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Lupus Pathogenesis May Involve Epstein-Barr Virus

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Lupus Pathogenesis May Involve Epstein-Barr Virus 28 Lupus/CT Diseases R HEUMATOLOGY N EWS • May 2006 Lupus Pathogenesis May Involve Epstein-Barr Virus BY NANCY WALSH antinuclear antibodies that begin to ap- his colleagues investigated a group of 117 also lend credence to its etiologic proba- New York Bureau pear in lupus patients’ sera long before children and adolescents with lupus. bility. It infects B cells—B-cell dysregula- clinical disease develops. An association of Among patients aged 4-19 years, an infec- tion is prominent in lupus—and EBV itself N EW Y ORK — Evidence is mounting lupus with Epstein-Barr virus (EBV) was tion rate of approximately 70% would be can cause B-cell activation and autoanti- that implicates the Epstein-Barr virus as first noted more than 3 decades ago, but the expected, and indeed, that was what was body production. Among the antibodies the trigger that sets off the autoantibody technical means of proving a connection found among 153 controls, he said. that have been identified in patients with production central to the pathogenesis of was lacking, and the idea was set aside. Among the lupus patients, however, EBV-related mononucleosis are those tar- systemic lupus erythematosus, according The EBV hypothesis was resurrected 99% had seroconverted against EBV. “This geting the Sm autoantigen, which other- to Dr. John B. Harley. during the 1990s, however. Because al- was an odds ratio of 50,” Dr. Harley said wise is considered specific for lupus. It has long been assumed that an etio- most all adults are infected with the at a rheumatology meeting sponsored by Infection is lifelong, providing continu- logic agent from the environment would be virus—a hindrance to finding an epi- New York University. ous immune stimulation, and curiously, required to initiate the production of the demiologic connection—Dr. Harley and Certain characteristics of the virus itself the virus also generates proteins that in- hibit its own immune-mediated destruc- tion, Dr. Harley said. ARTHROTEC® (diclofenac sodium /misoprostol) tablets diclofenac treatment. In a large, open, controlled trial, meaningful elevations of ALT and/or AST abortifacient, but the drug’s teratogenic mechanism has not been demonstrated. Several reports occurred in about 4% of 3,700 patients treated for 2–6 months, including marked elevations (ie, in the literature associate the use of misoprostol during the first trimester of pregnancy with skull In lupus, it is the host response to the Before prescribing, please consult complete prescribing information. more than 8 times the ULN) in about 1% of the 3,700 patients. In that open-label study, a higher defects, cranial nerve palsies, facial malformations, and limb defects. CONTRAINDICATIONS AND WARNINGS incidence of borderline (less than 3 times the ULN), moderate (3–8 times the ULN), and marked An oral teratology study has been performed at dose combinations 0.8 times the virus that is the crucial aberrant factor, ARTHROTEC® CONTAINS DICLOFENAC SODIUM AND MISOPROSTOL. ADMINISTRATION OF (>8 times the ULN) elevations of ALT or AST was observed in patients receiving diclofenac when recommended maximum human dose and has revealed no evidence of teratogenic MISOPROSTOL TO WOMEN WHO ARE PREGNANT CAN CAUSE ABORTION, compared to other NSAIDs. potential for ARTHROTEC. rather than the virus itself, said Dr. Harley, PREMATURE BIRTH, OR BIRTH DEFECTS. UTERINE RUPTURE HAS BEEN REPORTED WHEN Postmarketing surveillance has found rare cases of severe hepatic reactions, including liver However, animal reproduction studies are not always predictive of human response. There are no MISOPROSTOL WAS ADMINISTERED IN PREGNANT WOMEN TO INDUCE LABOR OR TO necrosis, jaundice, and fulminant fatal hepatitis with and without jaundice. Some of these rare adequate and well-controlled studies in pregnant women. INDUCE ABORTION BEYOND THE EIGHTH WEEK OF PREGNANCY (See also reported cases underwent liver transplantation. Severe hepatotoxicity may develop without a professor of immunology and medicine, PRECAUTIONS). ARTHROTEC SHOULD NOT BE TAKEN BY PREGNANT WOMEN (See prodrome of distinguishing symptoms. Transaminases should be monitored within 4 to 8 weeks Nursing mothers: Because of the potential for serious adverse reactions in nursing infants, CONTRAINDICATIONS, WARNINGS and PRECAUTIONS). after initiating treatment with diclofenac. The misoprostol component of ARTHROTEC does not ARTHROTEC is not recommended for use by nursing mothers. University of PATIENTS MUST BE ADVISED OF THE ABORTIFACIENT PROPERTY AND WARNED NOT TO GIVE appear to exacerbate the hepatic effects caused by the diclofenac sodium component. A patient Labor and Delivery: In rat studies with NSAIDs, as with other drugs known to inhibit THE DRUG TO OTHERS. with symptoms and/or signs suggesting liver dysfunction, or in whom an abnormal liver test has prostaglandin synthesis, an increased incidence of dystocia, delayed parturition, and decreased ‘Lupus patients Oklahoma ARTHROTEC should not be used in women of childbearing potential unless the patient occurred, should be evaluated for evidence of the development of more severe hepatic reaction pup survival occurred. Health Sciences requires nonsteroidal anti-inflammatory drug (NSAID) therapy and is at high risk of while on therapy with ARTHROTEC. If abnormal liver tests persist or worsen, if clinical signs Pediatric use: Safety and effectiveness of ARTHROTEC in pediatric patients have not were shown to developing gastric or duodenal ulceration or for developing complications from gastric or and/or symptoms consistent with liver disease develop, or if systemic manifestations occur (eg, been established. duodenal ulcers associated with the use of the NSAID. (See WARNINGS). In such patients, eosinophilia, rash, etc), ARTHROTEC should be discontinued immediately. Inform patients of the Center, Okla- warning signs and symptoms of hepatotoxicity (eg, nausea, fatigue, lethargy, pruritus, jaundice, Geriatric use: As with any NSAIDs, caution should be exercised in treating the elderly (65 ARTHROTEC may be prescribed if the patient: years and older). Of the more than 2,100 subjects in clinical studies with ARTHROTEC, 25% make higher •has had a negative serum pregnancy test within 2 weeks prior to beginning therapy. right upper quadrant tenderness, and “flu-like” symptoms), and the appropriate action patients homa City. An should take if these signs and symptoms appear. were 65 and over, while 6% were 75 and over. In studies with diclofenac, 31% of subjects were •is capable of complying with effective contraceptive measures. 65 and over. No overall differences in safety or effectiveness were observed between these alteration in hu- •has received both oral and written warnings of the hazards of misoprostol, the risk of possible Anaphylactoid reactions: As with other NSAIDs, anaphylactoid reactions may occur in patients subjects and younger subjects, and other reported clinical experience has not identified concentrations of contraception failure, and the danger to other women of childbearing potential should the drug without known prior exposure to ARTHROTEC. ARTHROTEC should not be given to patients with differences in responses between the elderly and younger patients, but greater sensitivity of moral response be taken by mistake. the aspirin triad. This symptom complex typically occurs in asthmatic patients who experience some older individuals cannot be ruled out. As with any NSAID, the elderly are likely to tolerate •will begin ARTHROTEC only on the second or third day of the next normal menstrual rhinitis with or without nasal polyps, or who exhibit severe, potentially fatal bronchospasm after adverse events less well than younger patients. Diclofenac is known to be substantially antibody against period. taking aspirin or other NSAIDs. Emergency help should be sought in cases where an anaphylactoid excreted by the kidney, and the risk of toxic reactions to ARTHROTEC may be greater in patients to Epstein-Barr Cardiovascular Risk reaction occurs. with impaired renal function. Because elderly patients are more likely to have decreased renal nuclear antigen •NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, Skin Reactions: NSAIDs, including ARTHROTEC, can cause serious skin adverse events such as function, care should be taken in dose selection, and it may be useful to monitor renal function. the fragments myocardial infarction, and stroke, which can be fatal. This risk may increase with exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), Based on studies in the elderly, no adjustment of the dose of ARTHROTEC is necessary in the duration of use. Patients with cardiovascular disease or risk factors for cardiovascular which can be fatal. These serious events may occur without warning. Patients should be informed elderly for pharmacokinetic reasons although many elderly may need to receive a reduced dose 1 (EBNA-1) ap- disease may be at greater risk. (see WARNINGS). about the signs and symptoms of serious skin manifestations and use of drug should be because of low body weight or disorders associated with aging. encompassing the pears to be in- •ARTHROTEC is contraindicated for treatment of peri-operative pain in the setting of coronary discontinued at the first appearance of skin rash or any other sign of hypersensitivity. ADVERSE REACTIONS: Adverse reactions associated with ARTHROTEC artery bypass graft (CABG) surgery (see WARNINGS). Pregnancy: In late pregnancy, as with other NSAIDs, ARTHROTEC should
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