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4. Multiple infliximab biosimilar switches appear to be safe and effective in a real-world inflammatory bowel disease cohort.

Author

Gros, B., Plevris, N., Constantine-Cooke, N., Lyons, M., O'Hare, C., Noble, C., Arnott, I.D., Jones, G.R., Lees, C.W., Derikx, L.A.A.P., Gros, B., Plevris, N., Constantine-Cooke, N., Lyons, M., O'Hare, C., Noble, C., Arnott, I.D., Jones, G.R., Lees, C.W., and Derikx, L.A.A.P.

Abstract

Item does not contain fulltext, BACKGROUND: Switching from originator infliximab (IFX) to biosimilar IFX is effective and safe. However, data on multiple switching are scarce. The Edinburgh inflammatory bowel disease (IBD) unit has undertaken three switch programmes: (1) Remicade to CT-P13 (2016), (2) CT-P13 to SB2 (2020), and (3) SB2 to CT-P13 (2021). OBJECTIVE: The primary endpoint of this study was to assess CT-P13 persistence following switch from SB2. Secondary endpoints included persistence stratified by the number of biosimilar switches (single, double and triple), effectiveness and safety. METHODS: We performed a prospective, observational, cohort study. All adult IBD patients on IFX biosimilar SB2 underwent an elective switch to CT-P13. Patients were reviewed in a virtual biologic clinic with protocol driven collection of clinical disease activity, C-reactive protein (CRP), faecal calprotectin (FC), IFX trough/antibody levels, and drug survival. RESULTS: 297 patients (CD n = 196 [66%], ulcerative colitis/inflammatory bowel disease unclassified n = 101, [34%]) were switched (followed-up: 7.5 months [6.8-8.1]). This was the third, second and first IFX switch for 67/297 (22.5%), 138/297 (46.5%) and 92/297 (31%) of the cohort respectively. 90.6% of patients remained on IFX during follow-up. The number of switches was not independently associated with IFX persistence after adjusting for confounders. Clinical (p = 0.77), biochemical (CRP ≤5 mg/ml; p = 0.75) and faecal biomarker (FC<250 µg/g; p = 0.63) remission were comparable at baseline, week 12 and week 24. CONCLUSION: Multiple successive switches from IFX originator to biosimilars are effective and safe in patients with IBD, irrespective of the number of IFX switches.

Published
2023

5. Rates, predictive factors and effectiveness of ustekinumab intensification to 4- or 6-weekly intervals in Crohn's disease.

Author

Derikx, L.A.A.P., Plevris, N., Su, S., Gros, B., Lyons, M., Siakavellas, S.I., Constantine-Cooke, N., Jenkinson, P., O'Hare, C., Noble, C., Arnott, I.D., Jones, G.R., Lees, C.W., Derikx, L.A.A.P., Plevris, N., Su, S., Gros, B., Lyons, M., Siakavellas, S.I., Constantine-Cooke, N., Jenkinson, P., O'Hare, C., Noble, C., Arnott, I.D., Jones, G.R., and Lees, C.W.

Abstract

01 augustus 2023, Contains fulltext : 295992.pdf (Publisher’s version ) (Open Access), BACKGROUND: The UNITI trial reports efficacy of ustekinumab (UST) dose intensification in Crohn's disease (CD) from 12- to 8-weekly, but not 4-weekly. We aimed 1) to assess the cumulative incidence of UST dose intensification to 4- or 6-weekly, 2) to identify factors associated with dose intensification, and 3) to assess the effectiveness of this strategy. METHODS: We performed a retrospective, observational cohort study in NHS Lothian including all UST treated CD patients (2015-2020). RESULTS: 163 CD patients were treated with UST (median follow-up: 20.3 months [13.4-38.4]), of whom 55 (33.7%) underwent dose intensification to 4-weekly (n = 50, 30.7%) or 6-weekly (n = 5, 3.1%). After 1 year 29.9% were dose intensified. Prior exposure to both anti-TNF and vedolizumab (HR 9.5; 1.3-70.9), and concomitant steroid use at UST start (HR 1.8; 1.0-3.1) were associated with dose intensification. Following dose intensification, 62.6% patients (29/55) remained on UST beyond 1 year. Corticosteroid-free clinical remission was achieved in 27% at week 16 and 29.6% at last follow-up. CONCLUSION: One third of CD patients treated with UST underwent dose intensification to a 4- or 6-weekly interval within the first year. Patients who failed both anti-TNF and vedolizumab, or required steroids at initiation were more likely to dose intensify.

Published
2023

6. Longitudinal Fecal Calprotectin Profiles Characterize Disease Course Heterogeneity in Crohn's Disease.

Author

Constantine-Cooke, N., Monterrubio-Gómez, K., Plevris, N., Derikx, L.A.A.P., Gros, B., Jones, G.R., Marioni, R.E., Lees, C.W., Vallejos, C.A., Constantine-Cooke, N., Monterrubio-Gómez, K., Plevris, N., Derikx, L.A.A.P., Gros, B., Jones, G.R., Marioni, R.E., Lees, C.W., and Vallejos, C.A.

Abstract

Contains fulltext : 296930.pdf (Publisher’s version ) (Open Access), BACKGROUND AND AIMS: The progressive nature of Crohn's disease is highly variable and hard to predict. In addition, symptoms correlate poorly with mucosal inflammation. There is therefore an urgent need to better characterize the heterogeneity of disease trajectories in Crohn's disease by utilizing objective markers of inflammation. We aimed to better understand this heterogeneity by clustering Crohn's disease patients with similar longitudinal fecal calprotectin profiles. METHODS: We performed a retrospective cohort study at the Edinburgh IBD Unit, a tertiary referral center, and used latent class mixed models to cluster Crohn's disease subjects using fecal calprotectin observed within 5 years of diagnosis. Information criteria, alluvial plots, and cluster trajectories were used to decide the optimal number of clusters. Chi-square test, Fisher's exact test, and analysis of variance were used to test for associations with variables commonly assessed at diagnosis. RESULTS: Our study cohort comprised 356 patients with newly diagnosed Crohn's disease and 2856 fecal calprotectin measurements taken within 5 years of diagnosis (median 7 per subject). Four distinct clusters were identified by characteristic calprotectin profiles: a cluster with consistently high fecal calprotectin and 3 clusters characterized by different downward longitudinal trends. Cluster membership was significantly associated with smoking (P = .015), upper gastrointestinal involvement (P < .001), and early biologic therapy (P < .001). CONCLUSIONS: Our analysis demonstrates a novel approach to characterizing the heterogeneity of Crohn's disease by using fecal calprotectin. The group profiles do not simply reflect different treatment regimens and do not mirror classical disease progression endpoints.

Published
2023

8. P127 Inflammatory Bowel Disease-associated colorectal cancers: retrospective cohort study from a tertiary centre surveillance programme over 10 years

Author

Porter, R, primary, Gillespie, S L, additional, Song, M, additional, Ball, G, additional, Crawford, A, additional, Churchhouse, A, additional, Gardner, M, additional, Plevris, N, additional, Chuah, C S, additional, Brindle, W, additional, Watson, E, additional, Jenkinson, P, additional, Fulforth, J, additional, Kedziora, M, additional, Dickson, B, additional, Megan, A, additional, Jones, G R, additional, and Din, S, additional

Published
2023
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14. Patterns of emergency admission for IBD patients over the last 10 years in Lothian, Scotland: a retrospective prevalent cohort analysis.

Author

Lyons, M., Derikx, L.A.A.P., Fulforth, J., McCall, S., Plevris, N., Jenkinson, P.W., Kirkwood, K., Siakavellas, S., Lucaciu, L., Constantine-Cooke, N., Arnott, I.D., Henderson, P., Russell, R.K., Wilson, D.C., Lees, C.W., Jones, G.R., Lyons, M., Derikx, L.A.A.P., Fulforth, J., McCall, S., Plevris, N., Jenkinson, P.W., Kirkwood, K., Siakavellas, S., Lucaciu, L., Constantine-Cooke, N., Arnott, I.D., Henderson, P., Russell, R.K., Wilson, D.C., Lees, C.W., and Jones, G.R.

Abstract

01 juli 2022, Item does not contain fulltext, OBJECTIVE: It is unclear how the compounding prevalence of inflammatory bowel disease (IBD) has translated into the causes and rates of hospitalisation, particularly in an era of increased biologic prescribing. We aimed to analyse these trends in a population-based IBD cohort over the last 10 years. DESIGN: The Lothian IBD registry is a complete, validated, prevalent database of IBD patients in NHS Lothian, Scotland. ICD-10 coding of hospital discharge letters from all IBD patient admissions to secondary care between 1 January 2010 and 31 December 2019 was interrogated for admission cause, with linkage to local/national data sets on death and prescribed drugs. RESULTS: Fifty-seven per cent (4673/8211) of all IBD patients were admitted to secondary care for >24 h between 1 January 2010 and 31 December 2019. In patients <40 years, IBD was the commonest reason for admission (38% of admissions), whereas infection was the most common cause in those >60 years (19% of admissions). Three per cent (243/8211) of IBD patients accounted for 50% of the total IBD bed-days over the study period. Age-standardised IBD admission rates fell from 39.4 to 25.5 admissions per 100,000 population between 2010 and 2019, an average annual percentage reduction of 3% (95% CI -4.5% to -2.1%, p < 0.0001). Non-IBD admission rates were unchanged overall (145-137 per 100,000 population) and specifically for serious (hospitalisation) and severe (ITU admission or death) infection over the same period. CONCLUSION: Despite compounding prevalence and increased biologic use, IBD admission rates are falling. The cause of admission varies with age, with infection the predominant cause in older patients.

Published
2022

17. P579 Rates, predictive factors and effectiveness of ustekinumab intensification to 4- or 6-weekly intervals in Crohns’s disease

Author

Derikx, L, primary, Plevris, N, additional, Su, S, additional, Gros, B, additional, Lyons, M, additional, Siakavellas, S, additional, Constantine-Cook, N, additional, Jenkinson, P, additional, O’Hare, C, additional, Merchant, L, additional, Noble, C, additional, Arnott, I, additional, Jones, G, additional, and Lees, C, additional

Published
2022
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22. P330 Long-term outcomes following a switch from originator adalimumab to the biosimilar SB5 (Imraldi) in IBD

Author

Derikx, L, primary, Dolby, H, additional, Plevris, N, additional, Lucaciu, L, additional, Rees, C, additional, Lyons, M, additional, Siakavellas, S, additional, Constantine-Cooke, N, additional, Noble, C, additional, O’Hare, C, additional, Merchant, L, additional, Arnott, I, additional, Jones, G R, additional, and Lees, C, additional

Published
2021
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23. Genetic and clinical analysis of epithelial ovarian cancer in Greek patients

Author

Vlachos G, Meletios A. Dimopoulos, Paraskevi Apostolou, Rodolakis A, Flora Zagouri, Michalis Liontos, Irene Konstantopoulou, Georgios Tsironis, Plevris N, Yanoukakos D, Florentia Fostira, Kalliopi I. Pappa, and Charvalos E

Subjects
Oncology, medicine.medical_specialty, Clinical pathology, business.industry, Internal medicine, Medicine, Epithelial ovarian cancer, General Medicine, business
Published
2020

24. Effectiveness of ustekinumab dose escalation in Crohn's disease patients with insufficient response to standard-dose subcutaneous maintenance therapy

Author

Kopylov, U., Hanzel, J., Liefferinckx, C., Marco, D. De, Imperatore, N., Plevris, N., Baston-Rey, I., Harris, R.J., Truyens, M., Domislovic, V., Vavricka, S., Biemans, V.B.C., Myers, S., Sebastian, S., Ben-Horin, S., Lama, Y. González, Gilletta, C., Ariella, B.S., Zelinkova, Z., Weisshof, R., Storan, D., Zittan, E., Farkas, K., Molnar, T., Franchimont, D., Cremer, A., Afif, W., Castiglione, F., Lees, C., Acosta, M. Barreiro-de, Lobaton, T., Doherty, G., Krznaric, Z., Pierik, M., Hoentjen, F., Drobne, D., Kopylov, U., Hanzel, J., Liefferinckx, C., Marco, D. De, Imperatore, N., Plevris, N., Baston-Rey, I., Harris, R.J., Truyens, M., Domislovic, V., Vavricka, S., Biemans, V.B.C., Myers, S., Sebastian, S., Ben-Horin, S., Lama, Y. González, Gilletta, C., Ariella, B.S., Zelinkova, Z., Weisshof, R., Storan, D., Zittan, E., Farkas, K., Molnar, T., Franchimont, D., Cremer, A., Afif, W., Castiglione, F., Lees, C., Acosta, M. Barreiro-de, Lobaton, T., Doherty, G., Krznaric, Z., Pierik, M., Hoentjen, F., and Drobne, D.

Abstract

Contains fulltext : 220068.pdf (Publisher’s version ) (Closed access), BACKGROUND: Ustekinumab is effective in Crohn's disease. However, a substantial proportion of patients will not respond or lose response to ustekinumab. The current evidence to support the effectiveness of dose-optimisation for ustekinumab nonresponse is limited. AIM: To assess the effectiveness of dose escalation of ustekinumab. METHODS: This was a multicentre retrospective cohort study. We included active Crohn's disease patients who received a standard-dose intravenous induction and at least one subcutaneous ustekinumab 90 mg dose. All enrolled patients received dose escalation by either shortening the interval between the doses to every 4 or 6 weeks, intravenous reinduction or a combination of strategies. The primary outcome of the study was clinical response at week 16 after dose escalation. RESULTS: A total of 142 patients (22 centres/14 countries) were included. The patients were dose-escalated after a median treatment duration of 30 weeks. At week 16 from escalation, 73/142 (51.4%) responded to treatment, including 55/142 (38.7%) in clinical remission. Corticosteroid-free remission was achieved in 6/34 (17.6%) patients on corticosteroids at the time of escalation; 118/142 (83%) continued treatment beyond week 16. Follow-up data beyond week 16 were available for 74/118 (62.7%) patients. On the last follow-up, 51/98 (52%) patients with available data responded to treatment, including 41/98 (42%) in clinical remission. CONCLUSIONS: Intensification of ustekinumab maintenance dosage was effective in over 50% of the patients. This strategy should be considered in patients who are nonresponsive to every 8 weeks ustekinumab maintenance dosing.

Published
2020

26. P713 Effects of vedolizumab on health-related quality of life, work productivity and patient concerns in patients with ulcerative colitis and Crohn’s disease in the UK and Ireland: OCTAVO cohort 2

Author

Parkes, G, primary, Akbar, A, additional, Beales, I, additional, Buckley, M, additional, Creed, T, additional, Din, S, additional, Fraser, A, additional, Plevris, N, additional, Meadowcroft, S, additional, Owen, G, additional, and Heggs, N, additional

Published
2020
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27. DOP74 Effectiveness of dose escalation in Crohn’s disease patients with insufficient response to standard-dose subcutaneous ustekinumab maintenance therapy: A multicentre international cohort study

Author

Kopylov, U, primary, Hanzel, J, additional, Liefferinckx, C, additional, De Marco, D, additional, Imperatore, N, additional, Plevris, N, additional, Baston-Rey, I, additional, Harris, R, additional, Truyens, M, additional, Domislovic, V, additional, Vavricka, S, additional, Biemans, V, additional, Myers, S, additional, Shaji, S, additional, Ben-Horin, S, additional, González Lama, Y, additional, Gilletta, C, additional, Bar-Gil Shitrit, A, additional, Zelinkova, Z, additional, Weishof, R, additional, Storan, D, additional, Zittan, E, additional, Franchimont, D, additional, Cremer, A, additional, Afif, W, additional, Castiglione, F, additional, Lees, C, additional, Barrero de Acosta, M, additional, Lobaton, T, additional, Doherty, G, additional, Krznaric, Z, additional, Pierik, M, additional, Hoentjen, F, additional, and Drobne, D, additional

Published
2020
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28. P575 Real-world effectiveness and safety of ustekinumab for the treatment of refractory Crohn’s disease: The Scottish ustekinumab cohort

Author

PLEVRIS, N, primary, Robertson, A, additional, Fulforth, J, additional, Hall, R, additional, Campbell, I, additional, Kane, C, additional, Veryan, J, additional, Lam, W, additional, Saunders, J, additional, Jenkinson, P, additional, Chuah, C, additional, Kelly, C, additional, Watts, D, additional, Gaya, D, additional, Macdonald, J, additional, Jafferbhoy, H, additional, Seenan, J P, additional, Mowat, C, additional, Sutherland, D, additional, Naismith, G, additional, Bain, G, additional, Arnott, I, additional, Jones, G, additional, and Lees, C, additional

Published
2020
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29. DOP57 Vedolizumab has similar efficacy rates in young and elderly patients: A binational, multicentre, retrospective case–control study

Author

Cohen, N A, primary, Plevris, N, additional, Kopylov, U, additional, Grinman, A, additional, Ungar, B, additional, Yanai, H, additional, Leibovitzh, H, additional, Fliss, N, additional, Hirsch, A, additional, Ritter, E, additional, Ron, Y, additional, Bar-Gil Shitrit, A, additional, Goldin, E, additional, Dotan, I, additional, Ben-Horin, S, additional, Lees, C, additional, and Maharshak, N, additional

Published
2020
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33. Real-world Effectiveness and Safety of Vedolizumab for the Treatment of Inflammatory Bowel Disease: The Scottish Vedolizumab Cohort

Author

Plevris, N, primary, Chuah, C S, additional, Allen, R M, additional, Arnott, I D, additional, Brennan, P N, additional, Chaudhary, S, additional, Churchhouse, A M D, additional, Din, S, additional, Donoghue, E, additional, Gaya, D R, additional, Groome, M, additional, Jafferbhoy, H M, additional, Jenkinson, P W, additional, Lam, W L, additional, Lyons, M, additional, Macdonald, J C, additional, MacMaster, M, additional, Mowat, C, additional, Naismith, G D, additional, Potts, L F, additional, Saffouri, E, additional, Seenan, J P, additional, Sengupta, A, additional, Shasi, P, additional, Sutherland, D I, additional, Todd, J A, additional, Veryan, J, additional, Watson, A J M, additional, Watts, D A, additional, Jones, G R, additional, and Lees, C W, additional

Published
2019
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34. DOP87 Multi-parameter datasets are required to identify the true prevalence of IBD: The Lothian IBD Registry (LIBDR)

Author

Jones, G-R, primary, Lyons, M, additional, Plevris, N, additional, Jenkinson, P, additional, Bisset, C, additional, Fulforth, J, additional, Chuah, C S, additional, Minnis, S, additional, Gillespie, S-L, additional, Brindle, W, additional, Burgess, C, additional, Henderson, P, additional, Wilson, D, additional, and Lees, C, additional

Published
2019
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43. P399 Vedolizumab therapy results in reduced hospitalisation and steroid use over 1-year: Results from the Scottish vedolizumab consortium

Author

Plevris, N, primary, Chuah, C S, additional, Allen, R, additional, Baker, P, additional, Brennan, P, additional, Churchhouse, A, additional, Donoghue, E, additional, Gaya, D, additional, Jafferbhoy, H, additional, Jenkinson, P, additional, Jones, G, additional, Macdonald, J, additional, MacMaster, M, additional, Mowat, C, additional, Naismith, G, additional, Potts, L, additional, Saffouri, E, additional, Seenan, J P, additional, Sengupta, A, additional, Shasi, P, additional, Todd, J, additional, Veryan, J, additional, Watson, A, additional, Watts, D, additional, Arnott, I, additional, Lees, C, additional, and Groome, M, additional

Published
2018
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46. Faecal Calprotectin and Magnetic Resonance Enterography in Ileal Crohn's Disease: Correlations Between Disease Activity and Long-Term Follow-Up.

Author

Jones, G R, Fascì-Spurio, F, Kennedy, N A, Plevris, N, Jenkinson, P, Lyons, M, Wong, L, MacLean, P, Glancy, S, and Lees, C W

Abstract

Background and Aims Magnetic resonance enterography [MRE] is the gold standard for assessing ileal inflammation in Crohn's disease [CD]. The aim of the present study was to correlate faecal calprotectin [FC] to MRE via a simple score in an exclusive ileal cohort with long-term follow-up for association with time to surgery or biologic therapy. Methods In total, 150 MRE studies with matched FC [±30 days] were identified from the Edinburgh FC Register [2008–12; n = 18138]. Scans were re-read blinded to clinical data, independently, by two expert gastrointestinal radiologists, to generate a simple MRE score [range 0–10] from assessment of the worst intestinal segment plus total disease extent. Results In total, 119 MRE scans were evaluated from 104 patients with ileal CD [L1 or L3 with panproctocolectomy]. Receiver operating characteristic analysis showed an area under the curve of 0.77 [0.67–0.87, p < 0.0001] for FC and MRE score >1, with an optimal cut-off of 145 μg/g for severe inflammation on MRE with 69.3% [57.6–79.5] sensitivity and 71.4% [53.7–85.4] specificity. Long-term follow-up over a median [interquartile range] of 2086 days [1786–2353] revealed FC ≥ 145 μg/g was associated with reduced biologic-free survival until 3 years following MRE, whereas MRE score [severe vs absent] was associated with reduced surgery- and biologic-free survival throughout follow-up. Backwards stepwise logistic regression revealed that length of ileal disease (odds ratio [OR] 3.8, 1.1–13.2, p = 0.034) and increased bowel wall thickness at MRE [OR 4.2, 1.6–10.7, p < 0.0001] or female sex [OR 5.2, 1.5–18.7, p = 0.011] increased the risk of biologic use or surgery, respectively. Conclusions FC correlates well with MRE assessment of ileal CD with MRE parameters associated with long-term biologic- and surgery-free remission. [ABSTRACT FROM AUTHOR]

Published
2019
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