WARNINGS
RISK OF INFECTIONS
Patients treated with REMICADE are at increased risk for infections, including progression to serious infections leading to hospitalization or death (see WARNINGS and ADVERSE REACTIONS). These infections have included bacterial sepsis, tuberculosis, invasive fungal and other opportunistic infections. Patients should be educated about the symptoms of infection, closely monitored for signs and symptoms of infection during and after treatment with REMICADE, and should have access to appropriate medical care. Patients who develop an infection should be evaluated for appropriate antimicrobial therapy and for serious infections REMICADE should be discontinued.
Tuberculosis (frequently disseminated or extrapulmonary at clinical presentation) has been observed in patients receiving REMICADE. Patients should be evaluated for tuberculosis risk factors and be tested for latent tuberculosis infection 1, 2 prior to initiating REMICADE and during therapy. Treatment of latent tuberculosis infection should be initiated prior to therapy with REMICADE. Treatment of latent tuberculosis in patients with a reactive tuberculin test reduces the risk of tuberculosis reactivation in patients receiving REMICADE. Some patients who tested negative for latent tuberculosis prior to receiving REMICADE have developed active tuberculosis. Physicians should monitor patients receiving REMICADE for signs and symptoms of active tuberculosis, including patients who tested negative for latent tuberculosis infection.
HEPATOSPLENIC T-CELL LYMPHOMAS
Rare postmarketing cases of hepatosplenic T-cell lymphoma have been reported in adolescent and young adult patients with Crohn's disease treated with REMICADE. This rare type of T-cell lymphoma has a very aggressive disease course and is usually fatal. All of these hepatosplenic T-cell lymphomas with REMICADE have occurred in patients on concomitant treatment with azathioprine or 6-mercaptopurine.
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REMICADE SUMMARY
REMICADE® is a chimeric IgG1(kappa) monoclonal antibody.
REMICADE, in combination with methotrexate, is indicated for reducing signs and symptoms, inhibiting the progression of structural damage and improving physical function in patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to methotrexate.
REMICADE is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in patients with moderately to severely active Crohn's disease who have had an inadequate response to conventional therapy.
REMICADE is indicated for reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in patients with fistulizing Crohn's disease.
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NEWS HIGHLIGHTSMedia Articles Related to Remicade (Infliximab)
Remicade Phase 3 data show long-term psoriasis response
Source: The Doctors Lounge - Dermatology
Findings from two Phase 3 studies show high-level, sustained response with maintenance therapy.
Need For Surgery Almost Halved By Ulcerative Colitis Treatment
Source: Irritable-Bowel Syndrome News From Medical News Today [2009.10.03]
A new study led by Mayo Clinic researchers has found that ulcerative colitis patients had a 41 percent reduction in colectomy after a year when treated with infliximab, according to a study published in the October 2009 issue of Gastroenterology...
Published Studies Related to Remicade (Infliximab)
Colectomy rate comparison after treatment of ulcerative colitis with placebo or infliximab. [2009.10]
BACKGROUND & AIMS: The efficacy of infliximab for treating patients with ulcerative colitis has been established... CONCLUSIONS: Patients with moderately to severely active ulcerative colitis treated with infliximab were less likely to undergo colectomy through 54 weeks than those receiving placebo.
Cost-effectiveness of two therapeutic regimens of infliximab in ankylosing spondylitis: economic evaluation within a randomized controled trial. [2009.09.09]
OBJECTIVE: To determine the incremental cost-effectiveness ratios (ICERs) of 2 therapeutic regimens of infliximab for ankylosing spondylitis (AS)... CONCLUSION: The administration of infliximab every 6 weeks is cost-effective as compared with a DEM regimen; however, the ICER is close to the acceptability threshold of 50,000 euro for one QALY gained.
Improvement in hemoglobin levels in patients with ankylosing spondylitis treated with infliximab. [2009.08.15]
OBJECTIVE: Anemia is a common complication in patients with inflammatory diseases such as ankylosing spondylitis (AS). This post hoc analysis of a large, randomized, placebo-controlled trial examined the effect of infliximab on hemoglobin levels, physical function, and fatigue in patients with AS... CONCLUSION: Infliximab treatment significantly decreased the proportion of AS patients with anemia and improved hemoglobin levels compared with placebo. Improvement in hemoglobin level was independently associated with improvements in physical function and fatigue.
Addition of infliximab compared with addition of sulfasalazine and hydroxychloroquine to methotrexate in patients with early rheumatoid arthritis (Swefot trial): 1-year results of a randomised trial. [2009.08.08]
BACKGROUND: New treatment strategies for early rheumatoid arthritis are evolving rapidly. We aimed to compare addition of conventional disease-modifying antirheumatic drugs (sulfasalazine and hydroxychloroquine) with addition of a tumour necrosis factor antagonist (infliximab) to methotrexate in patients with early rheumatoid arthritis... INTERPRETATION: In patients with early rheumatoid arthritis in whom methotrexate treatment failed, addition of a tumour necrosis factor antagonist to methotrexate monotherapy is clinically superior to addition of conventional disease-modifying antirheumatic drugs. FUNDING: Swedish Rheumatism Association, Schering-Plough.
Infliximab therapy in children with concurrent perianal Crohn disease: observations from REACH. [2009.08]
OBJECTIVE: Post hoc analyses evaluated the effect of infliximab upon concurrent perianal Crohn disease (CD) in a subpopulation of 31 patients from REACH, a randomized trial of 112 children with moderately to severely active luminal CD... CONCLUSIONS: Infliximab rapidly reduced concurrent perianal disease signs and symptoms in this REACH cohort.
Clinical Trials Related to Remicade (Infliximab)
A Study of the Safety and Effectiveness of Infliximab (Remicade) in Patients With Juvenile Rheumatoid Arthritis [Completed]
The purpose of this study is to evaluate the effectiveness and safety of infliximab
(Remicade) in patients with Juvenile Rheumatoid Arthritis (JRA).
Effects of Infliximab (Remicade) on Fat Free Mass in Patients With Moderate to Severe COPD Suffering From Cachexia [Completed]
The purpose of this study is to determine whether infliximab is effective on fat-free mass in
the treatment of patients with moderate to severe COPD suffering from cachexia.
Efficacy, Safety, and Tolerability Study of Infliximab in Juvenile Spondyloarthropathies [Completed]
Tumor necrosis factor (TNF) alpha is a pro-inflammatory cytokine playing a significant role
in the pathogenesis of the spondyloarthropathies (SpA). Infliximab is a TNF alpha blocking
monoclonal antibody efficacious and safe as treatment of adult-onset SpA.
In this study we will try to demonstrate that infliximab administered at 5mg/kg to patients
with juvenile onset SpA over a period of 12 weeks will have more efficacy than placebo and
that it will be well tolerated. At the end of this phase, patients will go into a 52-week
open extension to demonstrate sustained efficacy, safety, and tolerability of infliximab We
will include 34 patients with juvenile onset SpA unresponsive to standard treatment. Efficacy
will be assessed by counting the number of actively inflamed joints and a number of other
parameters.
A Safety and Efficacy Study of Infliximab (Remicade) in Patients With Plaque Type Psoriasis [Completed]
The purpose of the study is to evaluate the effectiveness and safety of infliximab (Remicade)
in patients with plaque-type psoriasis.
A Safety and Efficacy Study for Infliximab (Remicade) in Patients With Ulcerative Colitis [Completed]
The purpose of this study is to evaluate the effectiveness and safety of infliximab
(Remicade) in patients with Ulcerative Colitis. Infliximab (Remicade) targets specific
proteins in the body's immune system to help control the development of inflammation to help
reduce painful disease.
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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 5 ratings/reviews, Remicade has an overall score of 4.80. The effectiveness score is 8.80 and the side effect score is 4.40. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
| | Remicade review by 50 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Highly Effective |
| Side effects: | | No Side Effects | | |
Treatment Info |
| Condition / reason: | | psoriatic arthritis |
| Dosage & duration: | | 400 mg taken every 8 weeks for the period of still taking it |
| Other conditions: | | osteo arthritis |
| Other drugs taken: | | Lexapro, Immuran | | |
Reported Results |
| Benefits: | | This drug has helped the pain and swelling in my hands and back from psoriatic arthritis. My fingers were also starting to twist, and this has helped to slow that down. The psoriasis on my skin has almost gone completely away. About a week or two before time for the next dose, a little comes back, but nothing like it used to be. |
| Side effects: | | I don't notice any side effects. |
| Comments: | | I go in to the office for an inter venous infusion every 8 weeks for two hours at a time. |
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| | Remicade review by 22 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Moderately Effective |
| Side effects: | | Severe Side Effects | | |
Treatment Info |
| Condition / reason: | | Crohns Disease & Colitis |
| Dosage & duration: | | n/a (dosage frequency: 4 infussions) for the period of 3 months |
| Other conditions: | | Anemia |
| Other drugs taken: | | Iron 150 | | |
Reported Results |
| Benefits: | | Helped my abdominal pain and bowels. A little more energy after the first infussion but not much after the rest. Helped with fistulas. |
| Side effects: | | After 2nd and 3rd infussion: Itchy scalp and bumps like a pimples in scalp soon turned into lessions(dried patches/scabs). Itchy rash/bumps on chest. Night sweats, warm to touch but no tempature. Waited to get 4th infussion Doctor said not related to Remicade (not true) Recieved 4th infussion 7-9 weeks later discontinued remicade.
Developed full body rash,hives,pustular psoriosis looking rash on palms and soles. (Very itchy) In between fingers and toes.
Different looking rash on shins and legs. Really red and itchy after showers.
Genital bumps/dryness, cracks in vaginal area and buttocks.
Major hair loss on top of scalp and throughout scalp.
Ear problems, ringing, crusty scabs and drainage with an odor.
Swollen lymphnodes behind ears and groin.
Swollen ankles and feet. Joint pain. Heart palpitations
Tiredness,anxiety,depression and mood swings.
All of these symptoms have been in a cycle rash looks like its going away and comes back before it's gone. Hair is still falling. This is all during a 2 month period. |
| Comments: | | First two times had the IV steriod for an hour or so. Last two times took benadryl before. Recieved Remicade IV for 2hrs. Always slept after. Nurse would check on me during treatment everything was normal. |
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| | Remicade review by 51 year old male patient | | | Rating |
| Overall rating: | | |
| Effectiveness: | | Considerably Effective |
| Side effects: | | Extremely Severe Side Effects | | |
Treatment Info |
| Condition / reason: | | Stills Disase |
| Dosage & duration: | | According to my weight (dosage frequency: every 3 months) for the period of year |
| Other conditions: | | Major Headaches and High blood pressure, nasty skins sores |
| Other drugs taken: | | Ultram | | |
Reported Results |
| Benefits: | | To relieve muscle aches and joint pain |
| Side effects: | | Started getting severe headaches from the medication.It cause high blood pressure that lasted 12 to 14 weeks after my last infusion. Also sores on my scalp,arms, laegs and buttocks that hurt so bad and our so sore.They clear up and come right back at the same exact spot.
I ended up in the hospital. When I was at work a collapse to the floor and I didnt know what was going on until they found my blood pressure sky high and I had severe chest pains. They gave me nitro pill for my chest pain and medication to drop my blood pressure but it took almost 14 weeks before those side effects to go away. I stopped taking it back in 2004.
However the sores have nevr gone away and I keep getting these major flare ups with the sores all over my body.
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| Comments: | | The treatment is was fine how ever the side effects where much worest than the treatment.
Johnson and Johnson sent me a certified letter pertaining to my problems with the side effects and I answered their questions but they never did get back to me at all about my condition. |
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Page last updated: 2009-10-20
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