scholarly journals Bone Loss Prevention of Bisphosphonates in Patients with Inflammatory Bowel Disease: A Systematic Review and Meta-Analysis

2017 ◽  
Vol 2017 ◽  
pp. 1-11 ◽  
Author(s):  
Yan Hu ◽  
Xiaoting Chen ◽  
Xiaojing Chen ◽  
Shuang Zhang ◽  
Tianyan Jiang ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Bone Loss ◽  
Adverse Events ◽  
Bowel Disease ◽  
Meta Analysis ◽  
Occurrence Rate ◽  
Mineral Density ◽  
Significant Difference ◽  
Inflammatory Bowel

Objective. The purpose of this study was to evaluate the effect of bisphosphonates in improving bone mineral density (BMD) and decreasing the occurrence rate of fractures and adverse events in patients with inflammatory bowel disease (IBD). Methods. Randomized controlled trials (RCTs) which use bisphosphonates in IBD patients were identified in PubMed, MEDLINE database, EMBASE database, Web of Knowledge, and the Cochrane Databases between 1990 and June 2016. People received bisphosphonate or placebos with a follow-up of at least one year were also considered. STATA 12.0 software was used for the meta-analysis. Results. Eleven randomized clinical trials were included in the meta-analysis. The data indicated that the percentage change in the increased BMD in the bisphosphonates groups was superior to that of the control groups at the lumbar spine and total hip. At the femoral neck, there was no significant difference between the two groups. The incidence of new fractures during follow-up showed significant reduction. The adverse event analysis revealed no significant difference between the two groups. Conclusion. Our results demonstrate that bisphosphonates therapy has an effect on bone loss in patients with IBD but show no evident efficiency at increasing the incidence of adverse events.

scholarly journals SAT0462 ASSESSMENT OF BONE MINERAL DENSITY IN INFLAMMATORY BOWEL DISEASE

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1188.1-1188
Author(s):  
C. Daldoul ◽  
N. El Amri ◽  
K. Baccouche ◽  
H. Zeglaoui ◽  
E. Bouajina
Keyword(s):  
Bone Mineral Density ◽  
Inflammatory Bowel Disease ◽  
Bone Mineral ◽  
Bowel Disease ◽  
Mineral Density ◽  
Femoral Site ◽  
Significant Difference ◽  
History Of ◽  
Inflammatory Bowel ◽  
The Mean

Background:Inflammatory bowel disease (IBD), including ulcerative colitis (UC) and Crohn’s disease (CD), is considered as a risk factor of low bone mineral density (BMD). In fact, the prevalence of osteoporosis ranges from 17% to 41% in IBD patients. The possible contributing factors may include malabsorption, glucocorticoid treatment and coexisting comorbiditiesObjectives:The purpose of our work was to determine the frequency and the determinants of osteoporosis in patients with IBD and to assess whether there is a difference in BMD status between UC and CD.Methods:This is a retrospective study, over a period of 5 years (from January 2014 to December 2018) and including patients followed for IBD who had a measurement of BMD by DEXA. Clinical, anthropometric and densitometric data (BMD at the femoral and vertebral site) were recorded. The WHO criteria for the definition of osteoporosis and osteopenia were applied.Results:One hundred and five patients were collected; among them 45 were men and 60 were women. The average age was 45.89 years old. The average body mass index (BMI) was 25.81 kg/m2 [16.44-44.15]. CD and UC were diagnosed in respectively 57.1% and 42.9%. A personal history of fragility fracture was noted in 4.8%. Hypothyroidism was associated in one case. Early menopause was recorded in 7.6%. 46.8% patients were treated with corticosteroids. The mean BMD at the vertebral site was 1.023 g/cm3 [0.569-1.489 g/cm3]. Mean BMD at the femoral site was 0.920g/cm3 [0.553-1.286g / cm3]. The mean T-score at the femoral site and the vertebral site were -1.04 SD and -1.27 SD, respectively. Osteoporosis was found in 25.7% and osteopenia in 37.1%. Osteoporosis among CD and UC patients was found in respectively 63% and 37%. The age of the osteoporotic patients was significantly higher compared to those who were not osteoporotic (52.23 vs 43.67 years, p = 0.01). We found a significantly higher percentage of osteoporosis among men compared to women (35.6% vs 18.3%, p=0.046). The BMI was significantly lower in the osteoporotic patients (23.87 vs 26.48 kg/m2, p=0.035) and we found a significant correlation between BMI and BMD at the femoral site (p=0.01). No increase in the frequency of osteoporosis was noted in patients treated with corticosteroids (27.9% vs 21.6%, p=0.479). Comparing the UC and CD patients, no difference was found in baseline characteristics, use of steroids or history of fracture. No statistically significant difference was found between UC and CD patients for osteoporosis(p=0.478), BMD at the femoral site (p=0.529) and at the vertebral site (p=0.568).Conclusion:Osteoporosis was found in 25.7% of IBD patients without any difference between CD and UC. This decline does not seem to be related to the treatment with corticosteroids but rather to the disease itself. Hence the interest of an early screening of this silent disease.Disclosure of Interests:None declared

Su1421 Effectiveness and Adverse Events of Azathioprine in Inflammatory Bowel Disease: 9-Year Follow-Up Study

2014 ◽  
Vol 146 (5) ◽  
pp. S-465
Author(s):  
Iván Guerra ◽  
Alicia Algaba ◽  
Ángel Serrano ◽  
Carolina Aulló ◽  
Daniel Alcalde ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Adverse Events ◽  
Bowel Disease ◽  
Follow Up Study ◽  
Inflammatory Bowel

P082 ANTI-TNF EFFICACY AFTER PRIMARY VEDOLIZUMAB FAILURE IN PEDIATRIC INFLAMMATORY BOWEL DISEASE

2020 ◽  
Vol 26 (Supplement_1) ◽  
pp. S71-S72
Author(s):  
Michael Dolinger ◽  
Priya Rolfes ◽  
Becky Phan ◽  
Stephanie Pan ◽  
Marla Dubinsky
Keyword(s):  
Inflammatory Bowel Disease ◽  
Adverse Events ◽  
Median Duration ◽  
Bowel Disease ◽  
Clinical Remission ◽  
Secondary Loss ◽  
Loss Of Response ◽  
Inflammatory Bowel ◽  
Pediatric Ibd

Abstract Background Vedolizumab (VDZ) is less effective in Inflammatory Bowel Disease (IBD) when used in anti-Tumor Necrosis Factor (TNF) failures as compared to anti-TNF naïve patients. However, the outcomes of sequencing anti-TNF after VDZ failure remain unknown. We report on the effectiveness and safety of anti-TNF as a second-line biologic after VDZ failure in pediatric IBD patients. Methods Data was collected as part of an ongoing pediatric IBD observational treatment registry and included demographics, disease behavior, location, disease activity (Harvey Bradshaw index (HBI) for Crohn’s disease (CD) or partial Mayo score (pMS) for ulcerative colitis (UC) and IBD-unspecified (IBD-U)), adverse events, treatment and surgical history. Primary outcome was steroid-free clinical remission at last follow up. Secondary outcomes were CRP normalization and adverse events including infusion reactions, infections, hospitalizations, and IBD related surgeries. Descriptive statistics summarized the data (median [interquartile range (IQR)]) and univariate analyses tested associations. Results A total of 21 children and young adults (6 CD:14 UC:1 IBD-U; 19/21 colonic only disease) were treated with VDZ for a median [IQR] duration of 25 [11–59] weeks. VDZ was discontinued due to primary non-response (57%), secondary loss of response (38%), or an adverse event (5%). Nineteen (90%) patients were induced with infliximab (IFX), 1 with adalimumab, and 1 with golimumab and were followed for a median of 100 [35–148] weeks after anti-TNF induction (Table 1). Fifteen (71%) patients remained on anti-TNF therapy at last follow up for a median duration of 53 [34–112] weeks. All 15 patients achieved steroid-free clinical remission, and 9 (60%) patients also had a normal CRP (Figure 1). Remission rates were numerically higher in UC/IBD-U vs. CD (80% vs. 50% P = 0.27). All 6 (28%) patients (3 CD and 3 UC) who discontinued anti-TNF therapy after a median duration of 15 [7–24] weeks initially had a primary non-response to VDZ. Three patents had a primary non-response to anti-TNF, 2 had a secondary loss of response, and 1 had an anaphylactic infusion reaction. No serious adverse events, hospitalizations or serious infections attributable to anti-TNF therapy occurred. Conclusions Our results suggest that anti-TNF therapy is efficacious and safe after primary failure with VDZ in pediatric IBD patients and this was particularly so in patients with colonic disease location, regardless of IBD classification.

Incidence, Risk Factors and Evaluation of Osteoporosis in Patients With Inflammatory Bowel Disease: A Danish Population-Based Inception Cohort With 10 Years of Follow-Up

2020 ◽  
Vol 14 (7) ◽  
pp. 904-914 ◽  
Author(s):  
Bobby Lo ◽  
Jakob Præst Holm ◽  
Marianne Kajbæk Vester-Andersen ◽  
Flemming Bendtsen ◽  
Ida Vind ◽  
...  
Keyword(s):  
Risk Factors ◽  
Inflammatory Bowel Disease ◽  
At Risk ◽  
Bowel Disease ◽  
Population Based ◽  
Control Population ◽  
Inception Cohort ◽  
Mineral Density ◽  
Inflammatory Bowel

Abstract Background Patients with inflammatory bowel disease [IBD] including Crohn’s disease [CD] and ulcerative colitis [UC] are at risk of developing metabolic bone disease. The aims here were to investigate the screening strategy, incidence and risk factors of osteoporosis in a prospective population-based inception cohort. Method Between 2003 and 2004 all incident patients diagnosed with CD and UC in a well-defined Copenhagen area were included and followed until 2015. Data were compared with a control population [at a ratio of 1:20]. Regression models were performed with several covariates. The sensitivity of the Danish registries for osteoporosis was also assessed. Results A total of 513 patients were included [213 CD, 300 UC]. Overall, 338 (66%, CD: 164 [77%], UC: 174 [58%], p < 0.001] patients received ≥ 500 mg corticosteroid within a year, resulting in 781 patient-years at risk of osteoporosis. Of those, only 83 [10.6%] patient-years were followed by a dual-energy X-ray absorptiometry scan within the same or the following 2 years. Overall, 73 [14.2%] IBD patients (CD: 31 [14.6%], UC: 42 [14%]) and 680 [6.6%, p < 0.001] controls were diagnosed with osteoporosis during follow-up. The risk of osteoporosis was increased compared to the control population (odds ratio: CD: 2.9 [95% confidence interval: 2.0–4.1], UC: 2.8 [2.1–3.9]). Conclusion In this population-based inception cohort, the incidence of osteoporosis was significantly higher compared to a control population. Measurement of bone mineral density is infrequent, especially in patients at high risk of developing osteoporosis. These results demonstrate the need of further awareness of the risk of osteoporosis among IBD patients, and prospective population-based studies are warranted.

scholarly journals P512 Safety of reduced clinical monitoring in patients with stable Inflammatory Bowel Disease on maintenance thiopurine therapy

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S492-S492
Author(s):  
F M Jansen ◽  
L S Smits ◽  
P W A Thomas ◽  
N den Broeder ◽  
D J de Jong ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Adverse Events ◽  
Patient Preferences ◽  
Bowel Disease ◽  
Clinical Monitoring ◽  
Multiple Infections ◽  
Monitoring Strategy ◽  
Thiopurine Therapy ◽  
Inflammatory Bowel

Abstract Background Thiopurine-treated inflammatory bowel disease (IBD) patients are monitored every 3 to 4 months with outpatient visits and laboratory assessments to evaluate disease activity and safety of therapy. However, the risk of thiopurine-related adverse events decreases after the initiation phase. The aim of this study was to assess the safety of reduced clinical monitoring in steroid-free quiescent IBD patients on stable maintenance thiopurine monotherapy. Methods This single-centre prospective cohort study evaluated a reduced monitoring strategy that involved 6-monthly laboratory assessment combined with alternating outpatient and phone appointments, during 104 weeks. We enrolled IBD patients who were in steroid-free remission > 6 months on thiopurine monotherapy including azathioprine, 6-mercaptopurine or tioguanine. The primary outcome was thiopurine-related adverse events (AE) requiring change or discontinuation of thiopurine therapy after 104 weeks of follow-up. Secondary outcomes were assessed at week 52 and included other thiopurine-related AEs and laboratory abnormalities. Results We included 85 patients (42 years median age, 61.2% Crohn’s disease, 62% female) with a median disease duration of 12.5 years. At baseline, 47 patients were treated with azathioprine (55.3%), 25 with 6-mercaptopurine (29.4%) and 13 with tioguanine (15.3%) for a median duration of 6.7 years. During 104 weeks of follow-up, thiopurine therapy was ceased in two patients because of multiple infections (n=1) and gastrointestinal complaints (n=1). Other reasons for thiopurine cessation (n=37) were stable remission (n=26), patient preferences (n=9) and high 6-TGN levels (n=2). In total, 20 patients underwent thiopurine dose adjustments due to high metabolite levels (n=9), remission (n=3), disease flare (n=3), patient preferences (n=3), and low metabolite levels (n=2). At 52 weeks, 27 laboratory abnormalities were observed, yet none required therapy adjustments. In 13 patients (15.3%) myelotoxicity was detected, including mild leukopenia (n=11), mild and moderate thrombopenia (n=2). In 16.5%, hepatoxicity was observed (n=14) including mild (n=9) and moderate (n=1) elevated aspartate aminotransferase and mild elevated alkaline phosphatase (n=4). Conclusion A reduced monitoring strategy appeared relatively safe in a strictly selected cohort of stable thiopurine-treated IBD patients. Overall, two patients had to cease thiopurine therapy due to thiopurine-related AEs independent of monitoring frequency. No laboratory abnormalities required therapy adjustments and 57.1% of patients continued therapy throughout 104 weeks of follow-up. This strategy may contribute to safe reduction of time and health care costs for both IBD patients and physicians in daily IBD practice.

scholarly journals Safety of Ustekinumab in Inflammatory Bowel Disease: Pooled Safety Analysis of Results from Phase 2/3 Studies

2020 ◽  
Author(s):  
William J Sandborn ◽  
Brian G Feagan ◽  
Silvio Danese ◽  
Christopher D O’Brien ◽  
Elyssa Ott ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Adverse Events ◽  
Bowel Disease ◽  
Safety Profile ◽  
Phase 2 ◽  
Phase 3 ◽  
Number Of Patients ◽  
Serious Infections ◽  
Inflammatory Bowel

Abstract Background Ustekinumab is currently approved globally in Crohn’s disease (CD) and psoriatic diseases. Recent phase 3 data demonstrate safety/efficacy in ulcerative colitis (UC). Crohn’s disease and UC phase 3 programs had similar study designs, facilitating integrated safety analyses. Methods Data from 6 ustekinumab phase 2/3 CD and UC studies were pooled, and safety was evaluated through 1 year. Patients received 1 placebo or ustekinumab (generally 130 mg or ~6 mg/kg) intravenous induction, then subcutaneous (90 mg) maintenance every 8/12 weeks. Analyses incorporated all patients who received ≥1 ustekinumab dose. Safety outcomes are presented as percentages of patients (induction) and as number of patients with events per 100 patient-years of follow-up (through 1 year). For key safety events, 95% confidence intervals (CIs) are provided, as appropriate. Hazard ratios with 95% CIs from time-to-event analyses for serious adverse events and serious infections were also performed. Results Through 1 year, 2574 patients received ustekinumab (1733 patient-years of follow-up). The number of patients with adverse events per 100 patient-years (placebo 165.99 [95% CI, 155.81–176.67] vs ustekinumab 118.32 [95% CI, 113.25–123.55]), serious AEs (27.50 [95% CI, 23.45–32.04] vs 21.23 [95% CI, 19.12–23.51]), infections (80.31 [95% CI, 73.28–87.84] vs 64.32 [95% CI, 60.60–68.21]), serious infections (5.53 [95% CI, 3.81–7.77] vs 5.02 [95% CI, 4.02–6.19]), and malignancies excluding nonmelanoma skin cancer (0.17 [95% CI, 0.00–0.93] vs 0.40 [95% CI, 0.16–0.83]) were similar between placebo and ustekinumab. Conclusions The safety profile of ustekinumab across the pooled inflammatory bowel disease population through 1 year was favorable and generally comparable to placebo. These data are consistent with the established safety profile of ustekinumab across indications. ClinicalTrials.gov numbers NCT00265122; NCT00771667; NCT01369329; NCT01369342; NCT01369355; NCT02407236.

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