ProCHILDREN
Name the treatment arms (dose and frequency) for this trial
0.5g/kg
1.0g/kg
2.0g/kg
every 3 weeks
This drug was studied in the ICE trial
Gammunex/Gammaked
(Grifols)
This drug/company was the intervention in the PRIMA trial
Privigen/CSL
This company and drug was the focus of the PATH trial
CSL/Hizentra 20%
This is the storage requirement for Panzyga 10%
36 months frige-->12 months expired @ room temp
This is the n in the ProCID trial
142
This trial had this number of week as its washout period
10 weeks
These were the treatment arms in the PATH trial
0.2g/kg
0.4g/kg
placebo
This is the max infusion rate of Panzyga in CIPD
12mg/kg/min
79.7%
HA, Pyrexia, HTN
This was the percentage of patients who met the primary outcome
60.7%
This was the primary endpoint in the PATH trial
Proportion of patients with CIDP relapse
These are the features in which CIPD is characterized by
Progressive, Symmetric, Proximal, Distal with weakness and sensory issues
0.5-1g/kg: no improvement by week 6 OR worsening from week 3-18
This was the max mg of Prednisone allowed in this study
10mg/day
These were the top AEs in the PRIMA study
HA, extremity pain, weakness, leukopenia, HTN
What were the most common reactions in the PATH trial
infusion site reactions
This was the max dose of Prednisolone (or equivalent) allowed in the ProCID trial
20mg/day
These were the top 4 AEs in the ProCID trial
HA, Dermatitis, Pyrexia, Increased BP
Describe this trial design
LD with 2/kg then 1g/kg q 3 weeks or placebo
If INCAT worsened by at least 1 point @ anytime between day 16 or week 24 OR if INCAT did not change by week 6 pt crossed over to receive rescue treatment
After 24 week: randomized to get IVIG or placebo for 24 weeks @ dose of 1g/kg of IVIG or placebo over 1-2 days q 3 weeks
76.9 % :(
This was the author's conclusion in the PATH trial
Patients can be safely transitioned from IVIG to SCIG
This is what the abbreviation for PANS means
Pediatric Acute-onset Neuropsychiatric Syndrome