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P376. Safety results comparison of the pediatric ADAPT trial cohort to a seven years retrospective in 656 adult UC patients

T. Ruuska1, R. Gruber2, 1Tampere University Hospital, Dept. of Pediatrics, Tampere, Finland, 2Otsuka Pharmaceutical Europe Ltd., Frankfurt, Germany

Background

Pediatric onset UC is often more extensive and severe and has a higher rate of steroid dependency. Therapeutic strategies in most cases are long-term treatments associated with a broad range of side effects, which impact differently on an adolescent body compared to adult patients. Comparative risk-benefit profiles of existing treatments specifically for a pediatric UC population still lack today. We matched safety results from the small Adacolumn ADAPT study cohort to the safety data stemming from a seven years retrospective in 656 adult UC patients treated with Adacolumn.

Methods

Monitoring safety profiles of therapies includes all adverse reactions. The approximate frequency of each adverse reaction is expressed in terms of orders of magnitude as 1) the most frequent adverse reactions (MF), 2) less frequent adverse reactions (LF), and 3) reactions which occur rarely (RO).

A spreadsheet was set up for the comparison of adverse reactions (cf. Chang, Katzper; CDER/FDA, AMIA Proceedings 1996), per body system affected, per MF, LF, and RO; relatedness and unrelatedness; comparing a pediatric UC population (ADAPT trial data) treated with Adacolumn with published retrospective data for Adacolumn use in 656 adult UC patients (cf. Hibi et al., Dig Liver Dis. 2009; 41(8): 570–7).

Results

During the ADAPT trial, 143 apheresis procedures were performed in pediatric patients aged 13.5±2.6 years. Overall, 24 possibly or positively related adverse events were recorded in 9 out of 25 patients in the safety set, all but one mild to moderate. The 7 years retrospective on 656 treated adult UC patients aged 39.8±1.3 years overlooks 5287 procedures. 124 possibly or positively related events were recorded in 54 patients, all mild to moderate. Headache and procedural headache were the most frequent occurring adverse events (pediatric: 24% of all events; adult: 32%). The two safety profiles were found to be well comparable; and no additional safety messages were seen in the pediatric sample.

Conclusion

When used in a pediatric setting, Adacolumn showed a safety profile well comparable to historic observations in adult UC patients.

1. Chang M., Katzper M., (1996), An Efficient Method for Comparison of Safety Data of Drugs, AMIA, Proc AMIA Annu Fall Symp. 1996, Bethesda, Maryland (USA), 823, http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2233107/pdf/procamiaafs00002–0858.pdf, 2012–11–01.

2. Hibi et al., (2009), Treating ulcerative colitis by Adacolumn therapeutic leucocytapheresis: Clinical efficacy and safety based on surveillance of 656 patients, Elsevier, Dig Liver Dis. 2009; 41(8), 570–7.