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Arava (Leflunomide) - Summary

 



CONTRAINDICATIONS AND WARNINGS

PREGNANCY MUST BE EXCLUDED BEFORE THE START OF TREATMENT WITH ARAVA. ARAVA IS CONTRAINDICATED IN PREGNANT WOMEN, OR WOMEN OF CHILDBEARING POTENTIAL WHO ARE NOT USING RELIABLE CONTRACEPTION. (SEE CONTRAINDICATIONS AND WARNINGS.) PREGNANCY MUST BE AVOIDED DURING ARAVA TREATMENT OR PRIOR TO THE COMPLETION OF THE DRUG ELIMINATION PROCEDURE AFTER ARAVA TREATMENT.

 

ARAVA SUMMARY

ARAVA® (leflunomide) is a pyrimidine synthesis inhibitor. The chemical name for leflunomide is N-(4'-trifluoromethylphenyl)-5-methylisoxazole-4-carboxamide.

ARAVA is indicated in adults for the treatment of active rheumatoid arthritis (RA):

  1. to reduce signs and symptoms
  2. to inhibit structural damage as evidenced by X-ray erosions and joint space narrowing
  3. to improve physical function.

(see CLINICAL STUDIES)

Aspirin, nonsteroidal anti-inflammatory agents and/or low dose corticosteroids may be continued during treatment with ARAVA (see PRECAUTIONS -- Drug Interactions -- NSAIDs). The combined use of ARAVA with antimalarials, intramuscular or oral gold, D penicillamine, azathioprine, or methotrexate has not been adequately studied (see WARNINGS -- Immunosuppression Potential/Bone Marrow Suppression).


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NEWS HIGHLIGHTS

Media Articles Related to Arava (Leflunomide)

Adeona Announces Publication Of Results Of 160 Patient Phase 2 Clinical Trial Of Oral DnaJP1 For Rheumatoid Arthritis
Source: Arthritis / Rheumatology News From Medical News Today [2009.11.15]
Adeona Pharmaceuticals, Inc. (AMEX: AEN) announced the publication in the journal Arthritis & Rheumatism of results of a 160-patient, six-month, double-blind, placebo-controlled Phase 2 clinical trial using the company's oral dnaJP1 for the treatment of rheumatoid arthritis (RA). The results of the study were originally presented at the 2008 American College of Rheumatology Annual Meeting. The study was sponsored by the National Institutes of Health (NIH).

Judgement In Favour Of NICE On Judicial Review Of Abatacept For Rheumatoid Arthritis Guidance
Source: Arthritis / Rheumatology News From Medical News Today [2009.11.10]
The High Court has ruled in favour of NICE by dismissing the application from Bristol Myers Squibb (BMS), the manufacturer of abatacept, for a judicial review of the NICE guidance on the use of abatacept for the treatment of rheumatoid arthritis. In April 2008, NICE published final guidance which did not recommend abatacept as a treatment option for people with rheumatoid arthritis.

How Rheumatoid Arthritis Spreads
Source: MedicineNet Rheumatoid Arthritis Specialty [2009.11.10]
Title: How Rheumatoid Arthritis Spreads
Category: Health News
Created: 11/10/2009 9:50:00 AM
Last Editorial Review: 11/10/2009 9:50:12 AM

Rheumatoid Arthritis Treatment Doesn't Promote Cancer (HealthDay)
Source: Y! Health Arthritis News [2009.10.29]
HealthDay - THURSDAY, Oct. 29 (HealthDay News) -- Treatment with tumor necrosis factor (TNF) blockers doesn't increase rheumatoid arthritis patients' risk of cancer, new research has found.

Advancing Personalized Medicine In Rheumatoid Arthritis
Source: Arthritis / Rheumatology News From Medical News Today [2009.10.26]
The University of Alabama at Birmingham (UAB) is spearheading an effort to create a national database and repository to enable researchers to identify predictors of effectiveness of various treatments for rheumatoid arthritis (RA). RA is the most common type of inflammatory arthritis. Many effective medications exist, but they vary greatly in cost and side effects, and there is no way to predict which drug will work best on an individual. A two-year, $3.

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Published Studies Related to Arava (Leflunomide)

Elevated relapse rate under oral methotrexate versus leflunomide for maintenance of remission in Wegener's granulomatosis. [2007.07]
Objectives... Further studies testing other dosing regimens of lower doses of LEF are needed to confirm these promising results in larger patients cohorts.

Elevated relapse rate under oral methotrexate versus leflunomide for maintenance of remission in Wegener's granulomatosis. [2007.05.22]
Objectives... Further studies testing other dosing regimens of lower doses of LEF are needed to confirm these promising results in larger patients cohorts.

Safety and efficacy of Leflunomide in primary Sjogren's syndrome - A phase II pilot study. [2007.01.12]
OBJECTIVES: For invalidating symptoms in primary Sjogren's syndrome (pSS), a need remains for easy-to- administer, (cost)-effective and well-tolerated systemic therapy. Leflunomide (LEF) is structurally unrelated to other immunomodulatory drugs and might be efficacious in pSS, given its characteristic immunoregulatory modes of action. We performed a phase II open label pilot study to investigate the safety and efficacy of LEF in pSS... CONCLUSIONS: Although the safety profile seems fairly acceptable, the observed indications for efficacy were modest and may provide doubt on justifying a randomized controlled trial of LEF in pSS.

Randomised controlled trial of leflunomide in the treatment of immunoglobulin A nephropathy. [2006.04]
AIM: To investigate the effect of leflunomide for treatment of immunoglobulin A (IgA) nephropathy... CONCLUSION: These preliminary results are encouraging, but further randomised studies are required before leflunomide can be recommended for the treatment of IgA nephropathy.

Combination of cyclosporine and leflunomide versus single therapy in severe rheumatoid arthritis. [2006.03]
OBJECTIVE: This study assessed the efficacy and safety of combination (COMB) of cyclosporine (CSA) and leflunomide (LEF) versus each drug alone, in the treatment of severe rheumatoid arthritis (RA)... CONCLUSION: The combination of CSA and LEF in patients with refractory RA provided statistically significant benefit in ACR50 and ACR70. Adverse events were not substantially increased.

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Clinical Trials Related to Arava (Leflunomide)

Triple III Comparison of Leflunomide Alone Versus Two DMARD Combinations in the Treatment of Rheumatoid Arthritis [Active, not recruiting]
The study has been designed as a 48-week, double-blind, randomized, controlled study comparing the use of leflunomide alone to combinations of leflunomide-sulfasalazine-HCQ, and methotrexate-sulfasalazine-HCQ.

Bioavailability Study of Leflunomide Tablets Under Fed Conditions [Completed]

Bioavailability Study of Leflunomide Tablets Under Fasting Conditions [Completed]

Leflunomide + Methotrexate in Rheumatoid Arthritis [Completed]

Leflunomide to Treat Uveitis [Completed]
This study will investigate the safety and effectiveness of the drug Leflunomide to treat uveitis-an inflammation of the eye caused by an immune system abnormality. Leflunomide suppresses immune system activity and has been shown to control autoimmune diseases, such as arthritis (joint inflammation), in animals. It has also improved symptoms in patients with rheumatoid arthritis, and the Food and Drug Administration has approved it for treating patients with this disease. Eye and joint inflammation may have similar causes, and medicines for arthritis often help patients with eye inflammation. This study will examine whether Leflunomide can help patients with uveitis.

Patients with uveitis who are not responding well to steroid treatment and patients who have side effects from other medicines used to treat uveitis (such as cyclosporine, cyclophosphamide, methotrexate or azathioprine) or have refused treatment because of possible side effects of these medicines may be eligible for this study. Candidates will be screened with a medical history, physical examination, blood test and eye examination. The eye exam includes a check of vision and eye pressure, examination of the back of the eye (retina) with an ophthalmoscope and the front of the eye with a microscope. They will also undergo a procedure called fluorescein angiography to look at the blood vessels of the eye. A dye called sodium fluorescein is injected into the bloodstream through a vein. After the dye reaches the blood vessels of the eye, photographs are taken of the retina.

Study participants will be divided into two groups. One group will take 100 milligrams of Leflunomide once a day for 3 days and then 20 milligrams once a day for 6 months. The other group will take a placebo-a pill that looks like the Leflunomide pill but does not contain the medicine. All patients in both groups will also take prednisone. Patients will have follow-up examinations at weeks 1, 4, 8, 12, 16, and 24 (6 months) of the study. Each follow-up visit will include a repeat of the screening exams and an evaluation of side effects or discomfort from the medicine. Those who do well and want to continue their assigned treatment after 6 months can continue that treatment for another 6 months and will have follow-up exams at months 9 and 12.

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PATIENT REVIEWS / RATINGS / COMMENTS

Based on a total of 1 ratings/reviews, Arava has an overall score of 8. The effectiveness score is 10 and the side effect score is 8. The scores are on ten point scale: 10 - best, 1 - worst.
 

Arava review by 72 year old female patient

  Rating
Overall rating:  
Effectiveness:   Highly Effective
Side effects:   Mild Side Effects
  
Treatment Info
Condition / reason:   arthritis
Dosage & duration:   10mg taken 1 daily for the period of 6 months
Other conditions:   Lupus
Other drugs taken:   Remicade
  
Reported Results
Benefits:   Good I am able to walk better. My hips do not very much now.
Side effects:   Hair loss Extreem and I am having skin problems since i have been taking Arava.This has caused me to be very depressed.
Comments:   I take one arava tabs. each morning.It works very well. I can tell a big difference in my body since taking the arava.

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Page last updated: 2009-11-15

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