scholarly journals P037 Efficacy and Safety of 1-L NER1006 Bowel Preparation in Patients with Inflammatory Bowel Disease: Analysis of 2 Phase 3 Studies

2020 ◽  
Vol 115 (1) ◽  
pp. S10-S10
Author(s):  
Poppers David ◽  
Oneto Caterina ◽  
Allen Christopher ◽  
Albers C. Gregory
Keyword(s):  
Inflammatory Bowel Disease ◽  
Bowel Preparation ◽  
Bowel Disease ◽  
Efficacy And Safety ◽  
Phase 3 ◽  
Inflammatory Bowel ◽  
Disease Analysis

scholarly journals P290 Impact of concomitant 5-aminosalicylic acid therapy on vedolizumab efficacy and safety in Inflammatory Bowel Disease

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S321-S321
Author(s):  
R Ungaro ◽  
H Kadali ◽  
W Zhang ◽  
S Adsul ◽  
W Reinisch
Keyword(s):  
Inflammatory Bowel Disease ◽  
Bowel Disease ◽  
Safety Profile ◽  
Clinical Remission ◽  
Efficacy And Safety ◽  
Phase 3 ◽  
Post Hoc Analysis ◽  
Enteric Infections ◽  
Inflammatory Bowel ◽  
Post Hoc

Abstract Background Vedolizumab (VDZ), a gut-selective anti-lymphocyte trafficking monoclonal anti-a4β7-integrin antibody, has showed efficacy in multiple phase 3 clinical trials in patients (pts) with inflammatory bowel disease (IBD). Decreased likelihood of response to adalimumab was previously observed with concomitant 5-ASA.1 This post-hoc analysis assessed the impact of concomitant 5-ASA on efficacy and safety in VDZ-treated pts with IBD. Methods Pts with IBD treated with VDZ intravenous (IV) or subcutaneous (SC) in phase 3 trials who continued 5-ASA (at any dose) at the time of starting VDZ were compared with those who received no concomitant 5-ASA. Pts were also stratified by ulcerative colitis (UC) or Crohn’s disease (CD). Efficacy outcomes were the proportion of pts achieving clinical response, clinical remission and corticosteroid (CS)-free clinical remission at Wk 6 (end of induction phase) and Wk 52 (end of maintenance phase). Safety outcomes were the proportion of pts experiencing any infection and enteric infections. Studies included: GEMINI 1 and 2, and VISIBLE 1 and 2 in efficacy analyses; GEMINI 1, 2, 3 and long-term safety for VDZ IV, and VISIBLE 1, 2, and open-label extension (data cut-off 17 May 2019) for VDZ SC in safety analyses. Results At Wk 6, clinical response was achieved by 191 (70.0%) and 69 (61.6%) VDZ-treated pts with UC with and without 5-ASA, respectively, and by 139 (64.4%) and 161 (57.7%) pts with CD, respectively (Table 1). At week 52, clinical remission was achieved by 134 (46.0%) and 45 (38.8%) VDZ-treated pts with UC with or without 5-ASA, and by 116 (50.2%) and 132 (37.5%) pts with CD, respectively. CS-free clinical remission at Wk 52 was achieved by 55 (34.8%) and 19 (37.3%) VDZ-treated pts with UC with and without 5-ASA, respectively, and by 46 (41.4%) and 46 (31.5%) pts with CD, respectively. Multivariate analysis in general showed no differences in VDZ efficacy with or without 5-ASA. No new safety issues or signals were identified. A tendency towards lower incidence of all infections and enteric infections was observed in pts receiving VDZ (IV or SC) with versus without 5-ASA (Table 2). Conclusion In this post-hoc analysis of VDZ pivotal trial data, concomitant 5-ASA does not appear to significantly impact the efficacy of VDZ in pts with IBD. No new safety signals were identified. The safety profile of VDZ IV and SC, with and without 5-ASA was consistent with the known safety profile of VDZ. Although there was limited data in some subgroups, there was no evidence to suggest that concomitant 5-ASA usage was associated with higher infection rates. These data will be useful to inform risk-benefit assessments of continued 5-ASA in VDZ-treated pts. Reference

Su1920 - Real-World Evidence Comparison of the Efficacy and Safety of Different Bowel Preparation Agents in Individuals with Inflammatory Bowel Disease

2018 ◽  
Vol 154 (6) ◽  
pp. S-632-S-633
Author(s):  
Naomi Sacks ◽  
Abhishek Sharma ◽  
Philip L. Cyr ◽  
Gerald Bertiger ◽  
David N. Dahdal ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Bowel Preparation ◽  
Real World ◽  
Bowel Disease ◽  
Efficacy And Safety ◽  
Real World Evidence ◽  
Inflammatory Bowel

USTEKINUMAB FOR CHRONIC GRANULOMATOUS DISEASE-ASSOCIATED INFLAMMATORY BOWEL DISEASE

2021 ◽  
Vol 27 (Supplement_1) ◽  
pp. S59-S59
Author(s):  
Sumona Bhattacharya ◽  
Beatriz Marciano ◽  
Harry Malech ◽  
Steven Holland ◽  
Suk See De Ravin ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Chronic Granulomatous Disease ◽  
Bowel Disease ◽  
Clinical Remission ◽  
Colonic Disease ◽  
Cell Transplant ◽  
Granulomatous Disease ◽  
Efficacy And Safety ◽  
Serious Infections ◽  
Inflammatory Bowel

Abstract Introduction Chronic granulomatous disease (CGD) is a rare immunodeficiency caused by mutations in the NADPH oxidase complex. Dysregulated immune function may cause inflammatory bowel disease (IBD). Patients with CGD-associated IBD may not respond to or may develop serious infections as a result of traditional IBD therapies such as vedolizumab and infliximab. Ustekinumab is approved for use in Crohn’s disease and ulcerative colitis however there is scarce data on its efficacy and safety in CGD. Aims To evaluate the efficacy and safety of ustekinumab for CGD-associated IBD. Methods A retrospective chart review was conducted on CGD patients followed at a single center who had consented to participate in a natural history study. Clinical, laboratory, and endoscopic data were extracted in those that had received ustekinumab for IBD. Results Eight patients were found. Four were male and four were female. Five were white, one was Asian, one was black, and one was mixed race. Median age at diagnosis of CGD was 3 years (IQR 8) and of IBD was 15.5 years (IQR 20). Median age at initiation of ustekinumab was 27.5 years (IQR 14) and median duration on ustekinumab was 10 months (IQR 7). Six had colonic disease, two had ileocolonic disease, and six had perianal disease. Six failed other biologics (n=5 for vedolizumab, n=1 for infliximab, n=1 for adalimumab). Six patients symptomatically improved whereas two had no improvement. Changes in hemoglobin and C-reactive protein were equivocal. Three patients had improved endoscopic findings, two had unimproved findings, and three patients lacked this data. Overall, four patients achieved clinical remission. However, none of the five patients with endoscopic reevaluation achieved endoscopic remission. Three patients discontinued therapy due to lack of response: two required surgery and one underwent stem cell transplant. Fungal pneumonia (n=2), otitis media (n=1), oral herpes simplex virus 1 (n=1), and viral gastroenteritis (n=1) were reported. One infusion reaction occurred. Discussion In our cohort of eight patients with CGD-associated IBD receiving ustekinumab, results were mixed with four patients experiencing some degree of clinical or endoscopic improvement including four who achieved clinical remission. Multiple CGD-related variables may account for the mixed laboratory findings. Four of the five patients with endoscopic reevaluation had pre-existing strictures that would be unlikely to reverse with medical therapy alone. Of these, two had otherwise resolved endoscopic inflammation. Only two patients had no endoscopic improvement. Two serious infections occurred however CGD confers increased infectious susceptibility and no infections lead to discontinuation of therapy. Given these promising results, further formalized study of ustekinumab in CGD-associated IBD is needed.

scholarly journals Tofacitinib in Patients with Ulcerative Colitis: Inflammatory Bowel Disease Questionnaire Items in Phase 3 Randomized Controlled Induction Studies

2020 ◽  
Author(s):  
Marla C Dubinsky ◽  
Marco DiBonaventura ◽  
Haiyun Fan ◽  
Andrew G Bushmakin ◽  
Joseph C Cappelleri ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Inflammatory Bowel Disease ◽  
Bowel Disease ◽  
Janus Kinase ◽  
Effect Sizes ◽  
Phase 3 ◽  
Inflammatory Bowel Disease Questionnaire ◽  
Bowel Symptoms ◽  
Inflammatory Bowel ◽  
Disease Questionnaire

Abstract Background Tofacitinib is an oral, small molecule Janus kinase inhibitor for the treatment of ulcerative colitis (UC). We examined the effect of tofacitinib induction treatment on Inflammatory Bowel Disease Questionnaire (IBDQ) items in adults with moderate to severe UC. Methods Data were pooled from the randomized, 8‑week, double-blind, phase 3 OCTAVE Induction 1 and 2 studies. The IBDQ was self-administered by patients at baseline, week 4, and week 8, with higher scores indicating better health-related quality of life (HRQoL). Change from baseline in IBDQ items was analyzed for 10 mg of tofacitinib twice daily (BID) vs placebo using a linear mixed-effects model, with no multiplicity adjustment performed. Effect sizes were calculated. Subgroup analyses by tumor necrosis factor inhibitor (TNFi) experience were performed. Results Significant improvements (nominal P < 0.05) were observed in all IBDQ items with 10 mg of tofacitinib BID vs placebo at weeks 4 and 8. For the overall population, the largest treatment differences across all items were reported for “bowel movements been loose” at weeks 4 and 8, and “problem with rectal bleeding” at week 8 (mean treatment differences all 1.1; both in bowel symptoms domain). These items also showed the largest effect sizes. Treatment benefits were generally slightly numerically higher in TNFi-experienced vs TNFi-naïve patients. Conclusions Tofacitinib induction therapy improved all IBDQ items vs placebo in patients with UC, reflecting improvements in HRQoL, with greatest benefits reported in bowel symptoms domain items (Funded by Pfizer Inc; OCTAVE Induction 1 and OCTAVE Induction 2; ClinicalTrials.gov, NCT01465763 and NCT01458951, respectively).

scholarly journals P605 Eight-year efficacy and safety of azathioprine treatment in the maintenance of steroid-free remission in inflammatory bowel disease patients

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S505-S505
Author(s):  
C Cassieri ◽  
R Pica ◽  
E V Avallone ◽  
G Brandimarte ◽  
M Zippi ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Side Effects ◽  
Bowel Disease ◽  
Efficacy And Safety ◽  
Loss Of Response ◽  
Steroid Dependent ◽  
Azathioprine Treatment ◽  
Inflammatory Bowel ◽  
Maintenance Of Remission

Abstract Background Azathioprine (AZA) and thiopurine are widely used for induction and maintenance of remission in steroid-dependent patients with inflammatory bowel disease (IBD). The aim of this study has been to investigate its efficacy and safety in maintaining steroid-free remission in steroid-dependent IBD patients eight years after the institution of treatment. Methods Data from consecutive IBD outpatients referred in our Institution, between 1985–2017, were reviewed and all patients treated with AZA were included in this retrospective study. AZA was administered at the recommended dose of 2–2.5 mg/kg. Results Out of 2992 consecutive IBD outpatients visited in the index period, AZA was prescribed to 446 patients, 245 (54.9%) were affected by Crohn’s disease (CD) and 201 (45.1%) by ulcerative colitis (UC). One hundred and ninety-six patients with a follow-up < 96 months were excluded from the study. Two hundred and fifty patients were evaluated, 140 (56%) with CD and 110 (44%) with UC. One hundred and thirty-eight (55.2%) were male and 112 (44.8%) female (average age of 35.48 ± 14.26 SD years, range 14–74 years). Eight year after the institution of treatment, 123 (49.2%) patients still were in steroid-free remission (82 CD vs. 41 UC, 58.6% and 37.3%, respectively, p = 0.0009), 71 (28.4%) had a relapse requiring retreatment with steroids (29 CD vs. 42 UC, 20.7% and 38.2%, respectively, p = 0.0030), 56 (22.4%) discontinued the treatment due to side effects (29 CD vs. 27 UC, 20.7% and 24.5%, respectively). The loss of response from first to eighth year of follow-up was low, about 21%. Conclusion Eight years after the onset of treatment about 50% of patients did not require further steroid courses. After the first-year loss of response was low in seven subsequent years. In the present series, the maintenance of steroid-free remission was significantly higher in CD than in UC patients. The occurrence of side effects leading to the withdrawal of AZA treatment has been low.

VP151 Endovenous Iron Deficiency Anemia Treatment In Inflammatory Bowel Disease: Hospital-based Health Technology Assessment

2017 ◽  
Vol 33 (S1) ◽  
pp. 219-220
Author(s):  
Jovana Stojanovic ◽  
Flavia Kheiraoui ◽  
Enrica Maria Proli ◽  
Franco Scaldaferri ◽  
Massimo Volpe ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Iron Deficiency ◽  
Technology Assessment ◽  
Bowel Disease ◽  
Health Technology ◽  
Deficiency Anemia ◽  
Ferric Carboxymaltose ◽  
Efficacy And Safety ◽  
Iv Iron ◽  
Inflammatory Bowel

INTRODUCTION:Iron Deficiency Anemia (IDA), a common cause of anemia in the world, is a frequently neglected disease that represents the main extraintestinal manifestation affecting patients with inflammatory bowel disease (IBD) (1). The release of new intravenous (IV) iron compounds represents a great opportunity for both physicians and patients, but the higher costs might hold back their optimal diffusion. A Health Technology Assessment (HTA) approach was used to provide insights on the sustainability of the IV iron formulations in a hospital setting, with a special focus on ferric carboxymaltose.METHODS:Epidemiology of IBD, as well as IDA associated with these conditions, was assessed with a systematic appraisal of the published literature. Data on efficacy and safety of IV iron formulations currently used in Italy were retrieved from the available medical electronic databases. A hospital based cost-analysis of the outpatient delivery of IV iron treatments was performed. Organizational and ethical implications were discussed.RESULTS:The reported prevalence of anemia in patients with IBD varies markedly from 10 to 73 percent for Crohn's Disease and from 9 to 67 percent for Ulcerative Colitis. Although there are no studies on direct comparison of different IV iron preparations, the literature indicates good efficacy and safety profiles of these formulations. However, ferric carboxymaltose seemed to provide a better and faster correction of hemoglobin and serum ferritin levels in iron-deficient patients (2,3). Our analyses indicated that ferric carboxymaltose, in spite of a greater price, would have positive benefits for the hospital, in terms of reduced costs related to individual patient management, and for the patients themselves, by reducing the number of infusions and accesses to health facilities.CONCLUSIONS:This hospital-based HTA reports an overall positive organizational, economic and ethical evaluation for the sustainable introduction of ferric carboxymaltose in the Italian outpatient setting.

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