Intestinal Research

Original Articles

Inflammatory Bowel Diseases

Quality of life in inflammatory bowel diseases: it is not all about the bowel: Ronald Keller, Nazar Mazurak, Laura Fantasia, Stefano Fusco, Nisar P Malek, Jan Wehkamp, Paul Enck, Thomas Klag; Intest Res 2021;19(1):45-52. Published online February 27, 2020; DOI: https://doi.org/10.5217/ir.2019.00135

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Background/Aims
The inflammatory bowel diseases (IBD), ulcerative colitis (UC), and Crohn’s disease (CD) are chronic diseases mostly affecting young patients. As they are diseases accompanying patients for their entire life, and the quality of life (QUOL) interacts with disease activity, improving QUOL should be one of the main goals of therapy. This study aims to identify factors contributing to good or impaired QUOL.
Methods
Questionnaires addressing health-related QUOL and other psychological and social features were positioned on our institutions’ webpage and on the webpage of the largest self-help group for IBD in Germany. Patients were subdivided according to their QUOL score with a cutoff of <60. We used the Short Inflammatory Bowel Disease Questionnaire, the Assessment of the Demand for Additional Psychological Treatment, and the Fear of Progression Questionnaire Short Form.
Results
High numbers of patients in both subgroups showed an impaired QUOL (87.34% in UC, 91.08% in CD). Active extraintestinal manifestations, smoking, high fear of progression and high demand for psychotherapy were associated with reduced QUOL. In addition, polypharmacological interventions did not result in a good QUOL, but ostomies are linked to improved QUOL especially in CD patients.
Conclusions
Scores used in clinical day-to-day-practice mainly focusing on somatic factors do not sufficiently address important aspects concerning QUOL. Most importantly, extraintestinal manifestations show a hitherto underestimated impact on QUOL.

Citations

Citations to this article as recorded by

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Catherine Rowan, Ryan Ungaro, Saurabh Mehandru, Jean-Frederic Colombel
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Catherine Rowan, Robert Hirten
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Inflammatory bowel diseases

Ustekinumab is effective in biological refractory Crohn’s disease patients–regardless of approval study selection criteria: Sadik Saman, Martin Goetz, Judith Wendler, Nisar P. Malek, Jan Wehkamp, Thomas Klag; Intest Res 2019;17(3):340-348. Published online May 31, 2019; DOI: https://doi.org/10.5217/ir.2019.00012

Abstract PDF PubReader ePub

Background/Aims
Ustekinumab is effective in active Crohn’s disease. In a retrospective study we assessed the clinical outcome in nonresponders to anti-tumor necrosis factor therapy, and/or conventional therapy and/or the α4β7-integrin inhibitor vedolizumab. As approval study populations do not always reflect the average “real world” patient cohort, we assessed weather patients who would not have qualified for approval studies show similar outcomes.
Methods
Forty-one patients with mild to severe active Crohn’s disease were treated with ustekinumab (intravenous 6 mg per kg/body weight) followed by subcutaneous ustekinumab (90 mg) at week 8. Depending on the clinical response maintenance therapy was chosen every 8 or 12 weeks. Clinical response was defined by Crohn’s Disease Activity Index (CDAI) decline, decline of stool frequency or clinical improvement. Inclusion criteria for approval studies were assessed.
Results
The 58.5% (24/41) showed clinical response to ustekinumab. The 58.3% of this group (14/24) achieved clinical remission. Clinical response correlated significantly with drop of stool frequency and improvement of CDAI score. The 39 out of 41 patients had no side effects and we observed no serious infections. About a third of our patients would not have met ustekinumab approval study criteria. However, patients who did not meet study criteria showed clinical improvement numerically in the same range compared to patients who would have qualified for approval studies.
Conclusions
Ustekinumab is effective, safe and well tolerated in a highly therapy refractory patient cohort. Even though a reasonable number of patients did not meet ustekinumab approval study criteria, approval study results seem to be representative to the overall patient cohort.

Citations

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Therapeutic Advances in Gastroenterology.2024;[Epub] CrossRef
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Statement

IBD

Consensus recommendations for patient-centered therapy in mild-to-moderate ulcerative colitis: the i Support Therapy–Access to Rapid Treatment (iSTART) approach: Silvio Danese, Rupa Banerjee, JR Fraser Cummings, Iris Dotan, Paulo G Kotze, Rupert Wing Loong Leong, Kristine Paridaens, Laurent Peyrin-Biroulet, Glyn Scott, Gert Van Assche, Jan Wehkamp, Jesús K Yamamoto-Furusho; Intest Res 2018;16(4):522-528. Published online October 16, 2018; DOI: https://doi.org/10.5217/ir.2018.00073

Abstract PDF Supplementary Material PubReader ePub

Symptomatic ulcerative colitis (UC) can be a chronic, disabling condition. Flares in disease activity are associated with many of the negative impacts of mild-to-moderate UC. Rapid resolution of flares can provide benefits to patients and healthcare systems. i Support Therapy–Access to Rapid Treatment (iSTART) introduces patient-centered care for mild-to-moderate UC. iSTART provides patients with the ability to self-assess symptomology and self-start a short course of second-line treatment when necessary. An international panel of experts produced consensus statements and recommendations. These were informed by evidence from systematic reviews on the epidemiology, mesalazine (5-ASA) treatment, and patient use criteria for second-line therapy in UC. Optimized 5-ASA is the first-line treatment in all clinical guidelines, but may not be sufficient to induce remission in all patients. Corticosteroids should be prescribed as second-line therapy when needed, with budesonide MMX® being a preferred steroid option. Active involvement of suitable patients in management of UC flares has the potential to improve therapy, with patients able to show good accuracy for flare self-assessment using validated tools. There is a place in the UC treatment pathway for an approach such as iSTART, which has the potential to provide patient, clinical and economic benefits.

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