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* = Presenting author

P471 Safety analysis of multimatrix mesalazine amongst patients with ulcerative colitis or recurrent diverticulitis ≥ 55 years of age

G. Lichtenstein1, K. Barrett2, D. Stefani-Hunyady3, F. Cataldi*4, J. Raskin5

1University of Pennsylvania Healthy System, Inflammatory Bowel Disease Centre, Philadelphia, Pennsylvania, United States, 2Shire, Basingstoke, United Kingdom, 3Shire, Lexington, Massachusetts, United States, 4Shire, Gastroenterology, Lexington, Massachusetts, United States, 5University of Miami Health System, Gastroenterology and Internal Medicine, Miami, Florida, United States

Background

Safety data for mesalazine use in patients (pts) with ulcerative colitis (UC) or history of recurrent diverticulitis (DV) in older adults remain limited. This study examined safety data from 6 clinical trials evaluating long-term multimatrix mesalazine (MM) use (1.2–4.8 g/d for up to 24 mo) in pts with UC or a history of recurrent DV in pts < 55 and ≥ 55 years of age.

Methods

Safety data for MM in pts < 55 and ≥ 55 years of age were pooled and analysed separately from studies for maintenance of UC remission (NCT00151944, NCT00151892, NCT00446849, and NCT01124149) and from studies for prevention of recurrent DV (NCT00545103 and NCT00545740). Within the UC studies, pts had quiescent symptoms, partial remission, or completion remission (determined by combining qualifying endoscopy and symptom scores) and were treated for 6 to 12 mo with 2.4 g/d MM; in 3 of the 4 trials, pts may have received 8 wk acute treatment with 4.8 g/d MM before maintenance treatment. Data from both phases (acute and maintenance) were collected. Within the DV studies, pts who had prior acute DV that resolved in the absence of surgery received placebo or 1.2 to 4.8 g/d MM for 24 mo. The rate of treatment-emergent adverse events (TEAEs) per patient-year (P-Y) of exposure was calculated for the overall population as well as for the age sub-groups.

Results

Within the UC studies (n = 1 979), the overall incidence of TEAEs for pts < 55 (n = 1 514) and ≥ 55 (n = 465) years of age was 44.6% and 47.7%, respectively, with similar incidences of TEAEs observed up to 3 mo (27.7% vs 31.2%) and 6 mo (36.1% vs 38.9%) after start of treatment. Likewise, amongst MM-treated pts within the DV studies (n = 880), the incidences of TEAEs for pts < 55 (n = 407) and ≥ 55 (n = 473) years of age up to 3 mo of treatment (43.7% vs 42.9%), 6 mo of treatment (55.5% vs 53.1%), and overall (72.2% and 74.2%) were similar. The most common (> 2%) TEAEs for patients in the UC and DV studies are summarised in Table 1. The rate (95% confidence interval) of TEAEs per P-Y of exposure in the UC and DV studies was 1.54 (1.47–1.60) and 2.64 (2.55–2.74), respectively. Similar rates of TEAEs per P-Y of exposure were observed between pts < 55 and ≥ 55 years of age in the UC (1.51 [1.44–1.59] vs 1.62 [1.48–1.76], respectively) and DV (2.70 [2.56–2.85] vs 2.58 [2.46–2.72], respectively) studies.

Conclusion

The safety profile of MM is consistent across age sub-groups, with similar incidences of TEAEs and rates of TEAEs per P-Y observed between pts < 55 and ≥ 55 years of age within both UC and DV studies.

Table 1 Most Common TEAEs in Patients Treated with Multimatrix Mesalazine