ACG 2016. P394. 5-ASA and Chemoprevention in Inflammatory Bowel Disease: A Population-Based Analysis

Alastair Dorreen, MD1, Samuel A. Stewart, PhD1, Lisa Lix, PhD, MSc2, Jennifer Jones, MD, MSc1
1. Dalhousie University, Halifax, NS, Canada; 2. University of Manitoba, Winnipeg, MB, Canada

Results: A total of 8821 IBD patients were included in the study, of which 289 (3.3%) developed CRC. In the CRC-free group, 73.9% (n = 6307) of patients had exposure to 5-ASA, whereas 61.9% (n = 179) had exposure in the CRC group. Figure 1 contains a Kaplan Meier curve for time-to-diagnosis of CRC for the exposure groups. In the PS-matched cohort, the hazard ratio (HR) was 2.56 (95% CI: [1.9, 3.5]) while controlling for gender, location (urban/sub-urban/rural), diagnosis and previous corticosteroid use. The risk of CRC diagnosis was higher in the UC sub-group (HR=3.54, 95% CI: [2.3, 5.5]) when compared to the CD sub-group (1.73, 95% CI: [1.1, 2.6]), controlling for gender, location and decade of diagnosis. A dose response survival model was developed to attempt to control for the duration of 5-ASA exposure on CRC rates, and the HRs were similar.

Conclusions: This population-based cohort study suggests a chemoprotective effect of 5-ASA exposure for CRC diagnosis amongst patients with IBD. A larger protective effect was observed amongst UC patients than CD patients.

CARE™ Faculty Perspective: Colorectal cancer is a complication of IBD and is associated with IBD activity, extent and duration. The role of 5-ASA therapy for colorectal cancer chemoprevention continues to be debated. Sustained control of disease activity using 5ASA and other effective therapies may be the most important factor in cancer prevention. 

UEGW 2016. P0878. Effect of Adalimumab on Patients with Moderate-to-Severe Ulcerative Colitis in Italian Clinical Practice Setting : Results from INSPIRADA

Anna Kohn (Italy), Livia Biancone (Italy), Paolo Gionchetti (Italy), Silvio Danese (Italy), Ambrogio Orlando (Italy), Andreas Lazar (Germany)
Anne M Robinson (United States of America), Brandee L Pappalardo (United States of America), Mareike Bereswill (Germany)
Martha Skup (United States of America), Naijun Chen (United States of America), Rocco Merolla (Italy), Song Wang (United States of America),Roopal B Thakkar (United States of America), Simon Travis (United Kingdom)

Results : Data from 48 Italian patients (39.6% female, mean age 41.3 yrs) were analysed. Mean SCCAI at BL was 8.0. At week 2, 83.3% achieved SCCAI response and 31.3% achieved SCCAI remission. At week 8, 75.0% achieved SCCAI response, 43.8% were in remission and 37.5% had no blood in stool. At week 26, 66.7% achieved SCCAI response, 41.7% were in remission and 45.8% had no blood in stool. Significant improvements, as early as within 2 weeks, in SIBDQ (15.7 points, p<.001), EQ-5D-5L (0.13 index score and 19.5 VAS points, both p<.001), all 4 WPAI domains (-23.6%, -27.1%, -32.7%, -26.2%, all p<.001), and 2 of 4 TSQM domains (21.9%, 23.3%, all p<.001) occurred from BL to week 26. Significant decreases in number of hospitalization (UC-related:-0.21; all-cause: -0.23, both p<.05), all-cause hospitalization length of stay (-2.19 days, p<.05), and UC-related outpatient visit (-2.0, p<.001) occurred in the 6mo period after starting ADA compared to 6mo before starting ADA. No new safety signals were identified from the evaluation of adverse events.

Conclusion : Real world rates of response, remission and improvements in HRQoL with ADA for Italian patients with moderate to severe UC were clinically meaningful. ADA improved work productivity, increased patient satisfaction with therapy and reduced health care resource use for these patients.

CARE™ Faculty Perspective: While this is only a small study in Italy, it is encouraging to see that in the real-world, adalimumab continues to not only provide clinically meaningful rates of response, remission and improvements in quality of life, but also increases work productivity and patient satisfaction. 

UEGW 2016. OP005. Efficacy and Safety of Dose Adjustment and Delayed Response to Ustekinumab in Moderate-Severe Crohn’s Disease Patients : Results from the IM-UNITI Maintenance Study

Bruce E Sands (United States of America), Christopher Gasink (United States of America), Douglas Jacobstein (United States of America), Long Long Gao (United States of America), Jewel Johanns (United States of America), Philippe Szapary (United States of America), Jean-Frederic Colombel (United States of America), Stephan Targan (United States of America), Subrata Ghosh (Canada), William Sandborn (United States of America)

Results : Proportion of subjects achieving clinical response and remission 16 weeks after dose adjustment

Conclusion : In patients who met loss of response (LOR) criteria, dose adjustment from UST 90 mg q12w to 90 mg q8w provided some additional clinical benefit compared to patients who remained on UST 90 mg q8w. Additionally, patients who were initial induction non-responders can benefit from continued treatment with at least 1 SC UST dose 8 weeks after IV induction.

CARE™ Faculty Perspective: This study offers an important first look at the effect of dose intensification among patients who lose response to ustekinumab. We look forward to more such reports, and indeed to the introduction of this agent for treatment of IBD in Canada. 

ACG 2016. P376. Vedolizumab for the Treatment of Crohn’s Disease: Experience in an Inflammatory Bowel Disease Clinical Practice

 Blum Andrew, MD, PhD1, Gregory Nizialek, MD2, Keyur Parikh, MD1, Maneesh Dave, MD, MPH2, Jeffry Katz, MD2 1. University Hospitals Case Medical Center, Cleveland, OH;
2. University Hospitals Case Medical Center, Case Western Reserve University, Cleveland, OH

Results: Between August 2014 and December 2015 26 patients with Crohn’s disease started vedolizumab and were followed for at least 14 weeks (54% male; mean age, 47 +/- 15.1 years). The patients exhibited a significant decrease in HBAI, from 9.9 at baseline, 7.8 after 14 weeks, and 7.0 after 6 months (P < 0.001 and P=0.01 respectively). Thirty-six percent of patients were completely off steroids after 4 weeks and 63% were completely off steroids after 6 months. Clinical response, defined as improvement in disease severity as measured by HBAI, was achieved in 36% (8/22) and 50% (8/16) of patients after 14 weeks and 6 months of vedolizumab treatment, respectively. Clinical remission, defined as HBAI < 5, was achieved in 18% (4/22) and 31% (5/16) of patients after 14 weeks and 6 months of vedolizumab treatment, respectively. Additionally, C-reactive protein levels declined at 14 weeks and at 6 months (P < 0.01). The most common side effect recorded was arthralgia, affecting 15% of participants. Notable serious adverse events were hospitalization (2/26) and colectomy (1/26). Eighty-eight percent of patients followed for at least 6 months remained on vedolizumab.

Conclusion: In this real world CD cohort, vedolizumab was effective and had a favorable safety profile. Patients with longer treatment duration were more likely to have clinical improvement. Serum CRP levels decreased in aggregate during treatment, mirroring clinical improvement. Serious adverse events were uncommon and may reflect a refractory disease state rather than a drug reaction.

CARE™ Faculty Perspective: This real-world experience with vedolizumab confirms the favourable safety profile seen in controlled clinical trials. Long-term exposure to this agent appears to be both effective and safe. In another real-world treatment study of vedolizumab presented at ACG 2016 (P1918), results found that the majority (80%) of UC and CD patients receiving vedolizumab complete the induction phase, and ~75% of all patients on vedolizumab are persistent on therapy after 6 months of initiation.