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Biomedical subjects

G Pasero

Publications and source records attributed to G Pasero.

At least 37 records · Page 2Linked to original sources

Clinical trials in rheumatoid arthritis: methodological suggestions for assessing radiographs arising from the GRISAR Study. Gruppo Reumatologi Italiani Studio Artrite Reumatoide.

OBJECTIVES: The three x ray assessors of the GRISAR study (blinded to treatment) gave consensual erosion and damage scores to the baseline and 12 month radiographs of 284 rheumatoid arthritis (RA) patients using three different methods: single readings (blinded as to patient and chronological sequence of the x rays), paired readings (blinded as to sequence), and chronologically ordered paired readings. The aim was to evaluate which of these reading procedures is the most appropriate for clinical trials. METHODS: The progression of the scores obtained using each procedure was compared by means of descriptive statistics, principal components analysis, and intra-patient correlation coefficients of pairs of methods. Bootstrap estimates of the variance of the difference in the means of two equally sized random samples were calculated to evaluate the power of the statistical analysis performed to assess the possible treatment effect for both paired and chronological reading methods. RESULTS: (a) The standard deviations of the paired and chronological readings were similar, but that of the single readings was higher. (b) The knowledge that two x rays were of the same patient accounted for a sizeable proportion of the between method variability. (c) Agreement was satisfactory between the paired and chronological methods for both scores but, between them and the single readings, it was modest for erosions and poor for damage. (d) The bootstrap estimate of the variance of the difference was smaller for the paired than the chronological method, possibly giving it greater power to test treatment effect. CONCLUSIONS: These results suggested that paired readings were the most suitable for evaluating the progression of joint damage in the GRISAR study.

Arthritis, Rheumatoid↗

Psoriatic arthritis with spinal involvement in a patient receiving alpha-interferon for chronic hepatitis C.

A 26-year-old male patient being treated with alpha-interferon for chronic hepatitis C developed psoriasis, seronegative oligoarthritis and sacroiliitis after four months. The close temporal relationship between the alpha-interferon therapy and the onset of skin and articular lesions strongly suggests that the drug played a role in the induction of the disease despite the absence of HLA antigens related to psoriatic arthritis. We cannot exclude the possibility that immunological alterations associated with HCV infection could have constituted a predisposing factor in the onset of the disease.

Adult↗

Slow progression of joint damage in early rheumatoid arthritis treated with cyclosporin A.

OBJECTIVE: To evaluate the ability of low-dose cyclosporin A (CsA) to control radiologic disease progression, and to assess the clinical efficacy and tolerability of CsA, compared with conventional disease-modifying antirheumatic drugs (DMARDs), in patients with early active rheumatoid arthritis (RA). METHODS: In this long-term, multicenter, prospective, open, blinded end point, randomized trial, 361 consenting patients with early (<4 years since diagnosis) active RA were enrolled. Of the eligible patients, 167 were treated with CsA at 3 mg/kg/day, and 173 with DMARDs. The decision to use conventional antirheumatic drugs as controls was based on the fact that joint erosion could be expected to occur after 1 year regardless of the type of DMARD being used. The possibility of switching therapies in both groups was intended to keep the largest possible number of patients in the study. RESULTS: Blinded evaluation of hand and foot radiographs after 12 months of treatment showed that CsA led to a significant (P < 0.001) delay in the mean +/- SD progression in the eroded joint count (1.3 +/- 3.1 versus 2.4 +/- 3.0 for the control group) and in the joint damage score (3.6 +/- 8.9 versus 6.9 +/- 9.1 for the control group), both measured by the Larsen-Dale method. When only the patients without erosion at baseline were considered (37 in the CsA-treated group and 54 in the control group), erosion appeared in only 10.8% of the CsA-treated patients, but in 51.8% of the controls (P = 0.00005). Low-dose CsA was as effective as traditional DMARDs in controlling clinical symptoms. Maintenance on the initially prescribed treatment regimen ("survival on treatment") was also better at 12 months with CsA than with DMARDs (89.2% versus 77.5%; P = 0.002). The tolerability of CsA was acceptable. CONCLUSION: These 12-month results suggest that low-dose CsA decreases the rate of further joint damage in previously involved joints as well as the rate of new joint involvement in previously uninvolved joints, in patients with early RA.

Adult↗

Is the control of disease progression within our grasp? Review of the GRISAR study. (Gruppo Reumatologi Italiani Studio Artrite Reumatoide).

A prospective, open, multicentre, randomized study with a blinded radiological end-point was started in 1991. The aim of the study was to assess whether cyclosporin A (CyA) controls ongoing anatomical damage in active early rheumatoid arthritis (RA) better than conventional disease-modifying anti-rheumatic drugs (DMARDs) as used in everyday clinical practice. A total of 340 consenting patients with early RA (mean duration 1.4 yr) were recruited; 167 were randomized to CyA 3mg/kg per day and 173 to DMARDs. Hand, wrist and foot X-rays were blindly scored by a central committee of three radiologists using the Larsen-Dale method. Any side-effects were carefully recorded. The control of clinical symptoms was similar in both groups. Radiological evaluation of 284 patients (141 on CyA; 143 on DMARDs) after 12 months showed a significant decrease in the mean progression in the eroded joint count (1.3 +/- 3.1 vs 2.4 +/- 3.0, P < 0.001). There was also better maintenance on treatment with CyA than in the group treated with DMARDs (89.2 vs 77.5%, respectively; P = 0.002). CyA seems to offer greater control of ongoing anatomical joint damage in early RA than conventional DMARDs after 12 months.

Adult↗

Exacerbation of peripheral neuropathy during alpha-interferon therapy in a patient with mixed cryoglobulinemia and hepatitis B virus infection.

An association between hepatotropic viruses, chiefly hepatitis C virus (HCV), occasionally hepatitis B virus (HBV), and mixed cryoglobulinemia has been widely reported. Alpha-interferon (IFN-alpha) has usefully been employed in the treatment of mixed cryoglobulinemia, particularly for liver and renal involvement. IFN-alpha treatment may be associated with neurological complications, including peripheral neuropathy. We describe an HBV positive patient with mixed cryoglobulinemia with recurrent purpura, mild sensory peripheral neuropathy, and active hepatitis treated with IFN-alpha. Rapid improvement of the purpura, liver enzymes, and cryocrit, and disappearance of serum HBV DNA were observed after a 4 week treatment period. However, concomitant worsening of the neuropathy prompted us to discontinue IFN-alpha. Although in this case, a positive effect of IFN-alpha on the clinico-serological and virological variables was confirmed, due to the possible exacerbation of neurological manifestations, a careful patient evaluation is necessary before starting IFN-alpha in patients with mixed cryoglobulinemia.

Cryoglobulinemia↗

A multi-centre, double-blind comparative study of the efficacy and safety of aceclofenac and diclofenac in the treatment of rheumatoid arthritis.

A long term multi-centre, double-blind, parallel group study was undertaken to investigate the efficacy and safety of aceclofenac (170 patients, 100 mg b.i.d. and placebo once daily) in comparison to diclofenac (173 patients, 50 mg t.i.d.) given for 6 months to patients of both sexes with active rheumatoid arthritis. Efficacy was evaluated in 131 aceclofenac and 130 diclofenac patients at 15 days, 1, 2, 4 and 6 months. Although both treatment groups showed significant improvement in all evaluations of pain and inflammation (assessed by a Visual Analogue Scale and the Ritchie Index) and a progressive reduction in morning stiffness, there were no significant differences between the groups. There was, however, a trend towards greater improvement in hand grip strength with aceclofenac (22% improvement) than diclofenac (17% improvement). Adverse events in both groups were minor, predominantly gastro-intestinal, and fewer patients tended to experience gastro-intestinal events on aceclofenac (13%) than on diclofenac (17%). The overall assessment of tolerance, however, did not differ significantly between groups. In summary, this study supports a therapeutic role for aceclofenac in the treatment of rheumatoid arthritis, and suggests it is an effective and safe NSAID for the treatment of this disease.

Adult↗

Deflazacort versus methylprednisolone in polymyalgia rheumatica: clinical equivalence and relative antiinflammatory potency of different treatment regimens.

OBJECTIVE: To assess the clinical efficacy and equivalence of a daily vs alternate day regimen, and the potency ratio between 2 glucocorticoids, deflazacort and 6-methylprednisolone. METHODS: Thirty-one patients with recent onset polymyalgia rheumatica (PMR) were randomly assigned to deflazacort (n = 16) or 6-methylprednisolone (n = 15), according to a 2 period (duration of each period = 6 weeks), crossover, open design for comparing 2 dose regimens (daily vs alternate day), and according to a between-patients, double blind design for comparing the therapeutic effects of the 2 glucocorticoids (deflazacort vs 6-methylprednisolone). The patients, either during alternate day or daily regimen, were treated with fixed oral doses for the first 2 weeks (assuming a potency ratio deflazacort/6-methylprednisolone of 1.5 mg/1.0 mg: deflazacort 24 mg or 6-methylprednisolone 16 mg, daily; deflazacort 48 mg or 6-methylprednisolone 32 mg, alternate day), and with titrated doses for the next 10 weeks. RESULTS: Two patients dropped out during the first 6 week period. The time course and extent of the improvement of disease activity indices (limb-girdle pain, morning stiffness, erythrocyte sedimentation rate, C-reactive protein, and plasma fibrinogen) were not statistically different under the 2 regimens. The satisfactory equivalent glucocorticoid response observed in 12 pairs of patients treated with deflazacort and 6-methylprednisolone progressed significantly from baseline to the end of the study, under daily or alternate day regimen, with no significant difference between the 2 glucocorticoids. Deflazacort proved less potent than 6-methylprednisolone (1.78 mg: 1.0 mg minimum effective daily dose; 1.68: 1.0, alternate day), but equally effective. CONCLUSION: The 2 dose regimens, 6-methylprednisolone and deflazacort showed no significant differences in terms of efficacy during the short term treatment of PMR. Deflazacort proved less potent than initially estimated.

Aged↗

Infection of peripheral blood mononuclear cells by hepatitis C virus in mixed cryoglobulinemia.

A striking association between hepatitis C virus (HCV) infection and mixed cryoglobulinemia (MC) has been shown; thus, HCV seems to play an important etiopathogenetic role in this lymphoproliferative disorder. Because HCV is both a hepatotropic and lymphotropic virus, this study aimed to investigate the prevalence of HCV infection of peripheral blood mononuclear cells (PBMCs) in a series of 16 patients with type II (IgMk) MC. Antibodies against HCV were detected by commercially available kits (Second Generation Chiron enzyme-linked immunosorbent assay [ELISA] and recombinant-based immunoblot assay [RIBA]), and the presence of HCV RNA was evaluated in both sera and isolated PBMCs using the polymerase chain reaction technique. A previous exposure to HCV was shown by ELISA and confirmed by RIBA in all cases (100%). Moreover, HCV RNA was present in the sera of 8 of 16 patients (50%), whereas its frequency markedly increased (13 of 16 [81%]) when genomic sequences were detected in peripheral lymphocytes. HCV RNA was never detected in the PBMCs of 20 control subjects. These findings showed that HCV infection, alone or in combination with other factors, may be responsible for the clonal B-cell expansion underlying the systemic manifestations of MC, and may explain the appearance of a malignant non-Hodgkin's lymphoma in some subjects.

Aged↗

Seronegative spondylarthropathy without spine involvement in Behçet's syndrome.

The case of a 49-year-old man affected by Behçet's syndrome (BS) without any clinical or radiological evidence of ankylosing spondylitis, exhibiting a peripheral enthesitis typical of seronegative spondyloarthropathy (SpA) is reported. The diagnosis of SpA is supported by computed tomographic evidence of sacroiliitis. This case confirms our hypothesis that patients with BS may have other forms of SpA than AS.

Achilles Tendon↗

Hepatitis C virus-related autoimmunity in patients with porphyria cutanea tarda.

Hepatitis C virus (HCV) infection is frequently found in autoimmune hepatitis and mixed cryoglobulinaemia. In these conditions HCV could be responsible for immuno-mediated organ alterations. The aim of this study was to evaluate the presence of immunological alterations in PCT patients, in which HCV infection has been frequently found. Twenty-three PCT patients were evaluated for clinical and serological alterations, including: chronic hepatitis, other systemic symptoms, serum cryoglobulins and rheumatoid factor (RF), haemolytic complement, serum immunoglobulins, anti-nuclear (ANA), anti-smooth muscle (ASMA), anti-liver-kidney-microsomal (anti-LKM1), anti-soluble-liver-antigen (SLA), anti-mitochondrial (AMA), anti-GOR antibodies, anti-HCV and HCV RNA. Abnormal serum ALT were present in the majority of cases (20/23, 87%), while liver biopsy revealed a chronic persistent hepatitis or chronic active hepatitis in 15/20 (75%) PCT patients. In a high percentage of subjects (91%) the presence of anti-HCV was detected by ELISA and RIBA II (Chiron, Emeryville CA, USA). In 17/22 (77%) cases the ongoing HCV replication in the serum was demonstrated by the detection of HCV genomes (polymerase chain reaction). The prevalence of both anti-HCV and HCV RNA in PCT was significantly higher if compared to 22 systemic immunological diseases (P < 0.001) and 47 healthy subjects (P < 0.001). A possible HCV-induced autoimmunity in PCT was suggested by the presence of the following immunological parameter alterations: anti-GOR in 13/23 (57%), ANA in 4/23 (17%), ASMA in 18/23 (78%), anti-LKM1 in 1/23 (4%), RF in 23/23 (100%), mixed cryoglobulins in 4/23 (17%), complement consumption in 10/23 (43%).(ABSTRACT TRUNCATED AT 250 WORDS)

Aged↗