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Biomedical subjects

Francois Curtin

Publications and source records attributed to Francois Curtin.

6 recordsLinked to original sources
PubMed2006

A review of malignancies observed during efalizumab (Raptiva) clinical trials for plaque psoriasis.

BACKGROUND: Psoriasis is a chronic, incurable immune-mediated disease. Most therapies used for moderate to severe psoriasis are immunosuppressive. Agents that depress immune function, including traditional psoriasis therapies, have been associated with an increased incidence of malignancies. Efalizumab is a recombinant monoclonal immunoglobulin G1 (IgG1) antibody approved for use in psoriasis patients. OBJECTIVES: To evaluate the incidence of malignancy in patients receiving efalizumab during clinical trials compared with placebo-treated patients, psoriasis patients from external cohorts and the general US population. METHODS: Patient data were pooled from multiple phase III placebo-controlled, open-label efalizumab clinical trials, and the incidence rate of reported malignancies was calculated as a function of patient years of observation. The results for the efalizumab-treated patients were compared with the data on psoriasis patients from insurance claims databases and a registry of events in the general population. RESULTS: The efalizumab- and placebo-treated patients had similar incidence rates of malignancy, including lymphoproliferative disease, solid tumor, malignant melanoma and nonmelanoma skin cancer. The incidence of nonmelanoma skin cancers, including basal cell carcinoma and squamous cell carcinoma, in patients receiving efalizumab or placebo was elevated relative to the external databases. CONCLUSIONS: These results suggest that efalizumab treatment does not increase a patient's risk for malignancy. The difference observed with nonmelanoma skin cancer may be due to biases introduced by the clinical trial methodology. Additional patient observation is necessary to ascertain whether a link exists between efalizumab therapy and nonmelanoma skin cancer above that normally observed in psoriasis patients.

Antibodies, Monoclonal↗
PubMed2005

The relationship between depression and interferon beta-1a therapy in patients with multiple sclerosis.

It has been suggested that interferons (IFN) may cause depression de novo or worsen pre-existing depression. Depression data collected using validated instruments from individual clinical trials in multiple sclerosis, however, have consistently failed to identify an association. In this study, pooled data from 6 controlled studies and 17 noncontrolled clinical trials of subcutaneous IFN beta-1a were assessed to determine the relationship between IFN therapy with physician reports of depression and suicide. In distinction to the negative findings for depressive symptom ratings, pooling of physician-reported side effect data from these clinical trials identified a statistically significant association between depression and IFN use during the first six months of treatment There was an association between these reported episodes of depression and discontinuation of IFN therapy, but IFN treatment was not associated with suicide attempts. IFN beta-1a may induce a constellation of symptoms, particularly early in therapy, that may be labelled as depression by physicians. However, the lack of an increase in depression-rating scale scores and the lack of association with suicide risk suggests that the syndrome may be an atypical one.

Adjuvants, Immunologic↗
PubMed2002

Meta-analyses involving cross-over trials: methodological issues.

BACKGROUND: Meta-analysis of randomized controlled trials (RCTs) is usually based on trials where patients are randomized individually into two different, parallel, treatment groups. This paper concentrates on RCTs of a different design-two-period, two-treatment cross-over trials. METHODS: The characteristics of these trials are outlined, with detailed examples of methods for analysis for both continuous and binary data. These case studies are then extended into the context of a meta-analysis. The Cochrane Library was surveyed to assess current practice for synthesis. RESULTS: Methods are described for continuous and binary data for use both when the necessary paired data are given and also when they need to be calculated or imputed, and some suggestions are provided to help people wishing to synthesize data from cross-over trials into meta-analyses. The survey suggested that about 8% of the trials in the Cochrane library were cross-over trials and 18% of the reviews referred to such trials, although there was no consistent approach to their inclusion into the reviews. CONCLUSIONS: Methods do exist for including valuable information from two-period, two-treatment cross-over trials into quantitative reviews. However, poor reporting of cross-over trials will often impede attempts to perform a meta-analysis using the available methods.

Cross-Over Studies↗