- Remicade Side Effects
- In Summary
- For the Consumer
- For Healthcare Professionals
- Further information
- More about Remicade (infliximab)
- Consumer resources
- Professional resources
- Related treatment guides
- SIDE EFFECTS
- Clinical Trials Experience
- Adverse Reactions In Adults
- Adverse Reactions In Pediatric Patients
- Postmarketing Experience
- Remicade Infusion Therapy
- Remicade Infusion Side Effects
- Acute Reactions (Less Than 24 Hours After Infusion)
- Delayed Reactions (24 Hours to 14 Days After Infusion)
- How Remicade works
- Remicade in clinical trials
- Additional information
- Long-term efficacy of infliximab for refractory ulcerative colitis: results from a single center experience
Remicade is the brand name for infliximab, an injectable prescription drug that’s used to treat rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis (a type of spinal arthritis), psoriatic arthritis, and the red, scaly skin patches of plaque psoriasis.
Usually prescribed when other medicines or treatments have failed, Remicade belongs to a class of drugs called tumor necrosis factor inhibitors (TNFs), which work by suppressing the action of a protein called TNF, which has been tied to inflammation.
Doctors also prescribe Remicade “off label” to treat Takayasu disease, a rare disorder that causes inflammation of large arteries.
The FDA first approved Remicade for adult Crohn’s disease in 1998, and extended approvals to other immune system diseases, including rheumatoid arthritis in 2004, ulcerative colitis in 2005, pediatric Crohn’s in 2006, and pediatric ulcerative colitis in 2011.
Manufactured and sold by Johnson & Johnson subsidiary Janssen Biotech, Remicade, like all biologics – which are made from living material – cannot be easily copied, and so there are no generic versions of the drug.
The FDA is still working out its plan for regulating and approving biologic knockoffs, or “biosimilars,” which, while not exact replicas of the brand name drugs, have the same active ingredients and show the same clinical effectiveness.
Two biosimilars for Remicade have been approved by the European Union: Remsima, from South Korea’s Celltrion, and Inflectra, from U.S.-based Hospira. Remicade is given through a needle placed in a vein, and can only be administered by a health care professional. The needle needs to remain in place for about two hours. Since Remicade can raise the risk of infections, patients must take steps to avoid illness and injury.
Remicade (Infliximab) Warnings
The Food and Drug Administration (FDA) has issued a black-box warning for Remicade because of the risk of serious, sometimes fatal, infections, such as tuberculosis (TB), bacterial sepsis, invasive fungal infection, Listeria, and Legionnaire’s disease in patients receiving the drug.
There are also reports of lymphoma and other cancers in children and adolescents taking TNFs, including Remicade, for Crohn’s disease and ulcerative colitis.
Before starting the treatment, let your doctor know if you have ever had TB, or been exposed to it. All patients should be evaluated for tuberculosis risk factors and be tested for latent tuberculosis infection (with a tuberculin skin test or blood-based interferon-gamma release assay) prior to starting Remicade.Also let your doctor know if you ever lived in a region (such as Ohio or the Mississippi River Valleys) where certain fungal infections are common, have recurring infections, diabetes, an immune system disorder, any type of cancer, any heart condition, hepatitis B, multiple sclerosis, or Guillain-Barre syndrome.
Mention any allergies, too, and any vaccines you’re planning to have, as adults and children on Remicade should not receive live vaccines.
During its years on the market, Remicade has had its share controversy amid a growing list of black-box warnings. In 2013, the FDA updated the label for Remicade and adalimumab (Humira), another TNF blocker, to include a warning for skin cancer, noting that it tended to develop in children and young adults.
The manufacturer has also spent time in court, defending itself against claims that it failed to adequately warn patients about some of Remicade’s potential side effects. In 2006, a Texas jury awarded $19.4 million to a woman taking Remicade for Crohn’s disease – she claimed the drug company failed to adequately warn about the “lupus-like syndrome” she experienced while on the drug.
Pregnancy and Remicade (Infliximab)
Remicade is in the FDA’s Pregnancy Category B, meaning that there is no evidence of risk to a woman’s fetus if she takes Remicade during pregnancy.
Nonetheless, you should always tell your doctor if you are pregnant, plan to become pregnant, are breastfeeding, or used Remicade while pregnant.
Remicade Side Effects
Generic Name: infliximab
Medically reviewed by Drugs.com. Last updated on Jan 21, 2019.
- Side Effects
Note: This document contains side effect information about infliximab. Some of the dosage forms listed on this page may not apply to the brand name Remicade.
Common side effects of Remicade include: abdominal pain, back pain, chest pain, and nausea. Other side effects include: candidiasis, diarrhea, pruritus, sinusitis, and vomiting. See below for a comprehensive list of adverse effects.
For the Consumer
Applies to infliximab: intravenous powder for solution
Intravenous route (Powder for Solution)
Increased risk of serious infections leading to hospitalization or death, including TB, bacterial sepsis, invasive fungal infections (such as histoplasmosis) and infections due to other opportunistic pathogens. Discontinue infliximab-dyyb if a patient develops a serious infection. Perform test for latent TB; if positive, start treatment for TB prior to starting infliximab-dyyb. Monitor all patients for active TB during treatment, even if initial latent TB test is negative. Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with tumor necrosis factor (TNF) blockers, including infliximab. Postmarketing cases of fatal hepatosplenic T-cell lymphoma (HSTCL) have been reported in patients treated with TNF blockers including infliximab products. Almost all had received azathioprine or 6-mercaptopurine concomitantly with a TNF-blocker at or prior to diagnosis. The majority of reported cases have occurred in patients with Crohn’s disease or ulcerative colitis, most of whom were adolescent or young adult males.
Along with its needed effects, infliximab (the active ingredient contained in Remicade) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur while taking infliximab:
- Black, tarry stools
- bladder pain
- bloody or cloudy urine
- blurred vision
- body aches or pain
- chest pain
- cough producing mucus
- difficult, burning, or painful urination
- difficulty breathing
- dryness or soreness of the throat
- ear congestion
- frequent urge to urinate
- itching, rash
- loss of voice
- lower back or side pain
- nasal congestion
- pain or swelling in the arms or legs
- pain or tenderness around the eyes and cheekbones
- painful or difficult urination
- pale skin
- pounding in the ears
- slow or fast heartbeat
- sores, ulcers, or white spots on the lips or in the mouth
- stuffy or runny nose
- swollen glands
- tender, swollen glands in the neck
- tightness in the chest
- trouble swallowing
- troubled breathing with exertion
- unusual bleeding or bruising
- unusual tiredness or weakness
- voice changes
- Bleeding gums
- blood in the stool
- blue lips and fingernails
- blurred vision
- changes in skin color or tenderness of the foot or leg
- chest discomfort
- coughing that sometimes produces a pink frothy sputum
- dark urine
- decreased urination
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- dry mouth
- fast or noisy breathing
- feeling of discomfort
- general feeling of illness
- general tiredness and weakness
- high fever
- increase in heart rate
- increased sweating
- inflammation of the joints
- irregular heartbeat
- light-colored stools
- muscle aches
- pinpoint red spots on the skin
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- rapid, shallow breathing
- sunken eyes
- upper right abdominal pain
- weight loss
- wrinkled skin
- yellow eyes and skin
Incidence not known
- Back pain, sudden and severe
- blistering, peeling, loosening of the skin
- bloody nose
- burning, tingling, numbness or pain in the hands, arms, feet, or legs
- change in mental status
- clay-colored stools
- difficulty speaking
- dilated neck veins
- double vision
- heavier menstrual periods
- inability to move the arms, legs, or facial muscles
- inability to speak
- loss of appetite
- muscle weakness, sudden and progressing
- red, irritated eyes
- red skin lesions, often with a purple center
- sensation of pins and needles
- slow or irregular breathing
- slow speech
- stabbing pain
- temporary vision loss
- vomiting of blood
- weight gain
Some side effects of infliximab may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
- difficulty in moving
- feeling of warmth
- muscle stiffness
- redness of the face, neck, arms and occasionally, upper chest
- Constipation, severe
For Healthcare Professionals
Applies to infliximab: intravenous powder for injection
Very common (10% or more): Viral infection (e.g., influenza, herpes virus infection)
Common (1% to 10%): Bacterial infections (e.g., sepsis, cellulitis, abscess), moniliasis
Uncommon (0.1% to 1%): Tuberculosis, fungal infections (e.g., candidiasis), vaginitis
Rare (less than 0.1%): Meningitis, opportunistic infections (such as invasive fungal infections , bacterial infections , and viral infections ), parasitic infections, hepatitis B reactivation
Very common (10% or more): Upper respiratory tract infection (32%), sinusitis (14%), pharyngitis (12%), cough (12%), bronchitis (10%)
Common (1% to 10%): Lower respiratory tract infection (e.g., pneumonia), dyspnea, epistaxis
Uncommon (0.1% to 1%): Pulmonary edema, bronchospasm, pleurisy, pleural effusion
Rare (less than 0.1%): Interstitial lung disease (including rapidly progressive disease, lung fibrosis, pneumonitis), adult respiratory distress syndrome
Frequency not reported: Respiratory insufficiency, pulmonary embolism, shortness of breath
Common (1% to 10%): Hot flush, flushing, fatigue, fever, chills
Uncommon (0.1% to 1%): Impaired healing, autoantibody positive
Rare (less than 0.1%): Granulomatous lesion, complement factor abnormal
Uncommon (0.1% to 1%): Anaphylactic reaction, lupus-like syndrome, serum sickness or serum sickness-like reaction
Rare (less than 0.1%): Anaphylactic shock, vasculitis, sarcoid-like reaction
Frequency not reported: Facial, hand, or lip edema, sore throat
Very common (10% or more): Headache (18%)
Common (1% to 10%): Vertigo, dizziness, hypoesthesia, paresthesia
Uncommon (0.1% to 1%): Seizure, neuropathy
Rare (less than 0.1%): Transverse myelitis, central nervous system demyelinating disorders (multiple sclerosis-like disease and optic neuritis), peripheral demyelinating disorders (such as Guillain-Barre syndrome, chronic inflammatory demyelinating polyneuropathy and multifocal motor neuropathy), rheumatoid vasculitis, systemic vasculitis
Frequency not reported: Dysesthesia, meningitis, brain infarction, neuritis, peripheral neuropathy, Miller Fisher syndrome
Very common (10% or more): Nausea (21%), abdominal pain (12%), diarrhea (12%), dyspepsia (10%)
Common (1% to 10%): Gastrointestinal hemorrhage, gastroesophageal reflux, constipation, vomiting
Uncommon (0.1% to 1%): Intestinal perforation, intestinal stenosis, diverticulitis, pancreatitis, cheilitis
Frequency not reported: Abdominal hernia, abscess, intestinal obstruction, proctalgia, ileus, abdominal hernia, abscess, intestinal obstruction, peritonitis, proctalgia
Common (1% to 10%): Tachycardia, palpitation, chest pain
Uncommon (0.1% to 1%): Cardiac failure (new onset or worsening), arrhythmia, syncope, bradycardia, peripheral ischemia
Rare (0.01% to 0.1%): Cyanosis, pericardial effusion, circulatory failure, vasospasm
Very rare (less than 0.01%): Heart block
Frequency not reported: Myocardial ischemia/myocardial infarction occurring during or within 2 hours of infusion
Very common (10% or more): Rash (10%)
Common (1% to 10%): Ecchymosis, new onset or worsening psoriasis including pustular psoriasis (primarily palms and soles), urticaria, pruritus, hyperhidrosis, dry skin, fungal dermatitis, alopecia
Rare (0.01% to 0.1%): Petechia, granulomatous lesion
Very rare (less than 0.01%): Toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, necrotizing fasciitis, bullous skin lesions, aggressive cutaneous T-cell lymphomas
Postmarketing reports: Worsening of symptoms of dermatomyositis
Rare (less than 0.1%): Lymphoma, non-Hodgkin’s lymphoma, Hodgkin’s disease, leukemia, melanoma
Very rare (0.01% to 0.01%): Breast cancer, colorectal cancer
Frequency not reported: Hepatosplenic T-cell lymphoma (primarily in adolescents and young adults with Crohn’s disease and ulcerative colitis), Merkel cell carcinoma
Frequency not reported: Nonmelanoma skin cancer, neoplasms (basal cell and breast)
Common (1% to 10%): Hepatic function abnormal, transaminases increased
Uncommon (0.1% to 1%): Hepatitis, hepatocellular damage, cholecystitis, cholelithiasis
Rare (less than 0.1%): Autoimmune hepatitis, jaundice
Frequency not reported: Liver failure, autoimmune hepatitis, biliary pain, cytomegalovirus
Common (1% to 10%): Neutropenia, leucopenia, lymphadenopathy
Uncommon (0.1% to 1%): Thrombocytopenia, lymphopenia, lymphocytosis, thrombophlebitis, hematoma, pyelonephritis
Rare (less than 0.1%): Agranulocytosis, thrombotic thrombocytopenic purpura, pancytopenia, hemolytic anemia, idiopathic thrombocytopenic purpura,
Frequency not reported: Aplastic anemia, splenic infarction, splenomegaly
Common (1% to 10%): Arthralgia, myalgia, back pain
Uncommon (0.1% to 1%): Tendon injury
Frequency not reported: Intervertebral disk herniation, infective arthritis, swelling of fingers, paresthesia in the forearm region
Common (1% to 10%): Kidney infarction (less than 2%)
Uncommon (0.1% to 1%): Renal calculus, renal failure
Very rare (less than 0.01%): IgA nephropathy, pyelonephritis
Uncommon (0.1% to 1%): Dehydration
Frequency not reported: Extra-high levels of VLDL-triglycerides
Very common (10% or more): Injection site reaction (e.g., erythema, pruritus, rash, mild to moderate pain) (27%)
Common (1% to 10%): Urinary tract infection, moniliasis
Frequency not reported: Menstrual irregularity, herpes simplex, endometritis, dysuria, urethral obstruction
Common (1% to 10%): Conjunctivitis
Uncommon (0.1% to 1%): Keratitis, periorbital edema, hordeolum
Rare (0.01% to 0.1%): Endophthalmitis
Very rare (less than 0.01%): Retrobulbar optic neuritis of the left eye, orbital cellulitis, third nerve palsy, transient visual loss associated with infliximab (the active ingredient contained in Remicade) administration (during or within 2 hours of infusion)
Frequency not reported: Transient visual loss occurring during or within 2 hours of infusion
Common (1% to 10%): Depression, insomnia
Uncommon (0.1% to 1%): Amnesia, agitation, confusion, somnolence, nervousness
Rare (less than 0.1%): Apathy
Frequency not reported: Suicide attempt
1. “Product Information. Renflexis (inFLIXimab).” Merck & Company Inc, Whitehouse Station, NJ.
2. “Product Information. Inflectra (inFLIXimab).” Pfizer U.S. Pharmaceuticals Group, New York, NY.
3. “Product Information. Remicade (infliximab).” Centocor Inc, Malvern, PA.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Some side effects may not be reported. You may report them to the FDA.
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From last October to April, I was forced to take a break from taking my Remicade (infliximab) infusions. This was due to surgeries and dealing with severe illnesses. I ended up staying off Remicade for over five months, and I was definitely feeling it. Because I had been off Remicade for so long, my doctor ordered me to start over and complete loading doses to get the medication back into my system. This would give me the best chance for Remicade to get into my system sooner than if I were to start back up at eight-week intervals. Starting over with Remicade On April 26, I started the first of the loading doses. The infusion started off normally. I went to the infusion center, took my pre-medications, including Tylenol and Benadryl, and started the infusion. Shortly later, I began feeling a bit off. I experienced a strong headache, felt clammy and nauseated, and my skin was itchy. I also had a rash forming on my arm. My nurses came over and stopped the infusion. The symptoms improved a little, but not a lot. The physician’s assistant (PA) at the center decided to give me some IV Benadryl to see if it would help alleviate the symptoms. It did. The headache, nausea, and itchiness improved. The only lingering effect was some general itchiness for a couple days. These reactions just weren’t normal for me. I had been on Remicade since May 2016 and had never experienced any reactions from the infusions. Why was this happening? The PA had some theories as to what was going on and felt it may be due to the long break I had from the medication. She told me that studies have shown that sometimes patients who are off Remicade infusions for prolonged periods can develop certain side effects or even hypersensitivity toward the medication. This is due to the buildup of an Subscribe or log in to access all post and page content.
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Adverse Reactions In Adults
The data described herein reflect exposure to REMICADE in 4779 adult patients (1304 patients with rheumatoid arthritis, 1106 patients with Crohn’s disease, 202 with ankylosing spondylitis, 293 with psoriatic arthritis, 484 with ulcerative colitis, 1373 with plaque psoriasis, and 17 patients with other conditions), including 2625 patients exposed beyond 30 weeks and 374 exposed beyond 1 year. One of the most-common reasons for discontinuation of treatment was infusion-related reactions (e.g., dyspnea, flushing, headache and rash).
An infusion reaction was defined in clinical trials as any adverse event occurring during an infusion or within 1 hour after an infusion. In Phase 3 clinical studies, 18% of REMICADE-treated patients experienced an infusion reaction compared to 5% of placebo-treated patients. Of infliximab-treated patients who had an infusion reaction during the induction period, 27% experienced an infusion reaction during the maintenance period. Of patients who did not have an infusion reaction during the induction period, 9% experienced an infusion reaction during the maintenance period.
Among all REMICADE infusions, 3% were accompanied by nonspecific symptoms such as fever or chills, 1% were accompanied by cardiopulmonary reactions (primarily chest pain, hypotension, hypertension or dyspnea), and <1% were accompanied by pruritus, urticaria, or the combined symptoms of pruritus/urticaria and cardiopulmonary reactions. Serious infusion reactions occurred in <1% of patients and included anaphylaxis, convulsions, erythematous rash and hypotension. Approximately 3% of patients discontinued REMICADE because of infusion reactions, and all patients recovered with treatment and/or discontinuation of the infusion. REMICADE infusions beyond the initial infusion were not associated with a higher incidence of reactions. The infusion reaction rates remained stable in psoriasis through 1 year in psoriasis Study I. In psoriasis Study II, the rates were variable over time and somewhat higher following the final infusion than after the initial infusion. Across the 3 psoriasis studies, the percent of total infusions resulting in infusion reactions (i.e., an adverse event occurring within 1 hour) was 7% in the 3 mg/kg group, 4% in the 5 mg/kg group, and 1% in the placebo group.
Patients who became positive for antibodies to infliximab were more likely (approximately two-to three-fold) to have an infusion reaction than were those who were negative. Use of concomitant immunosuppressant agents appeared to reduce the frequency of both antibodies to infliximab and infusion reactions .
Infusion Reactions Following Re-administration
In a clinical trial of patients with moderate to severe psoriasis designed to assess the efficacy of long-term maintenance therapy versus re-treatment with an induction regimen of REMICADE following disease flare, 4% (8/219) of patients in the re-treatment therapy arm experienced serious infusion reactions versus <1% (1/222) in the maintenance therapy arm. Patients enrolled in this trial did not receive any concomitant immunosuppressant therapy. In this study, the majority of serious infusion reactions occurred during the second infusion at Week 2. Symptoms included, but were not limited to, dyspnea, urticaria, facial edema, and hypotension. In all cases, REMICADE treatment was discontinued and/or other treatment instituted with complete resolution of signs and symptoms.
Delayed Reactions/Reactions Following Re-administration
In psoriasis studies, approximately 1% of REMICADE-treated patients experienced a possible delayed hypersensitivity reaction, generally reported as serum sickness or a combination of arthralgia and/or myalgia with fever and/or rash. These reactions generally occurred within 2 weeks after repeat infusion.
In REMICADE clinical studies, treated infections were reported in 36% of REMICADE-treated patients (average of 51 weeks of follow-up) and in 25% of placebo-treated patients (average of 37 weeks of follow-up). The infections most frequently reported were respiratory tract infections (including sinusitis, pharyngitis, and bronchitis) and urinary tract infections. Among REMICADE-treated patients, serious infections included pneumonia, cellulitis, abscess, skin ulceration, sepsis, and bacterial infection. In clinical trials, 7 opportunistic infections were reported; 2 cases each of coccidioidomycosis (1 case was fatal) and histoplasmosis (1 case was fatal), and 1 case each of pneumocystosis, nocardiosis and cytomegalovirus. Tuberculosis was reported in 14 patients, 4 of whom died due to miliary tuberculosis. Other cases of tuberculosis, including disseminated tuberculosis, also have been reported post-marketing. Most of these cases of tuberculosis occurred within the first 2 months after initiation of therapy with REMICADE and may reflect recrudescence of latent disease . In the 1-year placebo-controlled studies RA I and RA II, 5.3% of patients receiving REMICADE every 8 weeks with MTX developed serious infections as compared to 3.4% of placebo patients receiving MTX. Of 924 patients receiving REMICADE, 1.7% developed pneumonia and 0.4% developed TB, when compared to 0.3% and 0.0% in the placebo arm respectively. In a shorter (22-week) placebo-controlled study of 1082 RA patients randomized to receive placebo, 3 mg/kg or 10 mg/kg REMICADE infusions at 0, 2, and 6 weeks, followed by every 8 weeks with MTX, serious infections were more frequent in the 10 mg/kg REMICADE group (5.3%) than the 3 mg/kg or placebo groups (1.7% in both). During the 54-week Crohn’s II Study, 15% of patients with fistulizing Crohn’s disease developed a new fistula-related abscess.
In REMICADE clinical studies in patients with ulcerative colitis, infections treated with antimicrobials were reported in 27% of REMICADE-treated patients (average of 41 weeks of follow-up) and in 18% of placebo-treated patients (average 32 weeks of follow-up). The types of infections, including serious infections, reported in patients with ulcerative colitis were similar to those reported in other clinical studies.
The onset of serious infections may be preceded by constitutional symptoms such as fever, chills, weight loss, and fatigue. The majority of serious infections, however, may also be preceded by signs or symptoms localized to the site of the infection.
Approximately half of REMICADE-treated patients in clinical trials who were antinuclear antibody (ANA) negative at baseline developed a positive ANA during the trial compared with approximately one-fifth of placebo-treated patients. Anti-dsDNA antibodies were newly detected in approximately one-fifth of REMICADE-treated patients compared with 0% of placebo-treated patients. Reports of lupus and lupus-like syndromes, however, remain uncommon.
In controlled trials, more REMICADE-treated patients developed malignancies than placebo-treated patients .
In a randomized controlled clinical trial exploring the use of REMICADE in patients with moderate to severe COPD who were either current smokers or ex-smokers, 157 patients were treated with REMICADE at doses similar to those used in rheumatoid arthritis and Crohn’s disease. Of these REMICADE-treated patients, 9 developed a malignancy, including 1 lymphoma, for a rate of 7.67 cases per 100 patient-years of follow-up (median duration of follow-up 0.8 years; 95% CI 3.51 -14.56). There was 1 reported malignancy among 77 control patients for a rate of 1.63 cases per 100 patient-years of follow-up (median duration of follow-up 0.8 years; 95% CI 0.04 -9.10). The majority of the malignancies developed in the lung or head and neck.
Patients with Heart Failure
In a randomized study evaluating REMICADE in moderate to severe heart failure (NYHA Class III/IV; left ventricular ejection fraction ≤35%), 150 patients were randomized to receive treatment with 3 infusions of REMICADE 10 mg/kg, 5 mg/kg, or placebo, at 0, 2, and 6 weeks. Higher incidences of mortality and hospitalization due to worsening heart failure were observed in patients receiving the 10 mg/kg REMICADE dose. At 1 year, 8 patients in the 10 mg/kg REMICADE group had died compared with 4 deaths each in the 5 mg/kg REMICADE and the placebo groups. There were trends toward increased dyspnea, hypotension, angina, and dizziness in both the 10 mg/kg and 5 mg/kg REMICADE treatment groups, versus placebo. REMICADE has not been studied in patients with mild heart failure (NYHA Class I/II) .
Treatment with REMICADE can be associated with the development of antibodies to infliximab. An enzyme immunoassay (EIA) method was originally used to measure antiinfliximab antibodies in clinical studies of REMICADE. The EIA method is subject to interference by serum infliximab, possibly resulting in an underestimation of the rate of patient antibody formation. A separate, drug-tolerant electrochemiluminescence immunoassay (ECLIA) method for detecting antibodies to infliximab was subsequently developed and validated. This method is 60-fold more sensitive than the original EIA. With the ECLIA method, all clinical samples can be classified as either positive or negative for antibodies to infliximab without the need for the inconclusive category.
The incidence of antibodies to infliximab was based on the original EIA method in all clinical studies of REMICADE except for the Phase 3 study in pediatric patients with ulcerative colitis where the incidence of antibodies to infliximab was detected using both the EIA and ECLIA methods .
The incidence of antibodies to infliximab in patients given a 3-dose induction regimen followed by maintenance dosing was approximately 10% as assessed through 1 to 2 years of REMICADE treatment. A higher incidence of antibodies to infliximab was observed in Crohn’s disease patients receiving REMICADE after drug-free intervals >16 weeks. In a study of psoriatic arthritis in which 191 patients received 5 mg/kg with or without MTX, antibodies to infliximab occurred in 15% of patients. The majority of antibody-positive patients had low titers. Patients who were antibody-positive were more likely to have higher rates of clearance, reduced efficacy and to experience an infusion reaction than were patients who were antibody negative. Antibody development was lower among rheumatoid arthritis and Crohn’s disease patients receiving immunosuppressant therapies such as 6-MP/AZA or MTX.
In the psoriasis Study II, which included both the 5 mg/kg and 3 mg/kg doses, antibodies were observed in 36% of patients treated with 5 mg/kg every 8 weeks for 1 year, and in 51% of patients treated with 3 mg/kg every 8 weeks for 1 year. In the psoriasis Study III, which also included both the 5 mg/kg and 3 mg/kg doses, antibodies were observed in 20% of patients treated with 5 mg/kg induction (weeks 0, 2 and 6), and in 27% of patients treated with 3 mg/kg induction. Despite the increase in antibody formation, the infusion reaction rates in Studies I and II in patients treated with 5 mg/kg induction followed by every 8 week maintenance for 1 year and in Study III in patients treated with 5 mg/kg induction (14.1%23.0%) and serious infusion reaction rates (<1%) were similar to those observed in other study populations. The clinical significance of apparent increased immunogenicity on efficacy and infusion reactions in psoriasis patients as compared to patients with other diseases treated with REMICADE over the long term is not known.
The data reflect the percentage of patients whose test results were positive for antibodies to infliximab in an immunoassay, and they are highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody positivity in an assay may be influenced by several factors including sample handling, timing of sample collection, concomitant medication, and underlying disease. For these reasons, comparison of the incidence of antibodies to infliximab with the incidence of antibodies to other products may be misleading.
Severe liver injury, including acute liver failure and autoimmune hepatitis, has been reported in patients receiving REMICADE . Reactivation of hepatitis B virus has occurred in patients receiving TNF-blocking agents, including REMICADE, who are chronic carriers of this virus .
In clinical trials in rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, plaque psoriasis, and psoriatic arthritis, elevations of aminotransferases were observed (ALT more common than AST) in a greater proportion of patients receiving REMICADE than in controls (Table 1), both when REMICADE was given as monotherapy and when it was used in combination with other immunosuppressive agents. In general, patients who developed ALT and AST elevations were asymptomatic, and the abnormalities decreased or resolved with either continuation or discontinuation of REMICADE, or modification of concomitant medications.
Table 1: Proportion of patients with elevated ALT in clinical trials
|Proportion of patients with elevated ALT|
|>1 to <3 x ULN||≥3 x ULN||≥5 x ULN|
| a Placebo patients received methotrexate while REMICADE patients received both REMICADE and methotrexate. Median follow-up was 58 weeks.
b Placebo patients in the 2 Phase 3 trials in Crohn’s disease received an initial dose of 5 mg/kg REMICADE at study start and were on placebo in the maintenance phase. Patients who were randomized to the placebo maintenance group and then later crossed over to REMICADE are included in the REMICADE group in ALT analysis. Median follow-up was 54 weeks.
c Median follow-up was 30 weeks. Specifically, the median duration of follow-up was 30 weeks for placebo and 31 weeks for REMICADE.
d Median follow-up was 24 weeks for the placebo group and 102 weeks for the REMICADE group.
e Median follow-up was 39 weeks for the REMICADE group and 18 weeks for the placebo group.
f ALT values are obtained in 2 Phase 3 psoriasis studies with median follow-up of 50 weeks for REMICADE and 16 weeks for placebo.
Adverse Reactions in Psoriasis Studies
During the placebo-controlled portion across the 3 clinical trials up to Week 16, the proportion of patients who experienced at least 1 serious adverse reaction (SAE; defined as resulting in death, life threatening, requires hospitalization, or persistent or significant disability/incapacity) was 0.5% in the 3 mg/kg REMICADE group, 1.9% in the placebo group, and 1.6% in the 5 mg/kg REMICADE group.
Among patients in the 2 Phase 3 studies, 12.4% of patients receiving REMICADE 5 mg/kg every 8 weeks through 1 year of maintenance treatment experienced at least 1 SAE in Study I. In Study II, 4.1% and 4.7% of patients receiving REMICADE 3 mg/kg and 5 mg/kg every 8 weeks, respectively, through 1 year of maintenance treatment experienced at least 1 SAE.
One death due to bacterial sepsis occurred 25 days after the second infusion of 5 mg/kg REMICADE. Serious infections included sepsis, and abscesses. In Study I, 2.7% of patients receiving REMICADE 5 mg/kg every 8 weeks through 1 year of maintenance treatment experienced at least 1 serious infection. In Study II, 1.0% and 1.3% of patients receiving REMICADE 3 mg/kg and 5 mg/kg, respectively, through 1 year of treatment experienced at least 1 serious infection. The most common serious infection (requiring hospitalization) was abscess (skin, throat, and peri-rectal) reported by 5 (0.7%) patients in the 5 mg/kg REMICADE group. Two active cases of tuberculosis were reported: 6 weeks and 34 weeks after starting REMICADE.
In the placebo-controlled portion of the psoriasis studies, 7 of 1123 patients who received REMICADE at any dose were diagnosed with at least one NMSC compared to 0 of 334 patients who received placebo.
In the psoriasis studies, 1% (15/1373) of patients experienced serum sickness or a combination of arthralgia and/or myalgia with fever, and/or rash, usually early in the treatment course. Of these patients, 6 required hospitalization due to fever, severe myalgia, arthralgia, swollen joints, and immobility.
Other Adverse Reactions
Safety data are available from 4779 REMICADE-treated adult patients, including 1304 with rheumatoid arthritis, 1106 with Crohn’s disease, 484 with ulcerative colitis, 202 with ankylosing spondylitis, 293 with psoriatic arthritis, 1373 with plaque psoriasis and 17 with other conditions. . Adverse reactions reported in ≥5% of all patients with rheumatoid arthritis receiving 4 or more infusions are in Table 2. The types and frequencies of adverse reactions observed were similar in REMICADE-treated rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, plaque psoriasis and Crohn’s disease patients except for abdominal pain, which occurred in 26% of REMICADE-treated patients with Crohn’s disease. In the Crohn’s disease studies, there were insufficient numbers and duration of follow-up for patients who never received REMICADE to provide meaningful comparisons.
Table 2: Adverse reactions occurring in 5% or more of patients receiving 4 or more infusions for rheumatoid arthritis
|Average weeks of follow-up||59||66|
|Upper respiratory tract infection||25%||32%|
|Skin and appendages disorders|
|Body as a whole-general disorders|
|Resistance mechanism disorders|
|Central and peripheral nervous system disorders|
|Musculoskeletal system disorders|
|Urinary system disorders|
|Urinary tract infection||6%||8%|
|Cardiovascular disorders, general|
The most common serious adverse reactions observed in clinical trials were infections . Other serious, medically relevant adverse reactions ≥0.2% or clinically significant adverse reactions by body system were as follows:
- Body as a whole: allergic reaction, edema
- Blood: pancytopenia
- Cardiovascular: hypotension
- Gastrointestinal: constipation, intestinal obstruction
- Central and Peripheral Nervous: dizziness
- Heart Rate and Rhythm: bradycardia
- Liver and Biliary: hepatitis
- Metabolic and Nutritional: dehydration
- Platelet, Bleeding and Clotting: thrombocytopenia
- Neoplasms: lymphoma
- Red Blood Cell: anemia, hemolytic anemia
- Resistance Mechanism: cellulitis, sepsis, serum sickness, sarcoidosis
- Respiratory: lower respiratory tract infection (including pneumonia), pleurisy, pulmonary edema
- Skin and Appendages: increased sweating
- Vascular (Extracardiac): thrombophlebitis
- White Cell and Reticuloendothelial: leukopenia, lymphadenopathy
Adverse Reactions In Pediatric Patients
Pediatric Crohn’s Disease
There were some differences in the adverse reactions observed in the pediatric patients receiving REMICADE compared to those observed in adults with Crohn’s disease. These differences are discussed in the following paragraphs.
Infections were reported in 56% of randomized pediatric patients in Study Peds Crohn’s and in 50% of adult patients in Study Crohn’s I. In Study Peds Crohn’s, infections were reported more frequently for patients who received every 8-week as opposed to every 12-week infusions (74% and 38%, respectively), while serious infections were reported for 3 patients in the every 8-week and 4 patients in the every 12-week maintenance treatment group. The most commonly reported infections were upper respiratory tract infection and pharyngitis, and the most commonly reported serious infection was abscess. Pneumonia was reported for 3 patients, (2 in the every 8-week and 1 in the every 12-week maintenance treatment groups). Herpes zoster was reported for 2 patients in the every 8-week maintenance treatment group.
In Study Peds Crohn’s, 18% of randomized patients experienced 1 or more infusion reactions, with no notable difference between treatment groups. Of the 112 patients in Study Peds Crohn’s, there were no serious infusion reactions, and 2 patients had non-serious anaphylactoid reactions.
In Study Peds Crohn’s, in which all patients received stable doses of 6-MP, AZA, or MTX, excluding inconclusive samples, 3 of 24 patients had antibodies to infliximab. Although 105 patients were tested for antibodies to infliximab, 81 patients were classified as inconclusive because they could not be ruled as negative due to assay interference by the presence of infliximab in the sample.
Elevations of ALT up to 3 times the upper limit of normal (ULN) were seen in 18% of pediatric patients in Crohn’s disease clinical trials; 4% had ALT elevations .3 x ULN, and 1% had elevations ≥5 x ULN. (Median follow-up was 53 weeks.)
Pediatric Ulcerative Colitis
Overall, the adverse reactions reported in the pediatric ulcerative colitis trial and adult ulcerative colitis (Study UC I and Study UC II) studies were generally consistent. In a pediatric UC trial, the most common adverse reactions were upper respiratory tract infection, pharyngitis, abdominal pain, fever, and headache.
Infections were reported in 31 (52%) of 60 treated patients in the pediatric UC trial and 22 (37%) required oral or parenteral antimicrobial treatment. The proportion of patients with infections in the pediatric UC trial was similar to that in the pediatric Crohn’s disease study (Study Peds Crohn’s) but higher than the proportion in the adults’ ulcerative colitis studies (Study UC I and Study UC II). The overall incidence of infections in the pediatric UC trial was 13/22 (59%) in the every 8 week maintenance treatment group. Upper respiratory tract infection (7/60 ) and pharyngitis (5/60 ) were the most frequently reported respiratory system infections. Serious infections were reported in 12% (7/60) of all treated patients.
In the pediatric UC trial, 58 patients were evaluated for antibodies to infliximab using the EIA as well as the drug-tolerant ECLIA. With the EIA, 4 of 58 (7%) patients had antibodies to infliximab. With the ECLIA, 30 of 58 (52%) patients had antibodies to infliximab . The higher incidence of antibodies to infliximab by the ECLIA method was due to the 60-fold higher sensitivity compared to the EIA method. While EIA-positive patients generally had undetectable trough infliximab concentrations, ECLIA-positive patients could have detectable trough concentrations of infliximab because the ECLIA assay is more sensitive and drug-tolerant.
Overall, 8 of 60 (13%) treated patients experienced one or more infusion reactions, including 4 of 22 (18%) patients in the every 8-week treatment maintenance group. No serious infusion reactions were reported.
In the pediatric UC trial, 45 patients were in the 12 to 17 year age group and 15 in the 6 to 11 year age group. The numbers of patients in each subgroup are too small to make any definitive conclusions about the effect of age on safety events. There were higher proportions of patients with serious adverse events (40% vs. 18%) and discontinuation due to adverse events (40% vs. 16%) in the younger age group than in the older age group. While the proportion of patients with infections was also higher in the younger age group (60% vs. 49%), for serious infections, the proportions were similar in the two age groups (13% in the 6 to 11 year age group vs. 11% in the 12 to 17 year age group). Overall proportions of adverse reactions, including infusion reactions, were similar between the 6 to 11 and 12 to 17 year age groups (13%).
Adverse reactions have been identified during post approval use of REMICADE in adult and pediatric patients. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
The following adverse reactions, some with fatal outcome, have been reported during post-approval use of REMICADE: neutropenia , agranulocytosis (including infants exposed in utero to infliximab), interstitial lung disease (including pulmonary fibrosis/interstitial pneumonitis and rapidly progressive disease), idiopathic thrombocytopenic purpura, thrombotic thrombocytopenic purpura, pericardial effusion, systemic and cutaneous vasculitis, erythema multiforme, Stevens-Johnson Syndrome, toxic epidermal necrolysis, peripheral demyelinating disorders (such as Guillain-Barre syndrome, chronic inflammatory demyelinating polyneuropathy, and multifocal motor neuropathy), new onset and worsening psoriasis (all subtypes including pustular, primarily palmoplantar), transverse myelitis, and neuropathies (additional neurologic reactions have also been observed) , acute liver failure, jaundice, hepatitis, and cholestasis , serious infections , malignancies, including melanoma, Merkel cell carcinoma, and cervical cancer and vaccine breakthrough infection including bovine tuberculosis (disseminated BCG infection) following vaccination in an infant exposed in utero to infliximab .
In post-marketing experience, cases of anaphylactic reactions, including laryngeal/pharyngeal edema and severe bronchospasm, and seizure have been associated with REMICADE administration.
Cases of transient visual loss have been reported in association with REMICADE during or within 2 hours of infusion. Cerebrovascular accidents, myocardial ischemia/infarction (some fatal), and arrhythmia occurring within 24 hours of initiation of infusion have also been reported .
The following serious adverse reactions have been reported in the post-marketing experience in children: infections (some fatal) including opportunistic infections and tuberculosis, infusion reactions, and hypersensitivity reactions.
Serious adverse reactions in the post-marketing experience with REMICADE in the pediatric population have also included malignancies, including hepatosplenic T-cell lymphomas , transient hepatic enzyme abnormalities, lupus-like syndromes, and the development of autoantibodies.
Read the entire FDA prescribing information for Remicade (Infliximab)
Remicade Infusion Therapy
Remicade infusion therapy is used to treat Crohn’s disease, ulcerative colitis and rheumatoid arthritis. Remicade (infliximab) helps decrease inflammation associated with inflammatory bowel disease and rheumatoid arthritis. For Crohn’s disease, Remicade can help decrease symptoms and achieve remission in patients who have not had success with other medical therapies.
Remicade is injected into a vein, called infusion. When patients begin receiving Remicade, they usually are prescribed treatments at two weeks and six weeks after the first infusion, then typically every eight weeks after that. Each infusion takes about three to four hours. Infusions can be done on an outpatient basis at a Norton Infusion Center
Remicade Infusion Side Effects
Remicade is a very potent drug that has potential side effects. These can occur during or after the infusion. Severe infections, including tuberculosis, pneumonia and sepsis, have been reported in patients taking Remicade. Tell your doctor if you have had or have been exposed to tuberculosis. Testing for tuberculosis generally is done before starting treatment with Remicade.
Patients with heart failure generally should not be treated with Remicade. Tell your physician if you have shortness of breath or new swelling of your ankles or feet. Rare reports of liver injury, blood disorders, lymphoma and other cancers, as well as neurologic disease, have occurred in patients receiving Remicade.
Allergic reactions to the protein in Remicade also can occur. Read important safety information at remicade.com.
Acute Reactions (Less Than 24 Hours After Infusion)
Reactions can occur during the Remicade infusion. Symptoms include fever, chest pain, heart palpitations, sweating, nausea, flushing, itching, changes in blood pressure and difficulty breathing.
These reactions usually go away by slowing the rate of infusion or taking acetaminophen, antihistamines, steroids and/or epinephrine. Your physician may recommend specific medications prior to your next infusion to decrease the chance of having another reaction.
Delayed Reactions (24 Hours to 14 Days After Infusion)
Reactions can occur after the Remicade infusion. Symptoms generally include muscle or joint aches, itching, rash, fever and fatigue.
These symptoms can be relieved by taking acetaminophen, antihistamines and/or steroids. If you experience these symptoms after your infusion, your physician may recommend specific medications prior to your next infusion to decrease the chance of having a delayed reaction.
How Remicade works
Inflammatory diseases such as ankylosing spondylitis are characterized by an excessive production of tumor necrosis factor-alpha (TNF-alpha), a cell-signaling protein involved in inflammation, leading to an imbalance in the immune system. Remicade works as a TNF-alpha blocker, which means that it binds to and inhibits the action of TNF-alpha. This inhibition helps reduce pain, stiffness and similar symptoms in patients with ankylosing spondylitis and other inflammatory conditions.
Remicade in clinical trials
It has had FDA approval to treat ankylosing spondylitis since 2004. This approval was based on the results of a randomized, multicenter, double-blind, placebo-controlled Phase 3 trial (NCT00207701) in 279 patients with active ankylosing spondylitis. Patients, ages 18 to 74 were injected with 5 mg/kg of Remicade or placebo into the bloodstream at weeks 0, 2, 6, 12 and 18. They were assessed at week 24 using the ankylosing spondylitis assessment score (ASAS) response criteria and the general health-related quality-of-life questionnaire short-form 36.
Of the patients receiving Remicade, 60 percent showed an improvement in signs and symptoms of ankylosing spondylitis, compared to only 18 percent of those on placebo. Remicade also led to an improvement in the physical component of health-related quality-of-life in patients treated with Remicade. They scored 10.2 on the questionnaire, compared to a score of 0.8 by those on placebo.
Several clinical studies are still investigating its effect on patients with ankylosing spondylitis.
For example, a Phase 3 international multi-center comparative double-blind randomized clinical trial (NCT02762812) aims to assess whether Remicade leads to a decrease in the symptoms of ankylosing spondylitis. To achieve the aim, the researchers will measure the ratio of patients who develop a decrease in ASAS by 20 percent or more after receiving Remicade for 30 weeks. The study is currently ongoing but no longer recruiting participants. It is expected to be completed by mid-2018.
Another study (NCT03074656), known as the Norwegian drug monitoring study (NOR-DRUM), is assessing Remicade’s effectiveness in achieving remission in patients with several immunological inflammatory diseases including ankylosing spondylitis. The study is now recruiting participants in Norway and will likely be completed in March 2022.
A study (NCT03006198) exploring disease characteristics and outcomes of patients with ankylosing spondylitis and other inflammatory diseases treated with Remicade is currently recruiting participants in Algeria, Egypt, Kuwait, Qatar and Saudi Arabia.
In addition, a nationwide biologics registry (NCT01965132) to study the safety profile of Remicade in patients with ankylosing spondylitis is being established in South Korea.
Finally, a study (NCT00085995) now recruiting U.S. participants aims to assess whether computed tomography (CT) scanning is a reliable, valid and sensitive measure of spinal fusion in patients with ankylosing spondylitis. Spinal fusion is the clinical, radiological and pathological hallmark of the disease, which develops slowly in patients with this condition. This study is evaluating the effectiveness of Remicade and other TNF-alpha medications in slowing or stopping the progression of spinal fusion.
Remicade can cause some side effects such as fever, extreme tiredness, flu-like symptoms, skin rashes, cough and stomach pain.
Ankylosing Spondylitis News is strictly a news and information website about the disease. It does not provide medical advice, diagnosis or treatment. This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this website. The opinions expressed in this column are not those of Ankylosing Spondylitis News, or its parent company, BioNews Services, and are intended to spark discussion about issues pertaining to Ankylosing Spondylitis.
Long-term efficacy of infliximab for refractory ulcerative colitis: results from a single center experience
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The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1471-230X/14/80/prepub