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Ridaura (Auranofin) - Summary

 



Ridaura (auranofin) contains gold and, like other gold-containing drugs, can cause gold toxicity, signs of which include: fall in hemoglobin, leukopenia below 4,000 WBC/cu mm, granulocytes below 1,500/cu mm, decrease in platelets below 150,000/cu mm, proteinuria, hematuria, pruritus, rash, stomatitis or persistent diarrhea. Therefore, the results of recommended laboratory work (See PRECAUTIONS) should be reviewed before writing each Ridaura prescription. Like other gold preparations, Ridaura is only indicated for use in selected patients with active rheumatoid arthritis. Physicians planning to use Ridaura should be experienced with chrysotherapy and should thoroughly familiarize themselves with the toxicity and benefits of Ridaura.

In addition, the following precautions should be routinely employed:

  1. The possibility of adverse reactions should be explained to patients before starting therapy.
  2. Patients should be advised to report promptly any symptoms suggesting toxicity. (See PRECAUTIONS—Information for Patients.)
 

RIDAURA SUMMARY

PRESCRIBING INFORMATION
RIDAURA.
Auranofin
Capsules

Ridaura (auranofin) is available in oral form as capsules containing 3 mg auranofin.

Ridaura (auranofin) is indicated in the management of adults with active classical or definite rheumatoid arthritis (ARA criteria) who have had an insufficient therapeutic response to, or are intolerant of, an adequate trial of full doses of one or more nonsteroidal anti-inflammatory drugs. Ridaura should be added to a comprehensive baseline program, including non-drug therapies.

Unlike anti-inflammatory drugs, Ridaura does not produce an immediate response. Therapeutic effects may be seen after three to four months of treatment, although improvement has not been seen in some patients before six months.

When cartilage and bone damage has already occurred, gold cannot reverse structural damage to joints caused by previous disease. The greatest potential benefit occurs in patients with active synovitis, particularly in its early stage.

In controlled clinical trials comparing Ridaura with injectable gold, Ridaura was associated with fewer dropouts due to adverse reactions, while injectable gold was associated with fewer dropouts for inadequate or poor therapeutic effect. Physicians should consider these findings when deciding on the use of Ridaura in patients who are candidates for chrysotherapy.


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NEWS HIGHLIGHTS

Media Articles Related to Ridaura (Auranofin)

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 Ridaura (Auranofin)

Does sulphasalazine cause drug induced systemic lupus erythematosus? No effect evident in a prospective randomised trial of 200 rheumatoid patients treated with sulphasalazine or auranofin over five years. [1999.05]
BACKGROUND: Sulphasalazine (SSZ) has been reported to cause drug induced systemic lupus erythematosus (SLE), but diagnosis of this complication in the context of rheumatoid arthritis (RA) is difficult. OBJECTIVE: To determine prospectively: (1) if patients become seropositive for antinuclear antibodies (ANA) during prolonged treatment with SSZ without clinical evidence of SLE; (2) if ANA positive patients develop more adverse reactions than ANA negative patients; (3) if drug induced SLE was identified in this cohort... CONCLUSION: ANA positivity is common in patients with RA, but the presence or development of ANA did not increase the likelihood of withdrawing from treatment. No case of drug induced SLE was seen over five years in this study.

A long-term five-year randomized controlled trial of hydroxychloroquine, sodium aurothiomalate, auranofin and penicillamine in the treatment of patients with rheumatoid arthritis. [1998.09]
CONCLUSION: Despite the increased popularity of sulphasalazine and inmmunosuppressives, the drugs in this study continue to be used worldwide. The natural history of rheumatoid arthritis requires long-term follow up to establish drug efficacy. Evidence is needed as to whether the newer regimens will prove to be more effective and safer in the longer term than the commonly prescribed DMARDs. The data from this trial will provide a reference for comparison with future studies.

CPH-82 (Reumacon) versus auranofin (Ridaura): a 36-week study of their respective onset of action rates in RA. [1998]
The onset of action rate of CPH-82 (Reumacon), was compared with that of auranofin (AUR; Ridaura) in a 36-week randomised, double-blind, multicentre study of 60 patients with rheumatoid arthritis (RA). As compared with respective baseline values, the CPH-82 group manifested significant improvement in grip strength, Ritchie's articular index (RAI), pain ratings, and HAQ (health assessment questionnaire) scores after 8, 12, 24, and 36 weeks of treatment, with the exception of the 24-week HAQ score...

Auranofin is safe and superior to placebo in elderly-onset rheumatoid arthritis. [1997.08]
The efficacy, toxicity and possible steroid-sparing properties of auranofin in the treatment of elderly-onset rheumatoid arthritis (EORA) were studied in a 2 yr prospective double-blind placebo-controlled clinical trial. Sixty-five patients with onset of arthritis after the age of 60 yr were randomized to either auranofin 3 mg b.i.d...

Sulfasalazine has a better efficacy/toxicity profile than auranofin--evidence from a 5 year prospective, randomized trial. [1996.11]
OBJECTIVE: To compare results of medium to longterm sulfasalazine and auranofin treatment in active rheumatoid arthritis (RA)... CONCLUSION: Sulfasalazine therapy was more likely to be continued for 5 years, suggesting better tolerability and/or efficacy than auranofin, and produced evidence of continuing benefit. Patients previously withdrawn from i.m. gold therapy because of inefficacy or minor toxicity should not be given auranofin therapy.

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Page last updated: 2009-11-15

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