The newer 5-ASA preparations were superior to placebo in maintenance therapy. However, the newer preparations had a statistically significant therapeutic inferiority relative to SASP. This review updates the existing review of oral 5-aminosalicylic acid for maintenance of remission in ulcerative colitis which was published in the Cochrane Library (Issue 3, 2002).
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To evaluate oro-cecal transit time in cirrhotic patients with and without hepatic encephalopathy.
The majority of rheumatoid arthritis patients were elder women. As a rule, the treatment with DMARDs, most commonly sulfasalazine, was prescribed to the patients who had been ill for a short period of time. The rheumatoid arthritis patients in Vilnius were more often unemployed, disabled, with worse physical function. The demografical data of responders and non-responders were similar.
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We report 2 cases of hypersensitivity syndrome induced by the use of sulfasalazine. The clinical features of the syndrome appeared 18 and 32 days after administration of sulfasalazine. Clinical signs included a maculopapular rash progressing to exfoliate erythroderma, fever, and lymphadenopathy. Leukocytosis, atypical lymphocytes, liver dysfunction, and renal disturbance were also observed. In 1 patient, human herpesvirus 6 variant B was isolated from peripheral blood mononuclear cells, and in both patients anti-human herpesvirus 6 IgG titers increased considerably.
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Adult patients with acute non-chemotherapy-induced agranulocytosis, developed in hospital or in the outpatient setting, were ascertained by active surveillance in all 51 Berlin hospitals between the years 2000 and 2010. Applying the criteria of the World Health Organization, a standardized drug causality assessment was conducted for each agranulocytosis patient to determine possible drug aetiology. Drug risks were quantified in a case-control design with unconditional logistic regression analysis.
Information on sex, date of birth, and date of special medicine reimbursement decision for all new RA patients was collected from a nationwide register maintained by the Social Insurance Institution (SII) during the time period from 1 January 2000 to 31 December 2007. Patient cohorts were registered in 2-year time periods (2000-01, 2002-03, 2004-05, 2006-07) and DMARDs purchased by the patient cohorts during the first year after the date of reimbursement decision for RA were registered. The frequencies of early drug treatment strategies (combination of DMARDs, single DMARD, or no DMARDs) were evaluated.
In established RA total cholesterol levels were only slightly raised, irrespective of disease activity. However, HDL cholesterol was significantly higher in patients in remission than in patients with active disease. In contrast, in active early RA at baseline total cholesterol was low normal: between 4.6 and 5.1 mmol/l in the different populations. The level of HDL cholesterol was highly dependent on the duration of storage. In both COBRA groups total cholesterol increased by a mean of 0.6 mmol/l. HDL cholesterol increased by more than 50% after treatment, leading to an improvement of the total cholesterol/HDL ratio (atherogenic index). This increase (and index improvement) was much more rapid in the group receiving combination treatment. A similar pattern was seen in the 2001 cohort with early RA. In all the groups with active disease HDL and total cholesterol levels correlated inversely with disease activity.
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Our pilot study demonstrated the feasibility of providing counselling on DMARDs to groups of patients with important time savings for specialist nurses and while maintaining high levels of patient satisfaction. There was a trend for better outcomes in terms of adherence and drug continuation rates for patients counselled in groups, indicating potential benefits from group interactions. However, these findings need to be investigated further in a larger, fully powered trial.
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Oral lesions occur in an impressive number of patients with Crohn's disease. The lesions often precede the intestinal symptoms, and follow a variable course from asymptomatic to severe. They are important because of their association with Crohn's disease and the possibility that they could lead to an earlier diagnosis of Crohn's disease. We present a patient with cheilitis which preceded the recognition of colonic and perianal Crohn's disease by 7 years. The cheilitis responded to injection of steroids into the lips, but was unaffected by oral prednisone, sulfasalazine, azathioprine, and metronidazole.
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Oral sulfasalazine (SASP) is now used clinically as a probe substrate of a breast cancer resistance protein (BCRP) activity; however the intestinal absorption characteristics of SASP are not well understood. The purpose of this study was to clarify the characteristics of SASP transport in the mouse intestine. The everted ileum was incubated with SASP in the absence or presence of the Bcrp inhibitor Ko134. The steady-state intestinal absorptive clearance was 0.14 µL/min/cm in the absence of Ko134 and increased by 4.8-fold in the presence of Ko134. These results indicate that Bcrp mediates the efflux of SASP in the intestine. The absorptive clearance of SASP did not change in a concentration-dependent manner in the range of 0.1 to 50 µM in wild-type mice. By contrast, the absorptive clearance of SASP decreased significantly in a concentration-dependent manner in the presence of Ko134. Similar results were obtained in Bcrp(-/-) mice. These results suggest the possible involvement of some influx transporters in the intestinal absorption of SASP. In conclusion, both the influx and efflux transporters are involved in the intestinal absorption of SASP, which would explain why the absorptive clearance did not appear to change at various SASP concentrations in wild-type mice.
Drug-induced agranulocytosis (DIA) is a potentially fatal disorder. Hematopoietic growth factors have been used in the treatment of DIA. We report nine cases of DIA treated with granulocyte macrophage - colony stimulating factor (GM-CSF) in a dose of 300 microg/day. All the patients had evidence of systemic infection. Mean time to reach an absolute neutrophil count of 0.5 x 10(9)/L was three days. One patient succumbed to the disease. The cause of death was multiorgan failure. No adverse events were observed with GM-CSF. We conclude that hematopoietic growth factors are useful in shortening the period of neutropenia and reducing morbidity and mortality in these patients.
Although this pilot study is encouraging, further work is needed before methotrexate can be recommended for inflammatory bowel disease.
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The current treatment of chronic inflammatory bowel diseases involves the administration of different immunosuppressive drugs, whose use is associated with several side effects. Among the treatment alternatives, clinicians are attracted by leukapheresis, a method able to selectively remove from the circulation molecules involved in the onset and maintenance of inflammation. From 2007 to 2008, six patients were recruited from our clinics; four patients were affected by ulcerative colitis and two by Crohn's disease. They presented symptoms including abdominal pain and diarrhea despite treatment with steroids and sulfasalazine. Leukapheresis sessions were performed weekly (1 hour/week) for five consecutive weeks. The leukapheresis sessions resulted in a significant improvement in the patients' clinical as well as general conditions. The abdominal pain disappeared and significant reduction of diarrhea and fecal calprotectin levels was observed. No side effects occurred. The clinical benefits were supported by resolution of ulcerative lesions. After six months of follow-up no disease relapse was observed. The leukapheresis treatment has also prevented surgical interventions in all patients enrolled in the study. Our results suggest that leukapheresis may be helpful in patients affected by inflammatory bowel diseases, allowing early reduction of immunosuppressive drug administration.
It is well recognized that medication adherence of rheumatoid arthritis (RA) patients is often poor. As less attention has been paid to physicians' adherence to targeted treatment, we aimed to investigate how it affects outcomes in aggressively treated early RA patients.
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The ACR20 and ACR50 responses in WM were higher than in CM group, but more improvement on the symptoms and less adverse events were observed in CM therapy. The 18 CM symptoms in RA could be grouped into four symptom combinations with factor analysis method. The factor loading value difference (which reflects the degree of improvement) in responded cases was lower than in non-responded cases in the symptom combination 1. The loading value difference in both responded and non-responded cases in CM treated patients were higher than those in WM treated group in the symptom combination 2 and 3.
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Eighty-two patients were randomly assigned, 42 to the DFPP group and 40 to the no-DFPP group. All patients received sulfasalazine (0.75 g 3 times daily) plus methotrexate (10 mg orally once weekly). All patients had been on stable doses for more than 3 months. DFPP was performed once a week for 2 to 3 sessions. A total of 121 plasmapheresis procedures were performed in 42 patients. Control patients did not receive sham DFPP. The efficacy measures recorded 1 day after the final treatment and every month in follow-up for 4 to 22 months included the American College of Rheumatology (ACR) 20%, 50%, and 70% improvement criteria (ACR20, ACR50, and ACR70), the Health Assessment Questionnaire estimate of disability and the disease activity index.
Triggers of indeterminate results from interferon-gamma release assays (IGRA) in patients with rheumatic diseases are still elusive. The aim of the present study was to describe predictors of indeterminate results from IGRA in the field of rheumatology. This cross-sectional study was retrospectively performed by using a database of patients with a request for QuantiFERON-TB Gold-In Tube test (QFT-GIT) for screening of latent tuberculosis infection. The study cohort included 631 patients with rheumatic diseases. All variables influencing indeterminate QFT-GIT results were investigated by logistic regression analysis. The overall frequency of indeterminate IGRA results was 6.8 % (43/631). Those with indeterminate results were more likely to be aged ≥70 years, female, visitors in winter, suffering from systemic lupus erythematosus (SLE), and using sulfasalazine or a tumor necrosis factor (TNF)-α inhibitor. In addition, a longer incubation time of >6 h increased the odds ratio of indeterminate IGRA results. In contrast, the automated ELISA processor, ankylosing spondylitis, and the use of a non-steroidal anti-inflammatory drug decreased the likelihood of indeterminate IGRA results. Lymphopenia, thrombocytopenia, anemia, and hypoalbuminemia were significantly associated with indeterminate IGRA results. Multivariate analysis revealed that SLE, use of sulfasalazine or a TNF-α inhibitor, and a manual ELISA system were significantly independent predictors of indeterminate IGRA results. The proportion of indeterminate results in patients with rheumatic diseases is not infrequent. Careful attention to the pre-analytical conditions should minimize the indeterminate results. Automation of the ELISA process seems to be a promising solution to decrease the rate of indeterminate response.
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High-grade evidence is lacking for most therapeutic decisions in Crohn's disease. Appropriateness criteria were developed for upper gastro-intestinal, extra-intestinal manifestations and drug safety during conception, pregnancy and breastfeeding in patients with Crohn's disease, to assist the physician in clinical decision making.
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The increased use of audit and resource management within the health service will focus attention on variations in clinical practice. We have looked at one rheumatological example; the extent rheumatologists vary in their clinical use of a slow-acting anti-inflammatory drug. We studied a single drug - sulphasalazine. In a prospective study sulphasalazine was given to 298 rheumatoid patients at 24 rheumatology centres in South East England. They were followed for 6 months. There were large differences between centres in: the types of patient started on therapy; the numbers of patients remaining on treatment; the responses after 6 months. The difference between some centres was more marked than the expected improvement in clinical and laboratory variables given by sulphasalazine. The use of a slow acting anti-rheumatic drug like sulphasalazine in rheumatoid arthritis is agreed by most rheumatologists in the UK and yet there are wide variations in its use. Our results question the validity of comparing clinical practice and associated costs between centres for even a simple clinical procedure.
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Inflammatory bowel disease (ulcerative colitis and Crohn's disease) is a chronic illness, often affecting people of reproductive age. Treatment involves drugs which have potential side effects and because of this pregnancy causes considerable concern. The course of the disease is not much affected by pregnancy. The relapse rate is only slightly increased when the disease is active at the time of conception. Relapses during pregnancy should be treated in the usual manner. Surgical intervention should be carried out on the same indications as in those who are not pregnant. Frequency of complications is not increased during pregnancy, at delivery or post partum. Sectio may be necessary in perianal disease. With few exceptions, drug treatment should be continued throughout pregnancy. No adverse effects are seen with normal doses of sulfasalazine, 5-amino-salicylic acid and steroids. Planned pregnancies should be started in periods of quiescent disease.
Mean HAQ scores declined progressively with treatment with all three DMARDs. Changes occurred rapidly, and at month 1 were most pronounced with leflunomide. HAQ scores correlated closely with clinical response, as seen in changes in non-responders and ACR 20% and 50% responders. Regression analysis indicated that pain intensity and global assessments were significant determinants of HAQ.
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RA remains a therapeutic challenge. Despite substantial data from therapeutic trials, the precise therapy of this often debilitating disease remains controversial. A variety of agents are available to the clinician for the treatment of this disease, yet the precise timing of their use and the determination of situations in which efficacy is most likely to be observed is still unclear. However, it is obvious that earlier intervention and more aggressive forms of therapy are currently advocated by most rheumatologists. Given the rapidity with which this disease can induce substantial morbidity, the use of second-line agents early in the course of this process is warranted. Whether or not combination therapy provides any benefit is still unproved. As our understanding of the pathogenic mechanisms involved in the development of RA evolve, and with the development of newer immunomodulatory agents, it is likely that more specific forms of therapy can be developed. It is hoped that these protocols will permit more precise treatment of the abnormalities leading to this disease without global suppression of the immune system or other unacceptable side effects.
The bioavailibity of mesalamine from enteric-coated mesalamine and sulphasalazine was determined following a single dose and at steady state in healthy subjects in crossover studies. Plasma concentrations and urinary excretion of mesalamine and its major metabolite, N-acetyl-5-aminosalicylic acid, were measured. After a single dose of enteric-coated mesalamine, about 10 h elapsed before the onset of measurable plasma drug concentrations, probably representing gastro-intestinal transit prior to drug release near the ileocaecal junction. The elimination kinetics were similar for a single oral dose and steady state using enteric-coated mesalamine, but after both single and multiple administration of enteric-coated mesalamine only about 20% of the mesalamine given was absorbed, with about 80% estimated to remain for colon therapeutic activity. It is concluded that, despite different mechanisms of mesalamine release, enteric-coated mesalamine and sulphasalazine produced similar mesalamine absorption.
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Alopecia areata is an autoimmune disease with no definitive treatment, and some cases persist despite standard therapies. Sulfasalazine has been reported to show success in the treatment of persistent cases of alopecia areata. Objective To assess the efficacy of sulfasalazine in cases of recalcitrant alopecia areata that do not respond to topical and intralesional corticosteroids, 5% minoxidil, or psoralen plus ultraviolet-A (PUVA) therapy.
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All randomized controlled trials (RCTs) and controlled clinical trials (CCTs) comparing oral cyclophosphamide against placebo (or an active drug at a dosage considered to be ineffective) in patients with rheumatoid arthritis.
A case of juvenile psoriatic arthritis in a 12 year-old boy was reported. The patient had a history of one and half a year of bilateral heel pain, followed by pain in the right knee and ankle and right hip joint. He developed psoriatic lesions affecting his nails and skin. He had increased erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) contents. Human leukocyte antigen (HLA) B27 was detected but serum rheumatoid factor was not in the patient. A skin biopsy revealed psoriasis and ultrasonography demonstrated synovitis in right knee and ankle. Juvenile psoriatic arthritis was diagnosed based on his physical, laboratory and skin biopsy findings. A treatment with nonsteroidal anti-inflammatory drugs and sulfasalazine produced no effect. Leflunomide in conjunction with anti-TNF biologic agents (Etanercept) was administered, followed by symptomatic improvement 2 weeks later.
Inflammatory bowel disease (IBD) is a multifactorial intestinal disorder that involves interactions among the immune system, genetic susceptibility, and environmental factors, especially the bacterial flora. Polydextrose, a polysaccharide constituted by 90% nondigestible and nonabsorbable soluble fibers, has several physiological effects consistent with those of dietary fibers, including proliferation of colon microflora. Because sulfasalazine presents serious side effects through long-term use at high doses, the aim of the present study was to evaluate the preventative effect of polydextrose on trinitrobenzenesulfonic acid-induced intestinal inflammation and its effects on the intestinal anti-inflammatory activity of sulfasalazine. Results indicated that polydextrose and its association with sulfasalazine present an anti-inflammatory effect that reduces myeloperoxidase activity, counteracts glutathione content, and promotes reductions in lesion extension and colonic weight/length ratio.
A case-history study of drug-induced liver disorders requiring hospitalization was carried out at the Group Health Cooperative of Puget Sound, a health maintenance organization with about 280,000 members, for the five-year period from January 1, 1977 to December 31, 1981. During this time, there were 12 instances of hospitalization for liver disorders judged to be probably (nine cases) or possibly (three cases) attributable to outpatient drug ingestion (other than antitumor agents). The rate was on the order of one per 100,000 person-years at risk. Drugs implicated as probable causes were ampicillin (two cases), carbamazepine (one case), erythromycin (one case), methyldopa (one case), sulfasalazine (one case), quinidine (one case), trimethoprim/sulfamethoxazole (one case), and multiple drugs (one case).
Until Dec 31, 2015, 3695 JIA patients were prospectively followed with a total of more than 13,198 observation years. 12 cases of suspected malignancies, including 7 lymphoid neoplasms, have been reported in patients treated with methotrexate (MTX) , and /or TNF-α inhibitors. 11 patients had received MTX, two received cyclosporine A, single patients received sulfasalazine, azathioprine or leflunomide. 10 patients were exposed to biologics, 9 etanercept, two adalimumab, one infliximab and one case was consecutively treated with adalimumab, etanercept, infliximab and abatacept. A case of mild myelodysplasia, in which the patient recovered spontaneously, a case of lymphoproliferation without clonality and a case of cervical dysplasia were treated as suspected, but not confirmed malignancies. Cases in which a malignant disease was confirmed included two cases of Hodgkin's lymphoma, one case of non-Hodgkin's lymphoma, two cases of acute lymphatic leukaemia (ALL) and one patient with lymphoproliferative disorder, who recovered after discontinuation of immunosuppressive therapy. Single confirmed cases of thyroid carcinoma, yolk sac carcinoma and anaplastic ependymoma have also been described. One patient not exposed to biologics died of ALL, all other patients recovered.