Remicade ulcerative colitis side effects

Infliximab also known as Remicade is a drug that is used to fight autoimmune diseases, and many ulcerative colitis patients know it rather well. In the drugs early days in the late 1990’s the drug was approved by the FDA to treat Crohn’s disease patients and in 2005 Remicade was also approved to treat UC patients. So, in the long history of drugs around the world, Remicade is relatively new to the scene, but the results from two large scale clinical trials showed some great signs to fight UC.

There is a long scientific theory on how the drug works to help UC patients, but the short version is based on the drugs ability to neutralize Tumor Necrosis Factor alpha. An even shorter label for Infliximab or Remicade is that it is considered an immunosuppressant drug. Somehow, Remicade knows how to suppress the immune system, and that is sometimes great. As many UC patients are told, UC symptoms are results of an overly active immune system where the body is constantly fighting and tearing up the colon causing the bleeding/pain/ and other common UC symptoms.

So, when does Remicade start working?

Over the past few months, I have come into contact via this website with quite a few people who have either tried Remicade previously or are currently using remicade to treat their ulcerative colitis. To give a general answer, I would definitely say that Remicade “works” quickly, often signs of improvement are noticed within the first 48 hours(if you take remicade and don’t see signs for two or three days, don’t freak out, other have said it has taken them over a week). For me, I noticed considerable positive signs that it was working within 24 hours. If you have been going to the bathroom and bleeding 10 plus times a day and in horrible pain, to see a drug like Remicade give you relief literally overnight is a pure miracle. Many people in the immunology world still consider Remicade a “Breakthrough Drug” of the past decade. From the clinical trials that were conducted several years ago, roughly 45% of patients who were treated with Remicade maintained a positive response to the medication after one year. That means that about half of patients with acute UC saw good signs after trying the medication for a year. The other half did not.

One of the concerns in the clinical world is that many patients who have a great initial positive response to their first remicade infusion may not go like that forever. Some patients who notice overnight or quick positive responses to Remicade might not have those same positive responses after their second or third or fourth infusion. This is what happened to me. Some of the speculation in the medical world is that people may develop antibodies to the medication which reduces its ability to perform its intended job as a treatment. Also, there is speculation that when patients who are using remicade use only once in a while, and not on a specific schedule, they have a higher chance of developing antibodies to the medication which make it less or not useful at all moving forward.
Needless to say, Remicade has the ability to work wonders, and it would not be too hard to find a few UC patients who have had great results with it, but like all medications, it’s not a 100% all the time type of drug. And for sure, there is no money back guarantee either.(I am still looking for a drug company who is offering a money back guarantee, please email if you know of one)

Here are some interesting facts about Infliximab aka Remicade:
-it was first concocted in mice as a mouse antibody
-it was originally used with patients who had Crohn’s Disease
-the cost for being on Remicade for a year can run around $20,000
-it is administered as an infusion with a needle and IV type of setup
-the infusion can last for a few hours, my infusions were usually 2-3 hours
-sometimes you are given a antihistamine pill prior to your infusion
-most insruance companies pay for the medication, but it needs to be medically necessary of course
-it is used for several other medical issues suck as skin diseases

Bottomline:

If I could go back in time and had the option to either take Remicade or do nothing back in January 2009, would I take it?
My Answer: Yes. Although it did not work for me long term, and I discontinued using it after the third infusion, I was in such bad shape at the time I was looking for anything to see some relief other than having surgery. Since I had already hit my deductible with the insurance company, the Remicade infusion was totally covered as well.
If my kids came down with UC and they were given the option to try Remicade would I approve right now?
My Answer: No. I for sure would have my kids(if I ever have any) try the diet I am working with before going down the road of immune suppressants. If and only if diet did not work, would I consider immune suppressants, and at that point, I still wouldn’t want to be making that decision, that’s got to be a tough one for parents with children who have UC.

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LEARN About REMICADE®

Only your doctor can recommend a course of treatment after checking your health condition. REMICADE® (infliximab) can cause serious side effects such as lowering your ability to fight infections. Some patients, especially those 65 years and older, have had serious infections caused by viruses, fungi or bacteria that have spread throughout the body, including tuberculosis (TB) and histoplasmosis. Some of these infections have been fatal. Your doctor should monitor you closely for signs and symptoms of TB during treatment with REMICADE®.

Unusual cancers have been reported in children and teenage patients taking TNF-blocker medicines. Hepatosplenic T-cell lymphoma, a rare form of fatal lymphoma, has occurred mostly in teenage or young adult males with Crohn’s disease or ulcerative colitis who were taking REMICADE® and azathioprine or 6-mercaptopurine. For children and adults taking TNF blockers, including REMICADE®, the chances of getting lymphoma or other cancers may increase.

You should discuss any concerns about your health and medical care with your doctor.

What should I tell my doctor before I take REMICADE®?

You should let your doctor know if you have or ever had any of the following:

  • Tuberculosis (TB) or have been near someone who has TB. Your doctor will check you for TB with a skin test. If you have latent (inactive) TB, you will begin TB treatment before you start REMICADE®.
  • Lived in a region where certain fungal infections like histoplasmosis or coccidioidomycosis are common.
  • Infections that keep coming back, have diabetes or an immune system problem.
  • Any type of cancer or a risk factor for developing cancer, for example, chronic obstructive pulmonary disease (COPD) or had phototherapy for psoriasis.
  • Heart failure or any heart condition. Many people with heart failure should not take REMICADE®.
  • Hepatitis B virus (HBV) infection or think you may be a carrier of HBV. Your doctor will test you for HBV.
  • Nervous system disorders (like multiple sclerosis or Guillain-Barré syndrome).

Also tell your doctor if you:

  • Use the medicines Kineret (anakinra), Orencia (abatacept) or Actemra (tocilizumab) or other medicines called biologics used to treat the same problems as REMICADE®.
  • Are pregnant, plan to become pregnant, are breast-feeding, or have a baby and were using REMICADE® during your pregnancy. Tell your baby’s doctor about your REMICADE® use. If your baby receives a live vaccine within 6 months after birth, your baby may develop infections with serious complications that can lead to death.
  • Recently received or are scheduled to receive a vaccine. Adults and children taking REMICADE® should not receive live vaccines or treatment with a weakened bacteria (such as BCG for bladder cancer) while taking REMICADE®.

What should I watch for and talk to my doctor about before or while taking REMICADE®?

The following serious (sometimes fatal) side effects have been reported in people taking REMICADE®.

You should tell your doctor right away if you have any of the signs listed below:

  • Infections (like TB, blood infections, pneumonia)—fever, tiredness, cough, flu, or warm, red or painful skin or any open sores. REMICADE® can make you more likely to get an infection or make any infection that you have worse.
  • Reactivation of HBV—feeling unwell, poor appetite, tiredness, fever, skin rash and/or joint pain.
  • Lymphoma, or any other cancers in adults and children.
  • Skin cancer—any changes in or growths on your skin.
  • Cervical cancer—your doctor may recommend that you be regularly screened. Some women with rheumatoid arthritis, particularly those over 60, have developed cervical cancer.
  • Heart failure—new or worsening symptoms, such as shortness of breath, swelling of your ankles or feet, or sudden weight gain.
  • Other heart problems within 24 hours of infusion, including heart attack, low blood flow to the heart, or abnormal heart rhythm—chest discomfort or pain, arm pain, stomach pain, shortness of breath, anxiety, lightheadedness, dizziness, fainting, sweating, nausea, vomiting, fluttering or pounding in your chest, and/or a fast or a slow heartbeat.
  • Liver injury—jaundice (yellow skin and eyes), dark brown urine, right-sided abdominal pain, fever, or severe tiredness.
  • Blood disorders—fever that doesn’t go away, bruising, bleeding or severe paleness.
  • Nervous system disorders—numbness, weakness, tingling, changes in your vision or seizures.
  • Stroke within 24 hours of infusion—numbness or weakness of the face, arm or leg, especially on one side of the body; sudden confusion, trouble speaking or understanding; sudden trouble seeing in one or both eyes; sudden trouble walking; dizziness; loss of balance or coordination; or a sudden, severe headache.
  • Allergic reactions during or after the infusion—hives, difficulty breathing, chest pain, high or low blood pressure, and fever or chills.
  • Delayed allergic reactions (3 to 12 days after infusion)—fever, rash, headache, sore throat, muscle or joint pain, swelling of the face and hands, or difficulty swallowing.
  • Lupus-like syndrome—chest discomfort or pain that does not go away, shortness of breath, joint pain, rash on the cheeks or arms that gets worse in the sun.
  • Psoriasis—new or worsening psoriasis such as red scaly patches or raised bumps on the skin that are filled with pus.

The most common side effects of REMICADE® include respiratory infections (that may include sinus infections and sore throat), headache, rash, coughing and stomach pain.

Please read the full Prescribing Information and Medication Guide for REMICADE® and discuss any questions you have with your doctor.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

cp-53017v1

Feb. 12, 2003 — Doctors once had little to offer patients with Crohn’s disease, but that changed five years ago with the introduction of Remicade — the first drug specifically designed to treat the chronic irritable bowel condition. The drug’s promise has not been fulfilled for many patients who have experienced side effects and dwindling responses to it, but new treatment approaches may change that.

In a study published in the Feb. 13 issue of TheNew England Journal of Medicine, Belgian researchers report that patients who took immune-suppressing drugs along with Remicade had far fewer side effects and better response to it than patients who were given Remicade alone.

The researchers found that 61% of the patients in their 125-person treatment group developed antibodies against the drug, also known as infliximab. Higher levels of these antibodies were associated with a much shorter response to treatment — an average of 35 days compared with 71 days for patients who had lower antibody levels. Patients who developed antibodies were also more than twice as likely to have moderate to severe side effects associated with Remicade.

“We found that immunosuppressive treatment prevented the formation of antibodies, and reduced the incidence of reactions,” researcher Paul Rutgeerts, MD, PhD, tells WebMD.

Crohn’s is an inflammatory disease that causes diarrhea, which may be severe and bloody, along with abdominal pain. Complications can lead to bowel obstruction or large abscess formation. Although the cause is unknown, there is evidence that it may be inherited.

Given intravenously, Remicade works by attacking a protein known as tumor necrosis factor (TNF), believed to cause the inflammation associated with Crohn’s disease. The drug is approved for use in patients with moderate to severe disease who have failed other treatment or have specific complications.

In the Belgian study, patients received an average of four doses of Remicade over roughly 10 months. Just over a quarter of the patients had reactions such as skin rashes, shortness of breath, or a potentially dangerous lowering of blood pressure. These patients responded well to the drug for an average of just 38 days, compared with 65 days for patients without reactions. Those who had lower antibodies levels and less severe reactions had been on immunosuppressive treatment.

Warning!

  • Allergic reactions may develop during or within two hours of infliximab infusion. This is most likely to occur during the first and second infusions. The reactions may be mild, or more severe requiring medical treatment and discontinuation of the infusion. Your doctor can explain more about this. You may be given medicines such as hydrocortisone, paracetamol or an antihistamine before the infusion to prevent allergic reactions. All people receiving infliximab infusions must be medically observed for one to two hours following the infusion in case these reactions develop.
  • Administration of this medicine after prolonged periods without treatment can cause a delayed allergic reaction. Symptoms of delayed allergic reactions include muscle and/or joint pain with fever and/or rash, itching, swelling of the hands, lips or face, difficulty swallowing, nettle-type rash, sore throat and/or headache. You should seek immediate medical advice if you experience any of these symptoms. If you have not received an infusion for 16 weeks or more, further readministration is not recommended.
  • This medicine can compromise the body’s ability to fight infections, and cases of tuberculosis (TB) have been seen. For this reason, you should be tested for TB prior to treatment. Tell your doctor immediately if you experience persistent coughing, weight loss or fever, as these can be symptoms of TB. It is important to try and avoid exposure to infections during your treatment. Let your doctor as soon as possible if you get any symptoms of any infection so that it can be treated without delay. This applies for up to six months after finishing treatment, as this is how long it may take for the medicine to be removed from the body. Be aware that this medicine can mask some of the usual symptoms of infection, such as a high temperature (fever), so it is important to be extra vigilant. If you develop a serious infection, further treatment with this medicine should not be given.
  • Consult your doctor immediately if you experience any of the following symptoms while receiving treatment with this medicine: unexplained confusion, numbness, changes in vision or difficulty walking.
  • This medicine may very rarely cause liver problems. Consult your doctor promptly if you develop unexplained itching, yellowing of the skin or eyes, unusually dark urine, nausea and vomiting, abdominal pains, loss of appetite or flu-like symptoms.
  • If you are due to have any surgery or dental procedures, it is important to inform your doctor or dentist that you are having treatment with this medicine.
  • Women who could get pregnant should use effective contraception to prevent pregnancy both during treatment with this medicine, and for at least six months after their last treatment. Seek medical advice from your doctor.

Use with caution in

  • Elderly people.
  • Liver disease.
  • Carriers of hepatitis B.
  • Kidney disease.
  • Dormant (currently inactive) tuberculosis infection.
  • History of recurrent infections.
  • People who are or who have recently been receiving treatment that suppresses the activity of the immune system, eg long-term oral corticosteroids, chemotherapy, radiotherapy, medicines to prevent transplant rejection.
  • Mild heart failure.
  • Multiple sclerosis.
  • Swelling of the optic nerve which results in blurring of vision (optic neuritis).
  • People who have had a joint surgically repaired.
  • History of or current cancer.
  • Heavy smokers.
  • Psoriasis patients who have had extensive immunosuppressant therapy or prolonged PUVA treatment.
  • Ulcerative colitis patients who have had the disease for several years, or who have a history of cell changes or colon cancer.

Not to be used in

  • Allergy to mouse protein.
  • Tuberculosis.
  • Severe infections, eg abscesses.
  • Infection of the blood or body tissues with pus-forming or other pathogenic organisms (sepsis).
  • Infections due to lowered resistance of the body (opportunistic infections).
  • Moderate to severe heart failure.
  • Pregnancy.
  • Breastfeeding.

This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.

If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

Pregnancy and breastfeeding

Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.

  • There is no information about the safety of this medicine during pregnancy, and it is not recommended for use during pregnancy. Women who could get pregnant should use effective contraception to avoid pregnancy during treatment, and for at least six months after their last treatment.
  • It is not known whether this medicine passes into breast milk. Women should not breastfeed during treatment with this medicine, or for six months after their last dose.

Side effects

Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here does not mean that all people using this medicine will experience that or any side effect.

  • Bacterial, viral or fungal infections, sometimes serious.
  • Headache.
  • Dizziness or loss of balance.
  • Difficulty in breathing (dyspnoea).
  • Flushing.
  • Disturbances of the gut such as diarrhoea, constipation, nausea, vomiting or abdominal pain.
  • Itchy rash (urticaria).
  • Increased sweating.
  • Fatigue.
  • Chest pain.
  • Depression.
  • Confusion.
  • Agitation.
  • Memory loss.
  • Disturbance in the normal numbers of blood cells in the blood.
  • Abnormal heart beats (arrhythmias).
  • Fainting.
  • Pain in the muscles and joints.
  • Worsening heart failure.
  • Lupus syndrome.
  • Allergic reactions.
  • Injection site reactions.
  • Changes in blood pressure.
  • Liver disorders.

The side effects listed above may not include all of the side effects reported by the drug’s manufacturer.

For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

How can this medicine affect other medicines?

Since this is a relatively new medicine, there is limited information about its potential interactions with other medicines. Always tell your doctor if you are taking any other medicines, including over-the-counter and herbal medicines, before starting treatment with infliximab. Similarly, always seek advice from your doctor or pharmacist before taking any new medicines while you are receiving treatment with infliximab, so they can check that the combination is safe.

Infliximab is not recommended for use in combination with anakinra, as this combination may increase the risk of serious infections, without an increase in efficacy against the disease treated.

This medicine suppresses part of the immune system. This means that vaccines may potentially be less effective if given during treatment, and live vaccines may cause serious infections. Live vaccines include: measles, mumps, rubella, MMR, oral polio, oral typhoid and yellow fever. It is recommended that live vaccines are not given to people being treated with this medicine.

Other medicines containing the same active ingredient

There are currently no other medicines available in the UK that contain infliximab as the active ingredient.

Last updated 17.01.2008

Inflammatory Bowel Disease Clinic

Infliximab REMICADE®

HOW LONG I WILL BE ON IT?

Some patients with UC may require ‘rescue therapy’ in order to try to prevent unplanned surgery, this treatment typically last three months or more. However, most patients with IBD will be treated for a long period of time.If you are on a planned course of infliximab infusions you should be reassessed regularly to see whether ongoing treatment is still right for you.

If you relapse after treatment is stopped, you should have the option to start treatment again or be switched to another biologic drug. In some people. Infliximab can lose its effectiveness over time. This means that to have the same effect, for example to keep someone in remission, the infliximab dose has to be increased or given more often. If you have lost response and still have ongoing inflammation, then another solution can be to switch to another biologic drug, such as adalimumab, golimumab, ustekinumab or vedolizumab. Infliximab can also cause a range of side effects that might mean the treatment is no longer suitable for you.

PMC

Discussion

Anti-tumor necrosis factor alpha therapy may be associated with alopecia, dermatitis, infections, and psoriasis . Rheumatoid arthritis is the most common underlying illness, present in 46.0% (80/174) of patients, associated with tumor necrosis factor alpha antagonist-induced psoriasis . This adverse event usually manifests as a pustular eruption on the palms of the hands and/or soles of the feet (palmoplantar pustulosis). Palmoplantar pustulosis is very rare within the general population, so its discovery should prompt investigation of the patient’s medications .

A retrospective analysis found 29.4% (203/690) of Crohn’s patients who began tumor necrosis factor alpha-antagonist therapy developed various skin lesions . Psoriasis composes 22.9% (8/35) of anti-tumor necrosis factor alpha-related cutaneous reactions with a prevalence of 1.5–5% in these patients . It may occur days to years after beginning treatment, and women from 40 to 50 years old are at the highest risk of developing a psoriasiform reaction .

Scalp psoriasis is usually characterized by discrete psoriatic plaques on the scalp, with or without alopecia, that may itch intensely . In contrast to palmoplantar pustulosis (where rheumatoid arthritis is the most common underlying disease), Crohn’s disease usually underlies the very rare manifestation of tumor necrosis factor alpha antagonist-induced scalp psoriasis. A case series and literature review reported 15 such individuals; 80% (12/15) of the patients had a history of Crohn’s disease .

The differential diagnosis of tumor necrosis factor alpha antagonist-induced hair loss includes alopecia areata, pityriasis amiantacea, psoriasis, and tinea capitis . A retrospective review of drug reactions found infliximab to be the most common tumor necrosis factor alpha-antagonist to cause alopecia (18/52 cases, 35%) . This study also noted that tumor necrosis factor alpha-antagonist exposure was three times more likely (reporting odds ratio = 3.0) in patients with alopecia than other adverse drug reactions. Another study found the average duration of exposure to tumor necrosis factor alpha-antagonists before the development of alopecia areata to be 22.5 months . This prospective report found 76% of alopecia areata cases to partially or completely resolve over a mean of 5 months with no difference in alopecia areata resolution between those that discontinued and continued tumor necrosis factor alpha-antagonist treatment.

Biopsy and histologic examination of the alopecia may be useful in establishing the diagnosis. In addition to classic psoriasiform epidermal changes of idiopathic psoriasis, the histopathology of tumor necrosis factor alpha antagonist-induced psoriasis can also show alterations similar to alopecia areata. These may include hair follicle miniaturization, increased catagen and telogen hairs, and peribulbar lymphocytic infiltrate occupying all levels of the terminal hair structure .

The histology of our patient’s scalp alopecia (consisting of chronic folliculitis and perifolliculitis, dermal scarring, and naked hair shafts in the dermal stroma) was consistent with the diagnosis of folliculitis decalvans—a type of scarring alopecia that may present with pustules, inflammatory papules, tunneling hairs, and permanent hair loss . The dramatic response to our intervention with complete regrowth of hair was unexpected based on this presumed diagnosis. Furthermore, infliximab has been used to treat folliculitis decalvans, so its discontinuation would not be expected to cure the disease .

Therefore, in our patient, it is possible that a reversible scarring alopecia resembling folliculitis decalvans concurrently occurred with psoriasis scalp. Alternatively, it is possible that the biopsy was obtained from a non-representative area of the scalp, and the true diagnosis was tumor necrosis factor alpha-induced psoriasis complicated by an overlying cellulitis. Minocycline was initially selected as a first-line therapy for folliculitis decalvans . However, it likely aided in resolving an overlying cellulitis or impetiginization and may have helped to decrease local dermal inflammation.

Infliximab may be used to treat psoriasis. Yet, paradoxically, infliximab is implicated in the development of this very disease especially in patients with Crohn’s disease . In vitro tumor necrosis factor alpha significantly inhibits hair growth . However, tumor necrosis factor alpha antagonists may cause hair loss instead of inhibiting it.

A possible mechanism for tumor necrosis factor alpha antagonist-induced psoriasis involves dermal plasmocytoid dendritic cells. These cells produce interferon-alpha, an important cytokine in the pathogenesis of psoriasis, and may be induced by tumor necrosis factor alpha antagonists. In turn, this would cause the migration of T cells to the skin via interleukin-15 and a psoriasiform reaction . It is possible that alopecia and psoriasis occurred in the patient secondary to the anti-tumor necrosis factor alpha agent as these diseases seem to be related to different aspects of the medication.

In tumor necrosis factor alpha antagonist-induced psoriasis, the offending drug should be discontinued and topical corticosteroid therapy should be initiated. In one review, 82% (50/61) of patients experienced complete resolution of their drug-induced psoriasis after discontinuing the offending tumor necrosis factor alpha antagonist. However, many patients cannot discontinue their tumor necrosis factor alpha antagonist; most of these patients experience complete (50%, 53/107) or partial (49%, 52/107) resolution of their drug-induced psoriasis. Alternatively, a different tumor necrosis factor alpha antagonist may be attempted, and 52% (13/25) of patients had no reoccurrence of their lesions following this change .

If scalp psoriasis continues without treatment, permanent alopecia may result . Topical corticosteroids, such as betamethasone 0.05% lotion and a daily shampoo with alternating agents (5% coal tar, 2% ketoconazole, and 6% salicylic acid) that are applied to the scalp can be used in the treatment of scalp psoriasis . In addition, mineral oil followed by occlusion with a shower cap can promote the desquamation of the plaques. Our patient’s scalp was very sensitive; therefore, we used a corticosteroid in a lotion instead of a solution.

A recent report described the efficacy of using ustekinumab, an anti-interleukin-12/-23 monoclonal antibody, to treat concurrent inflammatory bowel disease and plaque psoriasis . Our patient was also placed on ustekinumab to manage her Crohn’s disease. However, her scalp condition had significantly improved prior to beginning the treatment. She is doing well on this therapy and has had no recurrence of her alopecia or scalp psoriasis.

Remicade

Brand Names: Inflectra, Remicade, Renflexis

Generic Name: infliximab

  • What is infliximab (Inflectra, Remicade, Renflexis)?
  • What are the possible side effects of infliximab (Inflectra, Remicade, Renflexis)?
  • What is the most important information I should know about infliximab (Inflectra, Remicade, Renflexis)?
  • What should I discuss with my healthcare provider before receiving infliximab (Inflectra, Remicade, Renflexis)?
  • How is infliximab given (Inflectra, Remicade, Renflexis)?
  • What happens if I miss a dose (Inflectra, Remicade, Renflexis)?
  • What happens if I overdose (Inflectra, Remicade, Renflexis)?
  • What should I avoid while receiving infliximab (Inflectra, Remicade, Renflexis)?
  • What other drugs will affect infliximab (Inflectra, Remicade, Renflexis)?
  • Where can I get more information (Inflectra, Remicade, Renflexis)?

What is infliximab (Inflectra, Remicade, Renflexis)?

Infliximab reduces the effects of a substance in the body that can cause inflammation.

Infliximab is used to treat rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, Crohn’s disease, and ankylosing spondylitis. Infliximab is also used to treat severe or disabling plaque psoriasis.

Infliximab is often used when other medicines have not been effective.

Infliximab may also be used for purposes not listed in this medication guide.

What are the possible side effects of infliximab (Inflectra, Remicade, Renflexis)?

Some side effects may occur during the injection. Tell your caregiver if you feel dizzy, nauseated, light-headed, itchy or tingly, short of breath, or have a headache, fever, chills, muscle or joint pain, pain or tightness in your throat, chest pain, or trouble swallowing during the injection. Infusion reactions may also occur within 1 or 2 hours after injection.

Get emergency medical help if you have signs of an allergic reaction: hives; chest pain, difficult breathing; fever, chills, severe dizziness; swelling of your face, lips, tongue, or throat.

Serious and sometimes fatal infections may occur during treatment with infliximab. Call your doctor right away if you have signs of infection such as: fever, extreme tiredness, flu symptoms, cough, or skin symptoms (pain, warmth, or redness).

Also call your doctor if you have:

  • skin changes, new growths on the skin;
  • pale skin, easy bruising or bleeding;
  • delayed allergic reaction (up to 12 days after receiving infliximab)–fever, sore throat, trouble swallowing, headache, joint or muscle pain, skin rash, or swelling in your face or hands;
  • liver problems–stomach pain (upper right side), tiredness, dark urine, jaundice (yellowing of the skin or eyes);
  • lupus-like syndrome–joint pain or swelling, chest discomfort, feeling short of breath, skin rash on your cheeks or arms (worsens in sunlight);
  • nerve problems–numbness or tingling, problems with vision, or weak feeling in your arms or legs, seizure;
  • new or worsening psoriasis–skin redness or scaly patches, raised bumps filled with pus;
  • signs of heart failure–shortness of breath with swelling of your ankles or feet, rapid weight gain;
  • signs of lymphoma–fever, night sweats, weight loss, stomach pain or swelling, chest pain, cough, trouble breathing, swollen glands (in your neck, armpits, or groin); or
  • signs of tuberculosis–fever, cough, night sweats, loss of appetite, weight loss, feeling constantly tired.

Common side effects may include:

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about infliximab (Inflectra, Remicade, Renflexis)?

Using infliximab may increase your risk of developing certain types of cancer, including a rare fast-growing type of lymphoma that can be fatal. Ask your doctor about your specific risk.

Infliximab affects your immune system. You may get infections more easily, even serious or fatal infections. Call your doctor if you have a fever, tiredness, flu symptoms, cough, or skin pain.

LETTER TO THE EDITOR

Year : 2013 | Volume : 79 | Issue : 4 | Page : 529-531

Alopecia areata in a patient receiving infliximab
Nerea Ormaechea-Pérez1, Arantxa López-Pestaña1, Ana Isabel Muñagorri-Santos2, Ane Jaka Moreno1, Anna Tuneu-Valls1
1 Department of Dermatology, Hospital Donostia, San Sebastian, Spain
2 Department of Gastroenterology, Hospital Donostia, San Sebastian, Spain

Date of Web Publication 5-Jun-2013

Correspondence Address:
Nerea Ormaechea-Pérez
Paseo Doctor Begiristain, Department of Dermatology, Hospital Donostia, San Sebastian, CP: 20014
Spain

Source of Support: None, Conflict of Interest: None

Check

DOI: 10.4103/0378-6323.113097

How to cite this article:
Ormaechea-Pérez N, López-Pestaña A, Muñagorri-Santos AI, Moreno AJ, Tuneu-Valls A. Alopecia areata in a patient receiving infliximab. Indian J Dermatol Venereol Leprol 2013;79:529-31

Sir,
In the last few years, several tumor necrosis factor alfa (TNF-α) antagonists are being used for the treatment of chronic immune inflammatory disorders. With their increasing use and longer follow-up periods, adverse effects including a wide-spectrum of autoimmune diseases are emerging as adverse events. We report a case of alopecia areata (AA) in a patient receiving infliximab for Crohn’s disease.
A 36-year-old white woman with Crohn’s disease of 2 years duration was treated with infliximab in monotherapy as first-line therapy at an intravenous dose of 5 mg/kg, according to the standard schedule, for the last 9 months. After the fourth infusion, she developed a non-scarring hair loss involving sides and occiput (ophiasis area), eyebrows, and eyelashes. She had no nail changes, clinical features of collagen vascular disorders, nor personal or family history of AA. Blood analysis, including thyroid hormones, was normal except for positive anti-nuclear antibodies of 1/1280. A biopsy specimen of the scalp showed peribulbar lymphocytic infiltrates with a reduced number of hairs consistent with AA. Therapy with infliximab was discontinued, and she was treated with methotrexate at a weekly dose of 25 mg, in order to treat her Crohn’s disease and the AA, getting total recovery of the scalp hair in 2 months. Furthermore, the anti-nuclear antibodies became negative. She continued with methotrexate for 4 months for her inflammatory bowel disease, with no further alopecia or other adverse event during 12 months of follow-up.

Figure 1: Non-scarring alopecic patches involving ophiasis area and eyebrows
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Figure 2: Scalp biopsy histology showing peribulbar lymphocytic infiltrates (H and E, × 40)
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Figure 3: Almost complete re-growth after infliximab cessation
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AA is an autoimmune inflammatory disease, in which T lymphocytes play a central pathogenetic role. It is postulated that CD4+ and CD8+ T cells directed against hair bulb autoantigens lead to non-scarring hair loss. Nevertheless, some authors have suggested a complex and contradictory role of TNF-α in its pathogenesis. In vitro studies have shown that TNF-α and interleukin-1-β are potent inhibitors of hair follicle growth, by causing distorsion of the dermal papilla, vacuolization, and abnormal keratinization of the matrix. However, anti-TNF-α agents have shown no efficacy in the treatment of AA.
Infliximab is a chimeric monoclonal antibody against TNF- α that is used to treat autoimmune diseases. However, it has been associated with the development of other autoimmune disorders such as psoriasis, granuloma annulare, or vitiligo. It is proposed that TNF-α blocking switches off the primary disease’s inflammatory pathway, moving the unblocked proximal inflammatory response into an alternative signaling pathway. Depending on individual genetic susceptibility, this pathway could clinically manifest as another immune-mediated disease, such as AA.
Several AA cases have been described during anti-TNF-α therapy. In the literature reviewed, we found 5 cases of AA after therapy with infliximab: ,,,, Two cases in patients with rheumatoid arthritis, one in a patient with psoriasis pustulosa, and other two in patients with ankylosing spondylitis. Anti-nuclear antibodies titer was available in one case, and was negative.
AA is usually associated with other autoimmune disorders such as vitiligo and thyroid disease, but there is little data in the literature about the association of AA and Crohn’s disease. Considering that the patient had no history of AA, that AA happened after beginning treatment with infliximab and that it resolved when the anti-TNF-α therapy was discontinued, we believe that in our patient, infliximab might have had a predominant role in triggering the AA. In addition, the fact that the autoantibodies raised during treatment with infliximab, and the decrease of them when the therapy was discontinued strengthens our hypothesis that infliximab may have caused this autoimmune phenomenon. Taking into account that different TNF- α inhibitors have shown to induce diverse biological and clinical effects, AA may have been induced by infliximab, but other TNF- α inhibitors could not have led to the disease. On the other hand, MTX may have had some influence in the clinical course of AA. In conclusion, we describe the first case of AA during infliximab therapy in a patient with Crohn’s disease.

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