Gene/Protein Disease Symptom Drug Enzyme Compound
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Query: UMLS:C0033774 (pruritus)
 14,546 document(s) hit in 31,850,051 MEDLINE articles (0.00 seconds)

Data about adverse events can be particularly useful when assessing newly marketed drugs. However, spontaneous reporting of adverse events does not generally provide sufficient or highly accurate data on incidence and prevalence. In order to provide the most complete and accurate data, a postmarketing surveillance program (PMSP) for auranofin (AF) oral gold therapy for rheumatoid arthritis (RA) was conducted in the Federal Republic of Germany (FRG) from December 1982 through December 1985. The objectives of the program were to observe a large population treated with AF for more than a year; to compare the safety profile of AF with experience from clinical trials; and to register rare or previously unknown adverse events. The program included 2,777 patients with RA from 928 test centers. Disease duration was less than 2 years in 29%. 2-5 in 23.2%, 5-10 in 32.5%, and more than 10 in 13.3% (no data for 2%); disease was mild or moderate in 67.4% and severe in 29.9% (no data for 2.7%). Auranofin was given 6 mg/day as either two 3-mg tablets at breakfast or 1 tablet at breakfast and 1 at the evening meal. Laboratory studies and efficacy, as indicated by increase in grip strength and decrease in number of tender and swollen joints, were monitored regularly. A total of 1,595 patients completed 1 year of treatment with AF. Withdrawals included 12.9% for adverse events, 4.2% for insufficient therapeutic effect, and 33.1% for a variety of administrative or technical reasons. The most common adverse event was alteration in stool pattern, which occurred in 22.5% of patients, compared with 46.6% in worldwide AF clinical trials. Other gastrointestinal symptoms occurred in 17.4%, compared with 22.4% worldwide. The occurrence of most adverse events in the PMSP was much less than in worldwide studies, for example: skin rash 7.3% vs. 24.2% worldwide, pruritus 4.2% vs. 16.6%, proteinuria 1.0% vs. 5.0%, and leukopenia 0.7% vs. 1.9%. These discrepancies may be explained by the method of monitoring employed in the postmarketing study, which favored the reporting of only clinically relevant adverse events. The pattern of occurrence of adverse events was similar to that seen during other AF trials, indicating that any intolerance to AF occurs primarily within the first 6 months of treatment. However, hematologic or nephrologic adverse events appear to be independent of time on therapy, with a constant monthly prevalence of about 0.1-0.2%.(ABSTRACT TRUNCATED AT 400 WORDS)
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PMID:Postmarketing experience with auranofin in the Federal Republic of Germany. 329 83

An open study in Belgium assessed the clinical efficacy and safety of auranofin (AF) in treating psoriatic arthritis. The study enrolled 29 patients; median age was 46 years and median duration of disease was 5.5 years. Patients received 6 mg AF daily, given as two 3-mg tablets once a day. Concomitant therapy with nonsteroidal anti-inflammatory drugs (NSAIDs) and corticosteroids was permitted. Efficacy of auranofin was apparent by 3 months after the start of treatment, as evidenced by improvement over baseline in number of tender joints, severity of pain, and erythrocyte sedimentation rate. After 1 year of auranofin therapy there was 50% or greater improvement over baseline in these parameters in 11% to 41% of the total population, and in 19% to 69% of those who completed at least 1 year of treatment. Diarrhea was reported in 45% of patients, occurring most often during the first 6 months of therapy. Nausea occurred in 10%; abdominal pain in 7%; rash in 14%; and pruritus in 17%. Withdrawals because of adverse events totaled 4: 1 for rash, 2 for pruritus, and 1 for rash, pruritus, and purpura. Auranofin may be considered an effective and safe therapeutic alternative for the treatment of psoriatic arthritis.
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PMID:An open study on the efficacy and safety of auranofin in treating psoriatic arthritis. 347 79

The chemistry, pharmacology, pharmacokinetics, clinical use and efficacy, adverse effects, and dosage of auranofin, an oral chrysotherapeutic agent used in treatment of rheumatoid arthritis, are reviewed. Auranofin is lipid-soluble and is monomeric in solution. It has a modulatory effect on both the humoral and cellular immune systems. Auranofin may be a condition-dependent immunoregulating agent rather than an immunosuppressive agent. It inhibits (1) monocyte-mediated antibody-dependent cellular toxicity, (2) release of enzymes from polymorphonuclear leukocytes that may contribute to the pathogenesis of rheumatoid arthritis, and (3) neutrophil activity. In patients with rheumatoid arthritis, 15-33% of an oral dose of auranofin 6 mg is absorbed. Peak plasma gold concentrations are achieved in one to two hours. Gold is highly protein bound. Elimination occurs through the feces and urine; 73-100% of auranofin gold is excreted. Plasma half-life is three weeks. Patients receiving auranofin 3 mg twice daily for rheumatoid arthritis reported improvement after five weeks of therapy; improvement has also been reported with lower doses. Diarrhea, rashes, and pruritus were the most common adverse effects. Auranofin is safe and effective for short- and long-term treatment of patients with rheumatoid arthritis. Its relative safety and potency compared with injectable gold salts and other drugs need further study.
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PMID:Review of auranofin, an oral chrysotherapeutic agent. 642 43

Auranofin is the first orally active gold compound for the treatment of rheumatoid arthritis. Like other chrysotherapeutic agents, its exact mechanism of action is unknown, but it probably acts via immunological mechanisms and alteration of lysosomal enzyme activity. Although long term clinical experience with auranofin is limited, its efficacy appears to approach that of sodium aurothiomalate. Further comparative studies with aurothioglucose, hydroxychloroquine and D-penicillamine are required before definitive statements can be made regarding the relative efficacy of auranofin and these agents. While patients have demonstrated clinical remission of rheumatoid arthritis in response to auranofin therapy, radiological studies have been inconclusive regarding its effect on the occurrence or progression of erosive lesions. Auranofin is relatively well tolerated in most patients, but diarrhoea, skin rash, and pruritus are sometimes troublesome, and thrombocytopenia and proteinuria are potentially serious side effects which may occur during therapy. Whereas mucocutaneous side effects are more frequent with injectable gold compounds, gastrointestinal reactions are the most common adverse effect seen with auranofin. The frequency of side effects has been similar with auranofin and sodium aurothiomalate, but they are generally less severe with auranofin. While some of the side effects are controlled by a reduction in dosage, temporary or permanent withdrawal of auranofin may be necessary. Auranofin is clearly a useful addition to the limited list of agents with disease-modifying potential presently available for the treatment of rheumatoid arthritis. It will doubtless generate much interest as its final place in therapy becomes better defined through additional well-designed studies and wider clinical experience.
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PMID:Auranofin. A preliminary review of its pharmacological properties and therapeutic use in rheumatoid arthritis. 642 23

Auranofin (Ridaura SK and F 39 162) was tested in an open multicenter study with regard to its anti-inflammatory effect in 166 patients suffering from rheumatoid arthritis. The time for treatment lasted for one or two years. The therapeutic effect of the drug was judged by its influence on pain, joint swelling, morning stiffness, grip strength, blood-sedimentation rate and rheumatoid factor etc. The serum gold concentration was measured regularly. With Auranofin the majority of the patients achieved a lasting improvement of the condition. The therapeutical effect was observed gradually. Side-effects were frequent but removal from the therapy was rare. Most of the side-effects were diarrhea, rash, pruritus and conjunctivitis. Regular laboratory controls revealed in some cases toxic organic reactions.
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PMID:[Auranofin in the treatment of chronic polyarthritis. Results of an open multicenter study]. 644 53

A multicenter double-blind comparative study with auranofin (Ridaura) and Na-auro-thiomalate (Tauredon) was carried out in order to investigate under controlled conditions whether the new oral gold compound may be an alternative to injections of gold salts. 121 patients were included in the study, data of 86 patients treated for at least one year could be analysed. The following parameters were examined at regular intervals: number of painful and swollen joints, grip strength, morning stiffness, pain and general health on the visual analogue scale, ESR; from these data the articular index and activity index (according to Lansbury, with slight modifications) were calculated. Blood samples for routine safety monitoring and serum gold levels as well as urine tests were obtained regularly. Both treatment groups showed similar improvement in the values for efficacy measurements after one year, starting within 8 to 12 weeks. Patients in the auranofin group with a disease duration of less than 2 years showed greater improvement in the values for efficacy assessment with the exception of grip strength and the number of tender joints than patients with a disease duration of 2 years or more. No such trend was seen in the Tauredon-subgroups. Numerous side effects were recorded in both groups: 89.7% of the patients on Tauredon and 68.8% of the patients on auranofin had observed one symptom during the course of one year. There was a clear distinction concerning the nature of side effects: mucocutaneous symptoms, especially rash and pruritus, were approximately twice as common with Tauredon, whereas diarrhoea was much more frequent in patients treated with auranofin.(ABSTRACT TRUNCATED AT 250 WORDS)
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PMID:[Multicenter double-blind comparison of auranofin and Tauredon]. 644 55

Oral gold(Auranofin; SKF) 6 mg/d has been used in an open study in 31 patients with active rheumatoid disease, 19 of whom have been on continuous treatment for 1 year. Four of these patients were considered to be in remission and 9 had a good clinical response to treatment. Four showed only minimal improvement and 2 did not improve at all. There were, however, no changes in the biochemical parameters of inflammation, e.g. haemoglobin concentration, erythrocyte sedimentation rate, platelet count and rheumatoid factor, or in renal and hepatic function. Of the 31 patients, 9 (29%) have discontinued treatment but only 3 (9.7%) because of side-effects. Minor side-effects have been fairly common, occurring in 19 patients (61%), and included skin rashes and pruritus, diarrhoea and loose stools, nausea, stomatitis and thrombocytopenia or leucopenia. Oral gold would seem to be a safer, less potent form of chrysotherapy than parenteral gold.
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PMID:An oral gold formulation in rheumatoid arthritis. A 12-month follow-up report. 681 Apr 77

Auranofin (AF), a new gold compound, has been suggested as an alternative to parenteral gold in the treatment of rheumatoid arthritis (RA). This hypothesis has been tested within a double-blind comparative study and to date 103 patients have been enrolled. Forty-one RA patients have been treated for longer than 6 months. The patients were randomly allocated to treatment with either AF or sodium aurothiomalate (GSTM) and serial comparison of changes within the articular index, grip strength, pain, morning stiffness, and global assessment during treatment were measured. Improvement was noted within both treatment groups. Diarrhea as a side effect was most commonly seen during treatment with AF while rash often combined with pruritus was most commonly reported with GSTM; withdrawal from treatment as the result of this was nevertheless uncommon.
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PMID:Auranofin and sodium aurothiomalate in the treatment of rheumatoid arthritis. A double-blind, comparative multicenter study. 681 83