Remicade for Rheumatoid Arthritis: Is It Still the Gold Standard?

Remicade for rheumatoid arthritis is a cornerstone biologic therapy in rheumatology used to manage moderate to severe disease. It is particularly effective in patients with an inadequate response to conventional disease-modifying antirheumatic drugs (DMARDs). 

This article provides a comprehensive Remicade for rheumatoid arthritis review with its clinical applications, efficacy, and safety profile, supported by clinical trial data and real-world studies.

Key Takeaways

• Remicade (infliximab) is a chimeric monoclonal antibody that inhibits tumor necrosis factor-alpha (TNF-α), the main driver of inflammation in rheumatoid arthritis (RA).
• It is FDA-approved for moderate to severe RA and is used in combination with methotrexate (MTX) to improve efficacy and reduce anti-drug antibody (ADA) formation.
• Remicade is administered via intravenous (IV) infusion in a clinical setting. The dosing regimen includes 3 mg/kg IV at weeks 0, 2, and 6, followed by maintenance infusions every eight weeks. 
• The ATTRACT trial and subsequent cohort studies demonstrated that 67-87% of RA patients on Remicade achieve disease control within the first year.
• Remicade is best suited for patients with high disease activity, erosive RA, or extra-articular manifestations who have failed conventional DMARDs. 
• Compared to Humira (adalimumab) and Cimzia (certolizumab pegol), Remicade requires in-clinic IV infusions.
• Remicade increases susceptibility to severe infections, including tuberculosis (TB) reactivation, bacterial sepsis, and opportunistic fungal infections. Additional risks include infusion reactions, hepatotoxicity, demyelinating disorders, and heart failure exacerbation.
• Remicade is contraindicated in patients with active infections, severe heart failure (NYHA class III/IV), and hypersensitivity to murine-derived proteins.

What Is Remicade for Rheumatoid Arthritis and How Does It Work?

Remicade (infliximab) is a chimeric monoclonal antibody that targets tumor necrosis factor-alpha (TNF-α), the main pro-inflammatory cytokine in the pathophysiology of rheumatoid arthritis (RA). 

It is a biologic disease-modifying antirheumatic drug (bDMARD) indicated for moderate to severe RA in combination with methotrexate (MTX) to reduce immunogenicity.

Remicade’s mechanism of action involves TNF-α antagonism — it directly binds to both soluble and membrane-bound TNF-α. Without this blockage, the cytokine plays a major role in the destruction of synovial tissue by promoting:

• Pro-inflammatory cytokine release (IL-1, IL-6)
• Leukocyte migration and adhesion molecule expression
• Angiogenesis and synovial hyperplasia
• Osteoclast activation leading to joint erosion

Efficacy of Remicade in Rheumatoid Arthritis

Remicade was approved by the FDA in 1999 due to its clinical efficacy in reducing radiographic progression and improving functional outcomes in patients with moderate to severe RA. 

After the Anti-TNF Trial in Rheumatoid Arthritis with Concomitant Therapy (ATTRACT) that provided the basis for FDA approval of Remicade for rheumatoid arthritis, multiple real-world cohort studies have substantiated its therapeutic role. ^[1]

For example, a cohort study evaluated 24 rheumatoid arthritis patients with moderate to high disease activity who remained refractory to bDMARDs such as adalimumab, golimumab, tocilizumab, etanercept, and abatacept. 

Following a switch to Remicade, 37.5% achieved low disease activity, while 70.8% demonstrated a moderate or good EULAR response. ^[2]

Another retrospective longitudinal cohort study analyzed 183 rheumatoid arthritis patients who received adalimumab (30.6%), etanercept (34.9%), or infliximab (34.4%) over a seven-year period. 

Within the first year, 67%- 87% of patients achieved disease activity control and treatment response. 

Medication persistence was 95% to 98% at three years, 80% to 90% at five years, and 42% to 54% at seven years. The study concluded that the efficacy and persistence of anti-TNF-α therapies were comparable across the three agents. ^[3]

Remicade Dosing and Administration 

Remicade route of administration is an intravenous (IV) infusion over a minimum of two hours using an infusion set with an in-line, sterile, nonpyrogenic, low-protein-binding filter (pore size 1.2 µm or less). 

For adult patients with RA, the Remicade infusion dose is as follows:

• Initial induction dose: 3 mg/kg IV at weeks 0, 2, and 6
• Maintenance dose: 3 mg/kg IV every eight weeks ^[4]

Remicade is used concomitantly with MTX to enhance efficacy and reduce the risk of anti-drug antibody formation, which can lead to secondary loss of response. 

Incomplete responders may require dose escalation to 10 mg/kg or shortened dosing intervals (every four weeks). While higher doses or increased frequency may improve therapeutic efficacy, they are also associated with an increased risk of serious infections. 

To prepare an infusion of Remicade for rheumatoid arthritis, reconstitute each 100 mg vial with 10 mL of sterile water to achieve a concentration of 10 mg/mL. Use a 21-gauge or smaller needle for reconstitution. 

Further, dilute the reconstituted solution to a total volume of 250 mL with 0.9% sodium chloride. The final infusion concentration should be between 0.4 mg/mL (minimum recommended) and 4 mg/mL (maximum recommended). ^[5]

Remicade vs. Other Biologic Treatments

Besides Remicade, several other biologic treatments have been approved for rheumatoid arthritis treatment. Here’s how these agents compare.

Remicade vs. Cimzia

Cimzia (certolizumab pegol) is a PEGylated TNF-α inhibitor also indicated for rheumatoid arthritis. It was FDA-approved in 2009. 

It is administered via subcutaneous injection, with an induction regimen of 400 mg at weeks 0, 2, and 4, followed by a maintenance dose of either 200 mg every two weeks or 400 mg every four weeks. 

In contrast, Remicade is delivered via intravenous infusion, requiring administration in a clinical setting over at least two hours. 

Remicade vs. Humira

Humira (adalimumab), FDA-approved in 2002, is a fully human monoclonal antibody targeting TNF-α. It is administered subcutaneously either weekly or every other week, depending on the indication and patient response. 

Remicade, by contrast, is a chimeric monoclonal antibody against TNF-α and is exclusively administered via intravenous infusion in a clinical setting. 

Remicade vs. Orencia

Orencia (abatacept), FDA-approved in 2005, is a selective T-cell costimulation modulator that inhibits T-cell activation by binding to CD80 and CD86. It can be administered subcutaneously weekly or via intravenous infusion, with dosing based on body weight.

Remicade, by contrast, is a chimeric monoclonal antibody targeting TNF-α and is administered exclusively via intravenous infusion in a clinical setting.

Side Effects and Risks of Remicade for Rheumatoid Arthritis

TNF-α inhibition compromises host defense mechanisms, predisposing patients to severe bacterial, viral, and fungal infections. 

A 2020 clinical trial analyzed 198 patients who had received infliximab over the preceding 17 years, most commonly for rheumatoid arthritis. 

Serious adverse events occurred in 14% of patients, with 96.4% classified as mild hypersensitivity reactions. Five patients discontinued treatment due to infectious complications, including four cases of tuberculosis reactivation. ^[6]

Other common side effects of using Remicade for rheumatoid arthritis include: 

• Upper respiratory infections (sinusitis, pharyngitis)
• Headache
• Dizziness
• Gastrointestinal discomfort

Infliximab is associated with acute and delayed hypersensitivity reactions. Symptoms of acute infusion reactions include fever, chills, dyspnea, chest pain, hypotension or hypertension, pruritus, rash, and urticaria.

A delayed hypersensitivity reaction presenting with serum sickness-like syndrome with arthralgia, rash, and myalgia may also occur.

Serious adverse effects associated with Remicade are: 

• Latent TB reactivation
• Sepsis and bacteremia
• Hepatitis B virus reactivation
• Increased incidence of malignancies, particularly lymphoproliferative disorders
• Heart failure exacerbation
• Idiosyncratic hepatotoxicity
• Demyelinating disorders
• Cytopenias (pancytopenia, leukopenia, and thrombocytopenia)

Who Should and Shouldn’t Consider Remicade for Rheumatoid Arthritis?

Remicade indications include adult patients (≥18 years) with moderate to severe RA when DMARDs, including MTX, have been inadequate or for severe, progressive RA in DMARD-naive patients. 

Other candidates for Remicade therapy include: 

• Patients requiring rapid disease control to prevent irreversible joint damage
• Individuals with erosive RA and high disease activity with extra-articular manifestations
• Patients who tolerate IV administration and require a flexible dosing schedule
• Patients with psoriatic arthritis (PsA) or concurrent inflammatory bowel disease (IBD)

Remicade is contraindicated in some patients due to the risk of severe adverse effects. They include: 

• Patients with tuberculosis (latent or active), unless treated prior to initiation
• Patients with chronic or recurrent infections, including abscesses and opportunistic infections
• Patients who currently have sepsis, invasive fungal infections, or bacterial endocarditis
• Patients with a known allergy to mouse-derived proteins
• Those who are currently taking Anakinra (IL-1 receptor antagonist)
• Patients with severe CHF (those with mild CHF, i.e., NYHA Class I-II, should be closely monitored if treated) ^[7]

FAQs

Find answers to the most frequently asked questions.

Can Remicade Be Used for Psoriatic Arthritis?

Yes, the FDA has approved Remicade for psoriatic arthritis to reduce joint inflammation, pain, and skin symptoms. It can be used as an alternative to Orencia for psoriatic arthritis.

Does Remicade Work Immediately?

Remicade does not work immediately. Symptom improvement in rheumatoid arthritis begins within 1-2 weeks, and full therapeutic effects are seen in 6-12 weeks.

Does Remicade Work for Other Diseases?

Yes, Remicade is also FDA-approved for Crohn’s disease, ulcerative colitis, psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis.

How to Tell if Remicade Is Not Working?

If symptoms of rheumatoid arthritis persist despite normal Remicade trough levels and no significant antibodies on the Prometheus test, the medication is no longer therapeutic.

Final Words

If you’re a healthcare provider looking to purchase original Remicade for your practice, you can trust Doctor Medica to help you source it at the best price. 

Plus, our dedicated customer support team is available to address inquiries and assist with the ordering process. Find Remicade now.

References

1. Lipsky PE, van der Heijde DMFM, St. Clair EW, et al. Infliximab and Methotrexate in the Treatment of Rheumatoid Arthritis. New England Journal of Medicine. 2000;343(22):1594-1602. doi:https://doi.org/10.1056/nejm200011303432202
2. Umeda M, Koga T, Ichinose K, et al. Efficacy of infliximab as a switched biologic in rheumatoid arthritis patients in daily clinical practice. Immunological medicine. 2018;41(4):181-186. doi:https://doi.org/10.1080/25785826.2018.1542942
3. Santos-Moreno P, Gabriel-Santiago Rodríguez-Vargas, Rodríguez-Linares P, et al. Effectiveness and Persistence of Anti-TNFα Treatment in Patients with Rheumatoid Arthritis – A 7 Years Real-World Cohort Study. Biologics: Targets and Therapy. 2024;18:339-347. doi:https://doi.org/10.2147/BTT.S474733
4. REMICADE® (infliximab). Remicade.com. Published 2023. https://www.remicade.com/rheumatoid-arthritis/infusion-process.html
5. Dosing and Administration Guide for REMICADE®. https://www.remicadehcp.com/assets/pdf/remicade-dosing-and-admin-guide.pdf
6. Nahra V, Georges El Hasbani, Chaaya M, Uthman I. The Use of Infliximab (Remicade®) for the Treatment of Rheumatic Diseases at a Tertiary Center in Lebanon: A 17-Year Retrospective Chart Review. Mediterranean Journal of Rheumatology. 2020;31(4):400-400. doi:https://doi.org/10.31138/mjr.31.4.400
7. Remicade. NPS MedicineWise. Published September 12, 2024. Accessed March 16, 2025. https://www.nps.org.au/medicine-finder/remicade-powder-for-infusion