Novel Targets For Therapeutic Intervention in Inflammatory Bowel Disease. What is the Best Way to Assess the Safety Profile of a Drug?

2019 ◽  
Vol 25 (1) ◽  
pp. 57-63 ◽  
Author(s):  
Clara Yzet ◽  
Stacy S. Tse ◽  
Maia Kayal ◽  
Robert Hirten ◽  
Jean-Frédéric Colombel
Keyword(s):  
Inflammatory Bowel Disease ◽  
Bowel Disease ◽  
Evaluation Process ◽  
Population Based ◽  
Stage Of Development ◽  
Remission Rates ◽  
Safety Parameters ◽  
Post Marketing ◽  
Inflammatory Bowel

The emergence of biologic therapies has revolutionized the management of inflammatory bowel disease (IBD) by halting disease progression, increasing remission rates and improving long-term clinical outcomes. Despite these well-described benefits, many patients are reluctant to commence therapy due to drug safety concerns. Adverse events can be detected at each stage of drug development and during the post-marketing period. In this article, we review how to best assess the safety parameters of new IBD medications, from the earliest stage of development to population-based registries, with a focus on the special populations often excluded from the evaluation process.

scholarly journals The Information Needs and Preferences of Persons with Longstanding Inflammatory Bowel Disease

2012 ◽  
Vol 26 (8) ◽  
pp. 525-531 ◽  
Author(s):  
Samantha Wong ◽  
John R Walker ◽  
Rachel Carr ◽  
Lesley A Graff ◽  
Ian Clara ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Bowel Disease ◽  
Information Needs ◽  
Population Based ◽  
Information Delivery ◽  
Medical Specialist ◽  
Amount Of Information ◽  
Inflammatory Bowel ◽  
Long Term Prognosis

BACKGROUND: Understanding the information needs and preferred vehicles of information delivery to patients with inflammatory bowel disease (IBD) will enhance their care.OBJECTIVE: To survey persons with longstanding IBD as to their information needs and preferred vehicles of information delivery.METHODS: The population-based Manitoba IBD Cohort (n=271, mean disease duration 11 years) was surveyed to assess its information needs across 23 issues, both retrospectively at the time of diagnosis and currently.RESULTS: Most participants (64%) were initially diagnosed by a gastroenterologist, or otherwise by a family physician (19%) or surgeon (12%). Recalling time of diagnosis, at least 80% rated as very important information about common symptoms of IBD, possible complications, long-term prognosis, medication side effects, self management of symptoms and when to involve the doctor, yet only 10% to 36% believed they received the right amount of information about these issues. Dietary guidance was also regarded as important by 80% to 89%, yet only 8% to 16% received the correct amount of information. Regarding current needs, a large proportion believed it would be very helpful to have more information about long-term prognosis (66%) and diet considerations (60% to 68%). The following information sources were regarded as very acceptable: medical specialist (81%); brochure (79%); family doctor (64%); and website (64%), with 51% ranking the medical specialist as the first choice. In a comparison of the responses of this cohort to those of a recently diagnosed sample, there was remarkable consistency in the information needs and most desired sources of information.DISCUSSION: In the present population-based cohort with longstanding disease, dietary information was regarded as the least adequately addressed. There was clear openness to receiving information through other routes than just the medical specialist, suggesting that optimizing brochures and websites would be an important adjunct source of information.CONCLUSION: Approximately 10 years after diagnosis, only a small percentage of persons with IBD believed they received the correct amount of information about the issues they regarded as most important to have discussed at diagnosis.

Long-term health outcomes in pediatric inflammatory bowel disease: A population-based study

2009 ◽  
Vol 15 (1) ◽  
pp. 56-62 ◽  
Author(s):  
Pieta Turunen ◽  
Merja Ashorn ◽  
Anssi Auvinen ◽  
Sari Iltanen ◽  
Heini Huhtala ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Health Outcomes ◽  
Bowel Disease ◽  
Population Based ◽  
Population Based Study ◽  
Pediatric Inflammatory Bowel Disease ◽  
Inflammatory Bowel

scholarly journals P290 Long-term disease outcome of ulcerative colitis (UC) in South Ostrobothnia, Finland with a follow-up time of 25 years

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S297-S298
Author(s):  
K Kontola ◽  
P Oksanen ◽  
H Huhtala ◽  
H Tunturi-Hihnala ◽  
A Jussila
Keyword(s):  
Inflammatory Bowel Disease ◽  
Bowel Disease ◽  
Cumulative Risk ◽  
Population Based ◽  
Study Data ◽  
Disease Outcome ◽  
Inflammatory Bowel ◽  
The Mean

Abstract Background Finland has one of the highest prevalence of inflammatory bowel disease (IBD), especially UC. There is scarce data about long-term disease outcome in UC in population-based cohorts. The aim was to evaluate the long-term clinical outcome of patients with UC in the region of South Ostrobothnia, a district in rural central western Finland with a population of about 190 000. Methods All patients treated with diagnosis of UC or IBDU (inflammatory bowel disease Unclassified) during years 1981–2000 were included in this study. Data were collected retrospectively from the patient registry of the Central Hospital of South Ostrobothnia until 1 August 2019. Results There were 589 patients with a median follow-up time of 25 years. Median age at the diagnosis was 34 years. 59% of patients were male, 93% had UC and 7% IBDU. According to Montreal classification 80% had extensive disease, 15% left-sided disease and 5% proctitis. Medical treatment used at any point during the disease is shown in Table 1. Twenty-two per cent of patients had colectomy. Of operated patients, (pan)proctocolectomy with ileostomy was performed to 50%, IPAA (ileal pouch anal anastomosis) to 40% and IRA (ileorectal anastomosis) to 3%. Median time from the diagnosis to surgery was 11 years; the risk of surgery is shown in Table 2. Twenty-six per cent of the operations were emergency surgeries. The mean age at the time of surgery was 49 years. The indications for colectomy are specified in Table 3. Cumulative risk of colorectal cancer (CRC) and biliary tract cancer was 3.2% and 1.7%, respectively. Twenty-eight per cent of patients died during follow-up, at the mean age of 72 years. The cause of death was recorded for 91/167 and the most common causes were cardiovascular disease and malignancy. Conclusion In this population-based cohort with surveillance of 25 years 22% patients with UC or IBDU were operated. Even after becoming available, biological medication is rarely used for UC patients diagnosed in the prebiologic era.

scholarly journals Long-Term Effectiveness of Oral Ferric Maltol vs Intravenous Ferric Carboxymaltose for the Treatment of Iron-Deficiency Anemia in Patients With Inflammatory Bowel Disease: A Randomized Controlled Noninferiority Trial

2021 ◽  
Author(s):  
Stefanie Howaldt ◽  
Eugeni Domènech ◽  
Nicholas Martinez ◽  
Carsten Schmidt ◽  
Bernd Bokemeyer
Keyword(s):  
Inflammatory Bowel Disease ◽  
Iron Deficiency ◽  
Iron Deficiency Anemia ◽  
Primary Endpoint ◽  
Bowel Disease ◽  
Deficiency Anemia ◽  
Ferric Carboxymaltose ◽  
Inflammatory Bowel ◽  
Intent To Treat

Abstract Background Iron-deficiency anemia is common in inflammatory bowel disease, requiring oral or intravenous iron replacement therapy. Treatment with standard oral irons is limited by poor absorption and gastrointestinal toxicity. Ferric maltol is an oral iron designed for improved absorption and tolerability. Methods In this open-label, phase 3b trial (EudraCT 2015-002496-26 and NCT02680756), adults with nonseverely active inflammatory bowel disease and iron-deficiency anemia (hemoglobin, 8.0-11.0/12.0 g/dL [women/men]; ferritin, <30 ng/mL/<100 ng/mL with transferrin saturation <20%) were randomized to oral ferric maltol 30 mg twice daily or intravenous ferric carboxymaltose given according to each center’s standard practice. The primary endpoint was a hemoglobin responder rate (≥2 g/dL increase or normalization) at week 12, with a 20% noninferiority limit in the intent-to-treat and per-protocol populations. Results For the intent-to-treat (ferric maltol, n = 125/ferric carboxymaltose, n = 125) and per-protocol (n = 78/88) analyses, week 12 responder rates were 67% and 68%, respectively, for ferric maltol vs 84% and 85%, respectively, for ferric carboxymaltose. As the confidence intervals crossed the noninferiority margin, the primary endpoint was not met. Mean hemoglobin increases at weeks 12, 24, and 52 were 2.5 vs 3.0 g/dL, 2.9 vs 2.8 g/dL, and 2.7 vs 2.8 g/dL with ferric maltol vs ferric carboxymaltose. Treatment-emergent adverse events occurred in 59% and 36% of patients, respectively, and resulted in treatment discontinuation in 10% and 3% of patients, respectively. Conclusions Ferric maltol achieved clinically relevant increases in hemoglobin but did not show noninferiority vs ferric carboxymaltose at week 12. Both treatments had comparable long-term effectiveness for hemoglobin and ferritin over 52 weeks and were well tolerated.

Su1292 The Long-Term Influence of Anti-TNF Agents on Hemoglobin Levels in Patients With Inflammatory Bowel Disease

2015 ◽  
Vol 148 (4) ◽  
pp. S-463
Author(s):  
Ioannis E. Koutroubakis ◽  
Claudia Ramos Rivers ◽  
Miguel Regueiro ◽  
Efstratios Koutroumpakis ◽  
Benjamin H. Click ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Bowel Disease ◽  
Inflammatory Bowel
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