Positive Ph III results for AbbVie's Humira in pediatric Crohn's disease; five leukemia studies suspended

AbbVie (NYSE: ABBV), the new spin-out from Abbott Laboratories, has announced the first long-term, patient-reported health outcomes data from analyses of the Phase III IMAgINE-1 trial, reporting positive findings in pediatric patients with Crohn’s disease treated with the company’s blockbuster rheumatoid arthritis drug Humira (adalimumab), which generated sales of $9.26 billion in I 2012.

The analyses assessed improvements in health-related quality of life (HRQOL) measures for pediatric patients aged six to 17 years with severe active Crohn's disease, taking Humira, who had an inadequate response, were intolerant or had contraindications to conventional therapy, as well as the work productivity of their caregivers throughout the 52-week study. The results of these analyses were being presented last week at the European Crohn's and Colitis Organisation (ECCO) 8th Annual Congress.

"It is important to assess both clinical and health-related measures in the management of pediatric Crohn's disease to ensure better overall patient outcomes," said Johanna Escher, associate professor, Pediatric Gastroenterology, Erasmus MC-Sophia Children's Hospital, Rotterdam, the Netherlands, adding: "Quality of life analyses from studies like the IMAgINE trial can be of value to the medical community and ultimately patients as they both manage this long-term and difficult-to-treat condition."