Effect of disease duration and other characteristics on efficacy outcomes in clinical trials of tocilizumab for rheumatoid arthritis.

Objective: To determine the extent to which disease duration, alone or in combination with other baseline clinical and non-clinical factors, explains variations in outcome of tocilizumab initiated in biologic-naïve patients with established RA.

Methods: In this pooled analysis of phase 3 and 4 clinical trials conducted by the sponsor, predictors of response, including demographics, disease characteristics at baseline (start of tocilizumab dosing) and study characteristics (e.g.

Effect on efficacy and safety trial outcomes of also enrolling patients on ongoing glucocorticoid therapy in rheumatoid arthritis clinical trials of tocilizumab or adalimumab or methotrexate monotherapy.

Background: In rheumatoid arthritis (RA) trials, inclusion of patients on background treatment with glucocorticoids (GCs) might impact efficacy and safety outcomes.

Objectives: To determine if inclusion of patients on background GC use influenced efficacy and safety outcomes of RA randomised clinical trials on initiation of tocilizumab (TCZ) or adalimumab (ADA) or methotrexate (MTX) monotherapy.

Methods: Data of four double-blind RA randomised controlled trials (AMBITION, ACT-RAY, ADACTA and FUNCTION) with in total four TCZ, one ADA and two MTX monotherapy arms were analysed.

Meta-analysis and the reversed Theorem of the Means.

Conventional meta-analysis estimators are weighted means of study measures, meant to estimate an overall population measure. For measures such as means, mean differences and risk differences, a weighted arithmetic mean is the conventional estimator. When the measures are ratios, such as odds ratios, logarithms of the study measures are most frequently used, and the back-transform is a weighted geometric mean, rather than the arithmetic mean.

Evaluating cimetidine for GFR estimation in liver transplant recipients.

Background. Serum creatinine (Scr)-based equations lack accuracy in predicting glomerular filtration rate (GFR) in patients with liver disease. Cimetidine has been shown to improve the performance of Scr-based GFR formulae.

Calcineurin inhibitor substitution with sirolimus vs. reduced-dose calcineurin inhibitor plus sirolimus is associated with improved renal dysfunction in heart transplant patients.

Heart transplant (HTx) patients are at risk of developing renal dysfunction. Sirolimus has been used as an alternative for calcineurin inhibitors (CNI) in transplant patients with renal dysfunction. Recent data suggest that the combination of sirolimus with a CNI is associated with a deterioration of renal function in renal transplant patients.

Factors associated with a decrease in the prevalence of drug resistance in newly HIV-1 infected individuals in Montreal.

Objective: A decrease in the prevalence of drug resistance (DR) has been observed among recently infected (RI) individuals in Montreal. A study of chronically infected (CI) patients, who represent potential HIV-1 transmitters, was carried out in order to ascertain biological factors associated with this trend change.

Design And Methods: Retrospective analysis of CI patients was performed for the period 1996-2003.

Statistical analysis of correlated data using generalized estimating equations: an orientation.

The method of generalized estimating equations (GEE) is often used to analyze longitudinal and other correlated response data, particularly if responses are binary. However, few descriptions of the method are accessible to epidemiologists. In this paper, the authors use small worked examples and one real data set, involving both binary and quantitative response data, to help end-users appreciate the essence of the method.