STABILITY (Symptomatic Review during Biologic Therapy) of Inflammatory Bowel Disease Patients Receiving Infusion Therapy Improves Clinical Outcomes
Abstract
:1. Introduction
2. Materials and Methods
3. Results
3.1. Ulcerative Colitis Patients
3.2. Crohn’s Disease Patients
3.3. Female IBD Patients
3.4. Male IBD Patients
3.5. Female CD Patients
3.6. Male CD Patients
3.7. Female UC Patients
3.8. Male UC Patients
4. Discussions
4.1. Influence of Patient Sex on STABILITY Outcomes
4.2. Patient Surveys
5. Conclusions
6. Patents
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
- Seeding, S.S.; Nokhostin, F.; Malamir, M.D. A review of the diagnosis, prevention, and treatment methods of inflammatory bowel disease. J. Med. Life 2019, 12, 113–122. [Google Scholar] [CrossRef] [PubMed] [PubMed Central]
- Gajendran, M.; Loganathan, P.; Catinella, A.P.; Hashash, J.G. A comprehensive review and update on Crohn’s disease. Dis. Mon. 2018, 64, 20–57. [Google Scholar] [CrossRef] [PubMed]
- Viscido, A.; Aratari, A.; Maccioni, F.; Signore, A.; Caprilli, R. Inflammatory bowel diseases: Clinical update of practical guidelines. Nucl. Med. Commun. 2005, 26, 649–655. [Google Scholar] [CrossRef] [PubMed]
- Ng, S.C.; Shi, H.Y.; Hamidi, N.; Underwood, F.E.; Tang, W.; Benchimol, E.I.; Panaccione, R.; Ghosh, S.; Wu, J.C.Y.; Chan, F.K.L.; et al. Worldwide incidence and prevalence of inflammatory bowel disease in the 21st century: A systematic review of population-based studies. Lancet 2017, 390, 2769–2778, Erratum in Lancet 2020, 396, e56. [Google Scholar] [CrossRef] [PubMed]
- Baumgart, D.C.; Le Berre, C. Newer biologic and small-molecule therapies for inflammatory bowel disease. N. Engl. J. Med. 2021, 385, 1302–1315. [Google Scholar] [CrossRef] [PubMed]
- Ahmed, W.; Galati, J.; Kumar, A.; Christos, P.J.; Longman, R.; Lukin, D.J.; Scherl, E.; Battat, R. Dual biologic or small molecule therapy for treatment of inflammatory bowel disease: A systematic review and meta-analysis. Clin. Gastroenterol. Hepatol. 2022, 20, e361–e379. [Google Scholar] [CrossRef] [PubMed]
- Ahluwalia, B.; Moraes, L.; Magnusson, M.K.; Öhman, L. Immunopathogenesis of inflammatory bowel disease and mechanisms of biological therapies. Scand. J. Gastroenterol. 2018, 53, 379–389. [Google Scholar] [CrossRef] [PubMed]
- Bager, P.; Hentze, R.; Nairn, C. Outpatients with inflammatory bowel disease (IBD) strongly prefer annual telephone calls from an IBD nurse instead of outpatient visits. Gastroenterol. Nurs. 2013, 36, 92–96. [Google Scholar] [CrossRef] [PubMed]
- Carlsen, K.; Jakobsen, C.; Houen, G.; Kallemose, T.; Paerregaard, A.; Riis, L.B.; Munkholm, P.; Wewer, V. Self-managed eHealth, disease monitoring in children and adolescents with inflammatory bowel disease: A randomized controlled trial. Inflamm. Bowel Dis. 2017, 23, 357–365. [Google Scholar] [CrossRef] [PubMed]
- Rohatinsky, N.; Chauhan, U.M.; Currie, B.M.; Peacock, S.; Phalen-Kelly, K.M.; Russell, B.B.; Tooke, N.M. Older adults with inflammatory bowel disease in Canada: A mixed-methods exploratory study of care experiences and health-related quality of life. Gastroenterol. Nurs. 2023, 47, 41–51. [Google Scholar] [CrossRef] [PubMed]
- Karimi, N.; Kanazaki, R.; Lukin, A.; Moore, A.R.; Williams, A.J.; Connor, S. Clinical communication in inflammatory bowel disease: A systematic review of the study of clinician-patient dialogue to inform research and practice. BMJ Open 2021, 11, e051053. [Google Scholar] [CrossRef] [PubMed] [PubMed Central]
- Mosli, M.H.; Zou, G.; Garg, S.K.; Feagan, S.G.; MacDonald, J.K.; Chande, N.; Sandborn, W.J.; Feagan, B.G. C-reactive protein, fecal calprotectin, and stool lactoferrin for detection of endoscopic activity in symptomatic inflammatory bowel disease patients: A systematic review and meta-analysis. Am. J. Gastroenterol. 2015, 110, 802–819. [Google Scholar] [CrossRef] [PubMed]
- Gisbert, J.P.; McNicholl, A.G. Questions and answers on the role of faecal calprotectin as a biological marker in inflammatory bowel disease. Dig. Liver Dis. 2009, 41, 56–66. [Google Scholar] [CrossRef] [PubMed]
- Khaki-Khatibi, F.; Qujeq, D.; Kashifard, M.; Moein, S.; Maniati, M.; Vaghari-Tabari, M. Calprotectin in inflammatory bowel disease. Clin. Chim. Acta 2020, 510, 556–565. [Google Scholar] [CrossRef] [PubMed] [PubMed Central]
- Nehring, S.M.; Goyal, A.; Patel, B.C. C Reactive Protein; StatPearls Publishing: Treasure Island, FL, USA, 2021. [Google Scholar] [PubMed]
- Tishkowski, K.; Gupta, V. Erythrocyte Sedimentation Rate; StatPearls Publishing: Treasure Island, FL, USA, 2021. [Google Scholar] [PubMed]
- Menees, S.B.; Powell, C.; Kurlander, J.; Goel, A.; Chey, W.D. A meta-analysis of the utility of C-reactive protein, erythrocyte sedimentation rate, fecal calprotectin, and fecal lactoferrin to exclude inflammatory bowel disease in adults with IBS. Am. J. Gastroenterol. 2015, 110, 444–454. [Google Scholar] [CrossRef] [PubMed]
- Sands, B.E. Biomarkers of inflammation in inflammatory bowel disease. Gastroenterology 2015, 149, 1275–1285.e2. [Google Scholar] [CrossRef] [PubMed]
- Severs, M.; Spekhorst, L.M.; Mangen, M.J.; Dijkstra, G.; Löwenberg, M.; Hoentjen, F.; Jong, A.E.v.d.M.-D.; Pierik, M.; Ponsioen, C.Y.; Bouma, G.; et al. Sex-related differences in patients with inflammatory bowel disease: Results of 2 prospective cohort studies. Inflamm. Bowel Dis. 2018, 24, 1298–1306. [Google Scholar] [CrossRef] [PubMed]
- Greuter, T.; Manser, C.; Pittet, V.; Vavricka, S.R.; Biedermann, L.; on behalf of Swiss IBDnet, an Official Working Group of the Swiss Society of Gastroenterology. Gender differences in inflammatory bowel disease. Digestion 2020, 101, 98–104. [Google Scholar] [CrossRef] [PubMed]
- Pabla, B.S.; Schwartz, D.A. Assessing severity of disease in patients with ulcerative colitis. Gastroenterol. Clin. N. Am. 2020, 49, 671–688. [Google Scholar] [CrossRef] [PubMed] [PubMed Central]
- Xu, F.; Liu, Y.; Wheaton, A.G.; Rabarison, K.M.; Croft, J.B. Trends and factors associated with hospitalization costs for inflammatory bowel disease in the United States. Appl. Health Econ. Health Policy 2019, 17, 77–91. [Google Scholar] [CrossRef] [PubMed] [PubMed Central]
- Opstelten, J.L.; Vaartjes, I.; Bots, M.L.; Oldenburg, B. Mortality after first hospital admission for inflammatory bowel disease: A nationwide registry linkage study. Inflamm. Bowel Dis. 2019, 25, 1692–1699. [Google Scholar] [CrossRef] [PubMed] [PubMed Central]
- Mazzoni, D.; Cornet, A.; van Leeuw, B.; Myllys, K.; Cicognani, E. Living with systemic lupus erythematosus: A patient engagement perspective. Musculoskelet. Care 2018, 16, 67–73. [Google Scholar] [CrossRef] [PubMed]
- Farin, E. Die patient-behandler-kommunikation bei chronischen krankheiten: Überblick über den forschungsstand in ausgewählten themenbereichen [Patient-provider communication in chronic illness: Current state of research in selected areas]. Rehabilitation 2010, 49, 277–291. [Google Scholar] [CrossRef] [PubMed]
- Rees, S.; Williams, A. Promoting and supporting self-management for adults living in the community with physical chronic illness: A systematic review of the effectiveness and meaningfulness of the patient-practitioner encounter. JBI Evid. Synth. 2009, 7, 492–582. [Google Scholar] [CrossRef] [PubMed]
Group | Parameter | Before | STABILITY | After | STABILITY | p-Value | Significance | ||||
---|---|---|---|---|---|---|---|---|---|---|---|
Crohn’s | Disease | (CD) | Cohort | Patients | 93 | ||||||
Age | Range | (years) | 16 | to | 67 | ||||||
Female | (%) | N/A | |||||||||
Male | (%) | N/A | |||||||||
Mean | Disease | Severity | 1.6 | ± | 0.11 | 1.3 | ± | 0.097 | 0.0001 | Significant | |
Mean | FCP | (μg/g) | 464.11 | ± | 165 | 339 | ± | 112 | 0.2596 | NS | |
Mean | CRP | (mg/L) | 2.05 | ± | 0.36 | 1.49 | ± | 0.32 | 0.1957 | NS | |
Sed Rate | (mm/h) | 26.7 | ± | 2.9 | 25.1 | ± | 4.6 | 0.86 | NS | ||
Hospitalizations | 0.22 | ± | 0.04 | 0.1 | ± | 0.03 | 0.0013 | Significant | |||
Female | IBD | Patients | Patients | 71 | |||||||
Mean | Age | (years) | 38.25 | ± | 1.8 | ||||||
Mean | Disease | Severity | 1.69 | ± | 0.13 | 1.411 | ± | 0.12 | 0.0001 | Significant | |
Mean | FCP | (μg/g) | 388 | ± | 137 | 268 | ± | 141 | 0.5522 | NS | |
Mean | CRP | (mg/L) | 2.23 | ± | 0.42 | 1.37 | ± | 0.33 | 0.1642 | NS | |
Sed Rate | (mm/h) | 35.1 | ± | 4.1 | 30.2 | ± | 5.9 | 0.43 | NS | ||
Hospitalizations | 0.21 | ± | 0.05 | 0.11 | ± | 0.04 | 0.0072 | Significant | |||
Male | IBD | Patients | Patients | 40 | |||||||
Mean | Age | (years) | 41.1 | ± | 2.24 | ||||||
Mean | Disease | Severity | 1.58 | ± | 0.16 | 1.2 | ± | 0.135 | 0.004 | Significant | |
Mean | FCP | (μg/g) | 1079 | ± | 420 | 502.6 | ± | 163 | 0.4045 | NS | |
Mean | CRP | (mg/L) | 2.6 | ± | 0.73 | 1.4 | ± | 0.45 | 0.14 | NS | |
Sed Rate | (mm/h) | 21 | ± | 4 | 17.5 | ± | 5.1 | 0.3948 | NS | ||
Hospitalizations | 0.175 | ± | 0.06 | 0.05 | ± | 0.03 | 0.0234 | Significant | |||
Female | CD | Patients | Patients | 60 | |||||||
Mean | Age | (years) | 37.83 | ± | 1.9 | ||||||
Mean | Disease | Severity | 1.66 | ± | 0.15 | 1.4 | ± | 0.13 | 0.0003 | Significant | |
Mean | FCP | (μg/g) | 339.25 | ± | 149 | 277.4 | ± | 155 | 0.7693 | NS | |
Mean | CRP | (mg/L) | 2.25 | 1.56 | 0.3284 | NS | |||||
Sed Rate | (mm/h) | 32.2 | ± | 3.7 | 30.7 | ± | 6.4 | 0.72 | NS | ||
Hospitalizations | 0.23 | ± | 0.06 | 0.13 | ± | 0.5 | 0.013 | Significant | |||
Male | CD | Patients | Patients | 33 | |||||||
Mean | Age | (years) | 41.52 | ± | 2.6 | ||||||
Mean | Disease | Severity | 1.5 | ± | 0.17 | 1.15 | ± | 0.15 | 0.016 | Significant | |
Mean | FCP | (μg/g) | 699 | ± | 381 | 426 | ± | 166 | 0.613 | NS | |
Mean | CRP | (mg/L) | 2.09 | ± | 0.8 | 1.4 | ± | 0.53 | 0.558 | NS | |
Sed Rate | (mm/h) | 18.7 | ± | 4.5 | 16.9 | ± | 5.8 | 0.397 | NS | ||
Hospitalizations | 0.18 | ± | 0.07 | 0.06 | ± | 0.04 | 0.0435 | Significant | |||
Female | UC | Patients | of | Patients | 11 | ||||||
Mean | Age | (years) | 40.55 | ± | 4.7 | ||||||
Mean | Disease | Severity | 1.82 | ± | 0.32 | 1.45 | ± | 0.31 | 0.0379 | Significant | |
Mean | FCP | (μg/g) | 778.33 | ± | 615.11 | 155 | ± | 139 | 0.4931 | NS | |
Mean | CRP | (mg/L) | 2.08 | ± | 1.73 | 0.47 | ± | 0.05 | 0.3995 | NS | |
Sed Rate | (mm/h) | 80.7 | ± | 23.45 | 29.5 | ± | 5.5 | 0.19 | NS | ||
Hospitalizations | 0.91 | ± | 0.09 | 0 | ± | 0 | 0.34 | NS | |||
Male | UC | Patients | Patients | 7 | |||||||
Mean | Age | (years) | 39.14 | ± | 3.9 | ||||||
Mean | Disease | Severity | 1.86 | ± | 0.46 | 1.43 | ± | 0.3 | 0.0781 | Marginally | |
Mean | FCP | (μg/g) | 2316.75 | ± | 1144 | 1189 | ± | 195 | 0.66 | NS | |
Mean | CRP | (mg/L) | 4.6 | ± | 1.9 | 1.46 | ± | 0.3 | 0.138 | NS | |
Sed Rate | (mm/h) | 31.8 | ± | 5.38 | 21.5 | ± | 10.5 | NS | |||
Hospitalizations | 0.14 | ± | 0.14 | 0 | ± | 0 | 0.3559 | NS |
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Morgan, K.; Morris, J.; Cai, Q.; Kilgore, P.; Cvek, U.; Trutschl, M.; Lofton, K.T.; Mavuram, M.S.; Ramesh, P.; Dao, N.; et al. STABILITY (Symptomatic Review during Biologic Therapy) of Inflammatory Bowel Disease Patients Receiving Infusion Therapy Improves Clinical Outcomes. Pathophysiology 2024, 31, 398-407. https://doi.org/10.3390/pathophysiology31030030
Morgan K, Morris J, Cai Q, Kilgore P, Cvek U, Trutschl M, Lofton KT, Mavuram MS, Ramesh P, Dao N, et al. STABILITY (Symptomatic Review during Biologic Therapy) of Inflammatory Bowel Disease Patients Receiving Infusion Therapy Improves Clinical Outcomes. Pathophysiology. 2024; 31(3):398-407. https://doi.org/10.3390/pathophysiology31030030
Chicago/Turabian StyleMorgan, Kelli, James Morris, Qiang Cai, Phillip Kilgore, Urska Cvek, Marjan Trutschl, Katelynn T. Lofton, Meher Sindhoora Mavuram, Prerana Ramesh, Nhi Dao, and et al. 2024. "STABILITY (Symptomatic Review during Biologic Therapy) of Inflammatory Bowel Disease Patients Receiving Infusion Therapy Improves Clinical Outcomes" Pathophysiology 31, no. 3: 398-407. https://doi.org/10.3390/pathophysiology31030030
APA StyleMorgan, K., Morris, J., Cai, Q., Kilgore, P., Cvek, U., Trutschl, M., Lofton, K. T., Mavuram, M. S., Ramesh, P., Dao, N., Alhaque, A., & Alexander, J. S. (2024). STABILITY (Symptomatic Review during Biologic Therapy) of Inflammatory Bowel Disease Patients Receiving Infusion Therapy Improves Clinical Outcomes. Pathophysiology, 31(3), 398-407. https://doi.org/10.3390/pathophysiology31030030