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This study was performed to develop ultrasound composite scores for the assessment of inflammatory and structural lesions in Psoriatic Arthritis (PsA).
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Baseline characteristics were similar between groups. In the adalimumab group/placebo group the 12-month cumulative triamcinolone doses were 5.4/7.0 ml (p=0.08). Triple therapy was applied in 18/27 patients (p=0.17). At 12 months, DAS28CRP<3.2 was reached in 80%/76% (p=0.65) and DAS28CRP was 2.0 (1.7-5.2) (medians (5th/95th percentile ranges)), versus 2.6 (1.7-4.7) (p=0.009). Remission rates were: DAS28CRP<2.6: 74%/49%, Clinical Disease Activity Index≤2.8: 61%/41%, Simplified Disease Activity Index<3.3: 57%/37%, European League Against Rheumatism/American College of Rheumatology Boolean: 48%/30% (0.0008
Most drugs used in rheumatoid arthritis (RA) can have fatal side effects, but there are no good data on the frequency of such complications. Our study was designed to obtain information on deaths attributable to different antirheumatic drugs.
We report the case of a male patient with Crohn's disease associated with IgA nephropathy. He was treated surgically for the intestinal disorder and then with corticoids and sulfasalazine. Six years after treatment the patient was asymptomatic. As the intestinal situation improved there was concomitant normalization of urinary sediment, maintaining renal function. The fact that the digestive mucosa is one of the body's major sources of secretory IgA may account for the existence of a common for Crohn's disease and certain forms of IgA nephropathy.
This review deals with potential and possibly primary therapeutics that, through insight into the inflammatory cascade, result in more rational treatment principles replacing the classical therapy of inflammatory bowel disease (IBD), i.e. Crohn's disease (CD) and ulcerative colitis (UC). These new therapies might be useful for IBD patients, especially since the 'classical therapy' with agents like glucocorticoids, sulfasalazine, mesalazine, azathioprine, 6-mercaptopurine, cyclosporin and methotrexate is often only moderately effective and may have important side-effects. Controlled trials of the novel agents mentioned in this review have not yet been performed, however.
To compare statistical models for the analysis of two-state disease processes.
Included patients were randomized to either: 1. initial DMARD-monotherapy (sulfasalazine (SSZ) or methotrexate (MTX)), 2. Initial MTX / prednisolone-bridging, 3. Initial combination MTX/etanercept. Percentage inactive disease, adjusted (a) ACR Pedi30, 50 and 70 and JADAS after 6 and 12 weeks of treatment (intention to treat analysis) and side effects are reported.
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In comparison with both SSZ and ST, there was a statistically significant difference in favor of CSA in terms of the mean changes in the pain score (p < 0.05), which was considered the primary response variable. A significant decrease in favor of CSA versus ST alone was also observed for swollen joint count (p = 0.05), tender joint count (p = 0.01), joint/pain tenderness score (p = 0.002), patient and physician global assessment by at least one point (p = 0.04 and 0.01, respectively), total Arthritis Impact Measurement Scale score (p = 0.002), and spondylitis functional index (p = 0.002). There was a statistically significant difference in the ACR 50% and ACR 70% response rates between the CSA and ST groups (p = 0.02, 0.05). Comparing the SSZ and ST alone groups, only the spondylitis functional index decreased significantly in the SSZ treated patients (p = 0.03). The Psoriasis Area and Severity Index was significantly lower in the CSA than in the ST and SSZ groups (p = 0.0001 and 0.01, respectively). Decrease in erythrocyte sedimentation rate was significant only in the SSZ versus the ST group (p = 0.02), whereas reduction in C-reactive protein was significant in the CSA treated patients compared with the ST group (p = 0.006). The most common adverse event in the CSA group was mild, reversible kidney dysfunction.
The interaction of pregnancy and the rheumatic diseases varies, ranging from life-threatening conditions such as thromboembolic events and progressive renal disease in some autoimmune disorders, to minor flares of peripheral arthritis in inflammatory rheumatic disease. As a consequence, treatment strategy will vary according to the maternal or fetal compromise expected. All nonsteroidal anti-inflammatory drugs (NSAIDs), including high dose aspirin (acetylsalicylic acid), can cause adverse effects during pregnancy related to the inhibition of prostaglandin synthesis. Prolongation of gestation and labour, constriction of the ductus arteriosus, persistent fetal circulation, impairment of renal function and bleeding are risks of third trimester exposure of pregnant women to all inhibitors of cyclo-oxygenase. Most of these adverse effects can be prevented by discontinuing NSAIDs 8 weeks prior to delivery. Low dose aspirin has not been associated with fetal or neonatal toxicity. Some corticosteroids such as prednisone and prednisolone do not readily cross the placenta and can be safely used during pregnancy as immunosuppressive drugs. Maternal complications related to corticosteroids may occur and close monitoring is therefore mandatory. There is limited information on the safety of disease-modifying antirheumatic drugs including gold, antimalarials, penicillamine (D-penicillamine), sulfasalazine and cyclosporin. Of these agents, sulfasalazine has the best record for tolerability and can be used by pregnant patients. Gold compounds and penicillamine should be discontinued when pregnancy is recognised. Hydroxychloroquine has not been associated with congenital malformations and seems preferable to chloroquine in patients requiring treatment with antimalarials. Use of cyclosporin may be an alternative to other therapy in pregnant patients with severe rheumatic disease. Indications for treatment with colchicine during pregnancy are few, except for familial Mediterranean fever. Azathioprine can be used when the maternal condition requires a cytotoxic drug during the first trimester. Cyclophosphamide, chlorambucil and methotrexate are contraindicated during pregnancy because of their teratogenic potential. Their use may be considered in late pregnancy if the mother has a life-threatening condition.
Randomized controlled trials of 5-ASA compared with placebo or sulfasalazine of a minimum of 4 weeks duration for active disease and a minimum of 6 months for maintenance of disease remission. Sixteen trials of 5-ASA for active disease, published either in abstract or full manuscript, were available. Eleven trials of 5-ASA for maintenance of remission were also reviewed.
Anterior atlantoaxial subluxation (aAAS), atlantoaxial impaction (AAI; i.e., vertical subluxation), and subaxial subluxation (SAS) were found in only 6 (3.4%), 2 (1.1%), and 5 (2.8%) of the patients, respectively. Interestingly, none of the patients in the combination-therapy group had aAAS or AAI. The incidences of aAAS and AAI in the single-therapy group were 6.6% and 2.2%, respectively. SAS was present in 2 patients (2.2%) in the single-therapy group and in 3 patients (3.5%) in the combination-therapy group. The difference in the incidence of aAAS between the treatment groups was statistically significant (P = 0.029). None of the patients with cervical spine changes achieved remission of RA during the study.
Effects of the amount and the composition of meals on gastric emptying and small intestinal transit times of a suspension were investigated in beagle dogs using acetaminophen and salicylazosulfapyridine as markers. Gastric emptying time was affected both by the amount and the composition of a meal; it was prolonged proportionally to the amount of a solid meal and varied among the 3 kinds of test meals of the same energy content in the following rank order: lard greater than skimmed milk greater than mashed potatoes. The inter-individual variation of small intestinal transit time in a fed state was smaller than that in a fasted state, whereas the mean transit times in both states were similar. Small intestinal transit time was not affected by the amount of the solid meal. On the other hand, it varied among the 3 kinds of test meals in the following rank order: lard greater than mashed potatoes greater than skimmed milk. It is noteworthy that small intestinal transit time in the beagle dog is approximately 2 h shorter than that in humans both in fasted and fed states.
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The proposed disease controlling antirheumatic therapy (DC-ART) definition requires that the therapy change the course of rheumatoid arthritis (RA) for at least 1 year, evidenced by (1) sustained improvement in physical function, (2) decreased inflammatory synovitis, and (3) slowing or prevention of structural joint damage. Selected studies are reviewed. All studies were at least 1 year in duration, but most did not include all 3 of the DC-ART requirements. In these studies, patients treated with placebo generally had no improvement in inflammatory synovitis and progressive structural joint damage, judged by serial joint radiographs. A minority of studies significantly favored one or another of the available agents (gold injections, D-penicillamine, auranofin, antimalarials, azathioprine, sulfasalazine, methotrexate), but the evidence for any one agent is not convincing. For future DC-ART clinical trials patients with early RA should be studied. A hybrid study design may be useful, combining an initial double blind randomized controlled clinical trial with continuing longterm observation of all withdrawals using specified clinical, radiographic, and self report assessments at regular intervals, and an intent-to-treat analysis comparing longterm response rates of the original control and experimental therapy groups. Responsive subgroups should be sought, their characteristics identified, and their responsiveness confirmed in additional trials limited to the identified subgroup.
In the pathogenesis of spondyloarthropathies, infection and gut inflammation are the most important external triggering factors. Early antimicrobial therapy to treat urethritis caused by Chlamydia trachomatis is effective in preventing a recurrent reactive arthritis. When the arthritis appear, a short term conventional antimicrobial therapy is unable to modify its course. In acute chlamydia arthritis, patients benefit from a prolonged (3-month) treatment with tetracycline, while such a treatment has not proved to be effective in enteroarthritis or in chronic forms of reactive arthritis. The role of sulfasalazine in the treatment of patients with spondyloarthropathies is controversial. It might modify the disease course during acute and chronic reactive arthritis, and is working for patients with ankylosing spondylitis, especially patients with peripheral arthritis. Data showing an effect of sulfasalazine in the prevention of chronic spondyloarthropathy or in modification of the long-term prognosis of ankylosing spondylitis are, however, lacking.
Triple-negative breast cancer (TNBC) includes basal-like and claudin-low subtypes for which no specific treatment is currently available. Although the retinoblastoma tumor-suppressor gene (RB1) is frequently lost together with TP53 in TNBC, it is not directly targetable. There is thus great interest in identifying vulnerabilities downstream of RB1 that can be therapeutically exploited. Here, we determined that combined inactivation of murine Rb and p53 in diverse mammary epithelial cells induced claudin-low-like TNBC with Met, Birc2/3-Mmp13-Yap1, and Pvt1-Myc amplifications. Gene set enrichment analysis revealed that Rb/p53-deficient tumors showed elevated expression of the mitochondrial protein translation (MPT) gene pathway relative to tumors harboring p53 deletion alone. Accordingly, bioinformatic, functional, and biochemical analyses showed that RB1-E2F complexes bind to MPT gene promoters to regulate transcription and control MPT. Additionally, a screen of US Food and Drug Administration-approved (FDA-approved) drugs identified the MPT antagonist tigecycline (TIG) as a potent inhibitor of Rb/p53-deficient tumor cell proliferation. TIG preferentially suppressed RB1-deficient TNBC cell proliferation, targeted both the bulk and cancer stem cell fraction, and strongly attenuated xenograft growth. It also cooperated with sulfasalazine, an FDA-approved inhibitor of cystine xCT antiporter, in culture and xenograft assays. Our results suggest that RB1 deficiency promotes cancer cell proliferation in part by enhancing mitochondrial function and identify TIG as a clinically approved drug for RB1-deficient TNBC.
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To assess the efficacy, tolerability, and safety of sulfasalazine (SSZ) in the treatment of juvenile chronic arthritis (JCA).
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The extent and nature of seminal anomalies in colitic and ileitic patients were investigated using cytological, cytochemical, and electron microscopical methods. In addition to basic seminal variables, the gross and fine structure of spermatozoa were analyzed and the recorded data correlated with actual clinical conditions and therapeutic regimen of patients. Spermiograms revealed that the effect on the testicular function varied among patients, ranging from a subtle embarrassment of late spermiogenesis to a suppression of spermatogenesis as reflected in severe oligozoospermia. In several instances, excurrent ducts and accessory sex glands also were involved. The nuclear syndrome was an invariably observed phenomenon and consisted of increased pleomorphy, excessive vacuolation, postnuclear blebbing, malcondensation, and spontaneous decondensation of chromatin. The nuclear pleomorphy, malcondensation, and decondensation, apparently interrelated, constitute the characteristic condition, referred to as nucleomalacia. Other sperm defects seemed to be mere amplifications of deficiencies common in human semen. The correlation between the extent of intestinal lesions or severity of symptoms and the ratio of nuclear aberrations, demonstrated with acid-fast technique, was striking. No such relationship was found regarding the sulfasalazine treatment.
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This systematic literature search on MTX monotherapy with relatively low-dose use during at least 2 years shows favourable long-term safety.
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The chemopreventive and therapeutic efficacy of the cyclooxygenase (COX) inhibitor ibuprofen (IB) and of sulfasalazine (SASP), a drug that targets the antioxidant xc- system, were exploited in the experimental model of 3-methylcholantrene (3-MCA)-induced mouse sarcoma. The chemopreventive treatments gave unsatisfactory results because administration of IB one day after the 3-MCA injection only slightly delayed the tumor development, whereas SASP dispensed under the same conditions resulted in accelerated tumorigenesis. Similarly, the therapeutic treatment with either drug, administrated daily from the tumor detection, decreased the proliferation rate of tumor cells and increased the survival of treated mice only at a low extent. Remarkably, the combined chemopreventive treatment with IB and therapeutic treatment with SASP displayed a better efficacy, with strong delay of sarcoma growth, reduced tumor size and increased survival of treated mice. The two drugs target not only tumor cells but also tumor-associated macrophages that were dramatically decreased in the tumor infiltrate of mice subjected to the combined treatment. The synergistic effects of the association between a broad anti-inflammatory compound, such as IB, and a redox-directed drug, such as SASP, shed new light in the role of inflammation and of the redox response in chemical tumorigenesis and point to the combined chemopreventive plus therapeutic treatment with IB and SASP as a promising novel approach for antitumor therapy.
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Ten pieces of colon mucosal biopsy specimens were obtained from 31 cases with UC, 17 of which received sulphasalazine (SASP) or SASP plus glucocorticoid and 14 of which received no medication. Samples of normal mucosa around the lesion taken from 11 patients with colon cancer were used as controls. NF-kappaB DNA binding activity was evaluated by electrophoretic mobility shift assay. NF-kappaB p65 expression was determined by Western blot analysis and immunohistochemical staining with a NF-kappaB p65 antibody. The type of cells containing activated NF-kappaBp65 was identified by double immunofluorescence confocal laser scanning microscopy.
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Analysis of the Swedish Farmacotherapy (Swefot) trial at 12 months showed that the addition of an anti-tumour-necrosis-factor agent gave an improved clinical outcome compared with the addition of conventional disease-modifying antirheumatic drugs in patients with methotrexate-refractory early rheumatoid arthritis. Here we report the 2 year follow-up assessment.
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To report a case of warfarin resistance associated with the use of sulfasalazine.
Redox and ROS regulation of MAPK-mediated TNF-alpha biosynthesis is not well characterized. It was hypothesized that the involvement of the MAPK pathway in regulating LPS-mediated TNF-alpha secretion is redox-dependent, NF-kappaB-sensitive and attenuated by N-acetyl-L-cysteine (NAC) and other antioxidants. In alveolar epithelial cells, LPS induced a time- and dose-dependent phosphorylation of MAPK(p38). This was associated with the activation of MAPK-activated protein kinase, which phosphorylated the small heat-shock protein, Hsp27. MAPK(p38) inhibition (SB-203580) abrogated LPS-induced TNF-alpha production. MAPK(ERK) blockade (PD-98059) attenuated TNF-alpha secretion, an effect synergistically amplified in the presence of SB-203580. Regulation of NF-kappaB by selective inhibitors revealed that this pathway is partially involved in regulating LPS-mediated TNF-alpha secretion. Whereas the proteasome inhibitor, MG-132, had no effect on LPS-mediated TNF-alpha production, CAPE, sulfasalazine and SN-50, a cell-permeant NF-kappaB inhibitor, attenuated but did not abrogate TNF-alpha biosynthesis. LPS up-regulated ROS, an effect abrogated by 4'-hydroxy-3'-methoxy-acetophenone and NAC, which reduced TNF-alpha secretion, induced the accumulation of GSH, reduced the concentration of GSSG, and blockaded the phosphorylation/activation of MAPK(p38) pathway. ROS induced MAPK(p38) phosphorylation and selective antioxidants, including the permeant GSH precursor, gamma-GCE, reduced ROS-dependent MAPK(p38) phosphorylation. These results indicate that the MAPK pathway and MAPK-mediated regulation of TNF-alpha production is redox-dependent, GSH-mediated and requires, at least in part, a NF-kappaB/ROS-sensitive mechanism.
For pharmacological reasons, the effect of the combination of MTX and SSZ may be different in RA patients who are naïve to these drugs compared to patients with an insufficient response to one of them. Therefore, we compared the results of randomized controlled trials (RCTs) on the combination of MTX and SSZ in naïve patients and in patients with an insufficient response to SSZ.
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88 published studies were included. Over 12 years of treatment, the termination rate of MTX due to toxicity was less than for sulfasalazine, gold, d-penicillamine and higher than for hydroxychloroquine (level of evidence 2a-2b). Long-term use of MTX does not appear to be a risk factor for serious infections, including herpes zoster (2b-4), and could provide a survival benefit by reducing cardiovascular mortality (2b). The prevalence of raised liver enzymes (more than twice the upper limit of normal) is close to 13% of patients; 3.7% of patients stopped MTX permanently owing to liver toxicity (2b). Data on the risk for liver fibrosis/cirrhosis are conflicting: a meta-analysis showed an incidence of fibrosis of 2.7% after 4 years of MTX (2a). However, two other studies on sequential liver biopsies did not show evidence for developing severe damage (2b). Insufficient data are available to fully assess the risk of lymphoma and malignancies, although there is no strong evidence of increased risk (2b-4).
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The study showed that green tea alone and in combination with sulfasalazine reduced inflammatory changes induced by tri nitro benzene sulfonic acid in rats. This reduction is associated with reduced malondialdehyde, lipid peroxidation, and TNF-α. This correlates well with both gross morphological and histopathological scores.
This double-blind randomised study investigated the role of sulphydryl-containing agents in the management of recurrent attacks of ulcerative colitis. To this end, DL-cysteine (200 mg 4 times daily) and DL-methionine-methyl sulphonium chloride (MMSC, 500 mg 4 times daily) were administered orally. Patients with recurrent attacks of moderate proctosigmoidal ulcerative colitis, despite prophylaxis by oral sulphasalazine (2 g daily), were given prednisolone by mouth, 10 mg four times a day, sulphasalazine by mouth, 500 mg four times a day, and morning and evening retention enema (Predsol 20 mg) alone or with cysteine or MMSC. After 2 weeks of treatment with sulphasalazine and prednisolone, 51% of patients (n = 45) were symptom free. Addition of cysteine (n = 46) or MMSC (n = 47) to this regimen controlled the symptoms within 2 weeks in 85% of patients (p < 0.01). During 12 months of prophylactic treatment, 5% of patients (n = 42) receiving sulphasalazine (2 g daily) and cysteine and 5% of patients (n = 41) taking sulphasalazine (2 g daily) and MMSC relapsed, relative to 27% of cases with sulphasalazine (2 g daily) alone (p < 0.01). These results demonstrate that sulphydryl-containing agents play a key role in the treatment of and protection against ulcerative colitis.
Groups did not differ for age, gender, tumour site or irradiation procedure. Diarrhea occurred in 55 and 86% of the sulphasalazine and placebo groups, respectively (P=0.001). Gastrointestinal toxicity was seen in 80 and 93% of the sulphasalazine and placebo groups according to the maximum LENT-SOMA score (P=0.07). According to the maximum LENT-SOMA score between the two groups, significant differences in favor of sulphasalazine were found for each week.