Abstract
| Original language | English |
|---|---|
| Pages (from-to) | 1190-1201 |
| Number of pages | 12 |
| Journal | J. Crohn's Colitis |
| Volume | 14 |
| Issue number | 9 |
| DOIs | |
| Publication status | Published - 2020 |
Keywords
- IBD
- T cell subsets
- Vedolizumab
- alpha 4 beta 7
- chemokine receptor
- CXCL1 chemokine
- granulocyte colony stimulating factor
- heterodimer
- interleukin 17
- interleukin 7
- macrophage inflammatory protein 3beta
- tumor necrosis factor
- unclassified drug
- vedolizumab
- adult
- Article
- clinical article
- clinical outcome
- controlled study
- Crohn disease
- endoscopic biopsy
- female
- flow cytometry
- human
- human cell
- human tissue
- immunological parameters
- intervention study
- lamina propria
- lymphocyte
- male
- middle aged
- multivariate analysis
- open study
- oral biopsy
- phase 4 clinical trial
- priority journal
- prospective study
- remission
- Th1 cell
- Th17 cell
- treatment response
- ulcerative colitis
Fingerprint
Dive into the research topics of 'Immunological variables associated with clinical and endoscopic response to vedolizumab in patients with inflammatory bowel diseases: Journal of Crohn's and Colitis'. Together they form a unique fingerprint.Cite this
- APA
- Standard
- Harvard
- Vancouver
- Author
- BIBTEX
- RIS
Immunological variables associated with clinical and endoscopic response to vedolizumab in patients with inflammatory bowel diseases : Journal of Crohn's and Colitis. / Coletta, M.; Paroni, M.; Alvisi, M.F.; De Luca, M.; Rulli, E.; Mazza, S.; Facciotti, F.; Lattanzi, G.; Strati, F.; Abrignani, S.; Fantini, M.C.; Vecchi, M.; Geginat, J.; Caprioli, F.
In: J. Crohn's Colitis, Vol. 14, No. 9, 2020, p. 1190-1201.Research output: Contribution to journal › Article › peer-review
}
TY - JOUR
T1 - Immunological variables associated with clinical and endoscopic response to vedolizumab in patients with inflammatory bowel diseases
T2 - Journal of Crohn's and Colitis
AU - Coletta, M.
AU - Paroni, M.
AU - Alvisi, M.F.
AU - De Luca, M.
AU - Rulli, E.
AU - Mazza, S.
AU - Facciotti, F.
AU - Lattanzi, G.
AU - Strati, F.
AU - Abrignani, S.
AU - Fantini, M.C.
AU - Vecchi, M.
AU - Geginat, J.
AU - Caprioli, F.
N1 - Cited By :1 Export Date: 2 March 2021 Correspondence Address: Caprioli, F.; Department of Pathophysiology and Transplantation, Via F. Sforza 35, Italy; email: flavio.caprioli@unimi.it Chemicals/CAS: macrophage inflammatory protein 3beta, 181030-14-8; vedolizumab, 943609-66-3 References: Verstockt, B, Ferrante, M, Vermeire, S, Van Assche, G., New treatment options for inflammatory bowel diseases (2018) J Gastroenterol, 53, pp. 585-590; Picarella, D, Hurlbut, P, Rottman, J, Shi, X, Butcher, E, Ringler, DJ., Monoclonal antibodies specific for beta 7 integrin and mucosal addressin cell adhesion molecule-1 [MAdCAM-1] reduce inflammation in the colon of SCID mice reconstituted with CD45RBhigh CD4+ T cells (1997) J Immunol, 158, pp. 2099-2106; Erle, DJ, Briskin, MJ, Butcher, EC, Garcia-Pardo, A, Lazarovits, AI, Tidswell, M., Expression and function of the MAdCAM-1 receptor, integrin alpha 4 beta 7, on human leukocytes (1994) J Immunol, 153, pp. 517-528; von Andrian, UH, Engelhardt, B., Alpha4 integrins as therapeutic targets in autoimmune disease (2003) N Engl J Med, 348, pp. 68-72; Arihiro, S, Ohtani, H, Suzuki, M, Differential expression of mucosal addressin cell adhesion molecule-1 [MAdCAM-1] in ulcerative colitis and Crohn's disease (2002) Pathol Int, 52, pp. 367-374; Sandborn, WJ, Feagan, BG, Rutgeerts, P, Vedolizumab as induction and maintenance therapy for Crohn's disease (2013) N Engl J Med, 369, pp. 711-721. , GEMINI 2 Study Group; Feagan, BG, Rutgeerts, P, Sands, BE, Vedolizumab as induction and maintenance therapy for ulcerative colitis (2013) N Engl J Med, 369, pp. 699-710. , GEMINI 1 Study Group; Amiot, A, Serrero, M, Peyrin-Biroulet, L, One-year effectiveness and safety of vedolizumab therapy for inflammatory bowel disease: A prospective multicentre cohort study (2017) Aliment Pharmacol Ther, 46, pp. 310-321. , OBSERV-IBD study group and the GETAID; Kopylov, U, Ron, Y, Avni-Biron, I, Efficacy and safety of vedolizumab for induction of remission in inflammatory bowel disease the Israeli realworld experience (2017) Inflamm Bowel Dis, 23, pp. 404-408; Lenti, MV, Levison, S, Eliadou, E, A real-world, long-term experience on effectiveness and safety of vedolizumab in adult patients with inflammatory bowel disease: The Cross Pennine study (2018) Dig Liver Dis, 50, pp. 1299-1304; Vermeire, S, Loftus, EV, Colombel, JF, Long-term efficacy of vedolizumab for Crohn's disease (2017) J Crohns Colitis, 11, pp. 412-424; Loftus, EV, Colombel, JF, Feagan, BG, Long-term efficacy of vedolizumab for ulcerative colitis (2017) J Crohns Colitis, 11, pp. 400-411; Allegretti, JR, Barnes, EL, Stevens, B, Predictors of clinical response and remission at 1 year among a multicenter cohort of patients with inflammatory bowel disease treated with vedolizumab (2017) Dig Dis Sci, 62, pp. 1590-1596; Eriksson, C, Marsal, J, Bergemalm, D, Long-term effectiveness of vedolizumab in inflammatory bowel disease: A national study based on the Swedish National Quality Registry for Inflammatory Bowel Disease [SWIBREG] (2017) Scand J Gastroenterol, 52, pp. 722-729. , SWIBREG Vedolizumab Study Group; Baumgart, DC, Bokemeyer, B, Drabik, A, Stallmach, A, Schreiber, S, Vedolizumab induction therapy for inflammatory bowel disease in clinical practice - a nationwide consecutive German cohort study (2016) Aliment Pharmacol Ther, 43, pp. 1090-1102. , Vedolizumab Germany Consortium; Monteleone, G, Caprioli, F., T cell-directed therapies in inflammatory bowel diseases (2010) Clin Sci [Lond], 118, pp. 707-715; Harvey, RF, Bradshaw, MJ., A simple index of Crohn's-disease activity (1980) Lancet, 1, p. 514; Turner, D, Seow, CH, Greenberg, GR, Griffiths, AM, Silverberg, MS, Steinhart, AH., A systematic prospective comparison of noninvasive disease activity indices in ulcerative colitis (2009) Clin Gastroenterol Hepatol, 7, pp. 1081-1088; Daperno, M, D'Haens, G, Van Assche, G, Development and validation of a new, simplified endoscopic activity score for Crohn's disease: The SES-CD (2004) Gastrointest Endosc, 60, pp. 505-512; Nelson, BD., (2001) Variable reduction for modeling using PROC VARCLUS; (1999) SAS/STAT User's Guide Version 8, pp. 3592-3620. , SAS Institute Inc; Sanche, R, Lonergan, K., Variable reduction for predictive modeling with clustering (2006) Casualty Actuarial Society Forum, pp. 89-100; Revelle, W., (2013) Psych: Procedures for psychological, psychometric, and personality research, , R package version 1.3. 10. Evanston, IL: Northwestern University; Breiman, L., Random forests (2001) Machine Learning, 45, pp. 5-32; Murphy, MA, Evans, JS, Storfer, A., Quantifying Bufo boreas connectivity in Yellowstone National Park with landscape genetics (2010) Ecology, 91, pp. 252-261; (2019) R: A language and environment for statistical computing, , https://www.R-project.org/, R Core Team. Vienna, Austria: R Foundation for Statistical Computing; Satsangi, J, Silverberg, MS, Vermeire, S, Colombel, JF., The Montreal classification of inflammatory bowel disease: Controversies, consensus, and implications (2006) Gut, 55, pp. 749-753; Geginat, J, Paroni, M, Facciotti, F, The CD4-centered universe of human T cell subsets (2013) Semin Immunol, 25, pp. 252-262; Sands, BE, Sandborn, WJ, Van Assche, G, Vedolizumab as induction and maintenance therapy for Crohn's disease in patients naive to or who have failed tumor necrosis factor antagonist therapy (2017) Inflamm Bowel Dis, 23, pp. 97-106; Feagan, BG, Rubin, DT, Danese, S, Efficacy of vedolizumab induction and maintenance therapy in patients with ulcerative colitis, regardless of prior exposure to tumor necrosis factor antagonists (2017) Clin Gastroenterol Hepatol, 15, pp. 229-239. , e5; Stallmach, A, Langbein, C, Atreya, R, Vedolizumab provides clinical benefit over 1 year in patients with active inflammatory bowel disease a prospective multicenter observational study (2016) Aliment Pharmacol Ther, 44, pp. 1199-1212; Dulai, PS, Singh, S, Jiang, X, The real-world effectiveness and safety of vedolizumab for moderate-severe Crohn's disease: Results from the US VICTORY Consortium (2016) Am J Gastroenterol, 111, pp. 1147-1155; Shelton, E, Allegretti, JR, Stevens, B, Efficacy of vedolizumab as induction therapy in refractory IBD patients: A multicenter cohort (2015) Inflamm Bowel Dis, 21, pp. 2879-2885; Narula, N, Peerani, F, Meserve, J, Vedolizumab for ulcerative colitis: Treatment outcomes from the VICTORY Consortium (2018) Am J Gastroenterol, 113, p. 1345; Amiot, A, Grimaud, JC, Peyrin-Biroulet, L, Effectiveness and safety of vedolizumab induction therapy for patients with inflammatory bowel disease (2016) Clin Gastroenterol Hepatol, 14, pp. 1593-1601. , Observatory on Efficacy ofVedolizumab in Patients With Inflammatory Bowel Disease Study Group; Groupe d'Etude Therapeutique des Affections Inflammatoires du Tube Digestif. e2; Dulai, PS, Boland, BS, Singh, S, Development and validation of a scoring system to predict outcomes of vedolizumab treatment in patients with Crohn's disease (2018) Gastroenterology, 155, pp. 687-695. , e10; Zeissig, S, Rosati, E, Dowds, CM, Vedolizumab is associated with changes in innate rather than adaptive immunity in patients with inflammatory bowel disease (2019) Gut, 68, pp. 25-39; Pennell, LM, Galligan, CL, Fish, EN., Sex affects immunity (2012) J Autoimmun, 38, pp. J282-J291; Klein, SL, Flanagan, KL., Sex differences in immune responses (2016) Nat Rev Immunol, 16, pp. 626-638; Groom, JR, Luster, AD., CXCR3 in T cell function (2011) Exp Cell Res, 317, pp. 620-631; Luster, AD, Unkeless, JC, Ravetch, JV., Gamma-interferon transcriptionally regulates an early-response gene containing homology to platelet proteins (1985) Nature, 315, pp. 672-676; Kristensen, NN, Gad, M, Thomsen, AR, Lu, B, Gerard, C, Claesson, MH., CXC chemokine receptor 3 expression increases the disease-inducing potential of CD4+ CD25- T cells in adoptive transfer colitis (2006) Inflamm Bowel Dis, 12, pp. 374-381; Mayer, L, Sandborn, WJ, Stepanov, Y, Anti-IP-10 antibody [BMS-936557] for ulcerative colitis: A phase II randomised study (2014) Gut, 63, pp. 442-450; Arijs, I, De Hertogh, G, Lemmens, B, Effect of vedolizumab [anti-α4β7-integrin] therapy on histological healing and mucosal gene expression in patients with UC (2018) Gut, 67, pp. 43-52; Singh, SP, Zhang, HH, Foley, JF, Hedrick, MN, Farber, JM., Human T cells that are able to produce IL-17 express the chemokine receptor CCR6 (2008) J Immunol, 180, pp. 214-221; Zundler, S, Becker, E, Spocinska, M, Hobit- and Blimp-1-driven CD4+ tissue-resident memory T cells control chronic intestinal inflammation (2019) Nat Immunol, 20, pp. 288-300; Paroni, M, Magarotto, A, Tartari, S, Uncontrolled IL-17 production by intraepithelial lymphocytes in a case of non-IPEX autoimmune enteropathy (2016) Clin Transl Gastroenterol, 7, p. e182; Paroni, M, Maltese, V, De Simone, M, Recognition of viral and selfantigens by TH1 and TH1/TH17 central memory cells in patients with multiple sclerosis reveals distinct roles in immune surveillance and relapses (2017) J Allergy Clin Immunol, 140, pp. 797-808; Nizzoli, G, Burrello, C, Cribiu, FM, Pathogenicity of in vivo generated intestinal Th17 lymphocytes is IFNγ dependent (2018) J Crohns Colitis, 12, pp. 981-992; Burrello, C, Pellegrino, G, Giuffre, MR., Mucosa-associated microbiota drives pathogenic functions in IBD-derived intestinal iNKT cells (2019) Life Sci Alliance, 2; Ueno, A, Jeffery, L, Kobayashi, T, Hibi, T, Ghosh, S, Jijon, H., Th17 plasticity and its relevance to inflammatory bowel disease (2018) J Autoimmun, 87, pp. 38-49; Ronchi, F, Basso, C, Preite, S, Experimental priming of encephalitogenic Th1/Th17 cells requires pertussis toxin-driven IL-1β production by myeloid cells (2016) Nat Commun, 7, p. 11541; Acosta-Rodriguez, EV, Napolitani, G, Lanzavecchia, A, Sallusto, F., Interleukins 1beta and 6 but not transforming growth factor-beta are essential for the differentiation of interleukin 17-producing human T helper cells (2007) Nat Immunol, 8, pp. 942-949; Uhlig, HH, McKenzie, BS, Hue, S, Differential activity of IL-12 and IL-23 in mucosal and systemic innate immune pathology (2006) Immunity, 25, pp. 309-318; Verstockt, B, Verststockt, S, Veny, M., Expression levels of 4 genes in colon tissue might be used to predict which patients will enter endoscopic remission after vedolizumab therapy for inflammatory bowel diseases (2019) Clin Gastroenterol Hepatol; Boden, EK, Shows, DM, Chiorean, MV, Lord, JD., Identification of candidate biomarkers associated with response to vedolizumab in inflammatory bowel disease (2018) Dig Dis Sci, 63, pp. 2419-2429; Rath, T, Billmeier, U, Ferrazzi, F, Effects of anti-integrin treatment with vedolizumab on immune pathways and cytokines in inflammatory bowel diseases (2018) Front Immunol, 9, p. 1700; Norouzinia, M, Chaleshi, V, Alizadeh, AHM, Zali, MR., Biomarkers in inflammatory bowel diseases: Insight into diagnosis, prognosis and treatment (2017) Gastroenterol Hepatol Bed Bench, 10, pp. 155-167; Yanai, H, Lichtenstein, L, Assa, A, Levels of drug and antidrug antibodies are associated with outcome of interventions after loss of response to infliximab or adalimumab (2015) Clin Gastroenterol Hepatol, 13, pp. 522-530. , e2; Steenholdt, C, Brynskov, J, Thomsen, OO, Individualised therapy is more cost-effective than dose intensification in patients with Crohn's disease who lose response to anti-TNF treatment: A randomised, controlled trial (2014) Gut, 63, pp. 919-927; Battat, R, Dulai, PS, Vande Casteele, N, Biomarkers are associated with clinical and endoscopic outcomes with vedolizumab treatment in ulcerative colitis (2019) Inflamm Bowel Dis, 25, pp. 410-420; Mizoguchi, A, Yano, A, Himuro, H, Ezaki, Y, Sadanaga, T, Mizoguchi, E., Clinical importance of IL-22 cascade in IBD (2018) J Gastroenterol, 53, pp. 465-474
PY - 2020
Y1 - 2020
N2 - Background and Aims: Vedolizumab [VDZ] is a monoclonal antibody directed against the α4β7 integrin heterodimer, approved for patients with inflammatory bowel diseases [IBD]. This study aimed at identifying immunological variables associated with response to vedolizumab in patients with ulcerative colitis [UC] and Crohn's disease [CD]. Methods: This is a phase IV explorative prospective interventional trial. IBD patients received openlabel VDZ at Weeks 0, 2, 6, and 14. Patients with a clinical response at Week 14 were maintained with VDZ up to Week 54. At Weeks 0 and 14, their peripheral blood was obtained and endoscopy with biopsies was performed. The Week 14 clinical response and remission, Week 54 clinical remission, and Week 14 endoscopic response were evaluated as endpoints of the study. The expression of surface markers, chemokine receptors, and α4β7 heterodimer in peripheral blood and lamina propria lymphocytes was assessed by flow cytometry. A panel of soluble mediators was assessed in sera at baseline and at Week 14 by 45-plex. Results: A total of 38 IBD patients [20 UC, 18 CD] were included in the study. At Week 14, the clinical response and remission rates were 87% and 66%, respectively. Higher baseline levels of circulating memory Th1 cells were strongly associated with clinical response at Week 14 [p = 0.0001], whereas reduced baseline levels of lamina propria memory Th17 and Th1/17 cells were associated with endoscopic response. Immunological clusters were found to be independently associated with vedolizumab outcomes at multivariable analysis. A panel of soluble markers, including IL17A, TNF, CXCL1, CCL19 for CD and G-CSF and IL7 for UC, associated with vedolizumab-induced Week 54 clinical remission. Conclusions: The results of this exploratory study uncovered a panel of circulating and mucosal immunological variables associated with response to treatment with vedolizumab. © The Author(s) 2020.
AB - Background and Aims: Vedolizumab [VDZ] is a monoclonal antibody directed against the α4β7 integrin heterodimer, approved for patients with inflammatory bowel diseases [IBD]. This study aimed at identifying immunological variables associated with response to vedolizumab in patients with ulcerative colitis [UC] and Crohn's disease [CD]. Methods: This is a phase IV explorative prospective interventional trial. IBD patients received openlabel VDZ at Weeks 0, 2, 6, and 14. Patients with a clinical response at Week 14 were maintained with VDZ up to Week 54. At Weeks 0 and 14, their peripheral blood was obtained and endoscopy with biopsies was performed. The Week 14 clinical response and remission, Week 54 clinical remission, and Week 14 endoscopic response were evaluated as endpoints of the study. The expression of surface markers, chemokine receptors, and α4β7 heterodimer in peripheral blood and lamina propria lymphocytes was assessed by flow cytometry. A panel of soluble mediators was assessed in sera at baseline and at Week 14 by 45-plex. Results: A total of 38 IBD patients [20 UC, 18 CD] were included in the study. At Week 14, the clinical response and remission rates were 87% and 66%, respectively. Higher baseline levels of circulating memory Th1 cells were strongly associated with clinical response at Week 14 [p = 0.0001], whereas reduced baseline levels of lamina propria memory Th17 and Th1/17 cells were associated with endoscopic response. Immunological clusters were found to be independently associated with vedolizumab outcomes at multivariable analysis. A panel of soluble markers, including IL17A, TNF, CXCL1, CCL19 for CD and G-CSF and IL7 for UC, associated with vedolizumab-induced Week 54 clinical remission. Conclusions: The results of this exploratory study uncovered a panel of circulating and mucosal immunological variables associated with response to treatment with vedolizumab. © The Author(s) 2020.
KW - IBD
KW - T cell subsets
KW - Vedolizumab
KW - alpha 4 beta 7
KW - chemokine receptor
KW - CXCL1 chemokine
KW - granulocyte colony stimulating factor
KW - heterodimer
KW - interleukin 17
KW - interleukin 7
KW - macrophage inflammatory protein 3beta
KW - tumor necrosis factor
KW - unclassified drug
KW - vedolizumab
KW - adult
KW - Article
KW - clinical article
KW - clinical outcome
KW - controlled study
KW - Crohn disease
KW - endoscopic biopsy
KW - female
KW - flow cytometry
KW - human
KW - human cell
KW - human tissue
KW - immunological parameters
KW - intervention study
KW - lamina propria
KW - lymphocyte
KW - male
KW - middle aged
KW - multivariate analysis
KW - open study
KW - oral biopsy
KW - phase 4 clinical trial
KW - priority journal
KW - prospective study
KW - remission
KW - Th1 cell
KW - Th17 cell
KW - treatment response
KW - ulcerative colitis
U2 - 10.1093/ecco-jcc/jjaa035
DO - 10.1093/ecco-jcc/jjaa035
M3 - Article
VL - 14
SP - 1190
EP - 1201
JO - J. Crohn's Colitis
JF - J. Crohn's Colitis
SN - 1873-9946
IS - 9
ER -