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P376 Safety results comparison of the pediatric ADAPT trial cohort to a seven years retrospective in 656 adult UC patients
S160 males and females (p < 0.001 both). However, only males were found to have reduced ASMI (p < 0.001, females p = 0.08) and grip strength (p < 0.001, females p = 0.4). Sarcopaenia by our combined anatomical/functional definition was evident in 12 (29.3%) males and 2 (6%) females (Figure 1). Conclusions: Despite normal BMI, both males and females with IBD were found to have low muscle mass. Males are particularly affected, with loss of appendicular muscle and decreased grip strength constituting sarcopaenia in nearly one third. The causes and consequences of this striking finding warrant further evaluation. Reference(s) [1] Kelly TL, Wilson KE, Heymesfield SB., (2009), Dual energy X-ray absorptiometry body composition reference values from NHANES, PLoS One, e7038, 15;4(9), 2012 09 15. [2] Mathiowetz V, Kashman N, Volland G, Weber K, Dowe M, Rogers S., (1985), Grip and pinch strength: normative data for adults, Archives of Physical Medicine and Rehabilitation, 69 72, 66(2), 2012 09 12. P376 Safety results comparison of the pediatric ADAPT trial cohort to a seven years retrospective in 656 adult UC patients T. Ruuska1 *, R. Gruber2 . 1 Tampere University Hospital, Dept. of Pediatrics, Tampere, Finland, 2 Otsuka 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. Conclusions: When used in a pediatric setting, Adacolumn showed a safety profile well comparable to historic observations in adult UC patients. Reference(s) [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,
Poster presentations 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. P377 Safety profile and discontinuation rate of infliximab and adalimumab in patients with Crohn’s disease and ulcerative colitis: experience from a tertiary care hospital in Qatar over a 7 year period M. Sharma1 *, S. Al Kaabi1 , N. Al Dweik1 , A. John1 , H. Wani1 , K. Al Ejji1 , M. Al Mohanadi1 , M. Derbala1 , R. Yacoub1 , F. Pasic1 , T. Butt1 , M. ElBedawi2 , R. Singh3 . 1 Hamad Medical Corporation, Medicine, Doha, Qatar, 2 Weill Cornell Medical School in Qatar, Medicine, Doha, Qatar, 3 Hamad Medical Corporation, CCS, Doha, Qatar Background: Tumor Necrosis Factor (TNF) blockers (Infliximab and adalimumab) have been used in treatment of Crohn’s disease (CD) and Ulcerative colitis (UC) with a good safety record. Recent reports indicate that discontinuation of treatment with these agents in Crohn’s disease can result in relapse of disease. Aim: To evaluate safety profile and discontinuation rate of infliximab and adalimumab in patients with Crohn’s disease and Ulcerative colitis in Arabic population. Secondary aims included elucidating the reasons for discontinuation of drug. Methods: All consecutive patients diagnosed with either CD or UC from January 2005-December 2011 at a tertiary health care centre were included. Among those, patient with moderate to severe disease who failed treatment with immunomodulators (“step-up approach”) or had predicted severe disease at onset, received either infliximab or adalimumab on a scheduled basis. All patients were followed up prospectively to assess response and side effects to the therapy. Patients with unclassified colitis or with less than 6 months of follow up were excluded from the study. Results: In the study period, 364 patients were diagnosed with either Crohn’s disease or Ulcerative Colitis. Of them, 58 subjects (16%) (CD 40, UC-18) received either infliximab or adalimumab. The mean age of the patients was 32 years and 35 were males. 52 (89.7%) patients were of Arabic origin. The mean duration of treatment was 26 months. Fortyseven patients (84%) had initial response to the treatment, five (8.4%) developed side-effects and two were lost to follow up. Among the side-effects, two developed anaphylactic reaction to infliximab, two developed severe sepsis along the treatment, one developed cytomegalovirus related retinitis and in one patient with testicular seminoma remained well despite treatment with infliximab. Twenty-one patients (36.2%) discontinued treatment with antiTNF drugs (CD-13, UC-8). Among patients with CD, seven patients discontinued treatment due to non response, three due to sustained clinical benefit, two due to serious adverse effects and one was lost to follow up. Among UC patients, three stopped treatment due to non response, two because of persistent clinical remission, two due to adverse effects and one was lost to follow up. Conclusions: Infliximab and Adalimumab have a good safety profile in Arabic population on a long term basis. The main reason for discontinuation of these drugs is due to lack of response or achievement of clinical remission.
Poster presentations 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. P377 Safety profile and discontinuation rate of infliximab and adalimumab in patients with Crohn’s disease and ulcerative colitis: experience from a tertiary care hospital in Qatar over a 7 year period M. Sharma1 *, S. Al Kaabi1 , N. Al Dweik1 , A. John1 , H. Wani1 , K. Al Ejji1 , M. Al Mohanadi1 , M. Derbala1 , R. Yacoub1 , F. Pasic1 , T. Butt1 , M. ElBedawi2 , R. Singh3 . 1 Hamad Medical Corporation, Medicine, Doha, Qatar, 2 Weill Cornell Medical School in Qatar, Medicine, Doha, Qatar, 3 Hamad Medical Corporation, CCS, Doha, Qatar Background: Tumor Necrosis Factor (TNF) blockers (Infliximab and adalimumab) have been used in treatment of Crohn’s disease (CD) and Ulcerative colitis (UC) with a good safety record. Recent reports indicate that discontinuation of treatment with these agents in Crohn’s disease can result in relapse of disease. Aim: To evaluate safety profile and discontinuation rate of infliximab and adalimumab in patients with Crohn’s disease and Ulcerative colitis in Arabic population. Secondary aims included elucidating the reasons for discontinuation of drug. Methods: All consecutive patients diagnosed with either CD or UC from January 2005-December 2011 at a tertiary health care centre were included. Among those, patient with moderate to severe disease who failed treatment with immunomodulators (“step-up approach”) or had predicted severe disease at onset, received either infliximab or adalimumab on a scheduled basis. All patients were followed up prospectively to assess response and side effects to the therapy. Patients with unclassified colitis or with less than 6 months of follow up were excluded from the study. Results: In the study period, 364 patients were diagnosed with either Crohn’s disease or Ulcerative Colitis. Of them, 58 subjects (16%) (CD 40, UC-18) received either infliximab or adalimumab. The mean age of the patients was 32 years and 35 were males. 52 (89.7%) patients were of Arabic origin. The mean duration of treatment was 26 months. Fortyseven patients (84%) had initial response to the treatment, five (8.4%) developed side-effects and two were lost to follow up. Among the side-effects, two developed anaphylactic reaction to infliximab, two developed severe sepsis along the treatment, one developed cytomegalovirus related retinitis and in one patient with testicular seminoma remained well despite treatment with infliximab. Twenty-one patients (36.2%) discontinued treatment with antiTNF drugs (CD-13, UC-8). Among patients with CD, seven patients discontinued treatment due to non response, three due to sustained clinical benefit, two due to serious adverse effects and one was lost to follow up. Among UC patients, three stopped treatment due to non response, two because of persistent clinical remission, two due to adverse effects and one was lost to follow up. Conclusions: Infliximab and Adalimumab have a good safety profile in Arabic population on a long term basis. The main reason for discontinuation of these drugs is due to lack of response or achievement of clinical remission.