Remicade for Ulcerative Colitis: A Systematic Review

Remicade for ulcerative colitis (UC) is a biologic therapy used in the management of moderate-to-severe forms of chronic inflammatory bowel disease (IBD). 

The initial management of UC involves 5-aminosalicylates, corticosteroids, and immunosuppressants. Biologic agents like Remicade are indicated in corticosteroid-refractory or corticosteroid-dependent disease. 

This article provides a clinically focused review of Remicade for ulcerative colitis, its pharmacologic mechanism, evidence base, administration protocols, safety considerations, and criteria for patient selection. 

Key Takeaways

• Remicade is a chimeric monoclonal antibody targeting TNF-α, approved for moderate-to-severe UC in patients over six years of age. 
• It works by suppressing inflammatory pathways (e.g., NF-κB), which reduces cytokine activity and induces apoptosis in activated immune cells.
• Clinical studies on Remicade show that it has a strong efficacy. Up to 76% of patients achieve short-term response, and 50% maintain steroid-free remission for the long term.
• Remicade dosing for UC includes an induction phase (5 mg/kg IV at weeks 0, 2, 6) followed by maintenance every eight weeks.
• Infusion requires reconstitution, dilution, and administration over at least two hours using an in-line filter, with no co-infusion of other agents.
• Remicade contraindications include moderate-to-severe heart failure, hypersensitivity to murine proteins, active infections, or untreated latent tuberculosis (TB) infection.
• Common side effects include respiratory infections, headache, abdominal pain, and infusion reactions such as fever, rash, or hypotension.
• Serious adverse effects include TB reactivation, hepatosplenic T-cell lymphoma, demyelinating disease, and cardiovascular events.

What Is Remicade, and How Does It Work?

Remicade (infliximab) is a chimeric monoclonal IgG1 antibody that targets tumor necrosis factor-alpha (TNF-α), a pro-inflammatory cytokine in the pathogenesis of UC and other autoimmune disorders. ^[1]

The drug is FDA-approved for the treatment of moderate-to-severe active UC in adults and pediatric patients (≥6 years) who have had an inadequate response to 5-aminosalicylic acid (5-ASA) and immunomodulators. 

It binds with high affinity to both the soluble and transmembrane forms of TNF-α, leading to the following effects:

• NF-κB pathway inhibition
• Suppression of leukocyte infiltration
• Downregulation of adhesion molecules and pro-inflammatory cytokines (IL-1, IL-6, IFN-γ)
• Induction of apoptosis in activated T-lymphocytes and monocytes infiltrating colonic mucosa

Efficacy of Remicade for Ulcerative Colitis

Infliximab and ulcerative colitis have long been studied to assess the drug’s clinical efficacy. 

In a single-center study conducted between May 2006 and January 2012, a total of 44 patients (including 16 females) were treated with infliximab for acute severe UC.

Approximately two-thirds of the cohort was able to avoid colectomy, and over 50% achieved remission without the need for ongoing glucocorticosteroid therapy. ^[2]

Another multicenter retrospective study involving 250 patients with chronic active UC showed that 49-50% achieved steroid-free remission at both 12 months and at a median follow-up of 2.9 years. 

A primary clinical response at three months was observed in 76%, and most of these responders maintained remission long-term. ^[3]

A recent systematic review of 22 studies including 2,080 patients with UC compared infliximab to control treatments.

The meta-analysis demonstrated that infliximab significantly improved short-term response (odds ratio: 4.01), long-term response (odds ratio: 3.53), and long-term remission (odds ratio: 2.80) compared to controls.

However, short-term remission did not reach statistical significance (OR 1.88, p = 0.09). ^[4]

Dosage and Administration of Remicade for Ulcerative Colitis

Remicade is administered via intravenous infusion at a dose of 5 mg/kg. Remicade dosing for ulcerative colitis comprises two phases:

1. Induction phase: 5 mg/kg IV at weeks 0, 2, and 6
2. Maintenance phase: 5 mg/kg IV every eight weeks thereafter

Dose escalation to 10 mg/kg or shortening the interval to every four weeks can be considered in patients with suboptimal response. 

Follow these steps to make a Remicade infusion for ulcerative colitis: 

1. Calculate the total dose based on the patient’s weight (5 mg/kg). Each vial of the drug contains 100 mg of lyophilized infliximab.
2. Reconstitute each vial with 10 mL of sterile water for injection using a 21-gauge (or smaller) needle. Inject against the vial wall and gently swirl to dissolve it. Avoid shaking to prevent foaming.
3. Inspect the solution — it should be colorless to light yellow and slightly opalescent. Discard if any opaque particles or discoloration are present.
4. Withdraw an equal volume from a 250 mL bag of 0.9% sodium chloride injection, then slowly transfer the reconstituted infliximab into the bag to achieve a final concentration between 0.4 mg/mL and 4 mg/mL. 
5. Start the infusion within three hours of reconstitution. Administer intravenously over no less than two hours through a dedicated line using an infusion set with a sterile, non-pyrogenic, low-protein-binding in-line filter (pore size ≤1.2 µm).
6. Do not co-infuse Remicade with other agents in the same IV line.
   Discard any unused solution immediately after ulcerative colitis Remicade infusion. Vials do not contain preservatives and are not suitable for storage or reuse.

Do All Patients With Ulcerative Colitis Get Remicade?

Not all patients are appropriate candidates for Remicade treatment for ulcerative colitis. 

Patient selection is based on disease severity, prior treatment response, comorbid conditions, and individualized risk-benefit assessment.

Remicade is indicated for patients with moderately to severely active UC who have had an inadequate response to corticosteroids, 5-aminosalicylates, or immunomodulators. 

It is particularly valuable in steroid-refractory or steroid-dependent disease or in cases requiring rapid control of mucosal inflammation to avoid colectomy.

The use of Remicade is contraindicated in the following clinical scenarios:

• Moderate to severe heart failure (NYHA Class III/IV), particularly at doses >5 mg/kg, due to increased risk of mortality and hospitalization from worsening cardiac function
• History of severe hypersensitivity reactions to infliximab or its excipients
• Known hypersensitivity to murine proteins, as infliximab is a chimeric monoclonal antibody
• Presence of clinically significant active infections, including localized infections
• Untreated latent tuberculosis or inadequate evaluation for TB prior to initiation

All patients should undergo comprehensive infection screening (e.g., tuberculosis and hepatitis B) and cardiac evaluation when the drug is indicated. 

Remicade for Ulcerative Colitis Side Effects

Remicade has a well-documented profile of adverse effects ranging from mild to life-threatening.

The most common adverse effects (≥10%) include upper respiratory tract infections (e.g., sinusitis and pharyngitis), headache, abdominal pain, cough, and infusion-related reactions. 

In pooled safety data from pivotal ACT 1 and ACT 2 trials, infections were observed in up to 36% of patients receiving infliximab, compared to 25% in placebo groups. ^[5]

Infusion reactions can also occur within two hours and present as fever, chills, chest pain, hypertension or hypotension, dyspnea, pruritus, or urticaria.

Of greater clinical concern are serious infections, including tuberculosis and opportunistic viral, bacterial, and fungal infections. Cases of hepatosplenic T-cell lymphoma have also been noticed primarily in male adolescents and young adults receiving concurrent thiopurines. 

Additional rare but serious complications include:

• Demyelinating disorders
• Congestive heart failure exacerbation
• Hepatotoxicity
• Severe cytopenias
• Stroke and myocardial ischemia within 24 hours post-infusion
• Autoimmune syndromes, including lupus-like presentations and psoriasis

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FAQs

How Long Does Remicade Take To Work for Ulcerative Colitis?

Remicade is administered long-term for ulcerative colitis, starting with induction at weeks 0, 2, and 6, followed by maintenance infusions every eight weeks. 

Does Remicade Work Immediately?

Remicade does not work immediately. Clinical response in ulcerative colitis begins within one to two weeks, but full therapeutic effect takes up to six weeks post-induction.

What to Avoid While on Remicade?

Patients on Remicade should avoid live vaccines and close contact with individuals affected with TB and hepatitis B.

What Is the Success Rate of Remicade for Ulcerative Colitis?

As per a meta-analysis of 22 clinical trials, infliximab shows a 76% short-term response and 50% long-term steroid-free remission. 

References

1. Fatima R, Bittar K, Aziz M. Infliximab. PubMed. Published 2020. https://www.ncbi.nlm.nih.gov/books/NBK500021
2. Halpin SJ. Efficacy of infliximab in acute severe ulcerative colitis: A single-centre experience. World Journal of Gastroenterology. 2013;19(7):1091-1091. doi:https://doi.org/10.3748/wjg.v19.i7.1091
3. ‌Angelison L, Sven Almér, Eriksson A, et al. Long-term outcome of infliximab treatment in chronic active ulcerative colitis: a Swedish multicentre study of 250 patients. Alimentary Pharmacology & Therapeutics. 2016;45(4):519-532. doi:https://doi.org/10.1111/apt.13893
4. Guo C, Wu K, Liang X, Liang Y, Li R. Infliximab clinically treating ulcerative colitis: A systematic review and meta-analysis. Pharmacological Research. 2019;148:104455-104455. doi:https://doi.org/10.1016/j.phrs.2019.104455

Rutgeerts P, Sandborn WJ, Feagan BG, et al. Infliximab for Induction and Maintenance Therapy for Ulcerative Colitis. New England Journal of Medicine. 2005;353(23):2462-2476. doi:https://doi.org/10.1056/nejmoa050516