Remicade (Infliximab)

Infliximab (Remicade) is a immunoglobulin G1 (IgG1) monoclonal antibody manufactured by Janssen Biotech, Inc. It is indicated (approved for use) in combination with methotrexate for reducing signs and symptoms in RA, inhibiting the progression of structural damage, and improving physical function in patients with moderately to severely active RA. It is also indicated for other autoimmune diseases, including Crohn’s disease (both adult and pediatric), ulcerative colitis (both adult and pediatric), psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis.

 

Infliximab (Remicade): overview and efficacy

Infliximab (Remicade) is a immunoglobulin G1 (IgG1) monoclonal antibody manufactured by Janssen Biotech, Inc. It is indicated (approved for use) in combination with methotrexate for reducing signs and symptoms of RA, inhibiting the progression of structural damage, and improving physical function in patients with moderately to severely active RA. It is also indicated for other autoimmune diseases, including Crohn’s disease (both adult and pediatric), ulcerative colitis (both adult and pediatric), psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis.1

 

How does Remicade work?

Remicade is a immunoglobulin G1 (IgG1) monoclonal antibody partly derived from a mouse antibody. Remember that our bodies naturally produce antibodies against bacteria, viruses, and other foreign organisms that invade and pose a threat to our health. Following the example of our bodies, drug makers have engineered different antibodies designed to target the mechanisms that cause a variety of diseases, including RA. Remicade binds to human tumor necrosis factor alpha (TNF-α) receptors and, as a consequence, it inhibits TNF-α from carrying out its function in the immune process. Infliximab also kills cells that express TNF-α.1

 

How is Remicade taken?

Remicade is taken by intravenous (IV) infusion that typically takes about 2 hours. It is taken in conjunction with methotrexate, at a dose of 3 mg/kg (the exact dose of Remicade is determined by your body weight) when you start the drug, at 0, 2 and 6 weeks, and then every 8 weeks, thereafter. Increasing the dose of Remicade up to 10 mg/kg or treating more frequently, such as every 4 weeks, may provide benefits for some patients.1,2

 

Are there people who should not take Remicade?

Remicade is contraindicated (this means that it should not be used) in patients with moderate to severe heart failure or patients who have had a severe hypersensitivity reaction to Remicade or a known hypersensitivity to any of the active components (or to any murine [rodent] protein) of Remicade.1

There is an increased risk for serious infections and malignancy (cancer) with Remicade. This is because Remicade can decrease the ability of the immune system to fight infections and to protect against cancer. If you are taking Remicade and develop any symptoms of an infection contact your doctor immediately. Types of serious infections seen with Remicade include tuberculosis (TB), systemic fungal infections, and reactivation of hepatitis B virus (HBV) infections. Also, if you have a severe allergic reaction while taking Remicade, contact your doctor immediately.1

Remicade can cause a worsening of congestive heart failure, demyelinating disease (such as MS), a Lupus-like autoimmune disorder, or cytopenia (a deficiency of cells that make up blood, with symptoms including bruising, bleeding, or persistent fever). If you experience any of these, contact your doctor immediately.1 Patients diagnosed with multiple sclerosis or other demyelinating disease should not use Remicade.

Remicade is a pregnancy category B drug. There have been no well-controlled studies in pregnant women. Like other IgG antibodies, Remicade does cross the placental barrier and has been found in the serum of infants up to the age of 6 months and may increase risk of infection in new born infants. Therefore, Remicade should be used during pregnancy only if it is clearly needed.1

Remicade is excreted into human milk. Because of the risk of adverse effects, women who are taking Remicade should not breastfeed their children.1

 

What is the evidence that Remicade works in RA?

The effectiveness of Remicade in patients with RA was evaluated in two randomized, controlled trials, the ATTRACT study and the ASPIRE study. ATTRACT was conducted in 428 patients with active RA despite treatment with methotrexate. Patients were randomized to one of four treatment schedules with either Remicade 3 mg/kg or 10 mg/kg (given at 0, 2, 6 weeks, and every 4 or 8 weeks thereafter) + methotrexate or placebo + methotrexate. ASPIRE was conducted in 1,004 patients with active RA (with RA for 3 or less years) who had never received treatment with methotrexate. The study randomized patients to one of three Remicade treatment schedules with 3-mg/kg or 6-mg/kg doses (given at 0, 2, 6 weeks, and every 8 weeks thereafter) + methotrexate or placebo + methotrexate.1
Disease control and clinical response. In ATTRACT, the combination of Remicade and methotrexate resulted in higher percentages of ACR response (ACR20, 50, and 70) compared with methotrexate + placebo. Improvements in symptoms were seen as early as 2 weeks and were maintained through 102 weeks. In ASPIRE, the combination of Remicade and methotrexate resulted in significantly higher rates of ACR responses at both doses compared with placebo + methotrexate.1

 

Clinical responses (ACR20, 50, 70) with Remicade in ATTRACT and ASPIRE

ATTRACT study

ASPIRE study

Remicade + methotrexate (MTX) Remicade + MTX
3 mg/kg 10 mg/kg Placebo 3 mg/kg 10 mg/kg Placebo
Response every 8 wks every 4 wks every 8 wks every 4 wks + MTX every 8 wks every 8 wks + MTX
ACR20
Week 30 50%* 50%* 52%* 58%* 20%
Week 54 42%* 48%* 59%* 59%* 17% 62%** 66%* 54%
AC50
Week 30 27%* 29%* 31%* 26%* 5%
Week 54 21%** 34%* 40%* 38%* 9% 46%* 50%* 32%
ACR70
Week 30 8%*** 11%*** 18%* 11%* 0%
Week 54 11%** 18%* 26%* 19%* 2% 33%*** 37%* 21%
Major clinical response 7%** 8%*** 15%* 6%** 0% 12% 17%* 8%
*Statistical significance: P≤0.001 versus placebo + MTX. **P<0.01 versus placebo + MTX. ***P<0.05 versus placebo + MTX.

 

Radiographic progression. In both the ATTRACT and ASPIRE studies, infliximab + methotrexate resulted in significant decreases in radiographic progression of joint damage compared with placebo + methotrexate. In ATTRACT (based on x-ray results for 80% of patients at 54 weeks and 70% of patients at 102 weeks), in the infliximab + methotrexate group inhibition of structure damage was observed at 54 weeks and maintained through 102 weeks. In ASPIRE, patients with elevations in baseline acute phase reactants (ESR and CRP) and those without elevations both experienced less progression of structural damage with infliximab + methotrexate compared with placebo + methotrexate. Among patients who started the study without erosions, a significantly greater percentage of those who received Remicade + methotrexate were free of erosions in 1 year (79%) versus those who received placebo + methotrexate (58%; P<0.01).1

 

Radiographic changes from basline to 54 weeks with Remicade in ATTRACT and ASPIRE

ATTRACT study

ASPIRE study

Remicade + methotrexate (MTX) Remicade + MTX
3 mg/kg 10 mg/kg Placebo 3 mg/kg 10 mg/kg Placebo
Mean scores every 8 wks every 8 wks + MTX every8 wks every8 wks + MTX
Total Sharp Score 1.3* 0.2* 6.9 0.4* 0.5* 3.7
Erosion score 0.2* 0.2* 4.1 0.3* 0.1* 3.0
Joint space narrowing score 1.1* 0.0* 2.9 0.1* 0.2 0.6
*Statistical significance: P<0.001 versus placebo + MTX.

 

Is there a generic form of Remicade?

No, there is no generic equivalent to Remicade.

Written by: Jonathan Simmons | Last reviewed: September 2013.
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