Accepted for Publication: August 8, 2012.
Published Online: November 19, 2012. doi:10.1001/jamadermatol.2013.938
Authors Contributions: Drs Roujeau, Mockenhaupt, Tahan, Singhal, Kauffman, and Stern had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. Study concept and design: Roujeau, Mockenhaupt, Singhal, Kauffman, and Stern. Acquisition of data: Harding, Bengtsson, and Singhal. Analysis and interpretation of data: Roujeau, Mockenhaupt, Tahan, Henshaw, Martin, Harding, van Baelen, Singhal, Kauffman, and Stern. Drafting of the manuscript: Henshaw, Harding, Singhal, and Stern. Critical revision of the manuscript for important intellectual content: Roujeau, Mockenhaupt, Tahan, Henshaw, Martin, Harding, van Baelen, Bengtsson, Singhal, Kauffman, and Stern. Statistical analysis: Martin, van Baelen, and Bengtsson. Obtained funding: Singhal and Kauffman. Administrative, technical, and material support: Tahan and Henshaw. Study supervision: Singhal and Stern.
Conflict of Interest Disclosures: Drs Roujeau, Mockenhaupt, Tahan, and Stern served as consultants and received consulting fees from Vertex Pharmaceuticals. Drs Henshaw, Martin, Harding, Singhal, and Kauffman and Mr Bengtsson are employed by Vertex Pharmaceuticals and may hold Vertex Pharmaceuticals stocks and/or options. Dr van Baelen is employed by Janssen Pharma and may hold Janssen Pharma stocks and/or options. Dr Roujean has served on expert panels on severe cutaneous adverse reaction (SCAR) cases for AB Science, Menarini, and US Lawyers; has served on safety boards on SCAR for OM Pharma and Servier; and has received unrestricted research grants (RegiSCAR) from Novartis, GlaxoSmithKline, Boehringer-Ingelheim, OM Pharma, Astellas, and Servier. Dr Mockenhaupt is the coordinator of the international RegiSCAR-project, which is funded by grants from the European Commission (QLRT-2002-01738) and GIS-Institut des Maladies Rares and INSERM (4CH09G) in France and by a consortium of pharmaceutical companies (Bayer Vital, Boehringer-Ingelheim, Cephalon, GlaxoSmithKline, MSD Sharp and Dohme, Merck, Novartis, Pfizer, Roche, sanofi-aventis, Servier, and Tibotec); has received the Else Kröner Memorial Stipendium for support of clinical research through the Else Kröner-Fresenius Foundation; has been an expert in litigations concerning Stevens-Johnson syndrome and toxic epidermal necrolysis; and has served in expert panels and advisory boards coordinated by pharmaceutical companies (2009-2011: dermatology safety board Merck & Co). Currently, RegiSCAR Germany receives funding by the Ministry for Education and Research (Bundesministerium für Bildung und Forschung; grant 01KG1018). Dr Tahan served as a consultant for Tibotec-Jansen Pharmaceuticals. Dr Stern has received consulting fees for the assessment of skin reactions associated with drugs under development from InterMune, Johnson & Johnson, Boehringer Ingelheim, and Takeda and its Millennium Division; has served on a drug-safety panel for Takeda; and has served as an expert witness in product liability litigation relating to skin reactions for Johnson & Johnson and Mutual.
Funding/Support: This study was funded by Vertex Pharmaceuticals and Janssen Pharma.
Role of the Sponsors: All authors, including employees of the sponsors, contributed to the design and conduct of the study; the collection, management, analysis, and interpretation of the data; and the preparation, review, or approval of the manuscript.
Additional Contributions: Cherif Benattia, MD (an employee of Vertex Pharmaceuticals at the time this study was initiated), appointed the expert panel and provided thoughtful discussion; Frank Tomaka, MD (from Janssen Pharma), Ravi Ramachandran, PhD (from Vertex Pharmaceuticals), and Yuko Sakurai, MSc, and Ichimaro Yamada, PhD (both from Mitsubishi Tanabe Pharma Corporation), assisted with data collection; Mohammad Bsharat, PhD (from Vertex Pharmaceuticals), assisted with statistical analysis; Laura Bower, MD (from Vertex Pharmaceuticals), assisted with data compilation; and Valérie Philippon, PhD, and Elizabeth Dorn, PhD (from Vertex Pharmaceuticals), assisted with medical writing and provided editorial and coordination support. We would like to thank all patients, studies coordinators, nurses, and investigators of the telaprevir clinical trials program.