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Designing successful randomized controlled trials (RCTs) in systemic lupus erythematosus (SLE) poses many challenges. It remains difficult to correlate alterations in biologic markers with clinical outcome, especially when signs and symptoms are intermittent and broadly variable between patients. Disease activity indices were not designed specifically as outcome measures in RCTs, as they were developed in the context of longitudinal observational studies. Although all disease activity indices have been validated against each other and demonstrated to show change, organ system manifestations are variably weighted; fatigue and autoantibody titers are scored in some and not in others. Due to the variability of the underlying disease course an assessment of disease activity may most accurately be portrayed as change over time, such as an area under the curve analysis. Another lesson learned is that 'responder indices' proposed in the absence of prospective validation in RCTs do not function well. The argument can always be made that any response criteria will work if the treatment is effective; but without the precedent of a product specifically approved for use in SLE, this is hard to prove. The ACR/Systemic Lupus International Cooperating Clinics (SLICC) damage index was designed to score irreversible manifestations of disease or consequences of its treatment, provided they had been present for at least six months. The damage index may best be utilized to stratify patients or balance randomization at baseline. It may also be incorporated into an endpoint analysis, to ensure that treatment or disease associated deterioration in organ system function (that may be overlooked in scoring disease activity alone) has not occurred. Patient cohort data have demonstrated that the medical outcomes survey short form-36 (SF-36) reflected the effects of SLE better than other patient reported measures. Worsening SF-36 domain scores best correlate with higher disease activity, increased glucocorticoid doses and use of cytotoxic agents. It has been shown sensitive to change in RCTs and observational cohorts, and reflects the impact of treatment with high dose glucocorticoids and immunosuppressive agents, as well as end stage renal disease. There is now a body of data derived from RCTs in SLE. Albeit limited, yet to result in an approved therapy, evidence is accumulating that indicate 'early markers' of response can be defined which may correlate with longer term clinical outcomes. This should inform us in our ongoing efforts to clinically test a broad variety of promising interventions.
Lupus 2004
PMID:Clinical trial design in systemic lupus erythematosus: lessons learned and future directions. 1523 Mar

Cognitive dysfunction represents one of several neurological and psychiatric complications of Systemic Lupus Erythematosis (SLE). Additional manifestations of nervous system involvement subsumed under the term neuropsychiatric SLE (NPSLE) include cerebrovascular disorder, seizures, psychosis, acute confusional state, anxiety and mood disorders. Neuropsychological investigations have facilitated the identification and description of cognitive impairment in SLE and NPSLE. Salient findings from studies of SLE-related cognitive dysfunction are reviewed with respect to neuroimaging procedures, indices of disease activity, and potential moderator variables. Data on cognitive functioning are also discussed in reference to other disease aspects including fatigue, sleep disturbance, and impact on health-related quality of life (HRQL). To date, neuropsychological functioning has been studied extensively, albeit separately from other commonly reported SLE-related symptoms. Future research may profit from investigating relationships between cognitive impairment, sleep disturbance and fatigue and their collective impact on functional capacity and quality of life.
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PMID:Factors influencing cognitive function, sleep, and quality of life in individuals with systemic lupus erythematosus: a review of the literature. 1559 65

Intestinal pseudo-obstruction (IPO) is a rare complication of systemic lupus erythematosus (SLE). We present a 32-year old female with SLE for seven years. She was admitted with profound fatigue, frequent vomiting, colicky abdominal pain, diarrhoea and intermittent dysuria for the past 12 months. Imaging studies revealed dilated small and large bowel loops with thickened intestinal wall and multiple fluid levels. Urinary tract involvement was also demonstrated. The patient responded well to immunosuppressive treatment. IPO in the context of SLE has been described only in anecdotal case reports. Half of the cases developed this complication during the course of lupus as in the present case. Concomitant ureterohydronephrosis was present in approximately two-thirds of the cases. Early recognition of the syndrome is necessary for the institution of the appropriate medical treatment and prevention of inappropriate surgical intervention.
Lupus 2004
PMID:Intestinal pseudo-obstruction and ureterohydronephrosis as the presenting manifestations of relapse in a lupus patient. 1564 52

Scleroderma heart involvement (SHI) is often manifest, and virtually always present when accurately searched and holds a significant prognostic value. Myocardial involvement by patchy fibrosis (secondary to both repeated ischaemia and immunoinflammatory damage) leads to ventricular diastolic dysfunction, whereas right ventricle overload and failure may complicate pulmonary hypertension. Left ventricular systolic dysfunction is present in a minority of patients, namely those presenting atherosclerotic coronary artery disease and/or arterial hypertension, sometimes triggered by sclerodermic renal involvement. Dysrhythmias and conduction disturbances are considered an hallmark of SHI, facilitated by autonomic dysfunction. SHI is frequently linked to parenchimal and/or vascular lung disease; they determine symptom occurrence, particularly dyspnoea, fatigue, palpitations and chest pain when pericardium is affected. Accurate cardiologic baseline screening and subsequent follow-up are mandatory in all patients, initially consisting in some noninvasive diagnostic procedures: visit, electrocardiogram (EKG), chest X-ray, Doppler-echocardiography. When needed, these examinations should be integrated by EKG Holter-monitoring, cardiopulmonary stress tests, cardiac magnetic resonance imaging, nuclear studies of myocardial function and perfusion, cardiac catheterization to better estimate pulmonary hypertension, and cardiac natriuretic hormone evaluation. Several vasodilator approaches (prostacycline or NO/endothelin) may counteract the microvascular dysfunction at peripheral and cardiopulmonary level, and fight the sequelae of pulmonary hypertension.
Lupus 2005
PMID:Heart involvement and systemic sclerosis. 1621 71

Female sexual dysfunction (FSD) is a multifactorial set of conditions associated with multiple anatomical, physiological, biological, medical and psychological factors that can have major impact on self-esteem, quality of life, mood and relationships. Studies indicate that FSD is commonly seen in women who report a low level of satisfaction with partner relationship and in women with male partners who have erectile dysfunction. This complexity of FSD is augmented by the presence of chronic disease. Negative sexual effects are widely reported in studies of women with chronic diseases (such as metabolic syndrome, diabetes mellitus, chronic kidney disease, cancer, spinal cord injury, lupus, rheumatic diseases, Parkinson's disease, fibromyalgia and chronic pain) as compared to a general healthy female population. Physical problems, emotional problems and partnership difficulties arising from disease-related stress contribute to less active and less enjoyable sex life. Chronic pain, fatigue, low self-esteem as well as use of medications might reduce sexual function. These effects of chronic diseases on female sexual function still remain largely unstudied. The study by Manor and Zohar published in this issue of Harefuah draws our attention to the sexual dysfunction of women with breast cancer and examines their needs for information regarding their sexual function. In the absence of definite treatment evidence, psychological counseling, improved vaginal lubrication, low dose of hormonal therapy can be used to relieve FSD. Physicians must consider integrating diagnosis of their female patients' sexual needs and dysfunction, especially women with chronic diseases. Patients' education and counseling may contribute to a better quality of life in spite of their chronic disease.
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PMID:[Female sexual function and chronic disease]. 1650 15

A 39-years-old woman was admitted to our hospital with musculoskeletal complaints (myalgias and symmetric arthralgias in proximal interphalangeal, metacarpophalangeal joints of the hands and in knees), systemic symptoms like fever, fatigue, malaise and a six months previous history of a transient ischemic attack. The presence of antibodies to double-stranded deoxyribonucleic-acid (DNA) and antiphospholipid antibodies led to the diagnosis of systemic lupus erythematosus with secondary antiphospholipid syndrome. Cerebral infarction develops significantly more often in patients with lupus and antiphospholipid antibodies, but other clinical syndromes are associated with lupus anticoagulant: cognitive dysfunction, seizures, polyneuropathy, aseptic meningitis, myelopathy.
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PMID:[Systemic lupus erythematosus with neurologic onset and secondary antiphospholipid syndrome. A Case Study]. 1660 81

There is accumulating evidence that mycophenolate mofetil (MMF), when combined with corticosteroid, is an effective induction treatment for severe proliferative lupus nephritis and is associated with fewer adverse effects compared to cyclophosphamide (CTX), but the quality of life (QOL) associated with these regimens as perceived by the patient has not been compared. This study included patients who had experienced both treatment regimens, for distinct episodes of diffuse proliferative lupus nephritis. QOL parameters during the first six months of each treatment were assessed through SF36 and WHOQOL questionnaires. Twelve patients and 24 episodes of severe lupus nephritis were studied. CTX-treated and MMF-treated episodes showed comparable baseline characteristics and response rate, with complete remission occurring in 83.3%. MMF treatment was associated with higher numerical scores for all domains across both QOL instruments than CTX. MMF treatment was associated with significantly less fatigue, less impediment of physical and social functioning, and better psychological well being compared to CTX. When each patient served as her/his own control, most patients ascribed higher QOL domain scores to the MMF-treated episode. Seventy-five percent of patients found MMF treatment more acceptable and preferred when compared with CTX, and the complications that most concerned them included Cushingoid features, alopecia, menstrual disturbance and infections. These data showed that MMF-based induction immunosuppression for severe lupus nephritis was associated with better QOL than CTX as perceived by patients, which was most likely attributed to the reduced side-effects during MMF treatment.
Lupus 2006
PMID:Quality of life comparison between corticosteroid- and-mycofenolate mofetil and corticosteroid- and-oral cyclophosphamide in the treatment of severe lupus nephritis. 1683 Aug 84

We report the case of an 18-year-old woman with arthralgia and swelling of distal joints at hands and feet, photosensitive reaction, butterfly rash, fatigue, tachypnea and unspecific cardiac pain three months after beginning a treatment with minocycline for acne. Recurrence of symptoms at a higher intensity occurred within hours of reexposition with minocycline. The antinuclear antibody test was positive. After withdrawal of minocycline, the symptoms improved and minocycline-induced lupus was diagnosed. In the Swissmedic and WHO adverse drug reaction databases 267 other cases of possible minocycline-induced lupus were identified. Typical clinical and laboratory features are arthralgia, arthritis, myalgia, increased transaminases and/or jaundice, unspecific symptoms like fatigue and fever, skin disorders and positive antinuclear antibodies.
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PMID:[Minocycline-induced lupus erythematodes]. 1697 Jan 39

Widespread chronic pain, fatigue, and distress do not represent risk factors for future systemic lupus erythematosus (SLE) or other autoimmune syndromes. On the other hand, SLE seems to be a significant risk factor for fibromyalgia (FM). Up to 47% of SLE patients fulfill FM criteria. SLE patients with concomitant FM are often highly symptomatic and dysfunctional. The presence of FM symptoms in SLE patients, however, does not predict more extensive organ involvement or lupus activity. The high concordance of SLE with FM suggests common mechanisms related to pain and distress in both patient groups. Recent research suggests involvement of N-methyl-D-aspartate (NMDA) and neurokinin receptor systems. Thus, autoimmune activity against these receptor systems in SLE patients could result in pain, cognitive defects, and chronic pain states including FM. Conversely, treatment of SLE-FM patients with inhibitors of NMDA or neurokinin receptors may prevent or alleviate cognitive abnormalities and chronic pain, as well as FM.
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PMID:Are patients with systemic lupus erythematosus at increased risk for fibromyalgia? 1709 42

Health-related quality of life (HRQoL) is an important outcome measure in patients with systemic lupus erythematosus (SLE). A review was undertaken of the literature relating to HRQoL in SLE. MEDLINE, EMBASE, CINAHL, Allied and Complimentary Medicine were searched to locate full papers in the English language reporting on HRQoL in adult SLE patients published between 1990 and 2005. In total 53 papers were included and the review was subdivided into: 1) description of HRQoL in SLE patients; 2) HRQoL and disease activity and/or damage; 3) the impact of other variables on HRQoL; and 4) HRQoL measures used in clinical trials in SLE patients. The findings were as follows: HRQoL is reduced in SLE patients; HRQoL is not correlated to disease activity or damage; age appears to have a negative impact on HRQoL especially physical health but the effect of disease duration is unclear; other potentially modifiable variables such as fatigue and psychosocial factors impact on HRQoL in a complex manner; and HRQoL measures which are sensitive to change should be an essential outcome measure in all clinical trials on SLE patients.
Lupus 2006
PMID:A review of health related quality of life in systemic lupus erythematosus. 1712 May 89


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