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PubMed2000

The benefit of combining hydroxychloroquine with quinacrine in the treatment of SLE patients.

BACKGROUND: Although the benefit of antimalarials in the treatment of cutaneous LE is well established, the effect of combined hydroxychloroquine and quinacrine treatment in systemic lupus erythematosus with major organ involvement remains underappreciated. PATIENTS: Six active SLE patients (SLEDAI score > 5 points), with a mean duration of illness 9.1 yr (range 2-17 yr) were started on quinacrine (100 mg/d) following failure to achieve clinical remission on a therapeutic regimen which included a maintenance dose of hydroxychloroquine (400 mg/d) together with prednisone (either 10-20 mg/d or higher daily doses of this agent for short periods) and azathioprine (150 mg/d) or methotrexate (7.5 mg/week). OUTCOME: In 5/6 of the patients the addition of quinacrine to the previous treatment resulted in complete remission (SLEDAI 0-2 points), which persisted over the follow-up period [mean +/- 2.2 yr (range 0.5-3.5)]. During this period hydroxychloroquine and azathioprine were reduced to 200 mg/d and 100 mg/d respectively, whereas prednisone was modified as follows: in 2 patients daily administration was discontinued; in one the dose was reduced to 2.5 mg/d (from that of > or = 20 mg/d); in 2 others the previous need for an intermittent course was avoided. However, in one out of the six patients the addition for 3 months of quinacrine to the therapeutic protocol did not result in clinical improvement and was therefore discontinued. CONCLUSIONS: The promising results of this preliminary investigation encourages the combined use of the two antimalarial drugs in appropriate candidates. This modality may induce remission, seems to be safe and possesses a steroid sparing effect.

Adult↗

PubMed2000

How accelerated atherosclerosis in SLE has changed our management of the disorder.

Basic science insights along with the assessment of risk factors so clearly documented by the Canadian and Hopkins cohorts in earlier papers of this special issue have clearly led to a change in the way rheumatologists manage SLE. This review will highlight specific ways it should alter our day to day treatment of lupus patients.

Antibodies, Antiphospholipid↗

PubMed2000

Lost-to-follow-up study in systemic lupus erythematosus (SLE).

OBJECTIVE: To determine the extent of and reasons for lost-to-follow-up, as well as its impact on outcome studies in a cohort of lupus patients. METHODS: As of September 1991, 247 patients, in a cohort of 621 patients with SLE, being followed in a long-term prognosis study, had not been seen since 1 March, 1990 and were considered lost-to-follow-up. Patients were contacted and encouraged to return for an evaluation or to answer a questionnaire by telephone. Descriptive statistics were used to compare the lost-to-follow-up and non-lost-to-follow-up patients and the survival experience during the lost-to-follow-up period was compared with that when patients were not considered lost-to-follow-up. Estimated survival curves with and without the information gained through contacts with lost-to-follow-up patients were compared. RESULTS: Of the 247 patients, 29 have died, 66 returned for a full assessment, 84 completed a questionnaire and 68 (11%) were true lost-to-follow-up. The lost-to-follow-up patient group had 10% more Caucasians and 6% more males than the patients under regular follow-up. The estimated survival curves of the entire cohort with and without the new lost-to-follow-up data, calculated as of July 1992, were very similar. There was no evidence of a differential mortality rate during the period in which patients were lost-to-follow-up. Some suggestive evidence that the relative mortality rate comparing the rate during a period of lost-to-follow-up and during a period of active follow-up may depend on disease duration at the time of lost-to-follow-up was found. CONCLUSIONS: While it would be prudent to limit lost-to-follow-up as much as possible, especially for outcomes such as mortality which do not necessarily require a clinic visit, it does not appear that significant bias will be present in prospective studies based on our single clinic database. Since the retrieved 179 lost-to-follow-up patients did not affect survival studies it is likely that the 68 true lost-to-follow-up patients will also not have an impact on prognostic studies. Lupus (2000) 9, 363-367

Adolescent↗

PubMed2001

A swollen leg unmasks longstanding SLE.

We report a case of long-standing SLE which presented with symptomatic muscle vasculitis on a background of photosensitivity, arthralgia and myalgia. The diagnosis was complicated by cardiomyopathy, nephrotic syndrome and diabetes. We highlight the benefits of aggressive treatment in severe disease and the importance of recognising and treating comorbidity especially ih relation to atherosclerosis.

Adult↗

PubMed2001

Cat scratch disease (bartonellosis) mimicking an SLE flare.

Only recently Bartonella species have been recognized as important human pathogens. Cat scratch disease (CSD), caused by infection with Bartonella henselae, shows a steady increase in the number of cases throughout the world. We report a case of an 18-year-old woman with systemic lupus erythematosus (SLE) who presented with ongoing fever, arthralgias and loss of weight which did not respond to increasing doses of corticosteroids. After exclusion of common infections a photograph of her cat in combination with scratch marks on her arms finally led to the suspicion of CSD. This tentative diagnosis was confirmed serologically. Under clarithromycin treatment the patient rapidly responded and her temperature dropped within 2 days.

Adolescent↗

PubMed2002

Conservation of FcepsilonRI gamma chain coding region in normals and in SLE patients.

High-frequency single nucleotide polymorphism (SNP) alleles are useful in mapping genes responsible for disease susceptibility. Functionally, Fcgamma receptors (FcgammaR) have been implicated in autoimmune disease, and the gene encoding the signaling element for several FcgammaR, Fc-epsilon-receptor gamma-chain (FcepsilonRIgamma), has several SNPs in the immunoreceptor tyrosine activation motif (ITAM) recorded in GenBank. Direct sequencing of the FcepsilonRIgamma coding region found potentially polymorphic sites in the 5'-->3' direction in control donors, which were not confirmed in the reverse direction (n = 66), and further exploration of 80 SLE patients revealed no non-synonymous SNPs. One normal donor was heterozygous for a non-synonymous SNP at nt 38 which changed the fifth codon from valine (GTG) to methionine (ATG). Although the EST databases suggest candidate SNPs, insertions and deletions, these appear to be artifacts, most probably due to secondary structure. The coding region of FcepsilonRIgamma shows a remarkable absence of nucleotide diversity. Either as yet unidentified regulatory elements of FcepsilonRIgamma or other genes in the region of human chromosome 1q23 are likely to be systemic lupus erythematosus disease susceptibility and severity genes.

Amino Acid Sequence↗

PubMed1999

A case of SLE with acute, subacute and chronic cutaneous lesions successfully treated with Dapsone.

We describe a patient with systemic lupus erythematosus (SLE) who exhibited severe cutaneous involvement characterized by the simultaneous presence of acute, subacute and discoid lesions in association with anti-S1 antibodies. After she failed to respond to chloroquine, medium to low dose steroids, steroid pulses, retinoids and cyclophosphamide, the patient was treated with Dapsone and a dramatic improvement in the cutaneous lesions was seen after only one month.

Acute Disease↗

PubMed1999

Equivalence trials in SLE research: issues to consider.

In contrast to the objective of most clinical trials, which is to demonstrate superiority of an experimental treatment over a standard or placebo, the aim of an equivalence trial is to show that two treatments are equivalent in outcome or only marginally different. This would be of interest when an experimental treatment offers advantages such as reduced toxicity, ease of administration, or cost relative to the standard. Demonstrating equivalence may also be a goal when evaluating the safety of certain drugs because similarity in the risks of an adverse event in subjects exposed and unexposed to the drug is an indication of its safety. The classical formulation of the null hypothesis of treatment equality that is used in superiority trials is not applicable to equivalence trials because absolute equivalence between treatment groups cannot be proven. The strategy in equivalence trials is to define a maximum difference between treatment groups that is clinically acceptable and then assess whether there is sufficient evidence from the trial to conclude that the true treatment difference is within this acceptable range. In this paper, we discuss issues surrounding the planning, conduct, and analysis of equivalence trials in the context of SLE, with examples from the SELENA study.

Biometry↗

PubMed1999

Recruitment strategies in superiority trials in SLE: lessons from the study of methotrexate in lupus erythematosus (SMILE).

The task of recruiting patients for a research project can prove to be the most difficult aspect of the entire research process. A large portion of the work of research is devoted to the identification of strategies which ensure a successful recruitment of patients. Every researcher has learned from experience the many methods needed to enhance patient enrollment into trials. Superiority trials in SLE have not been frequent in previous years. This paper describes the challenges encountered with the multicentre SMILE trial in progress across Canada. We identify areas where patient recruitment is a problem, potential reasons for the problem, and the results of tactics used to increase enrollment.

Canada↗

PubMed1999

Methodological issues of corticosteroid use in SLE clinical trials.

OBJECTIVE: To describe and analyze how investigators handled concurrent steroid intake in SLE clinical trials; to identify remaining methodological problems and to discuss potential solutions. METHODS: A review of the literature was performed in Medline to identify randomized controlled trials (RCT) in lupus published during the past decade. A set of criteria was defined a priori to analyze these trials covering different aspects of steroid use in RCTs with regard to eligibility, randomization, post-randomization steroid use, analysis and reporting. RESULTS: Seventeen trials met the inclusion criteria and were analyzed. Median sample size was 30, ranging from 10-71. In three trials corticosteroid application was the study intervention. Three reports did not address steroid use among study subjects at all. In seven trials steroid use was part of the eligibility criteria in some way. Of the trials that allowed concurrent steroid use, seven checked for equal distribution of baseline steroids. In some cases clinically relevant differences did not reach statistical significance as sample sizes were very small. In only one study was randomization stratified for steroid use. Instructions for post-randomization steroid use were specified in only 3 of 14 trials where steroids were not part of the intervention. In 11 RCTs concurrent steroid use was free or no information was provided. Steroid dosing during the intervention was reported as a secondary outcome measure in four trials. CONCLUSIONS: As sample sizes are often small, simple randomization is not reliable to avoid relevant between-group differences in baseline steroids. The power of statistical testing for group differences is limited for the same reason. Stratified randomization is rarely used. Free concurrent steroid use during the intervention is frequently allowed in lupus RCTs despite the risk of bias. Better data and accepted standards for a priori specified steroid regimens in RCTs are highly warranted.

Adrenal Cortex Hormones↗

PubMed1999

Responsiveness and sensitivity to change of SLE disease activity measures.

The ability of outcome measures to detect change over time is critical for their usefulness in clinical trials. Two concepts are applied in the assessment of evaluative instruments: We endorse the recommendation that a distinction be made between sensitivity and responsiveness. Sensitivity to change refers to the capacity of instruments to measure change statistically. Sensitivity statistics relate the magnitude of observed change to some measure of variablity and are essentially signal-to-noise ratios. Responsiveness addresses the detection of clinically relevant change. The methodology is still evolving but a common approach has been to correlate the observed change in scores with external standards that are believed to indicate clinical relevance (e.g., physician- or patient-based transition scales). Sensitivity to change and responsiveness of SLE activity indices have been addressed in a small number of studies. These indicate that the most widely used systems (SLEDAI. SLAM, BILAG) are sensitive to change although the available evidence does not allow preference for one instrument over the others. Little research has been done on the responsiveness of these measures. This article reviews the methodological concepts in measuring clinical change and summarizes reports on sensitivity and responsiveness of lupus activity scores.

Analysis of Variance↗

PubMed2003

Understanding and managing systemic lupus erythematosus (SLE).

Systemic lupus erythematosus (SLE) is a chronic autoimmune disease that many people know little about. Lupus can affect the skin, joints, kidney, heart, lungs, nervous system, blood and other organs or systems. For most people it is a relatively mild disease; for others it causes life-threatening problems. Social workers and related health professionals must learn to recognize how lupus affects individuals and their families' physical, psychological and social functioning in order to develop effective interventions for their patients. This article provides basic medical information about lupus and discusses strategies to help facilitate understanding, coping and management of this disease.

Adaptation, Psychological↗

PubMed1987

A case of systemic lupus erythematosus (SLE) and Sjögren's syndrome associated with anti-T3 autoantibodies.

A case of systemic lupus erythematosus (SLE) associated with Sjögren's syndrome had extremely low serum triiodothyronine (T3) with normal levels of serum thyroxine (T4) measured by single antibody radioimmunoassays (RIAs) and thyroid stimulating hormone (TSH) during steroid treatment. Measurement of serum T3 and T4 with double antibody RIAs showed unusually high T3 and normal T4 concentrations. Examination of her serum revealed the presence of IgG class anti-T3 autoantibodies whose Scatchard plot was analyzed in two components; one with a higher associate constant (8.6 X 10(8)M-1) and a lower binding capacity (5.6 X 10(-7) mol/ml serum); the other a lower associate constant (3.5 X 10(7)M-1) and a higher binding capacity (2.1 X 10(-6) mol/ml serum). Antithyroglobulin (Tg) autoantibody has been positive throughout the seven year observation period. A significant positive correlation between titers of anti-Tg autoantibodies indicated that the antigen of anti-T3 antibodies in the patient could be T3 containing antigenic site(s) on the Tg molecule.

Adult↗

PubMed1991

Complement fragment C4d and Bb levels in inflammatory skin diseases (e.g. SLE, atopic dermatitis, erythroderma and pustulosis palmaris et plantaris) for assessment of complement activation.

The complement is one of the major effector system in the process of inflammation. Complement activation has been shown to occur in inflammatory dermatoses such as systemic lupus erythematosus, atopic dermatitis, erythroderma of unknown origin, and pustulosis palmaris et plantaris by the elevated blood levels of complement fragments. To clarify the complement activation, especially the alternative pathway involvement, we have measured the concentrations of classical pathway-specific C4d and alternative pathway-derived Bb in the plasma of patients with these inflammatory disorders at a mild to exacerbated stage. Only the SLE plasma showed significantly elevated Bb levels. These results suggest that assessments of plasma C4d and Bb levels may be of value in monitoring the involvement of the complement system in patients with inflammatory dermatoses with significant complement activation.

Adult↗

PubMed2002

An anti-nuclear antibody-negative patient with systemic lupus erythematosus (SLE) accompanied with anti-ribosomal P antibody (anti-P).

We report a case of an anti-nuclear antibody (ANA)-negative patient with systemic lupus erythematosus (SLE) accompanied with anti-phospholipid antibody syndrome (APS) and lupus nephritis (LN). Histological examination of placenta obtained by an artificially-induced abortion revealed multiple thromboses in the placental villi. Histology of biopsied kidney tissue revealed minimal change with deposits of immunoglobulin and complement. Anti-ribosomal P antibodies (anti-P) and lupus anticoagulant (LAC) were positive and anti-double stranded DNA antibody (anti-DNA) showed only a slightly positive titer in her serum. The intensity of proteinuria of the patient was correlated with the anti-P, but not anti-DNA titers.

Adult↗

PubMed1999

[A case of SLE with positive antiphospholipid antibody and various coagulopathy].

We described an 11 year-old boy with systemic lupus erythematosus (SLE) and various coagulopathy. He had purpura on the legs, pancytopenia, positive anti-DNA antibodies and hypocomplementia. Hematological examination also showed that platelet counts were 80 x 10(3)/microliter, lupus anticoagulant and anticardiolipin antibodies were positive. The aPTT was remarkably prolonged. Those laboratory findings fulfilled the criteria of antiphospholipid syndrome. Following treatment with predonisolone and heparin, thrombocytopenia improved. When heparin discontinued and renal biopsy was performed, severe thrombocytopenia recureded. FDP and FDP-DD became high, but the aPTT was not prolonged. Thrombocytopenia didn't improved by the therapy with heparin, high dose of methylpredonisolone, FOY and gamma-globulin. However by the therapy with both warfarin and cyclophosphamide, remarkable improvement of coagulopathy was absorbed. Probably anticardiolipin antibodies and disseminated intravascular coagulation (DIC) participate in the various coagulopathy in this case.

Antibodies, Antiphospholipid↗

PubMed2005

[Three cases of childhood-onset male systemic lupus erythematosus (SLE) successfully treated with a combination of pulse methylprednisolone and pulse cyclophosphamide].

We reported three cases of childhood-onset male systemic lupus erythematosus (SLE), all of whom successfully treated with a combination of pulse methylprednisolone (mPSL) and pulse cyclophosphamide (IVCY). All of them had severe lupus nephritis and were complicated with other collagen diseases. Two cases were complicated with Sjögren syndrome (SS) and the other was complicated with both SS and anti-phospholipid syndrome (APS). After a combination of pulse mPSL and IVCY for a year, followed by oral predonisolone (PSL) and azathioprine (AZA), following up renal biopsy were performed in all cases, which showed histological improvement in glomerulonephritis. One case had flares a year later, but no flares were observed either in clinical symptoms or in laboratory examinations in the others. Their autoantibodies except anti-nuclear antibody (ANA) were eliminated. We suggest a combination of pulse mPSL and IVCY is effective for the patients who are suffering with severe lupus nephritis complicated with the other collagen diseases.

Adolescent↗

PubMed1992

Specificity of antibodies to single-stranded (ss) DNA in SLE patients with anti-phospholipid syndrome.

Although the concept of anti-phospholipid syndrome has been proposed in patients with SLE and other rheumatic diseases, the immunological mechanism is still controversial. Recently, the crossreactivity between anti-cardiolipin antibody and anti-ssDNA antibodies has been discussed in relation to this syndrome. In the present study, the specificity such as the avidity and the crossreactivity of anti-ssDNA antibodies was examined to find a clue to clarify the question why all of anti-cardiolipin antibody positive patients do not have any specific clinical features, thrombosis and spontaneous abortion. The avidity of IgG anti-ssDNA antibodies was examined by salt elution studies in solid phase ELISA. The avidity of anti-ssDNA antibodies tended to be lower in 10 patients with specific features than in other 10 patients without those features. The crossreactivity of affinity purified IgG anti-ssDNA antibodies was investigated by competitive ELISA. Purified anti-ssDNA antibodies from 4 patients without specific features were slightly inhibited by negatively charged phospholipids, cardiolipin and phosphatidylserine, whereas purified anti-ssDNA antibodies from 2 patients with specific features, who were considered to have anti-phospholipid syndrome, were little inhibited by these phospholipids. The above results suggest that the specificity of anti-ssDNA antibodies appears, at least partly, in different manners whether specific features are present or absent in anti-cardiolipin antibody positive patients. Moreover, anti-ssDNA antibodies and anti-phospholipid antibodies may form separate groups of antibodies in patients with anti-phospholipid syndrome.

Antibody Specificity↗