A systematic monitoring approach to biologic therapies in inflammatory bowel disease: patients’ and physicians’ preferences and adherence

Christensen, Katrine Risager; Steenholdt, Casper; Buhl, Sine; Brynskov, Jørn; Ainsworth, Mark

doi:10.1080/00365521.2021.2002397

Cited by 4 publications

(14 citation statements)

References 34 publications

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“…Eight patients were excluded due to incomplete responses, leaving 164 patients for analysis. 16 Patient characteristics are shown in table 1 .…”

Section: Resultsmentioning

confidence: 99%

“…A total of 172 of 371 (46%) eligible patients responded to the survey. Eight patients were excluded due to incomplete responses, leaving 164 patients for analysis 16table 1.…”

Section: Resultsmentioning

confidence: 99%

“…The questionnaire comprised 13 questions (online supplemental table A1) and was part of a larger survey answered using REDCap via a touch screen 14–16. The survey was designed to identify the symptoms and outcomes patients with IBD found important in daily life and when visiting the outpatient clinic.…”

Section: Methodsmentioning

confidence: 99%

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Identifying and understanding disease burden in patients with inflammatory bowel disease

Christensen

Ainsworth

Skougaard

et al. 2022

BMJ Open Gastroenterol

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ObjectivePhysicians tend to focus on biomedical targets while little is known about issues important to patients. We aimed to identify critical concepts impacting patients with inflammatory bowel disease (IBD).DesignWe performed a survey of patients with IBD in biologic therapy (n=172) and used a validated qualitative method called group concept mapping (GCM) in patient workshops. The survey included 13 questions on attitudes toward symptoms and issues related to IBD. In the eight workshops, patients (n=26) generated statements later clustered into concepts identifying issues impacting a patient’s life. Patients ranked the statements.ResultsIn the survey, patients’ mean age were 40 years (SD 13), 53% were women, and 38% had ulcerative colitis. They identified fatigue (57%) and stool frequency (46%) as the most critical symptoms impacting their daily lives regardless of disease activity. In the GCM workshops with Crohn’s disease (n=13) (median age 42 years (IQR 39–51) and 62% were women), 335 statements divided among 10 concepts were generated, and the three most important concepts were ‘Positive attitudes’, ‘Accept and recognition’, and ‘Sharing knowledge and experiences in life with Crohn’s disease’. In the workshops with ulcerative colitis (n=13) (median age 43 years (IQR 36–49) and 69% were women), 408 statements divided into 11 concepts were generated; the most important concepts were ‘Take responsibility and control over your life’, ‘Medication’, and ‘Everyday life with ulcerative colitis’.ConclusionFocusing solely on IBD symptoms, patients identified fatigue and stool frequency to impact daily life the most. However, when investigating the disease burden in a broader perspective beyond classic IBD symptoms, patients identified concepts with focus on emotional health to be most important.Trial registrationThe Copenhagen University Hospital, Herlev and Gentofte approved the questionnaire and methodology (work-zone no: 18015429).

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“…Eight patients were excluded due to incomplete responses, leaving 164 patients for analysis. 16 Patient characteristics are shown in table 1 .…”

Section: Resultsmentioning

confidence: 99%

“…A total of 172 of 371 (46%) eligible patients responded to the survey. Eight patients were excluded due to incomplete responses, leaving 164 patients for analysis 16table 1.…”

Section: Resultsmentioning

confidence: 99%

See 1 more Smart Citation

Identifying and understanding disease burden in patients with inflammatory bowel disease

Christensen

Ainsworth

Skougaard

et al. 2022

BMJ Open Gastroenterol

Self Cite

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“…13 From April 2019 onwards, all patients were additionally, systematically and prospectively, assessed specifically for disability caused by fatigue after inclusion of this parameter in our routine monitoring regimen as well. 13 Patients were retrospectively identified using electronic patient files and data were retrospectively collected. Patients receiving VDZ due to fistulizing Crohn's disease, pouchitis, or as prophylaxis while in remission were excluded.…”

Section: Methodsmentioning

confidence: 99%

“…As part of our standard monitoring program, clinical disease activity scorings were carried out at all VDZ infusions and objective assessments, preferably endoscopy, were routinely performed at 1 year or treatment failure. 13 Clinical remission in patients with Crohn's disease was defined as Harvey-Bradshaw Index (HBI) < 5, and in ulcerative colitis as Simple Clinical Colitis Activity Index (SCCAI) ≤ 2. Clinical response at week 14 was assessed in exploratory analyses and defined as a reduction in HBI or SCCAI of ≥ 3 and ≥ 2, respectively.…”

Section: Methodsmentioning

confidence: 99%

Trajectories of health‐related quality of life and fatigue during vedolizumab therapy in inflammatory bowel disease

Steenholdt

Lorentsen

Petersen

et al. 2023

J of Gastro and Hepatol

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Background and Aim Normalizing health‐related quality of life (QoL) and fatigue are important long‐term treatment targets in inflammatory bowel disease (IBD). We examined their evolution in relation to changes in disease activity during vedolizumab therapy. Methods Cohort study of biologically refractory IBD patients treated with vedolizumab. Patients were prospectively evaluated at all infusions by Short Health Scale (SHS) (QoL questionnaire covering four health dimensions) (n = 79), visual analogous scale for fatigue (VAS‐F) (n = 30), and clinical disease activity. Objective disease assessment was carried out after 1 year or at treatment failure. Results Patients in steroid‐free clinical remission at end of induction improved significantly in all SHS items already from week 2 with full implementation by week 14 (“Symptoms” 59% improvement, P < 0.001; “Function” 63%, P < 0.001; “Worries” 59%, P < 0.001; “Well‐being” 40%, P < 0.01). Then, SHS remained stable at background levels (< 20) for 1 year (improvements 67%; 65%; 62%; 57%; P < 0.001). Combined clinical‐objective remission at 1 year was associated with highest SHS improvements (64–72%; P < 0.001). Of note, early SHS improvements preceded manifestation of clinical remission in most patients (22 of 33; 67%). Clinical response materialized into late (week 6 or later) and minor SHS improvements (31–46%, P < 0.001). Fatigue improved steadily over 6 months to background levels (VAS‐F < 4) among patients in clinical remission (45% decrease) or clinical‐objective remission (41%). SHS and VAS‐F impairment remained elevated in patients without effect of therapy. Conclusion QoL rapidly improves and predicts later significant clinical‐objective efficacies of vedolizumab at end of induction and 1 year. Fatigue improves slowly after remission is attained.

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The Role of Noninvasive Surrogates of Inflammation in Monitoring Pediatric Inflammatory Bowel Diseases

Dolinger

2023

Gastroenterology Clinics of North America

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A systematic monitoring approach to biologic therapies in inflammatory bowel disease: patients’ and physicians’ preferences and adherence

Cited by 4 publications

References 34 publications

Identifying and understanding disease burden in patients with inflammatory bowel disease

Identifying and understanding disease burden in patients with inflammatory bowel disease

Trajectories of health‐related quality of life and fatigue during vedolizumab therapy in inflammatory bowel disease

The Role of Noninvasive Surrogates of Inflammation in Monitoring Pediatric Inflammatory Bowel Diseases

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