PIANO Interim Reports 2014


Year 7 Progress Report (May 2014)


  • Enrollment
    1. 1315 Enrolled as of 3/4/2014
    2. 482 enrolled in the longterm extension
    3. Current enrollment is limited to mothers on anti-TNF agents (goal 150)
  • Check anti-TNF Levels
    1. New consent form will ask for permission for a release of contact information to UCSF so we can mail them the kits
    2. Anti-TNF levels will be checked at birth in mother, cord and infant. If levels detectable, will check infant at 3 months; if detectable at 6 months.
    3. If you have a patient enrolled who is on anti-TNF therapy will be eligible for this. We would really LOVE to capture these patients.
    4. 12 patients have delivered, 23 more waiting to deliver
  • Optional
    1. If a patient is on anti-TNF we would like to check breast milk samples in a small number of patients. Ideally the tubes will be mailed out with the kits for delivery.  These kits will be mailed to the patient in the third trimester with a copy of her consent form and a letter to the OB with instructions
      • 15 breastmilk results received
    2. Response to vaccines will also be measured in all infants greater than 7 months of age.  This is part of standard of care to see if they responded to their vaccines given immunosuppression use. We can enroll any existing PIANO patients in this regardless of medication exposure.  We are targeting 300-400 patients.
      • Not yet started
    3. T and B cell development. This is a substudy, separately funded, where we are measuring T and B cell development in children exposed to anti-TNF in utero. We are looking for specific populations.
      • 30 exposed and 30 unexposed 1-year old infants of IBD mothers studied
      • Exposed will be 25 INF/ADA plus AZA/6MP; 5 CZP + AZA/6MP
      • Unexposed will be 10 CZP without AZA/6MP; 10 AZA/6mp only; 10  no biologic/IMM
  • Three abstracts accepted as oral presentations at DDW
    1. Achievement of Developmental Milestones Among Offspring of Women with Inflammatory Bowel Disease: The PIANO Registry
    2. Exposure to anti-TNFα therapy in the Third Trimester of Pregnancy is Not Associated with Increased Adverse Outcomes: Results from the PIANO Registry
    3. Pregnancy outcomes amongst mothers with inflammatory bowel disease exposed to systemic corticosteroids: Results of the PIANO Registry