A134 ANTI-IL-12/23P40 ANTIBODIES FOR MAINTENANCE OF REMISSION IN CROHN’S DISEASE

Ustekinumab (CNTO 1275) is a monoclonal antibody that targets the standard p40 subunit of cytokines interleukin-12 and interleukin-23 (IL-12/23p40), which are involved in the pathogenesis of Crohn’s disease. To assess the efficacy and safety of anti-IL-12/23p40 antibodies for maintenance of remission in Crohn’s disease. A comprehensive search of MEDLINE, EMBASE, The Cochrane Central Register of Controlled Trials, and The Cochrane IBD Group Specialized Register through September 2016 was completed. Randomized controlled trials (RCTs) in which monoclonal antibodies against IL-12/23p40 were compared to placebo or another active comparator in adult patients with active Crohn’s disease were identified for inclusion. Two RCTs (n=542) met the inclusion criteria. However, the two studies were not pooled due to differences in time points for analysis. One study (n=145) compared doses of 1, 3, and 6 mg/kg of ustekinumab to placebo for 22 weeks. There was no statistically significant difference in remission rates in this study (RR=0.80, 95% CI 0.63 to 1.02, low-quality evidence). However, ustekinumab was statistically superior to placebo in rates of clinical response (RR=0.53, 95% CI 0.36 to 0.79, low-quality evidence). The other included study (n=259) compared doses of 90 mg of ustekinumab administered every 8 weeks and every 12 weeks to placebo for 44 weeks. Ustekinumab was shown superior to placebo in maintenance of remission in both 90 mg every 8 weeks and every 12 weeks (RR= 0.73, 95% CI 0.58 to 0.92, moderate-quality evidence and RR=0.80, 95% CI 0.65 to 0.99, moderate quality evidence respectively). Ustekinumab was also shown to be superior to placebo with respect to clinical response in the 8 and 12 week dosing groups (RR=0.73, 95% CI 0.56 to 0.94, low-quality evidence and RR=0.75, 95% CI 0.58 to 0.97, low-quality evidence respectively). Data on adverse effects was pooled from both studies and showed there was no statistically significant differences in incidence of adverse events (AE) or serious adverse events (SAE) (RR=0.94, 95% CI 0.86–1.03, low quality of evidence and RR=0.69, 95% CI 0.42 to 1.15 respectively). Low to moderate quality evidence suggests that ustekinumab is effective for maintenance of clinical response when administered for 22 and 44 weeks and maintenance of clinical remission when administered for 44 weeks. Ustekinumab appears to be safe with no increased risk of AE’s, SAE’s or withdrawal due to AE’s. Further studies are required to increase the quality of evidence available for the use of ustekinumab in the maintenance of moderate to severe Crohn’s disease. Cochrane IBD Group and Summer Opportunities Research Program, Schulich School of Medicine and Dentistry

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