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 HIGHLIGHTS
Published Studies Related to Remicade (Infliximab)
Remission induction comparing infliximab and high-dose intravenous steroid,
followed by treat-to-target: a double-blind, randomised, controlled trial in
new-onset, treatment-naive, rheumatoid arthritis (the IDEA study). [2014]
infliximab (IFX) with MTX and intravenous corticosteroid for remission induction... CONCLUSIONS: In DMARD-naive early RA patients, initial therapy with MTX+high-dose
A clinical trial and extension study of infliximab in Korean patients with active
rheumatoid arthritis despite methotrexate treatment. [2013]
Currently, infliximab is given for disease control for active rheumatoid
arthritis (RA) patients despite methotrexate treatment. However, the efficacy and
safety of infliximab in Korean patients has not been assessed appropriately...
Hand bone loss in patients with psoriatic arthritis: posthoc analysis of IMPACT
II data comparing infliximab and placebo. [2013]
or infliximab (IFX)... CONCLUSION: This pilot study indicates that hand bone loss in PsA patients
Cost-efficacy of adalimumab, etanercept, infliximab and ustekinumab for moderate-to-severe plaque psoriasis. [2011.11.30]
Background Different biological agents are used for the treatment of psoriasis. Previous data have shown adalimumab to be the most efficient drug in terms of cost-efficacy... The robustness of this finding was confirmed by sensitivity analysis.
Efficacy and safety of infliximab vs. methotrexate in patients with moderate-to-severe plaque psoriasis: results of an open-label, active-controlled, randomized trial (RESTORE1). [2011.11]
BACKGROUND: Infliximab is indicated for treatment of moderate-to-severe plaque psoriasis in adults whose disease cannot be controlled with other systemic therapies, including methotrexate (MTX). To date, no studies have directly compared the efficacy and safety of infliximab and MTX. OBJECTIVES: To compare the efficacy and safety of infliximab vs. MTX in adults with moderate-to-severe plaque psoriasis... CONCLUSIONS: Infliximab was well tolerated and more efficacious than MTX in patients with moderate-to-severe plaque psoriasis. Infliximab also was efficacious in patients who failed MTX and switched to infliximab. (c) 2011 The Authors. BJD (c) 2011 British Association of Dermatologists.
Clinical Trials Related to Remicade (Infliximab)
Real Life Dosing of Remicade for Rheumatoid Arthritis in Austria Monitored Over 9 Infusions (Study P03756)(COMPLETED) [Completed]
This is a prospective, open-label, 1-arm, multicenter observational study to determine the
average Remicade dosage and time span between 9 infusions in subjects with rheumatoid
arthritis (RA)
Evaluation of Pharmacokinetics and Safety of BCD-055 and Remicade in Patients With Ankylosing Spondylitis [Recruiting]
ASART-1 clinical study is a phase 1 study which carried out to establish the pharmacokinetic
equivalence and equal safety profile of BCD-055 (infliximab manufactured by JSC BIOCAD,
Russia) and Remicade when used as multiple IV infusions for the treatment of ankylosing
spondylitis.
Investigation of 9 Consecutive Remicade Infusions in Ankylosing Spondylitis in Austria (Study P04044)(COMPLETED) [Completed]
This is a prospective, open-label, 1-arm, multicenter observational study to determine the
dose and time span of Remicade between infusions for ankylosing spondylitis (AS).
A Study of the Efficacy and Tolerance of Remicade in the Treatment of Active Ankylosing Spondylitis (Study P04042)(COMPLETED) [Completed]
The objective of this study is to prove reasonability of registration in Russian federation
this new indication (ankylosing spondylitis [AS]) through evaluation of safety and efficacy
rate of Remicade 5mg/kg, given as an intravenous infusion over a 2-hour period followed by
additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 6 to
8 weeks (maximum 9 infusions).
Sleep and Immunity in Rheumatoid Arthritis : Remicade Substudy [Completed]
More than half of rheumatoid arthritis (RA) patients complain of sleep disturbance and this
cardinal complaint is associated with fatigue, pain, and depressed mood in patient with
chronic inflammatory disorder. Despite the frequency of this complain, there is limited
efforts to evaluate sleep or the abnormal increases in the expression of proinflamatory
cytokines play a key role in the progression of RA, we hypothesize that the cytokine network
is one physiological system that is associated with sleep disturbances in RA patients.
Proinflamatory cytokines signal the central nervous system and are associated with increased
symptoms of pain, fatigue, and depressed mood in rheumatic patients. Moreover, sleep loss
is coincident with alterations in sympathetic tone, which is thought to contribute to
increases of proinflammatory cytokine activity. The specific aims of the study are to
examine the contribution of cytokines on sleep by administering a TNF antagonist vs. placebo
to probe the action of proinflammatory cytokines on sleep in RA Patients. Examination of
sleep and its consequences for autonomic functioning and proinflamatory cytokine activity
within the framework of an observational and experimental research design will have
implications for understanding the psycho-biological mechanisms that link sleep and the
clinical manifestations of RA. Results from this study will guide the developments of
interventions that target disordered sleep with potential effects on disability in RA.
Reports of Suspected Remicade (Infliximab) Side Effects
Infusion Related Reaction (1121),
Crohn's Disease (639),
Dyspnoea (576),
Drug Ineffective (445),
Skin Cancer (440),
Arthralgia (391),
Pneumonia (375),
Pain (356),
Herpes Zoster (344),
Nausea (341), more >>
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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 12 ratings/reviews, Remicade has an overall score of 6.50. The effectiveness score is 8.67 and the side effect score is 5.50. 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 46 year old male patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Moderately Effective |
| Side effects: | | Severe Side Effects | | |
Treatment Info |
| Condition / reason: | | Colitis |
| Dosage & duration: | | Not sure (dosage frequency: 8 weeks) for the period of Still taking |
| Other conditions: | | None |
| Other drugs taken: | | None | | |
Reported Results |
| Benefits: | | Stopped bleeding and relieved some abdominal cramps. |
| Side effects: | | After only 3 treatments I have developed common side effects, as in dizzines which keeps me from being too active. I am always tired even though I am finally sleeping most of the night, I have developed the bumps on the forhead that everyone talks about, and I have the need to constantly unrinate. I have been reading reviews online now for a week and am getting concerned because most comments show that people find the side effects worse than the condition and I have just started. I believe that I am also suffering from depression, but because I am a single parent I try to keep myself busy with family issues which allows me to put aside the bad feelings temporarily. |
| Comments: | | Have done 3 infusions, starting with 2 weeks after first and then 4 weeks. Now I am awaiting my 4th which will be 8 weeks. The staff have been great, from the nurse who does the procedure to the councillor at Bio-Advance, but the one draw back is that I have been telling both the nurse and the councillor about my side effects and they acted so surprised. So why did I find out by going online myself that these side effects are common? |
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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: 2014-12-01
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