Accepted for Publication: April 10, 2011.
Published Online: June 16, 2011. doi:10.1001/archdermatol.2011.161
Author Contributions: Drs Szapary and Fakharzadeh had full access to all 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: Szapary, Goyal, and Fakharzadeh. Acquisition of data: Gratton, Szapary, Germain, and Saltiel. Analysis and interpretation of data: Szapary, Goyal, Fakharzadeh, Germain, and Saltiel. Drafting of the manuscript: Fakharzadeh and Saltiel. Critical revision of the manuscript for important intellectual content: Gratton, Szapary, Goyal, Fakharzadeh, Germain, and Saltiel. Administrative, technical, or material support: Szapary. Study supervision: Gratton, Szapary, and Goyal.
Financial Disclosure: Dr Gratton served as an investigator in the PHOENIX 2 trial35 and has received honoraria as an investigator, speaker, and advisory board member for Centocor, Abbott, Amgen, and Schering-Plough. Drs Szapary, Goyal, and Fakharzadeh are employed by subsidiaries of Johnson & Johnson.
Funding/Support: The study in which this case was first reported was supported by Centocor Research & Development, Inc, a subsidiary of Johnson & Johnson.
Role of the Sponsors: The sponsor contributed in part to the design and conduct of the study in which this case was first reported; the collection, management, analysis, and interpretation of the data in the manuscript; and the preparation, review, and approval of the manuscript. This case report was prepared jointly by the study investigator, diagnosing physicians, and the sponsor in carrying out due diligence to inform the medical community of this important adverse event.
Additional Contributions: Jennifer Han and Mary Whitman, PhD, of Centocor Ortho Biotech Services, LLC, drafted and revised the manuscript. Drs Julie Gr égoire, Pierre Pascual, Marie Jolivet, H él ène Marinier, and Jean-Dominique Gervais participated in the care of this patient.