates
• Reduced medication costs could allow for broader access to biologic treatments

These savings could potentially be reinvested in other areas of healthcare or passed on to patients in the form of lower premiums or out-of-pocket costs.

Future Perspectives: The Evolving Landscape of Biologics and Biosimilars

As the field of biologic medications continues to advance, the role of biosimilars is likely to expand. Understanding the potential future developments in this area can help patients and healthcare providers prepare for upcoming changes.

What new biosimilars are in development?

The biosimilar market is rapidly evolving, with numerous products in various stages of development. Some areas of focus include:

• Additional biosimilars for existing biologics like Remicade
• Biosimilars for other popular biologic medications used in rheumatology, gastroenterology, and dermatology
• Development of biosimilars for oncology treatments

As more biosimilars enter the market, patients and healthcare providers will have an increasing number of treatment options to consider.

How might regulatory changes impact biosimilar use?

Regulatory bodies like the FDA continue to refine their approach to biosimilar approval and use. Potential future developments may include:

• Updated guidelines for demonstrating interchangeability between biosimilars and reference products
• Streamlined approval processes for biosimilars to expedite market entry
• Enhanced post-marketing surveillance to ensure long-term safety and efficacy

These changes could potentially increase confidence in biosimilar use and facilitate broader adoption in clinical practice.

As the landscape of biologic medications and biosimilars continues to evolve, staying informed about new developments and options is crucial for patients and healthcare providers alike. The ongoing research and advancements in this field promise to expand treatment possibilities and potentially improve access to these important medications for those who need them most.

Remicade vs. Biosimilars (Inflectra, Renflexis, Avsola)

If you take biologic medications like Remicade to treat a chronic inflammatory autoimmune condition, you’ve probably heard of biosimilars from your physician or other healthcare providers. Biosimilars can be complex to understand, leaving you with many questions.

We put together this comprehensive guide of common questions and answers to better understand the differences between Remicade and biosimilars. 

(We always advise you to speak to your doctor before switching medications.)

What is a biologic medication?

Utilizing biotechnology, biologic medications are made from components that stem from human, animal or microorganism sources including sugars, proteins, DNA, whole cells, or tissue or other various elements of living things such as bacteria, birds, insects, mammals, and plants. 

Since biologics come from diverse sources that can be hard to identify, they are more complex than conventional drugs. In addition, once these drugs are formed, they also tend to be more unpredictable in how they can take effect and are more sensitive to light and temperature. 

With advances in the field of medicine, some biologics (gene-based and cellular) are now being used as treatments for many illnesses and diseases that may have previously otherwise had no treatment options available.

How do biologics work?

Depending on the disease and medication, biologics can:

• Help manage the immune system’s signals involved in the inflammatory process that can lead to joint tissue damage 
• Target certain proteins that encourage inflammation, help cancer cells grow, or play a role in developing psoriasis. 
• Stimulate the immune system helping it work more effectively to fight infection

What is Remicade?

Remicade (infliximab) is a biologic prescription used to treat chronic inflammatory autoimmune diseases by reducing the effects of substances in the body that can cause inflammation. These conditions include:

•  rheumatoid arthritis
•  psoriatic arthritis
• ankylosing spondylitis (chronic inflammation of the spine and the sacroiliac joints)
• plaque psoriasis in adults (severe or disabling cases)
• ulcerative colitis (patients at least six years old)
• Crohn’s disease (patients at least six years old)

This medication is given through intravenous infusions (IV), and dosage depends on the patient’s medical condition, weight, and response to treatment.

What are biosimilars?

Biosimilars are medications made using the same amino acid materials and specific processes as their reference drug. The reference drug refers to the well-tested, FDA-approved biologic drug that’s been on the market for years. The biosimilar presents with no significant differences in its safety or efficacy from the biologic product and is only available with a prescription from a healthcare professional.  

The Biologics Price Competition and Innovation Act (BPCI Act) of 2009 was created as an “abbreviated licensure pathway” for biological products to : 

• provide more treatment options
• increase access to lifesaving medications
• possibly lower health care costs through competition

Are biosimilars the same as generic drugs?

No, they are not. Unlike generic drugs, biosimilars are not identical copies of their reference drugs. However, each biosimilar drug is manufactured by a complex process that includes the exact steps that were made to make the biologic medication. 

While the same process is followed, small changes are common from batch to batch since biosimilars are made from living cells. These variations are expected and acceptable because every lot is still required to meet the same high standards of purity, safety and efficacy as per the guidelines of the FDA.

What are the biosimilars to Remicade?

There are currently 3 FDA-approved biosimilars to Remicade in the United States; Inflectra, Reneflexis, and Avsola.  

Inflectra was the first biosimilar to Remicade, manufactured by Pfizer and released in April 2016. Renflexis was approved in April 2017 and Avsola was approved in December 2019, though it is unavailable. 

All three biosimilars belong to the class of drugs called tumor necrosis factor (TNF) alpha inhibitors and work similarly to block TNF-alpha proteins that cause inflammation and swelling. Like Remicade, they are also given through an IV injection. 

Inflectra, Renflexis, and Avsola are used to treat the same conditions as Remicade, including rheumatoid arthritis, Crohn’s disease, ankylosing spondylitis, ulcerative colitis, psoriatic arthritis, and plaque psoriasis. 

These biosimilars are commonly used when other treatment options haven’t worked and can cost less than Remicade. 

Final Thoughts

At this time, Inflectra, Renflexis, and Avsola aren’t considered “interchangeable” by the FDA, meaning a pharmacist can’t switch someone from a biologic to a biosimilar without a prescription from a physician/healthcare provider. If you are currently on Remicade, and it’s not working, you may want to speak with your doctor about biosimilar options. 

At Speciality Infusion Centers, we specialize in managing chronic conditions and work with you, your insurance carrier, and your healthcare doctor to provide a personalized treatment plan. Find the most convenient location for you to start on your Remicade, Inflectra, or Renflexis IV therapy today. 

Top Remicade alternatives and how to switch your Rx

Remicade doesn’t work for everyone. Renflexis, Humira, Stelara, Xeljanz XR, and Trexall are some Remicade alternatives. Get the full list here.

Compare Remicade alternatives | Renflexis | Humira | Stelara | Xeljanz XR | Trexall | Natural alternatives | How to switch meds

Suppressing your own immune system by taking medication is naturally frightening but is absolutely necessary to control many autoimmune conditions. Crohn’s disease, ulcerative colitis, rheumatoid arthritis, psoriasis, psoriatic arthritis, and ankylosing spondylitis are all autoimmune diseases, and they stem from an immune system malfunction, which causes our immune cells to attack body parts such as bowel, joints, and skin. Remicade, a brand-name form of infliximab given intravenously, can be used to treat all of these medical conditions. Remicade is also FDA approved for use in pediatric patients ages six and older for the treatment of Crohn’s and ulcerative colitis. 

Due to the expense, its significant side effects (including the possibility of heart failure or nervous system problems), and the inconvenience of needing an intravenous infusion, you may be curious to know if an alternative to Remicade exists. The short answer is an emphatic ‘Yes,’ because there has been an impressive proliferation of these types of drugs. In fact, they pop up in commercials frequently. The long answer is more complex and worth delving into as we list the other options and hone in on the most common ones.

What can I take in place of Remicade?

Remicade belongs to the tumor necrosis factor (TNF) inhibitor subclass of immunosuppressants. By blocking TNF, the drug disrupts the chemical messaging between the body’s immune cells which blunts the inflammation our immune system can produce. A number of other TNF inhibitors are available if Remicade is the wrong fit for you. 

In addition, Remicade falls under the larger category of biologics, a term under the umbrella of immunosuppressants. Alternative biologics block cytokines other than TNF. Interleukins (ILs) are a diverse group of cytokines, our body’s chemical signaling proteins, and interleukin inhibitors may be another option for you. Biologic medications can also interrupt immune cell function in other ways.

Biologics may get a lot of attention, but they are far from the only choice. Janus kinase (JAK) inhibitors are medicines composed of small molecules which block immune cell internal processes. Like TNF and IL inhibitors, JAK blockers target the root cause of autoimmune disease. Biologics modify the disease itself rather than just covering up symptoms, and this feature earns them the distinction as disease modifying antirheumatic drugs (DMARDs). More traditional DMARDs for you to consider might include methotrexate, hydroxychloroquine, sulfasalazine, and leflunomide.  

The classifications of immunosuppressants sounds a bit like alphabet soup with the abundance of acronyms like TNF, IL, JAK, and DMARDs. As we break the categories down to specific drugs, your options become more clear. The list is lengthy, so we will focus on a few common choices.

Other alternatives to Remicade

• Inflectra (infliximab)
• Avsola (infliximab)
• Actemra (tocilizumab)
• Kevzara (sarilumab)
• Siliq (brodalumab)
• Kineret (anakinra)
• Ilumya (tildrakizumab)
• Entyvio (vedolizumab)
• Tysabri (natalizumab)
• Olumiant (baricitinib)
• Xeljanz (tofacitinib)
• Rinvoq (upadacitinib)
• Imuran (azathioprine)
• Mercaptopurine
• Prednisone or other corticosteroids

Top 5 Remicade alternatives

The following are some of the most common alternatives to Remicade.

1. Renflexis

You would be hard-pressed to find a difference between Renflexis and Remicade. The reason is that Renflexis is one of the multiple biosimilars to Remicade, having only a minor, insignificant structural difference in the monoclonal antibody infliximab. Renflexis is biosimilar to Remicade, which accounts for their similarity in terms of effectiveness, dosage, and side effects. 

Biologics are very complex to manufacture, so when a product like Remicade is no longer under patent protection, competing companies can make an extremely similar drug, but not identical. The result is a biosimilar rather than an identical generic product. Cheaper development costs translate to a lower price for the consumer, meaning Renflexis might offer you savings compared to Remicade, without sacrificing safety or efficacy. Regardless of being biosimilar or not, biologics come at a hefty price. If cost is a major motivator for you to change drugs, try showing a SingleCare discount card at your local pharmacy to see if that helps you save money.

2. Humira

Convenience is always appreciated, and going to an infusion center to get intravenous Remicade every few weeks is not quick and easy. Humira presents as an alternative TNF inhibitor that can be injected at home every two weeks. The most common side effects of Humira include respiratory infections and abdominal pain. Since the list of diagnoses for which Humira is approved by the Food and Drug Administration (FDA) matches up nicely with Remicade, chances are that it is a viable option for you to consider. 

RELATED: Remicade vs. Humira: Differences, similarities, and which is better for you

3. Stelara

If you are looking for an alternative to Remicade because it has failed to control your autoimmune condition or has given you unacceptable side effects, Stelara could make your final list of possibilities. Instead of blocking TNF, Stelara is an antibody that binds to the interleukins IL-12 and IL-23. The inhibition of these cytokines reduces inflammation in many of the same diseases as Remicade. Generally, Stelara comes up for use when TNF agents have not worked out. Of the IL blockers, it has the advantage of only requiring an injection every 8 or 12 weeks.

4. Xeljanz XR

The bane of therapy with TNF or IL inhibitory agents is their large molecular size that requires them to be given intravenously or by injection. Janus kinase inhibitors are small molecules permitting them to be given as oral tablets. Remicade or another TNF inhibitor is often tried first, but a JAK inhibitor like Xeljanz XR can be an option thereafter if need be. Once daily dosing of a Xeljanz XR tablet probably sounds appealing compared to taking the time to go for a Remicade infusion. 

5. Trexall

Long before any form of biologic drug, there was, a drug with utility for treating various arthritic and cancer conditions. Trexall is an oral form of methotrexate that can be taken once a week. The efficacy of methotrexate as a DMARD for rheumatoid arthritis is impressive enough that it is often used as a first-line treatment before biologic agents or other nonbiologic drugs, like Plaquenil, Arava, and Azulfidine.  

Natural alternatives to Remicade

The potency and potential of biologic and nonbiologic DMARDs is not in debate. These drugs can do wonders to reduce the damage done to joints in rheumatoid or psoriatic arthritis and the intestinal tract in inflammatory bowel diseases (IBD) like Crohn’s disease and ulcerative colitis. Unfortunately, their immunosuppressive mechanism is fraught with risk. The dangers include allergic reactions, serious infections, lymphoma, and other cancers, arising in the setting of less immune system surveillance. In fact, prior to treatment with Remicade, testing is typically done for latent tuberculosis and hepatitis B, because infections like this could reactivate if the immune system lets its guard down. This explains why many of the FDA-approved indications specify moderate to severe forms of the disease to warrant treatment with a biologic. Mild cases can be addressed with other anti-inflammatory prescription drugs.

Respect for the potential adverse effects is warranted, but the fear of them often pushes people to turn to unproven options. Natural alternatives are a popular pick. For example, interest exists for treating IBD with probiotics, prebiotics, antioxidants, and fish oil, and for each, the results of clinical trials have either been disappointing or insufficient to warrant their use at this time. The autoimmune conditions that DMARDs address are too damaging and disabling to make decisions without getting the medical advice of your healthcare provider.

How to switch to a Remicade alternative

At this point, you may have some valid points regarding wanting to switch away from Remicade, and you now know what alternative drugs sound best. Call up the prescribing healthcare professional and ask for an appointment to discuss your experiences with Remicade and your ideas about other options. Points about effectiveness, safety, risk factors, drug interactions, cost and convenience can all be raised. At the conclusion of the discussion, a mutual decision can be made about your treatment. 

Optimization of therapy for ulcerative colitis.

A kaleidoscope of clinical observations

Oksana Mikhailovna Drapkina , professor, doctor of medical sciences:

– I give the floor to Oksana Borisovna Shchukina. We are back in St. Petersburg. Oksana Borisovna, “Optimization of therapy for ulcerative colitis. Kaleidoscope of clinical observations.

Oksana Borisovna Schukina , associate professor, candidate of medical sciences:

– Dear colleagues, good afternoon! First of all, I would like to say that when we touch on the treatment of ulcerative colitis, we necessarily emphasize the differences regarding the standard approaches for the relief of severe, fulminant attacks of ulcerative colitis and the induction of remission of mild and moderate ulcerative colitis. In addition, when prescribing therapy, we must take into account the localization of the lesion – is it proctitis, left-sided ulcerative colitis or total, widespread ulcerative colitis. And, finally, our treatment tactics will differ depending on the stage of the disease – we are dealing with an exacerbation of ulcerative colitis, and then we are talking about remission induction, clinical and endoscopic remission with steroid withdrawal, or we are talking about already achieved remission of ulcerative colitis, and it is about maintenance without steroids with endoscopic evaluation.

It should be emphasized that ulcerative colitis is currently an incurable disease, and therefore therapy for patients is lifelong. Unlike Crohn’s disease, the lesion affects only the large intestine, so surgical cure is possible by performing a coproctectomy. As for the treatment with 5-aminosalicylic acid preparations for mild and moderate ulcerative colitis, in 80% of patients with patients, these drugs are quite effective. The consensus says that all mesalazine preparations are equally effective, in some cases increasing the dose of mesalazine more than 3-4 g leads to a faster response. Prescribing mesalazine is recommended, taking into account not only the effectiveness, but also the method of release of the active substance, the frequency of administration, which affects adherence to treatment, and various delivery systems of mesalazine, because the drug works specifically in the segment of the colon where it is delivered. Therefore, speaking in general about the same effectiveness of mesalazines, in each individual patient, the effectiveness can be individual, depending on these properties.

I will focus on three clinical cases – these will be a fulminant attack of ulcerative colitis, severe attack and moderate ulcerative colitis – and on clinical examples I will try to emphasize the features of optimizing therapy for inducing remission and maintaining remission in these patients. So, the patient, born in 1972, quits smoking at the age of thirty-four. Subsequently, about a year after birth, a fulminant attack of ulcerative colitis – stool up to 12 times, high fever, with a decrease in hemoglobin to 96, with accelerated ESR to 62, C-reactive protein at a rate of 5 to 136, and the endoscopic severity index is 8 points, that is, the maximum. The patient was transferred from the infectious diseases hospital, where an intestinal infection was ruled out, to our specialized hospital. This is a severe attack on the Truelow-Witts index, so intravenous steroid therapy was prescribed, but there was no response to therapy within two weeks.

The patient did not worsen, therefore, whenever discussing surgical treatment with coloproctologists, the question of the operation was postponed, and it was decided to achieve remission induction with anticytokine therapy, that is, the patient was prescribed remicade due to the lack of response to intravenous steroids. Azathioprine immunosuppressive therapy was also included. The patient responded to the induction course and received combination therapy with remicade and azathioprine for almost 8 months. 6 infusions were carried out. She received remicade, azathioprine, 5-aminosalicylic acid preparations, and remained in clinical remission in September, but the drug disappears from the pharmacy network, and the seventh infusion in November was not carried out. But the patient remained in remission, continued to receive azathioprine, 5-aminosalicylic acid preparations, and when remicade appeared 3 months later, in February 2010, the question arose whether the patient in remission should continue anticytokine therapy. According to the examination, normal calprotectin, normal state of health, and it was decided to refrain from continuing infusions and continue them if the state of health deteriorates.

The patient comes back a year later, in January 2012. She has normal calprotectin, she has a normal endoscopic picture, a study is being carried out for friability, vulnerability (. ..) (05:11), the test is negative, which indicates good, deep healing of the mucous membrane, histological remission is also confirmed, and the patient asks to cancel immunosuppressants due to the fact that among the side effects she does not like, she is wary of the side effects of immunosuppressors listed there. Therapy with 5-aminosalicylic acid continues, within a year she has been receiving Mezavant. At first, there was 1 tablet, but after the abolition of immunosuppressants, we switch to 2 Mezavant tablets, and a year later, clinical remission by calprotectin is assessed, and today the patient is in a state of clinical and laboratory remission.

Why did we get away with azathioprine in this case? Azathioprine is indicated in the following situations, says the latest Ulcerative Colitis Consensus: relapses occurring on the background of maintenance therapy with adequate doses of 5-aminosalicylic acid, or intolerance to these drugs. Our patient did not receive treatment, it was a fulminant attack of ulcerative colitis, so in this case, despite the fact that the induction of remission was achieved by remicade, we allowed ourselves to get away from azathioprine and remain on adequate doses of 5-aminosalicylic acid. Thus, a feature of this clinical observation is that this is the fulminant onset of ulcerative colitis. The patient was resistant to intravenous steroids, which led to the need to include “rescue” therapy as an alternative to colectomy with remicade (infliximab).

Remission was achieved with a combination regimen of Remicade, azathioprine, 5-aminosalicylic acid. Maintenance therapy was carried out with azathioprine and 5-aminosalicylic acid. Went away from remicade because she had not previously received azathioprine, this is consistent with the Consensus data, and a very important factor is that the patient was fully adherent to treatment. Finally, azathioprine withdrawal became possible, again, on the condition that maintenance therapy was adhered to with adequate doses of 5-aminosalicylic acid, the patient had not previously received pre-fulminant attacks. Well, the rejection of local forms of 5-aminosalicylic acid with the transition to the multimatrix form of mesalazine (Mezavant) made it possible to achieve very good adherence. Clinical case – patient 1987 year of birth. He also quit smoking, and after about 7 months, a twenty-one-year-old young man has a fever, more frequent stools, laboratory activity in the form of an acceleration of ESR, an increase in C-reactive protein, and a rather severe endoscopic severity index of ulcerative colitis. This is ulcerative colitis, widespread, also severe, highly active, and intravenous steroids are prescribed to induce remission, followed by a switch to oral steroids.

Azathioprine is also prescribed, why, because induction is carried out with the appointment of intravenous prednisolone, so we must immediately connect azathioprine, and he receives mesalazine orally and rectally, a combined regimen. He receives steroids for a very long time, gradual withdrawal – for 6 months we gradually reduce the dose, continue to receive azathioprine, mesalazine, and after the withdrawal of steroids, leukopenia develops on azathioprine, and therefore we are forced to abandon this drug. He remains on 5-aminosalicylic acid, in general, the full dose is 3 g orally and the Salofalk candle 0.5 g rectally. remission control. He feels well, remission is controlled by the level of fecal calprotectin, and without azathioprine he keeps remission on mesalazine, on combination drugs. Naturally, the young man does not really like local treatment, and therefore, at the beginning of 2011, he switches to the appointment of multimatrix mesalazine (“Mezavant”) at a dose of 2 tablets. He comes for a control visit in March 2012, a year later – normal fecal calprotectin, completely healed mucosa with an endoscopic severity index of 0, and a test for friability and bleeding – she is also negative, deep histological remission without basal plasmacytosis.

The patient continues to take Mezavant 2 tablets once in the morning, a very convenient regimen. He is fully committed to therapy, which suits him perfectly, and is currently in remission. Features of this clinical observation: severe attack, intravenous prednisolone is prescribed to induce remission; steroid dependence develops, it is overcome by the appointment of azathioprine. Maintenance therapy with azathioprine and 5-aminosalicylic acid preparations, unfortunately, is not possible due to the development of leukopenia, that is, myelotoxicity on the background of azathioprine, and the possibility of azathioprine withdrawal against the background of the fact that the patient is fully adherent to 5-aminosalicylic acid therapy. And we immediately emphasize that before the onset of the disease, before the first symptoms appeared, he was an untreated patient with 5-aminosalicylic acid, so we can safely get away from azathioprine. Well, and the rejection of local forms of 5-aminosalicylic acid, the appointment of multimatrix mesalazine only inside, and once a day, it is very convenient, it made it possible to achieve excellent adherence.

And finally, the third case – a patient with moderate severity of ulcerative colitis, twenty-nine-year-old patient. A weaker stool with an admixture of blood appeared, the endoscopic severity index was 5 points. Standard therapy was prescribed – this is mesalazine orally and in enemas, with a quick remission – in fact, in 2 months the patient already felt fine and stopped taking these drugs, that is, she stopped taking them. Against this background, an exacerbation develops, with an acceleration of ESR, with endoscopic activity, and the patient is still recommended to take an induction course of mesalazine 3 g and a rectal mesalazine suppository 2 times a day to induce remission. She achieves remission quite quickly, but then again she starts taking mesalazine, then not taking mesalazine, then puts a candle, when blood appears, then stops putting it on. And when she came again for an appointment – it was January 2011 – a tough conversation was held with her about the need to maintain remission, that the appearance of blood in the stool is only the tip of the iceberg, that persistent inflammation in the mucosa leads to completely unnecessary, terrible consequences . The standard induction dose was prescribed again – 3 g orally and 0.5 g rectally, remission was achieved very quickly, and she felt so good that she again began to doubt therapy. She turned literally after 3 months, is it possible to do something with rectal forms, she doesn’t like candles. Remission maintenance therapy with multimatrixine mesalazine (Mezavant) was prescribed, only one tablet, although the instructions for the drug indicate that remission maintenance should be provided with 2 tablets, 2.4 g per day.

But given that the patient did not have any severe symptoms of proctitis, and she responded very well to therapy with 5-aminosalicylic acid, one maintenance dose of 1.2 g was quite enough for her. She came in almost a year later – normal calprotectin, fully committed to therapy, and the next year, in January 2013, she turns to us with a question of what to do, she is going to get pregnant. She generally doubts whether she has ulcerative colitis, that she feels so great, maybe she should stop taking this pill already. We’re sending the patient for testing. Clinical remission is confirmed by endoscopic remission, there is no friability, vulnerability during the pressure test on the mucous membrane, the morphologist proves to us that there is no basal plasmacytosis, that is, complete deep histological remission, and the patient was asked to continue mesalazine one tablet constantly, to plan pregnancy.

This is a completely acceptable drug, and even you need to take it, be sure to protect the mucous membrane at the time of pregnancy, childbirth and feeding. Control fecal calprotectin – she does it, the data in 2013, as of January 2014, is quite suitable for us, and it is recommended to control fecal calprotectin every 4-6 months. Continue taking Mezavant one tablet, and if there is an increase in the level of fecal calprotectin, add suppositories with 5-aminosalicylic acid. In this case, the localization of ulcerative colitis was left-sided, but the caecum was involved, so we could not confine ourselves to topical mesalazine, we definitely had to prescribe oral therapy with 5-aminosalicylic acid. And the main factor in the lack of stable remission was the lack of adherence to treatment. The patient did not like a large number of tablets, did not like the rectal forms, and the rejection of the rectal forms, switching to actually one tablet a day in the morning, not burdening, so to speak, for life, led to good adherence.

And the last two slides. We often come across in our center with the fact that patients are very inadequate, steroids are not always prescribed on time. What does the consensus say about this? When to prescribe steroids to patients? How should the response to 5-aminosalicylic acid therapy be assessed correctly? Steroids are prescribed if deterioration occurs on an adequate dose of mesalazine. That is, when more than 2 g per day is prescribed, and the patient worsens, then we turn on steroids. The next situation is when there is no improvement within 10-14 days of mesalazine therapy, that is, an admixture of blood in the stool remains, we discuss the issue of prescribing steroids. And finally, if by 4-6 weeks there is also no complete clinical response, that is, blood remains in the stool. An interesting study was conducted on Mezavant, on multimatrix mesalazine. Patients who did not respond to Mezavant by week 8 achieved clinical remission in 60% of cases in the next 8 weeks. That is, if they took the maximum dose of the drug for 8 consecutive weeks – this is 4 tablets, 4.8 g – 60% of those who did not respond by the 8th week responded within the next 8 weeks. This is very important information for clinicians. That is, if the patient does not worsen, then slowly and surely you need to try to wait for these another 8 weeks, because everyone heals at a different pace, everyone has a slightly different response from the mucosa to therapy.

Finally, we say that left-sided ulcerative colitis can generally be treated topically with enemas or foams, but the Consensus in this case says that one can try to start therapy for mild, moderate ulcerative colitis with multimatrix mesalazine, which covers not only the ascending, transverse colon, descending colon, and in the rectum, in general, there is enough 5-aminosalicylic acid. Therefore, you can start with tablet forms, and only if the symptoms persist, the rectum does not heal, add topical forms. Thank you for your attention.

price $ 4560, reviews, Assuta

Ulcerative colitis is a chronic inflammation of the colon mucosa. Treatment of ulcerative colitis in Israel includes, along with traditional , innovative methods such as the use of monoclonal antibodies. In severe cases of ulcerative colitis, the patient needs surgery to remove part of the intestine. In Israel, such surgical interventions are carried out whenever possible with gentle, minimally invasive methods .

Ulcerative colitis (a more correct name for this disease is non-specific ulcerative colitis) is manifested by persistent diarrhea and loose stools, abdominal pain . Sometimes there may be blood in the stool. The reason for this is the formation of ulcers in the intestines . With this disease, the patient usually loses weight.

The difference between ulcerative colitis and other inflammations of the intestine is that it only affects the large intestine (damage from the bottom – from the rectum). The main function of the large intestine is the absorption of water. Due to the formation of ulcers, the large intestine does not perform this function, which is why loose stools appear.

Examinations are performed by experienced gastroenterologists: Prof. Zamir Galperin, Dr. Khenit Yanai and others.

Diagnosis takes 3-4 days . Treatment can begin the next day after an accurate diagnosis. Assuta is a private clinic, it has the latest generation equipment, there are no interns or interns, only professors and doctors with over 15 years of experience.

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EXAMINATION FOR ULCERATIVE COLITIS

HOW THE DIAGNOSIS IS GOING ON IN ASSUTA

The Assuta Clinic (Israel) uses the following methods to diagnose ulcerative colitis:

1. Colonoscopy from $987 This examination is the main method for diagnosing ulcerative colitis. It consists in examining the intestines from the inside using a flexible and thin probe, at the end of which a tiny video camera is installed. In Israel, the patient undergoes this procedure in a state of medical sleep and does not experience any discomfort. During the test, a tissue sample may be taken for a biopsy.
2. Laboratory blood tests from $83. Blood test determines anemia, accelerated erythrocyte sedimentation, elevated albumin level. It is also possible the presence of specific antibodies characteristic of this disease.

Day 1 – Initial inspection

10:00
Meeting the patient at the airport, meeting with the personal coordinator of the Assuta clinic, checking into a hotel or apartment

13:00
Consultation with a diagnostician, initial examination of the patient, taking an anamnesis in Hebrew and issuing referrals for examinations

Day 2 – Diagnosis

08:00
General and biochemical blood test, stool test

09:00
Colonoscopy with drug sleep

Day 3 – Treatment Plan

10:00 am
Consultation of the leading gastroenterologist of the Assuta clinic, examination of the patient and study by the doctor of the results of examinations

11:30
Drawing up an individual treatment protocol, issuing prescriptions for medications

14:00
Meeting with a dietician-nutritionist of the Assuta clinic, development of a personal therapeutic diet

16:00
Translation of medical documentation into Russian

The cost of the ulcerative colitis diagnostic program at Assuta is $2328 .

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Professor Ran Oren

Head of the Institute of Gastroenterology and Hepatology

TREATMENTS FOR ULCERATIVE COLITIS IN ISRAEL

The only way to completely get rid of the disease is to completely remove the large intestine. But, of course, Israeli doctors resort to this radical measure only in the most difficult situations. Treatment begins with conservative therapy.

Medication

The first drug prescribed for ulcerative colitis is mesalamine . This medicine contains 5-amnosalicylic acid. It is prescribed in the form of enemas, suppositories or tablets. Candles are used in cases where only the lowest part of the rectum is affected.

Steroid hormones may be prescribed to suppress inflammation. These drugs are used when mesalamine and other drugs containing 5-amnosalicylic acid have failed.

An alternative to steroid hormones, which have many side effects, in some cases is mercaptopurine , an immunosuppressive drug. The disadvantage of this drug is that its therapeutic effect does not appear immediately, but only after a few months. At this time, the patient may be prescribed another medicine – cyclosporine , which begins to act in a few days.

Innovative treatments for ulcerative colitis in Israel include the use of the drug Remicade (infliximab) . The drug contains monoclonal antibodies and has long been used to treat another inflammatory bowel disease – Crohn’s disease. Recently, Israeli gastroenterologists have begun to use it for the treatment of non-specific ulcerative colitis.

Diet therapy

For non-specific ulcerative colitis, the patient is recommended diet with a reduced amount of coarse fiber and dairy products . In Israeli clinics, such patients are regularly consulted by nutritionists.

How to get treatment in Israel?

You can ask any questions about treatment at the Assuta clinic using the application on the website or by phone. +7495-7899230 (your call will be forwarded free of charge to the international department of the clinic in Israel). Our consultant doctor will call you back within 1-2 hours. The consultation is completely free. Privacy is guaranteed.

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HOW MUCH IT COSTS TO TREAT ULCERATIVE COLITIS IN ISRAEL

Gastroenterologist consultation

562

Blood tests

84

Colonoscopy

987

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FAQ

Yes, ulcerative colitis can be treated with a combination of medications, lifestyle changes, and in some cases, surgery.