Dia 1

1
Delivering Biological Therapies The Nurses
RoleECCO Nurses Network Meeting Lyon 2008
BELGIUM Liesbeth Moortgat Studycoordinator IBD
specialist Department of Gastroenterology and
Gastrointestinal oncology H.-Hartziekenhuis vzw
Roeselare-Menen
2
BELGIUM IBD population
No data avalaible. Global prevalence 1 à 2 /1000
in North America and West-Europe
3
Who are we?

• H. Hartziekenhuis Roeselare-Menen vzw
• 714 beds (4 full-time gispecialists)
• 36 beds GI ward
• 6 GI beds infusion unit
• 1 (1) dedicated to IBD
• gt 10 y clinical trials in IBD
• 1 (1)FT CNS IBD - study coördinator
• Dbase with 409 IBD patients(280 CD/129UC)

4
BELGIUM Biologics in IBD

• APPROVED
• Infliximab in CD (1/12/01) and UC (15/12/06)
• Pt cost 10/vial
• 5 mg/kg
• Q8W max in UC
• Adalimumab in CD (reimbursed March 1 2008)
• Pt cost 10.60/2 syringes
• 160/80/40mg

5
BELGIUM Biologics in IBD
NOT APPROVED (yet) Adalimumab in UC
Certolizumab in CD Abatacept in UC and CD
Golimumab in UC () Natalizumab ( currently
used in clinical trials)
6
H.-Hartziekenhuis RoeselareBiologics experience

• 2007
• 340 Infliximab infusions administered in
  70 IBD patients (61 CD, 9 UC)
• 46 pts on adalimumab treatment (42 CD 4 UC)
• 10 CD pts were treated by Certolizumab
• 2 pts received Abatacept
• M05-769 ,M06-829 and MNP
• M06-826 study
• Welcome 1 and 2, COMPAS
• IM101-084 study

7
Infliximab administration IV

• Patient references
• Known pt or new pt send by GP
• Diagnosis made by anamnesis, physical examination
  and technical examinations
• Mandatory assessments for reimbursement
• TB testing
• Chest X-Ray
• Mantoux/PPD (Purified Protein Derivative) skin
  test
• Patient communication and education

8
Infliximab administration IV

• Practical planning
• Flexible administration times
• Pt anamnesis (infection, fever, AEs,)
• Blood sampling
• Vital parameters
• Consult GIspecialist (before, during or after
  infusion), scheduled every 8 weeks

9
Infliximab administration IV

• Practical planning (2)
• Drug preparation (5mg/kg) by pharmacist,
  prescription made by Gispecialist
• No standard premedication (only by history of
  infusionreaction or fear of immunogenicity)
• Patient monitoring during infusion, vitals every
  30
• SOP infusion reaction
• Scheduling next appointment

10
Adalimumab administration SC

• Patient references
• Till now mostly known pts (infliximab failures,
  pts known with infusionreactions, or for fear of
  immunogenicity reasons)
• Will this change in the future????
• Diagnosis made by anamnesis, physical examination
  and technical examinations
• No mandatory assessments for reimbursement
• TB testing same as for IFX treatment
• Patient communication and EDUCATION!!

11
Adalimumab administration SC

• Practical planning
• Flexible administration times
• Pt anamnesis (infection, fever, AEs,)
• Blood sampling
• GI consult, W0, W2, W4, thereafter every 12 Weeks
  

12
Adalimumab administration SC

• Practical planning (2)
• Prefilled syringes
• No premedication necessary
• Patient monitoring not available
• SOP infusion reaction, not available
• Scheduling next appointment prescriptions

13
Adalimumab administration SCH.-Hartziekenhuis
Roeselare

• Practical planning
• On baseline, day 1, week 0, patients come in our
  practice and get their first 4 injections GI
  consult
• 2 weeks later, day 15, patients come back to the
  hospital to have an other 2 injections. On this
  day I give one injection myself and the other
  injection must be placed by the patient himself
  or a relative. Place an injection seems sometimes
  easy, but on reality this can cause some
  troubles!!On that day patients were also seen by
  the GIspecialist.
• Another 2 weeks later, patient come to our GI
  pratice, they place the injection by themselves
  and are seen by the doctor. At this timepoint
  they take 5 injections back home to inject
  themselves during the upcoming 10 weeks.
• 60 of our pts do the injections themselves,
  15 were done by relatives, 25 ask a nurse at
  home to do the injections.

14
QUESTIONS?