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8. Meta-Analysis Combining Parallel and Crossover Trials Using Generalised Estimating Equation Method

Author

Curtin, François

Abstract

Clinical trials have different designs: In late stage drug development, the parallel trial design is the most frequent one; however, the crossover design is not rare; different techniques are used to analyse their results. Although both designs measure the same treatment effect, combining parallel and crossover trials in a meta-analysis is not straightforward. We present here a meta-analysis method based on generalised estimating equation (GEE) regression to combine aggregated results of crossover and parallel trials using a marginal estimation approach. This method is based on the fixed effects meta-analytic model; it allows combining average outcomes belonging to the exponential distributions obtained from trials of different designs and in particular from crossover trials with more than 2 periods and 2 treatments. By extending the methods proposed so far to combine the 2 trial designs, the GEE regression allows for adjusting for bias, such as a carry-over effect typical in crossover trials. In this paper, the GEE meta-analysis method is compared to the classical weighted average method with examples of published and simulated meta-analyses. Although the GEE can account for crossover specificities, it is limited by the availability of detailed trial information often encountered with reports of these trials.

Published
2017
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9. Meta-Analysis Combining Parallel and Cross-Over Trials with Random Effects

Author

Curtin, François

Abstract

Meta-analysis can necessitate the combination of parallel and cross-over trial designs. Because of the differences in the trial designs and potential biases notably associated with the crossover trials, one often combines trials of the same designs only, which decreases the power of the meta-analysis. To combine results of clinical trials from parallel and cross-over designs, we extend the method proposed in an accompanying study to account for random effects. We propose here a hierarchical mixed model allowing the combination of the 2 types of trial designs and accounting for additional covariates where random effects can be introduced to account for heterogeneity in trial, treatment effect, and interactions. We introduce a multilevel model and a Bayesian hierarchical model for combined trial design meta-analysis. The analysis of the models by restricted iterative generalised least square and Monte Carlo Markov Chain is presented. Methods are compared in a combined design meta-analysis model on salt reduction. Both models and their respective advantages in the perspective of meta-analysis are discussed. However, the access to the trial data, in particular sequence and period data in cross-over trials, remains a major limitation to the meta-analytic combination of trial designs.

Published
2017
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18. Impact of SARS-CoV-2 Infection (COVID-19) on Cytochromes P450 Activity Assessed by the Geneva Cocktail

Author

Lenoir, Camille, Terrier, Jean, Gloor, Yvonne, Curtin, François, Rollason, Victoria, Desmeules, Jules Alexandre, Daali, Youssef, Reny, Jean-Luc, and Samer, Caroline Flora

Abstract

Coronavirus disease 2019 (COVID-19), caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, is a severe acute respiratory syndrome with an underlying inflammatory state. We have previously demonstrated that acute inflammation modulates cytochromes P450 (CYPs) activity in an isoform-specific manner. We therefore hypothesized that COVID-19 might also impact CYP activity, and thus aimed to evaluate the impact of acute inflammation in the context of SARS-CoV-2 infection on the six main human CYPs activity. This prospective observational study was conducted in 28 patients hospitalized at the Geneva University Hospitals (Switzerland) with a diagnosis of moderate to severe COVID-19. They received the Geneva phenotyping cocktail orally during the first 72 hours of hospitalization and after 3 months. Capillary blood samples were collected 2 hours after cocktail administration to assess the metabolic ratios (MRs) of CYP1A2, 2B6, 2C9, 2C19, 2D6, and 3A. C-reactive protein (CRP), interleukin 6 (IL-6), and tumor necrosis factor-alpha (TNF-alpha) levels were also measured in blood. CYP1A2, CYP2C19, and CYP3A MRs decreased by 52.6% (P = 0.0001), 74.7% (P = 0.0006), and 22.8% (P = 0.045), respectively, in patients with COVID-19. CYP2B6 and CYP2C9 MRs increased by 101.1% (P = 0.009) and 55.8% (P = 0.0006), respectively. CYP2D6 MR variation did not reach statistical significance (P = 0.072). As expected, COVID-19 was a good acute inflammation model as mean serum levels of CRP, IL-6, and TNF-alpha were significantly (P < 0.001) higher during SARS-CoV-2 infection. CYP activity are modulated in an isoform-specific manner by SARS-CoV-2 infection. The pharmacokinetics of CYP substrates, whether used to treat the disease or as the usual treatment of patients, could be therefore clinically impacted., Clinical Pharmacology & Therapeutics, 110 (5), ISSN:0009-9236, ISSN:1532-6535

Published
2021

19. Do Selective Serotonin Reuptake Inhibitors Cause Suicide?

Author

Curtin, François, Schulz, Pierre, Healy, David, Gunnell, David, Saperia, Julia, Ashby, Deborah, Jones, Hugh M., Sakinofsky, Isaac, Streiner, David L., Mitchell, Alex J., Fergusson, Dean, Doucette, Steve, Hebert, Paul, Shapiro, Stan, Raven, Melissa K., Cipriani, Andrea, Barbui, Corrado, Geddes, John R., Murray, Macey L., Wong, Ian C. K., and Thompson, Mary

Published
2005

22. Impact of Acute Inflammation on Cytochromes P450 Activity Assessed by the Geneva Cocktail

Author

Lenoir, Camille, primary, Daali, Youssef, additional, Rollason, Victoria, additional, Curtin, François, additional, Gloor, Yvonne, additional, Bosilkovska, Marija, additional, Walder, Bernhard, additional, Gabay, Cem, additional, Nissen, Michael John, additional, Desmeules, Jules Alexandre, additional, Hannouche, Didier, additional, and Samer, Caroline Flora, additional

Published
2021
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27. A phase IIa randomized clinical study testing GNbAC1, a humanized monoclonal antibody against the envelope protein of multiple sclerosis associated endogenous retrovirus in multiple sclerosis patients — A twelve month follow-up

Author

Derfuss, Tobias, Curtin, François, Guebelin, Claudia, Bridel, Claire, Rasenack, Maria, Matthey, Alain, Du Pasquier, Renaud, Schluep, Myriam, Desmeules, Jules, Lang, Alois B., Perron, Hervé, Faucard, Raphael, Porchet, Hervé, Hartung, Hans-Peter, Kappos, Ludwig, and Lalive, Patrice H.

Published
2015
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31. Individuality and stability of nocturnal secretion patterns for eight hormones in healthy young men

Author

Schulz, Pierre, Curtin, François, and Steimer, Thierry

Subjects
Poster
Abstract

The concentration of hormones in the bloodstream shows oscillations, reflecting the fact that endocrine physiology is structured over time. In many cases, these oscillations have an ultradian configuration that can be superimposed on a circadian rhythm. Secretion of hormones can be linked to the phases of sleep, as is the case with growth hormone (GH); can depend strongly on the circadian pacemaker, as in the case of cortisol; or be under the influence of both, as seen for thyroid-stimulating hormone (TSH). Thus, the temporal pattern of secretion of several hormones, and the resulting plasma concentration (also influenced by hormone tissue distribution and clearance), depends on impulses from biological clocks and is influenced by endogenous and exogenous masking factors. The extent of interindividual differences in the phenotypes of temporal patterns of hormone secretion is not well known. In this study, a series of eight hormones were measured over one night, and these measurements were repeated over another night. The study had two goals. The first was to explore the extent of inter individual differences in nocturnal and ultradian rhythms of these hormones. The second was to see how stable the individual patterns of nocturnal hormone secretion could be. Our results indicate that the temporal organization of hormone secretion into the blood is highly individual, and that these intraindividual patterns are conserved over time. This is relevant in view of the changes in secretion of several hormones that have been described in biological psychiatry research.

Published
2007

32. Human Endogenous Retrovirus and Neuroinflammation in Chronic Inflammatory Demyelinating Polyradiculoneuropathy

Author

Faucard, Raphaël, primary, Madeira, Alexandra, additional, Gehin, Nadège, additional, Authier, François-Jérôme, additional, Panaite, Petrica-Adrian, additional, Lesage, Catherine, additional, Burgelin, Ingrid, additional, Bertel, Mélanie, additional, Bernard, Corinne, additional, Curtin, François, additional, Lang, Aloïs B., additional, Steck, Andreas J., additional, Perron, Hervé, additional, Kuntzer, Thierry, additional, and Créange, Alain, additional

Published
2016
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36. A phase IIa randomised clinical study of GNbAC1, a humanised monoclonal antibody against the envelope protein of multiple sclerosis-associated endogenous retrovirus in multiple sclerosis patients

Author

Derfuss, Tobias, primary, Curtin, François, additional, Guebelin, Claudia, additional, Bridel, Claire, additional, Rasenack, Maria, additional, Matthey, Alain, additional, Du Pasquier, Renaud, additional, Schluep, Myriam, additional, Desmeules, Jules, additional, Lang, Alois B, additional, Perron, Hervé, additional, Faucard, Raphael, additional, Porchet, Hervé, additional, Hartung, Hans-Peter, additional, Kappos, Ludwig, additional, and Lalive, Patrice H, additional

Published
2014
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38. The DNA Copy Number of Human Endogenous Retrovirus-W (MSRV-Type) Is Increased in Multiple Sclerosis Patients and Is Influenced by Gender and Disease Severity

Author

Garcia-Montojo, Marta, primary, Dominguez-Mozo, María, additional, Arias-Leal, Ana, additional, Garcia-Martinez, Ángel, additional, De las Heras, Virginia, additional, Casanova, Ignacio, additional, Faucard, Raphaël, additional, Gehin, Nadège, additional, Madeira, Alexandra, additional, Arroyo, Rafael, additional, Curtin, François, additional, Alvarez-Lafuente, Roberto, additional, and Perron, Hervé, additional

Published
2013
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43. A phase IIa randomised clinical study of GNbAC1, a humanised monoclonal antibody against the envelope protein of multiple sclerosis-associated endogenous retrovirus in multiple sclerosis patients.

Author

Derfuss, Tobias, Curtin, François, Guebelin, Claudia, Bridel, Claire, Rasenack, Maria, Matthey, Alain, Du Pasquier, Renaud, Schluep, Myriam, Desmeules, Jules, Lang, Alois B, Perron, Hervé, Faucard, Raphael, Porchet, Hervé, Hartung, Hans-Peter, Kappos, Ludwig, and Lalive, Patrice H

Subjects
*MULTIPLE sclerosis, *HUMAN endogenous retroviruses, *MONOCLONAL antibodies, *IMMUNOGLOBULIN G, *CLINICAL trials, *PATIENTS
Abstract

The article presents a phase IIa randomised clinical study which investigates the safety and tolerability of GNbAC1, an immunoglobulin (IgG4) humanised monoclonal antibody, among patients with multiple sclerosis (MS). The study involves a six-month open label phase to measure the efficacy of GNbAC1 against multiple sclerosis-associated retovirus (MSRV)-Env, a protein of endogenous retroviral origin. Results show the significant effect of GNbAC1 in all patients.

Published
2015
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