Early Surgery Versus Biologic Therapy in Limited Nonstricturing Ileocecal Crohn’s Disease—A Decision-making Analysis

2020 ◽  
Vol 26 (11) ◽  
pp. 1648-1657
Author(s):  
Efrat Broide ◽  
Adi Eindor-Abarbanel ◽  
Timna Naftali ◽  
Haim Shirin ◽  
Tzippora Shalem ◽  
...  
Keyword(s):  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Markov Model ◽  
Treatment Strategy ◽  
Early Surgery ◽  
Published Data ◽  
Model Parameters ◽  
Decision Analysis Model ◽  
Biologic Treatment ◽  
Life Years

Abstract Background Surgery is the preferred option for patients with symptomatic localized fibrostenotic ileocecal Crohn’s disease (CD) but not for those with predominantly active inflammation without obstruction. The benefit of early surgery in patients with a limited nonstricturing ileocecal CD over biologic treatment is still a debate. Objective Our objective is to formulate a decision analysis model based on recently published data to explore whether early surgery in patients with limited nonstricturing CD is preferred over biologic treatment. Methods We constructed a Markov model comparing 2 strategies of treatment: (1) early surgery vs (2) biologic treatment. To estimate the quality-adjusted life years (QALYs) and the costs in each strategy, we simulated 10,000 virtual patients with the Markov model using a Monte Carlo simulation 100 times. Sensitivity analyses were performed to evaluate the robustness of the model and address uncertainties in the estimation of model parameters. Results The costs were $29,457 ± $407 and $50,382 ± $525 (mean ± SD) for early surgery strategy and biologic treatment strategy, respectively. The QALY was 6.24 ± 0.01 and 5.81 ± 0.01 for early surgery strategy and biologic treatment strategy, respectively. Conclusion The strategy of early surgery dominates (higher QALY value [efficacy] and less cost) compared with the strategy of biologic treatment in patients with limited ileocecal CD.

scholarly journals Is administration of proton pump inhibitors in functional dyspepsia worth the risk of developing gastric cancer: a Markov model to bridge the gap between scientific evidence and clinical practice

BMJ Open ◽  
2020 ◽  
Vol 10 (2) ◽  
pp. e031091
Author(s):  
Efrat Broide ◽  
Adi Eindor-Abarbanel ◽  
Haim Shirin ◽  
Vered Richter ◽  
Shay Matalon ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Gastric Cancer ◽  
Markov Model ◽  
Functional Dyspepsia ◽  
Proton Pump Inhibitors ◽  
Proton Pump ◽  
Model Parameters ◽  
Decision Analysis Model ◽  
Life Years

ObjectiveTo formulate a decision analysis model based on recently published data that addresses the dilemma, whether improvement in quality of life rationalises continued proton pump inhibitors (PPI) use despite the risk of gastric cancer (GC) in patients with functional dyspepsia (FD).DesignA Markov model consisting of an initial decision regarding treatment with PPI (denoting it by PPI strategy) or any other treatment without PPI (denoting it by placebo strategy) was designed.Data sourcesData from prospective cross-sectional studies indicating risk stratification for GC after the use of PPI, combined with a Markov model that comprised the following states: Live, GC stages 1–4, Death.Outcome measuresThe primary outputs included quality-adjusted life years (QALYs) and life expectancy (LE). The improvement in utility in FD without PPI as compared with PPI use was tested (PPI vs placebo strategies). Sensitivity analyses were performed to evaluate the robustness of the model and address uncertainty in the estimation of model parameters.SettingWe considered only patients whose symptoms were relieved with PPIs and thus, had a better quality of life compared with patients who did not receive PPIs.ResultsThe base case model showed that PPIs compared with placebo decreased LE by 58.4 days with a gain of 2.1 QALY. If utility (quality of life of patients with FD using PPI compared with patients with FD without PPI) improved by more than 0.8%, PPI use is considered better than placebo. Older patients benefited less from PPI treatment than did younger patients.ConclusionTo bridge the gap between evidence and decision making, we found that even a small improvement in the QALY justified continuing PPI treatment.

scholarly journals Markov model projection of remission status for early versus delayed step-up adalimumab use in moderate to severe crohn's disease

Gut ◽  
2011 ◽  
Vol 60 (Suppl 1) ◽  
pp. A137-A137
Author(s):  
E. V. Loftus ◽  
J. Chao ◽  
M. Yang ◽  
P. F. Pollack ◽  
Z. Li ◽  
...  
Keyword(s):  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Markov Model ◽  
Model Projection ◽  
Remission Status

scholarly journals Funding the New Biologics – CCOHTA Report on the Cost Effectiveness of Infliximab for Crohn’s Disease: Pearls and Pitfalls

2002 ◽  
Vol 16 (12) ◽  
pp. 877-879 ◽  
Author(s):  
John K Marshall
Keyword(s):  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Economic Analysis ◽  
Safety Data ◽  
Cost Utility ◽  
Sensitivity Analyses ◽  
State Transitions ◽  
Health State ◽  
Life Years ◽  
The Cost

The Canadian Coordinating Office for Health Technology Assessment (CCOHTA) published an economic analysis, using a Markov model, of infliximab therapy for Crohn’s disease that is refractory to other treatments. This was the first fully published economic analysis that addresses this treatment option. Health state transitions were based on data from Olmsted County, Minnesota, health state resource profiles were created using expert opinion and a number of assumptions were made when designing the model. The analysis was rigorous, the best available efficacy and safety data were used, state-of-the art sensitivity analyses were undertaken and an ‘acceptability curve‘ was constructed. The model found that infliximab was effective in increasing quality-adjusted life years when offered in a variety of protocols, but it was associated with high incremental cost utility ratios compared with usual care. The results should be interpreted, however, in view of a number of limitations. The time horizon for the analysis was short (one year), because of a lack of longer-term efficacy data, and might have led to an underestimation of the benefits from averting surgery. Because the analysis was performed from the perspective of a Canadian provincial ministry of health, only direct medical costs were considered. Patients with active Crohn’s disease are likely to incur significant indirect costs, which could be mitigated by this medication. The analysis should be updated as new data become available. Moreover, small changes in the cost of the medication could make the treatment cost effective, according to this model. Economic analyses, such as the one undertaken by the CCOHTA, cannot by themselves solve dilemmas in the allocation of limited health care resources, and other considerations must be included when formulating policy. This is especially important for patients with severe Crohn’s disease, who have significant disability and for whom few therapeutic options exist.

scholarly journals OP26 Risankizumab induces early clinical remission and response in patients with Moderate-to-Severe Crohn’s Disease: Results from the phase 3 ADVANCE and MOTIVATE studies

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S026-S027
Author(s):  
S W Schreiber ◽  
M Ferrante ◽  
R Panaccione ◽  
J F Colombel ◽  
T Hisamatsu ◽  
...  
Keyword(s):  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Clinical Response ◽  
Induction Therapy ◽  
Clinical Remission ◽  
Activity Index ◽  
Unmet Need ◽  
Inadequate Response ◽  
Biologic Treatment ◽  
Double Blind

Abstract Background Present therapies leave an unmet need for early and effective treatment for patients with Crohn’s disease (CD). Risankizumab (RZB), a humanized immunoglobulin G1 monoclonal antibody against the p19 subunit of interleukin-23, was evaluated as an induction therapy to induce early clinical remission and response in patients with moderate-to-severe CD in two double-blind, randomized, placebo (PBO)-controlled studies (ADVANCE [NCT03104413] and MOTIVATE [NCT03105128]). Methods Patients with moderate-to-severe CD (CD Activity Index [CDAI] of 220–450, Simple Endoscopic Score for CD [SES-CD] ≥ 6 [≥ 4 for isolated ileal disease] excluding the narrowing component, and average daily [liquid/very soft] stool frequency [SF] ≥ 4 and/or average daily abdominal pain [AP] score ≥ 2) who had inadequate response or intolerance to conventional and/or biologic treatment (ADVANCE), or biologic treatment only (MOTIVATE) were randomised 2:2:1 (ADVANCE) or 1:1:1 (MOTIVATE) to receive intravenous RZB 600 mg, RZB 1200 mg, or PBO as induction therapy at weeks 0, 4, and 8. Clinical remission (per either CDAI or a composite of SF and AP criteria), clinical response (per CDAI criterion), and enhanced clinical response (per a composite of SF and AP criteria) were evaluated at weeks 4, 8, and 12 (endpoints defined in Figure 1 footnotes). Safety was assessed throughout the studies. Results A total of 1419 patients from ADVANCE (N = 850) and MOTIVATE (N = 569) respectively, were randomised and included in the intention-to-treat population. In both studies, starting at week 4 (the first prespecified measurement), greater proportions of RZB 600 mg or RZB 1200 mg- vs PBO-treated patients achieved clinical remission per either CDAI (P = .01/P < .05) or SF/AP criteria (P < .01/P < .01), clinical response per CDAI criterion (P = .001/P < .01), and enhanced clinical response per SF/AP criteria (P < .01/P = .14) (Figure 1). For both RZB 600 mg and RZB 1200 mg, the efficacy and treatment effect increased through week 12 (P ≤ .001/P ≤ .001) (Figure 1). Treatment with RZB 600 mg or 1200 mg was well tolerated, and no new safety risks were identified.1,2 Conclusion Induction therapy with both RZB 600 mg and 1200 mg intravenous resulted in significantly greater clinical remission and response vs PBO as early as week 4 and sustained through week 12 in patients with moderate-to-severe CD who had inadequate response or intolerance to conventional and/or biologic treatment. References

scholarly journals Decreased Enteric Bacterial Composition and Diversity in South American Crohn’s Disease Vary With the Choice of Treatment Strategy and Time Since Diagnosis

2019 ◽  
Vol 14 (6) ◽  
pp. 791-800
Author(s):  
Angélica Cruz-Lebrón ◽  
Leticia D’argenio Garcia ◽  
Aarthi Talla ◽  
Samira Joussef-Piña ◽  
Miguel E Quiñones-Mateu ◽  
...  
Keyword(s):  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Gut Microbiota ◽  
Bacterial Diversity ◽  
Relative Abundance ◽  
Treatment Strategy ◽  
Chronic Inflammatory Disease ◽  
Rrna Gene ◽  
Faecal Calprotectin ◽  
Time Since Diagnosis

Abstract Background and Aims The symptomology of Crohn’s disease [CD], a chronic inflammatory disease of the digestive tract, correlates poorly with clinical, endoscopic or immunological assessments of disease severity. The prevalence of CD in South America is rising, reflecting changes in socio-economic stability. Many treatment options are available to CD patients, including biological agents and corticosteroids, each of which offers variable efficacy attributed to host genetics and environmental factors associated with alterations in the gut microbiota. Methods Based on 16S rRNA gene sequencing and taxonomic differences, we compared the faecal microbial population of Brazilian patients with CD treated with corticosteroid or anti-tumour necrosis factor [anti-TNF] immunotherapy. Faecal calprotectin and plasma sCD14 levels were quantified as markers for local and systemic inflammation, respectively. Results Anti-TNF treatment led to an increased relative abundance of Proteobacteria and a decreased level of Bacteroidetes. In contrast, corticoid treatment was associated with an increase in the relative abundance of Actinobacteria, which has been linked to inflammation in CD. Disruption of the faecal microbiota was related to decreased bacterial diversity and composition. Moreover, the choice of clinical regimen and time since diagnosis modulate the character of the resulting dysbiosis. Conclusions Enteric microbial populations in CD patients who have been treated are modulated by disease pathogenesis, local inflammatory microenvironment and treatment strategy. The dysbiosis that remains after anti-TNF treatment due to decreased bacterial diversity and composition abates restoration of the microbiota to a healthy state, suggesting that the identification and development of new clinical treatments for CD must include their capacity to normalize the gut microbiota.

Mo1875 EVALUATION OF BIOLOGIC TREATMENT PATTERNS AMONG CROHN'S DISEASE PATIENTS USING THREE LARGE UNITED STATES CLAIMS DATABASES

2020 ◽  
Vol 158 (6) ◽  
pp. S-958-S-959
Author(s):  
Erik Muser ◽  
Camilo Obando ◽  
Amanda M. Teeple ◽  
Wendy Bibeau ◽  
Janvi Sah ◽  
...  
Keyword(s):  
United States ◽  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Treatment Patterns ◽  
Biologic Treatment

scholarly journals Long-Term Outcomes After Primary Bowel Resection in Pediatric-Onset Crohn’s Disease

2017 ◽  
Vol 24 (1) ◽  
pp. 149-158 ◽  
Author(s):  
Firas Rinawi ◽  
Noam Zevit ◽  
Rami Eliakim ◽  
Yaron Niv ◽  
Raanan Shamir ◽  
...  
Keyword(s):  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Protective Factor ◽  
Bowel Resection ◽  
Intestinal Resection ◽  
Biologic Treatment ◽  
Long Term Outcome ◽  
Year 2000 ◽  
Pediatric Onset

Abstract Background There is limited evidence on the long-term outcome of intestinal resection in pediatric-onset Crohn’s disease (POCD) with no established predictors of adverse outcomes. We aimed to investigate clinical outcomes and predictors for adverse outcome following intestinal resection in POCD. Methods The medical records of patients with POCD who underwent at least 1 intestinal resection between 1990 and 2014 were reviewed retrospectively. Main outcome measures included time to first flare, hospitalization, second intestinal resection, and response to nonprophylactic biologic therapy. Results Overall, 121 patients were included. Median follow-up was 6 years (range 1–23.6). One hundred and seven (88%) patients experienced at least 1 postsurgical exacerbation, 52 (43%) were hospitalized, and 17 (14%) underwent second intestinal resection. Of 91 patients who underwent surgery after the year 2000, 37 (41%) were treated with antitumor necrosis factor ɑ (anti-TNFɑ) (nonprophylactic) following intestinal resection. Time to hospitalization and to second intestinal resection were shorter among patients with extraintestinal manifestations (EIMs) (HR 2.7, P = 0.006 and HR = 3.1, P = 0.03, respectively). Time to initiation of biologic treatment was shorter in patients with granulomas (HR 2.1, P = 0.038), whereas being naïve to anti-TNFɑ treatment before surgery was a protective factor for biologic treatment following surgery (HR 0.3, P = 0.005). Undergoing intestinal resection beyond the year 2000 was associated with shorter time to first flare (HR 1.9, P = 0.019) and hospitalization (HR 2.6, P = 0.028). Conclusion Long-term risk for flares, hospitalization, or biologic treatment is significant in POCD following bowel resection. EIMs increase the risk for hospitalization and second intestinal resection.

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