41 results on '"Janneke van der Woude C"'
Search Results
2. Infant Ustekinumab Clearance, Risk of Infection, and Development After Exposure During Pregnancy
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Korgaard, Julie, Vestergaard, Thea, Lystbæk, Uffe Lund, Berg, Anne, Mikkelsen, Anette Tyrsted, Holm, Anne Marie, Hansen, Annebirthe Bo, Mathiesen, Ole, Jensen, Jette Krüger, Neumann, Lone, Boris, Jane, Lemming, Marianne, Rahbek, Marianne, Søresen, Heidi Gram, Storkholm, Marie Højriis, Ziska, Jeanette, Vestergaard, Else Marie, Bøggild Ipsen, Sidsel Elisabeth, Gram, Jørgen, Brixen, Gunhild, Westergaard, Hanne Brix, Friis-Hansen, Lennart Jan, Olsen, Bettina Friis, Fischer, Heidi, Bjerrum, Poul Jannik, Ibsen, Anne Haahr, Jaeger, Vibeke, Madsen, Jesper Clausager, Møller, Lars Alling, Søeby, Karen, Damm, Jane Hansen, Hilsted, Linda, Christiansen, Lone, Sharif, Heidi, Johansen, Britt Strøm, Dahl, Karina Mattebjerg, Langholz, Ebbe, Kamstrup, Pia R., Jochumsen, Anja, Huusom, Lene Drasbek, Bathum, Lise, Wilken-Jensen, Charlotte, Julsgaard, Mette, Wieringa, Jantien W., Baunwall, Simon M.D., Bibby, Bo M., Driessen, Gertjan J.A., Kievit, Linda, Brodersen, Jacob B., Poulsen, Anja, Kjeldsen, Jens, Hansen, Mette M., Tang, Hai Q., Balmer, Christina L., Glerup, Henning, Seidelin, Jakob B., Haderslev, Kent V., Svenningsen, Lise, Wildt, Signe, Juel, Mie A., Neumann, Anders, Fuglsang, Jens, Jess, Tine, Haase, Anne-Mette, Hvas, Christian L., Kelsen, Jens, and Janneke van der Woude, C.
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- 2024
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3. Risk Prediction and Comparative Efficacy of Anti-TNF vs Thiopurines, for Preventing Postoperative Recurrence in Crohn's Disease: A Pooled Analysis of 6 Trials
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Beelen, Evelien M.J., Nieboer, Daan, Arkenbosch, Jeanine H.C., Regueiro, Miguel D., Satsangi, Jack, Ardizzone, Sandro, López-Sanromán, Antonio, Savarino, Edoardo, Armuzzi, Alessandro, Janneke van der Woude, C., and de Vries, Annemarie C.
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- 2022
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4. Prediction of Relapse After Anti–Tumor Necrosis Factor Cessation in Crohn’s Disease: Individual Participant Data Meta-analysis of 1317 Patients From 14 Studies
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de Vries, Annemarie C., Pauwels, Renske W.M., Janneke van der Woude, C., Nieboer, Daan, Steyerberg, Ewout W., Sleutjes, Jasmijn A.M., Duijvestein, Marjolijn, D’Haens, Geert R., Casanova, María J., Gisbert, Javier P., Kennedy, Nick A., Lees, Charlie W., Louis, Edouard, Molnár, Tamás, Szántó, Kata, Leo, Eduardo, García-Ortiz, José M., Downey, Robert, Brooks, Alenka J., Hamlin, Peter J., Sebastian, Shaji, Lobo, Alan J., Lukas, Milan, Lin, Wei C., Amiot, Aurelien, Lu, Cathy, Dieleman, Levinus (Leo) A., Roblin, Xavier, Ben-Horin, Shomron, Farkas, Klaudia, Seidelin, Jakob B., Steenholdt, Casper, Bots, Steven, and van der Woude, C. Janneke
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- 2022
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5. IBD risk loci are enriched in multigenic regulatory modules encompassing putative causative genes.
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Momozawa, Yukihide, Dmitrieva, Julia, Théâtre, Emilie, Deffontaine, Valérie, Rahmouni, Souad, Charloteaux, Benoît, Crins, François, Docampo, Elisa, Elansary, Mahmoud, Gori, Ann-Stephan, Lecut, Christelle, Mariman, Rob, Mni, Myriam, Oury, Cécile, Altukhov, Ilya, Alexeev, Dmitry, Aulchenko, Yuri, Amininejad, Leila, Bouma, Gerd, Hoentjen, Frank, Löwenberg, Mark, Oldenburg, Bas, Pierik, Marieke J, Vander Meulen-de Jong, Andrea E, Janneke van der Woude, C, Visschedijk, Marijn C, International IBD Genetics Consortium, Lathrop, Mark, Hugot, Jean-Pierre, Weersma, Rinse K, De Vos, Martine, Franchimont, Denis, Vermeire, Severine, Kubo, Michiaki, Louis, Edouard, and Georges, Michel
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International IBD Genetics Consortium ,Humans ,Inflammatory Bowel Diseases ,Crohn Disease ,Genetic Predisposition to Disease ,Cohort Studies ,Gene Expression Profiling ,Sequence Analysis ,DNA ,Genotype ,Multifactorial Inheritance ,Polymorphism ,Single Nucleotide ,Quantitative Trait Loci ,Adult ,Aged ,Aged ,80 and over ,Middle Aged ,Female ,Male ,Genetic Association Studies ,and over ,Polymorphism ,Single Nucleotide ,Sequence Analysis ,DNA - Abstract
GWAS have identified >200 risk loci for Inflammatory Bowel Disease (IBD). The majority of disease associations are known to be driven by regulatory variants. To identify the putative causative genes that are perturbed by these variants, we generate a large transcriptome data set (nine disease-relevant cell types) and identify 23,650 cis-eQTL. We show that these are determined by ∼9720 regulatory modules, of which ∼3000 operate in multiple tissues and ∼970 on multiple genes. We identify regulatory modules that drive the disease association for 63 of the 200 risk loci, and show that these are enriched in multigenic modules. Based on these analyses, we resequence 45 of the corresponding 100 candidate genes in 6600 Crohn disease (CD) cases and 5500 controls, and show with burden tests that they include likely causative genes. Our analyses indicate that ≥10-fold larger sample sizes will be required to demonstrate the causality of individual genes using this approach.
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- 2018
6. Alterations in Fecal Microbiomes and Serum Metabolomes of Fatigued Patients With Quiescent Inflammatory Bowel Diseases
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Borren, Nienke Z., Plichta, Damian, Joshi, Amit D., Bonilla, Gracia, Peng, Vincent, Colizzo, Francis P., Luther, Jay, Khalili, Hamed, Garber, John J., Janneke van der Woude, C., Sadreyev, Ruslan, Vlamakis, Hera, Xavier, Ramnik J., and Ananthakrishnan, Ashwin N.
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- 2021
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7. Discontinuation of Anti-Tumour Necrosis Factor Therapy in Patients with Perianal Fistulizing Crohn's Disease:Individual Participant Data Meta-Analysis of 309 Patients from 12 Studies
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Ten Bokkel Huinink, Sebastiaan, Thomassen, Doranne, Steyerberg, Ewout W., Pauwels, Renske W.M., Casanova, Maria J., Bouguen, Guillaume, Mak, Joyce W.Y., Molnár, Tamas, Lobo, Alan J., Seidelin, Jacob B., Amiot, Aurelien, D'Haens, Geert, Rivière, Pauline, Guidi, Luisa, Bor, Renata, Lin, Wei Chen, Peyrin-Biroulet, Laurent, Gisbert, Javier P., Janneke van der Woude, C., de Vries, Annemarie C., Ten Bokkel Huinink, Sebastiaan, Thomassen, Doranne, Steyerberg, Ewout W., Pauwels, Renske W.M., Casanova, Maria J., Bouguen, Guillaume, Mak, Joyce W.Y., Molnár, Tamas, Lobo, Alan J., Seidelin, Jacob B., Amiot, Aurelien, D'Haens, Geert, Rivière, Pauline, Guidi, Luisa, Bor, Renata, Lin, Wei Chen, Peyrin-Biroulet, Laurent, Gisbert, Javier P., Janneke van der Woude, C., and de Vries, Annemarie C.
- Abstract
BACKGROUND: The risk of relapse after anti-tumour necrosis factor [TNF] therapy discontinuation in Crohn's disease patients with perianal fistulas [pCD] is unclear. We aimed to assess this risk. METHODS: A systematic literature search was conducted to identify cohort studies on the incidence of relapse following anti-TNF discontinuation in pCD patients. Individual participant data were requested from the original study cohorts. Inclusion criteria were age ≥16 years, pCD as a (co)indication for start of anti-TNF therapy, more than three doses, and remission of luminal and pCD at anti-TNF discontinuation. The primary outcome was the cumulative incidence of CD relapse using Kaplan-Meier estimates. Secondary outcomes included response to re-treatment and risk factors associated with relapse as assessed by Cox regression analysis. RESULTS: In total, 309 patients from 12 studies in ten countries were included. The median duration of anti-TNF treatment was 14 months [interquartile range 5.8-32.5]. Most patients were treated for pCD without active luminal disease [89%], received first-line anti-TNF therapy [87%], and continued immunomodulatory therapy following anti-TNF discontinuation [78%]. The overall cumulative incidence of relapse was 36% (95% confidence interval [CI] 25-48%) and 42% [95% CI 32-53%] at 1 and 2 years after anti-TNF discontinuation, respectively. Risk factors for relapse included smoking (hazard ratio [HR] 1.5 [1.0, 2.1]) and history of proctitis (HR 1.7 [1.1, 2.5]). The overall re-treatment response rate was 82%. CONCLUSIONS: This individual participant data meta-analysis, on predominantly patients with pCD without active luminal disease and first-line anti-TNF therapy, shows that over half of patients remain in remission 2 years after anti-TNF discontinuation. Therefore, anti-TNF discontinuation may be considered in this subgroup.
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- 2024
8. Infant ustekinumab Clearance, Risk of Infection, and Development after exposure during pregnancy
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Julsgaard, Mette, primary, Wieringa, Jantien W., additional, Baunwall, Simon M.D., additional, Bibby, Bo M., additional, Driessen, Gertjan J.A., additional, Kievit, Linda, additional, Brodersen, Jacob B., additional, Poulsen, Anja, additional, Kjeldsen, Jens, additional, Hansen, Mette M., additional, Tang, Hai Q., additional, Balmer, Christina L., additional, Glerup, Henning, additional, Seidelin, Jakob B., additional, Haderslev, Kent V., additional, Svenningsen, Lise, additional, Wildt, Signe, additional, Juel, Mie A., additional, Neumann, Anders, additional, Fuglsang, Jens, additional, Jess, Tine, additional, Hasse, Anne-Mette, additional, Hvas, Christian L., additional, Kelsen, Jens, additional, and Janneke van der Woude, C., additional
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- 2024
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9. S842 Pharmacokinetics, Exposure-Response Relationships, and Immunogenicity in Crohn’s Disease Patients With Ustekinumab Secondary Loss of Response Following Ustekinumab IV Re-Induction: Week 16 Results From the POWER Study
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Feagan, Brian G., primary, Lee, Scott D., additional, Janneke van der Woude, C., additional, Marín-Jiménez, Ignacio, additional, Wolf, Douglas C., additional, Schnoy, Elisabeth, additional, Salzberg, Bruce, additional, Busse, Christopher, additional, Nazar, Maciej, additional, Langholff, Wayne, additional, Gasink, Christopher, additional, Baker, Thomas, additional, Godwin, Bridget, additional, Adedokun, Omoniyi, additional, and Schreiber, Stefan, additional
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- 2023
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10. S1035 Analysis of Baseline Characteristics Associated With Clinical Response to Ustekinumab IV Re-Induction Strategy in Patients With Crohn’s Disease in the POWER Trial
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Wolf, Douglas C., primary, Lee, Scott D., additional, Schreiber, Stefan, additional, Janneke van der Woude, C., additional, Marín-Jiménez, Ignacio, additional, Schnoy, Elisabeth, additional, Salzberg, Bruce, additional, Busse, Christopher, additional, Nazar, Maciej, additional, Langholff, Wayne, additional, Gasink, Christopher, additional, Baker, Thomas, additional, Godwin, Bridget, additional, and Feagan, Brian G., additional
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- 2023
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11. S1161 Pregnancy Outcomes in the Ozanimod Clinical Development Program in Patients With Ulcerative Colitis, Crohn’s Disease, and Relapsing Multiple Sclerosis
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Dubinsky, Marla C., primary, Charles, Lorna, additional, Selmaj, Krzysztof W., additional, Comi, Giancarlo, additional, Krakovich, Anthony, additional, Janneke van der Woude, C., additional, and Mahadevan, Uma, additional
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- 2023
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12. Retreatment with anti-tumor necrosis factor therapy in combination with an immunomodulator for recurrence of Crohn's disease after ileocecal resection results in prolonged continuation as compared to anti-tumor necrosis factor monotherapy
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Huinink, Sebastiaan ten Bokkel, Beelen, Evelien M.J., Huinink, Thomas ten Bokkel, Hoentjen, F., Bodelier, Alexander G.L., Dijkstra, Gerard, Janneke van der Woude, C., Vries, Annemarie C. de, Huinink, Sebastiaan ten Bokkel, Beelen, Evelien M.J., Huinink, Thomas ten Bokkel, Hoentjen, F., Bodelier, Alexander G.L., Dijkstra, Gerard, Janneke van der Woude, C., and Vries, Annemarie C. de
- Abstract
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- 2023
13. Increased versus conventional adalimumab dose interval for patients with Crohn's disease in stable remission (LADI) a pragmatic, open-label, non-inferiority, randomised controlled trial
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Linschoten, Reinier C.A. van, Jansen, F.M., Pauwels, Renske W.M., Smits, Lisa J.T., Atsma, F., Kievit, W., Jong, D.J. de, Jansen, Jeroen, Janneke van der Woude, C., Hoentjen, F., Linschoten, Reinier C.A. van, Jansen, F.M., Pauwels, Renske W.M., Smits, Lisa J.T., Atsma, F., Kievit, W., Jong, D.J. de, Jansen, Jeroen, Janneke van der Woude, C., and Hoentjen, F.
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- 2023
14. Cost-Effectiveness Analysis of Increased Adalimumab Dose Intervals in Crohn's Disease Patients in Stable Remission: The Randomized Controlled LADI Trial
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Jansen, F.M., Linschoten, Reinier C.A. van, Kievit, W., Smits, L.J.T., Pauwels, Renske W.M., Jong, D.J. de, Jansen, J.M, Hoentjen, F., Janneke van der Woude, C., Jansen, F.M., Linschoten, Reinier C.A. van, Kievit, W., Smits, L.J.T., Pauwels, Renske W.M., Jong, D.J. de, Jansen, J.M, Hoentjen, F., and Janneke van der Woude, C.
- Abstract
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- 2023
15. Assessing fatigue and sleep in chronic diseases using physiological signals from wearables: A pilot study
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Antikainen, Emmi, primary, Njoum, Haneen, additional, Kudelka, Jennifer, additional, Branco, Diogo, additional, Rehman, Rana Zia Ur, additional, Macrae, Victoria, additional, Davies, Kristen, additional, Hildesheim, Hanna, additional, Emmert, Kirsten, additional, Reilmann, Ralf, additional, Janneke van der Woude, C., additional, Maetzler, Walter, additional, Ng, Wan-Fai, additional, O’Donnell, Patricio, additional, Van Gassen, Geert, additional, Baribaud, Frédéric, additional, Pandis, Ioannis, additional, Manyakov, Nikolay V., additional, van Gils, Mark, additional, Ahmaniemi, Teemu, additional, and Chatterjee, Meenakshi, additional
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- 2022
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16. Assessing fatigue and sleep in chronic diseases using physiological signals from wearables : A pilot study
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on behalf of the IDEA-FAST project consortium, Antikainen, Emmi, Njoum, Haneen, Kudelka, Jennifer, Branco, Diogo, Rehman, Rana Zia Ur, Macrae, Victoria, Davies, Kristen, Hildesheim, Hanna, Emmert, Kirsten, Reilmann, Ralf, Janneke van der Woude, C., Maetzler, Walter, Ng, Wan Fai, O’Donnell, Patricio, Van Gassen, Geert, Baribaud, Frédéric, Pandis, Ioannis, Manyakov, Nikolay V., van Gils, Mark, Ahmaniemi, Teemu, Chatterjee, Meenakshi, Tampere University, Computing Sciences, and BioMediTech
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217 Medical engineering ,113 Computer and information sciences - Abstract
Problems with fatigue and sleep are highly prevalent in patients with chronic diseases and often rated among the most disabling symptoms, impairing their activities of daily living and the health-related quality of life (HRQoL). Currently, they are evaluated primarily via Patient Reported Outcomes (PROs), which can suffer from recall biases and have limited sensitivity to temporal variations. Objective measurements from wearable sensors allow to reliably quantify disease state, changes in the HRQoL, and evaluate therapeutic outcomes. This work investigates the feasibility of capturing continuous physiological signals from an electrocardiography-based wearable device for remote monitoring of fatigue and sleep and quantifies the relationship of objective digital measures to self-reported fatigue and sleep disturbances. 136 individuals were followed for a total of 1,297 recording days in a longitudinal multi-site study conducted in free-living settings and registered with the German Clinical Trial Registry (DRKS00021693). Participants comprised healthy individuals (N = 39) and patients with neurodegenerative disorders (NDD, N = 31) and immune mediated inflammatory diseases (IMID, N = 66). Objective physiological measures correlated with fatigue and sleep PROs, while demonstrating reasonable signal quality. Furthermore, analysis of heart rate recovery estimated during activities of daily living showed significant differences between healthy and patient groups. This work underscores the promise and sensitivity of novel digital measures from multimodal sensor time-series to differentiate chronic patients from healthy individuals and monitor their HRQoL. The presented work provides clinicians with realistic insights of continuous at home patient monitoring and its practical value in quantitative assessment of fatigue and sleep, an area of unmet need. publishedVersion
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- 2022
17. Prediction of Relapse After Anti–Tumor Necrosis Factor Cessation in Crohn’s Disease: Individual Participant Data Meta-analysis of 1317 Patients From 14 Studies
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Pauwels, Renske W.M., primary, van der Woude, C. Janneke, additional, Nieboer, Daan, additional, Steyerberg, Ewout W., additional, Casanova, María J., additional, Gisbert, Javier P., additional, Kennedy, Nick A., additional, Lees, Charlie W., additional, Louis, Edouard, additional, Molnár, Tamás, additional, Szántó, Kata, additional, Leo, Eduardo, additional, Bots, Steven, additional, Downey, Robert, additional, Lukas, Milan, additional, Lin, Wei C., additional, Amiot, Aurelien, additional, Lu, Cathy, additional, Roblin, Xavier, additional, Farkas, Klaudia, additional, Seidelin, Jakob B., additional, Duijvestein, Marjolijn, additional, D’Haens, Geert R., additional, de Vries, Annemarie C., additional, Pauwels, Renske W.M., additional, Janneke van der Woude, C., additional, Sleutjes, Jasmijn A.M., additional, García-Ortiz, José M., additional, Brooks, Alenka J., additional, Hamlin, Peter J., additional, Sebastian, Shaji, additional, Lobo, Alan J., additional, Dieleman, Levinus (Leo) A., additional, Ben-Horin, Shomron, additional, and Steenholdt, Casper, additional
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- 2022
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18. Prediction of Relapse After Anti–Tumor Necrosis Factor Cessation in Crohn's Disease:Individual Participant Data Meta-analysis of 1317 Patients From 14 Studies
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Pauwels, Renske W.M., van der Woude, C. Janneke, Nieboer, Daan, Steyerberg, Ewout W., Casanova, María J., Gisbert, Javier P., Kennedy, Nick A., Lees, Charlie W., Louis, Edouard, Molnár, Tamás, Szántó, Kata, Leo, Eduardo, Bots, Steven, Downey, Robert, Lukas, Milan, Lin, Wei C., Amiot, Aurelien, Lu, Cathy, Roblin, Xavier, Farkas, Klaudia, Seidelin, Jakob B., Duijvestein, Marjolijn, D'Haens, Geert R., de Vries, Annemarie C., Janneke van der Woude, C., Sleutjes, Jasmijn A.M., García-Ortiz, José M., Brooks, Alenka J., Hamlin, Peter J., Sebastian, Shaji, Lobo, Alan J., Dieleman, Levinus (Leo) A., Ben-Horin, Shomron, Steenholdt, Casper, Pauwels, Renske W.M., van der Woude, C. Janneke, Nieboer, Daan, Steyerberg, Ewout W., Casanova, María J., Gisbert, Javier P., Kennedy, Nick A., Lees, Charlie W., Louis, Edouard, Molnár, Tamás, Szántó, Kata, Leo, Eduardo, Bots, Steven, Downey, Robert, Lukas, Milan, Lin, Wei C., Amiot, Aurelien, Lu, Cathy, Roblin, Xavier, Farkas, Klaudia, Seidelin, Jakob B., Duijvestein, Marjolijn, D'Haens, Geert R., de Vries, Annemarie C., Janneke van der Woude, C., Sleutjes, Jasmijn A.M., García-Ortiz, José M., Brooks, Alenka J., Hamlin, Peter J., Sebastian, Shaji, Lobo, Alan J., Dieleman, Levinus (Leo) A., Ben-Horin, Shomron, and Steenholdt, Casper
- Abstract
Background & Aims: Tools for stratification of relapse risk of Crohn's disease (CD) after anti–tumor necrosis factor (TNF) therapy cessation are needed. We aimed to validate a previously developed prediction model from the diSconTinuation in CrOhn's disease patients in stable Remission on combined therapy with Immunosuppressants (STORI) trial, and to develop an updated model. Methods: Cohort studies were selected that reported on anti-TNF cessation in 30 or more CD patients in remission. Individual participant data were requested for luminal CD patients and anti-TNF treatment duration of 6 months or longer. The discriminative ability (concordance-statistic [C-statistic]) and calibration (agreement between observed and predicted risks) were explored for the STORI model. Next, an updated prognostic model was constructed, with performance assessment by cross-validation. Results: This individual participant data meta-analysis included 1317 patients from 14 studies in 11 countries. Relapses after anti-TNF cessation occurred in 632 of 1317 patients after a median of 13 months. The pooled 1-year relapse rate was 38%. The STORI prediction model showed poor discriminative ability (C-statistic, 0.51). The updated model reached a moderate discriminative ability (C-statistic, 0.59), and included clinical symptoms at cessation (hazard ratio [HR], 2.2; 95% CI, 1.2–4), younger age at diagnosis (HR, 1.5 for A1 (age at diagnosis ≤16 years) vs A2 (age at diagnosis 17 - 40 years); 95% CI, 1.11–1.89), no concomitant immunosuppressants (HR, 1.4; 95% CI, 1.18–172), smoking (HR, 1.4; 95% CI, 1.15–1.67), second line anti-TNF (HR, 1.3; 95% CI, 1.01–1.69), upper gastrointestinal tract involvement (HR, 1.3 for L4 vs non-L4; 95% CI, 0.96–1.79), adalimumab (HR, 1.22 vs infliximab; 95% CI, 0.99–1.50), age at cessation (HR, 1.2 per 10 years younger; 95% CI, 1–1.33), C-reactive protein (HR, 1.04 per doubling; 95% CI, 1.00–1.08), and longer disease duration (HR, 1.07 per 5 years; 95% CI, 0.9
- Published
- 2022
19. Assessing fatigue and sleep in chronic diseases using physiological signals from wearables:A pilot study
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Antikainen, Emmi, Njoum, Haneen, Kudelka, Jennifer, Branco, Diogo, Rehman, Rana Zia Ur, Macrae, Victoria, Davies, Kristen, Hildesheim, Hanna, Emmert, Kirsten, Reilmann, Ralf, Janneke van der Woude, C., Maetzler, Walter, Ng, Wan Fai, O’Donnell, Patricio, Van Gassen, Geert, Baribaud, Frédéric, Pandis, Ioannis, Manyakov, Nikolay V., van Gils, Mark, Ahmaniemi, Teemu, Chatterjee, Meenakshi, Antikainen, Emmi, Njoum, Haneen, Kudelka, Jennifer, Branco, Diogo, Rehman, Rana Zia Ur, Macrae, Victoria, Davies, Kristen, Hildesheim, Hanna, Emmert, Kirsten, Reilmann, Ralf, Janneke van der Woude, C., Maetzler, Walter, Ng, Wan Fai, O’Donnell, Patricio, Van Gassen, Geert, Baribaud, Frédéric, Pandis, Ioannis, Manyakov, Nikolay V., van Gils, Mark, Ahmaniemi, Teemu, and Chatterjee, Meenakshi
- Abstract
Problems with fatigue and sleep are highly prevalent in patients with chronic diseases and often rated among the most disabling symptoms, impairing their activities of daily living and the health-related quality of life (HRQoL). Currently, they are evaluated primarily via Patient Reported Outcomes (PROs), which can suffer from recall biases and have limited sensitivity to temporal variations. Objective measurements from wearable sensors allow to reliably quantify disease state, changes in the HRQoL, and evaluate therapeutic outcomes. This work investigates the feasibility of capturing continuous physiological signals from an electrocardiography-based wearable device for remote monitoring of fatigue and sleep and quantifies the relationship of objective digital measures to self-reported fatigue and sleep disturbances. 136 individuals were followed for a total of 1,297 recording days in a longitudinal multi-site study conducted in free-living settings and registered with the German Clinical Trial Registry (DRKS00021693). Participants comprised healthy individuals (N = 39) and patients with neurodegenerative disorders (NDD, N = 31) and immune mediated inflammatory diseases (IMID, N = 66). Objective physiological measures correlated with fatigue and sleep PROs, while demonstrating reasonable signal quality. Furthermore, analysis of heart rate recovery estimated during activities of daily living showed significant differences between healthy and patient groups. This work underscores the promise and sensitivity of novel digital measures from multimodal sensor time-series to differentiate chronic patients from healthy individuals and monitor their HRQoL. The presented work provides clinicians with realistic insights of continuous at home patient monitoring and its practical value in quantitative assessment of fatigue and sleep, an area of unmet need.
- Published
- 2022
20. Healthy Cotwins Share Gut Microbiome Signatures With Their Inflammatory Bowel Disease Twins and Unrelated Patients
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Brand, Eelco C., primary, Klaassen, Marjolein A.Y., additional, Gacesa, Ranko, additional, Vich Vila, Arnau, additional, Ghosh, Hiren, additional, de Zoete, Marcel R., additional, Boomsma, Dorret I., additional, Hoentjen, Frank, additional, Horjus Talabur Horje, Carmen S., additional, van de Meeberg, Paul C., additional, Willemsen, Gonneke, additional, Fu, Jingyuan, additional, Wijmenga, Cisca, additional, van Wijk, Femke, additional, Zhernakova, Alexandra, additional, Oldenburg, Bas, additional, Weersma, Rinse K., additional, Brand, Eelco C., additional, Honkoop, Pieter, additional, Jacobs, Rutger J., additional, Ponsioen, Cyriel Y., additional, de Boer, Nanne K.H., additional, Alderlieste, Yasser A., additional, van Herwaarden, Margot A., additional, van Tuyl, Sebastiaan A.C., additional, Lutgens, Maurice W., additional, Janneke van der Woude, C., additional, Mares, Wout G.M., additional, de Koning, Daan B., additional, Bosman, Joukje H., additional, Vecht, Juda, additional, de Schryver, Anneke M.P., additional, van der Meulen-de Jong, Andrea E., additional, Pierik, Marieke J., additional, Boekema, Paul J., additional, Verburg, Robert J., additional, Jharap, Bindia, additional, Jansen, Jeroen M., additional, Stokkers, Pieter C.F., additional, Quispel, Rutger, additional, Mahmmod, Nofel, additional, West, Rachel L., additional, Willems, Marleen, additional, Minderhoud, Itta M., additional, Fidder, Herma H., additional, van Schaik, Fiona D.M., additional, Hirdes, Meike M.C., additional, Boontje, Nynke A., additional, Müskens, Bart L.M., additional, and Romberg-Camps, Marielle J.L., additional
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- 2021
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21. No Superiority of Tacrolimus Suppositories vs Beclomethasone Suppositories in a Randomized Trial of Patients With Refractory Ulcerative Proctitis
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Lie, M.R.K.L. (Mitchell), Kreijne, J.E. (Joany), Dijkstra, G. (Gerard), Löwenberg, M., Assche, G. (Gert) van, West, R.L. (Rachel), Leemreis - van Noord, D. (Désirée), Meulen-de Jong, A.E. (Andrea) van der, Oldenburg, B. (Bas), Zaal, R.J. (Rianne), Hansen, B.E. (Bettina), Vries, A.C. (Annemarie) de, Janneke van der Woude, C. (Christien), Lie, M.R.K.L. (Mitchell), Kreijne, J.E. (Joany), Dijkstra, G. (Gerard), Löwenberg, M., Assche, G. (Gert) van, West, R.L. (Rachel), Leemreis - van Noord, D. (Désirée), Meulen-de Jong, A.E. (Andrea) van der, Oldenburg, B. (Bas), Zaal, R.J. (Rianne), Hansen, B.E. (Bettina), Vries, A.C. (Annemarie) de, and Janneke van der Woude, C. (Christien)
- Abstract
Background & Aims: Ulcerative proctitis (UP) refractory to 5-aminosalicylic acid (5-ASA) suppositories is a challenge to treat, often requiring step up to immunomodulator or biological therapy. Topical tacrolimus is effective and safe in patients with refractory UP. However, it is not clear how tacrolimus suppositories fit into in the treatment algorithm of UP. Methods: We performed a randomized controlled, double-blind study at 8 hospitals in the Netherlands and Belgium from 2014 through 2017. Eighty-five patients with refractory UP (65% women) were randomly assigned to groups given once daily tacrolimus suppositories (2 mg; n = 43) or beclomethasone (3 mg; n = 42) for 4 weeks. The primary outcome was clinical response (decrease in Mayo score of 3 or more). Secondary outcomes included clinical remission, endoscopic response and remission, adverse events and quality of life. Outcomes were compared using Fisher's exact test and Mann-Whitney U test. Results: Proportions of patients with clinical responses were 63% in the tacrolimus group and 59% in the beclomethasone group (P =.812); proportions of patients in clinical remission were 46% and 38%, respectively (P =.638). Proportions of patients with an endoscopic response were 68% and 60% in the tacrolimus group and in the beclomethasone group (P =.636); proportions in endoscopic remission rates were 30% and 13%, respectively (P =.092) Median increases in the inflammato
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- 2020
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22. Inflammatory Bowel Disease Management During the Coronavirus-19 Outbreak: A Survey From the European Crohn’s and Colitis Organization
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D’Amico, Ferdinando, primary, Danese, Silvio, additional, Peyrin-Biroulet, Laurent, additional, Ailsa, Hart, additional, Kucharzik, Torsten, additional, Magro, Fernando, additional, Rahier, Jean-François, additional, Siegmund, Britta, additional, Janneke van der Woude, C., additional, and Vavricka, Stephan R., additional
- Published
- 2020
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23. IBD risk loci are enriched in multigenic regulatory modules encompassing putative causative genes
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UCL - SSS/IREC/GAEN - Pôle d'Hépato-gastro-entérologie, UCL - (SLuc) Service de gastro-entérologie, Momozawa, Yukihide, Dmitrieva, Julia, Théâtre, Emilie, Deffontaine, Valérie, Rahmouni, Souad, Charloteaux, Benoît, Crins, François, Docampo, Elisa, Elansary, Mahmoud, Gori, Ann-Stephan, Lecut, Christelle, Mariman, Rob, Mni, Myriam, Oury, Cécile, Altukhov, Ilya, Alexeev, Dmitry, Aulchenko, Yuri, Amininejad, Leila, Bouma, Gerd, Hoentjen, Frank, Löwenberg, Mark, Oldenburg, Bas, Pierik, Marieke J., vander Meulen-de Jong, Andrea E., Janneke van der Woude, C., Visschedijk, Marijn C., Lathrop, Mark, Hugot, Jean-Pierre, Weersma, Rinse K., De Vos, Martine, Franchimont, Denis, Vermeire, Severine, Kubo, Michiaki, Louis, Edouard, Georges, Michel, Dewit, Olivier, UCL - SSS/IREC/GAEN - Pôle d'Hépato-gastro-entérologie, UCL - (SLuc) Service de gastro-entérologie, Momozawa, Yukihide, Dmitrieva, Julia, Théâtre, Emilie, Deffontaine, Valérie, Rahmouni, Souad, Charloteaux, Benoît, Crins, François, Docampo, Elisa, Elansary, Mahmoud, Gori, Ann-Stephan, Lecut, Christelle, Mariman, Rob, Mni, Myriam, Oury, Cécile, Altukhov, Ilya, Alexeev, Dmitry, Aulchenko, Yuri, Amininejad, Leila, Bouma, Gerd, Hoentjen, Frank, Löwenberg, Mark, Oldenburg, Bas, Pierik, Marieke J., vander Meulen-de Jong, Andrea E., Janneke van der Woude, C., Visschedijk, Marijn C., Lathrop, Mark, Hugot, Jean-Pierre, Weersma, Rinse K., De Vos, Martine, Franchimont, Denis, Vermeire, Severine, Kubo, Michiaki, Louis, Edouard, Georges, Michel, and Dewit, Olivier
- Abstract
GWAS have identified >200 risk loci for Inflammatory Bowel Disease (IBD). The majority of disease associations are known to be driven by regulatory variants. To identify the putative causative genes that are perturbed by these variants, we generate a large transcriptome data set (nine disease-relevant cell types) and identify 23,650 cis-eQTL. We show that these are determined by ∼9720 regulatory modules, of which ∼3000 operate in multiple tissues and ∼970 on multiple genes. We identify regulatory modules that drive the disease association for 63 of the 200 risk loci, and show that these are enriched in multigenic modules. Based on these analyses, we resequence 45 of the corresponding 100 candidate genes in 6600 Crohn disease (CD) cases and 5500 controls, and show with burden tests that they include likely causative genes. Our analyses indicate that ≥10-fold larger sample sizes will be required to demonstrate the causality of individual genes using this approach.
- Published
- 2018
24. Defective ATG16L1-mediated removal of IRE1α drives Crohn’s disease–like ileitis
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Tschurtschenthaler, Markus, primary, Adolph, Timon E., additional, Ashcroft, Jonathan W., additional, Niederreiter, Lukas, additional, Bharti, Richa, additional, Saveljeva, Svetlana, additional, Bhattacharyya, Joya, additional, Flak, Magdalena B., additional, Shih, David Q., additional, Fuhler, Gwenny M., additional, Parkes, Miles, additional, Kohno, Kenji, additional, Iwawaki, Takao, additional, Janneke van der Woude, C., additional, Harding, Heather P., additional, Smith, Andrew M., additional, Peppelenbosch, Maikel P., additional, Targan, Stephan R., additional, Ron, David, additional, Rosenstiel, Philip, additional, Blumberg, Richard S., additional, and Kaser, Arthur, additional
- Published
- 2017
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25. Convergent Transcription of Interferon-Stimulated Genes by TNF-A and IFN-A Augments Antiviral Activity against HCV and HEV
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Wang, W., primary, Xu, L., additional, Brandsma, J., additional, Wang, Y., additional, Hakim, M., additional, Zhou, X., additional, Yin, Y., additional, Fuhler, G., additional, Van Der Laan, L.J.W., additional, Janneke Van Der Woude, C., additional, Sprengers, D., additional, Metselaar, H., additional, Smits, R., additional, Poot, R., additional, Peppelenbosch, M., additional, and Pan, Q., additional
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- 2016
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26. Disappointing Durable Remission Rates in Complex Crohnʼs Disease Fistula
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Molendijk, Ilse, primary, Nuij, Veerle J. A. A., additional, van der Meulen-de Jong, Andrea E., additional, and Janneke van der Woude, C., additional
- Published
- 2014
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27. Novel developments in Crohn's disease
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Janneke van der Woude, C., primary and Lee, James C., additional
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- 2014
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28. THU-274 - Convergent Transcription of Interferon-Stimulated Genes by TNF-A and IFN-A Augments Antiviral Activity against HCV and HEV
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Wang, W., Xu, L., Brandsma, J., Wang, Y., Hakim, M., Zhou, X., Yin, Y., Fuhler, G., Van Der Laan, L.J.W., Janneke Van Der Woude, C., Sprengers, D., Metselaar, H., Smits, R., Poot, R., Peppelenbosch, M., and Pan, Q.
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- 2016
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29. The second European evidence-based Consensus on the diagnosis and management of Crohns disease: Special situations
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Van Assche, Gert, Dignass, Axel, Reinisch, Walter, Janneke van der Woude, C, Sturm, Andreas, Guslandi, Mario, Oldenburg, Bas, Marteau, Philippe, Ardizzone, Alessandro, C Baumgart, Daniel, DHaens, Geert, Gionchetti, Paolo, Portela, Francisco, Vucelic, Boris, Söderholm, Johan D, Escher, Johanna, Koletzko, Sibylle, Kolho, Kaija-Leena, Lukas, Milan, Mottet, Christian, Tilg, Herbert, Vermeire, Severine, Carbonnel, Frank, Cole, Andrew, Novacek, Gottfried, Reinshagen, Max, Tsianos, Epameinondas, Herrlinger, Klaus, Bouhnik, Yoram, Kiesslich, Ralf, Stange, Eduard, Travis, Simon, Lindsay, James, Van Assche, Gert, Dignass, Axel, Reinisch, Walter, Janneke van der Woude, C, Sturm, Andreas, Guslandi, Mario, Oldenburg, Bas, Marteau, Philippe, Ardizzone, Alessandro, C Baumgart, Daniel, DHaens, Geert, Gionchetti, Paolo, Portela, Francisco, Vucelic, Boris, Söderholm, Johan D, Escher, Johanna, Koletzko, Sibylle, Kolho, Kaija-Leena, Lukas, Milan, Mottet, Christian, Tilg, Herbert, Vermeire, Severine, Carbonnel, Frank, Cole, Andrew, Novacek, Gottfried, Reinshagen, Max, Tsianos, Epameinondas, Herrlinger, Klaus, Bouhnik, Yoram, Kiesslich, Ralf, Stange, Eduard, Travis, Simon, and Lindsay, James
- Abstract
n/a
- Published
- 2010
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30. Increased Suppressor of Cytokine Signaling-3 Expression Predicts Mucosal Relapse in Ulcerative Colitis
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Li, Yi, primary, Nuij, Veerle J.A.A., additional, Baars, Judith E., additional, Biermann, Katharina, additional, Kuipers, Ernst J., additional, Peppelenbosch, Maikel P., additional, de Haar, Colin, additional, and Janneke van der Woude, C., additional
- Published
- 2013
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31. Predictors of dose escalation of adalimumab in a prospective cohort of Crohn’s disease patients
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Bultman, E., primary, de Haar, C., additional, van Liere‐Baron, A., additional, Verhoog, H., additional, West, R. L., additional, Kuipers, E. J., additional, Zelinkova, Z., additional, and Janneke van der Woude, C., additional
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- 2011
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32. Role of defective autophagia and the intestinal flora in Crohn disease
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Regeling, Anouk, primary, Somasundaram, Rajesh, additional, Haar, Colin de, additional, Janneke van der Woude, C., additional, Braat, Henri, additional, and Peppelenbosch, Maikel P., additional
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- 2010
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33. Wnt pathway-related gene expression during malignant progression in ulcerative colitis
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van Dekken, Herman, primary, Wink, Josiane C., additional, Vissers, Kees J., additional, Franken, Patrick F., additional, Ruud Schouten, W., additional, J. Hop, Wim C., additional, Kuipers, Ernst J., additional, Fodde, R., additional, and Janneke van der Woude, C., additional
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- 2007
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34. Treatment of bone loss in osteopenic patients with Crohn's disease: a double-blind, randomised trial of oral risedronate 35 mg once weekly or placebo, concomitant with calcium and vitamin D supplementation.
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van Bodegraven, Ad A., Bravenboer, Nathalie, Witte, Birgit I., Dijkstra, Gerard, Janneke van der Woude, C., Stokkers, Pieter C. M., Russel, Maurice G., Oldenburg, Bas, Pierik, Marieke, Roos, Jan C., van Hogezand, Ruud A., Dik, Vincent K., Oostlander, Angela E., Coen Netelenbos, J., van de Langerijt, Lex, Hommes, Daniel W., and Lips, Paul
- Subjects
CROHN'S disease ,SCRIMSHAWS ,STEROID hormones ,VITAMIN D ,HIGH-calcium diet - Abstract
Objective Osteoporosis and fractures are frequently encountered in patients with Crohn's disease. In order to prevent fractures, treatment with bone protecting drugs appears warranted early in the course of bone disease when bone loss is not yet prominent. We therefore aimed to demonstrate a beneficial effect on bone density of the bisphosphonate risedronate in osteopenic Crohn's disease patients. Methods This double-blind, placebo-controlled randomised trial of risedronate with calcium and vitamin D supplementation was performed in osteopenic Crohn's disease patients. Patients were treated for 2 years with follow-up after 3 and after every 6 months. Disease characteristics and activity and bone turnover markers were assessed at all visits; dual x-ray absorptiometry was performed at baseline, 12 and 24 months; radiographs of the spine at baseline and 24 months. Results Of 132 consenting patients, 131 were randomised (67 placebo and 64 risedronate). Patient characteristics were similar in both groups, although the risedronate group was slightly heavier (body mass index 24.3 vs 23.0 kg/m
2 ). Bone mineral density at lumbar spine increased 0.04 g/cm2 on average in the risedronate group versus 0.01 g/cm2 in the placebo group (p=0.007). The mean increase in total hip bone mineral density was 0.03 versus 0.01 g/cm2 , respectively (p=0.071). Fracture prevalence and incidence were similar. Change of T-scores and concentrations of bone turnover markers were consistent with a beneficial effect of risedronate when compared with placebo. The effect of risedronate was primarily demonstrated in the first 12 months of treatment. No serious unexpected suspected adverse events were observed. Conclusions A 24-month treatment course with risedronate 35 mg once weekly, concomitant with calcium and vitamin D supplementation, in osteopenic Crohn's disease patients improved bone density at lumbar spine. [ABSTRACT FROM AUTHOR]- Published
- 2014
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35. Predictors of dose escalation of adalimumab in a prospective cohort of Crohn's disease patients.
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Bultman, E., de Haar, C., van Liere‐Baron, A., Verhoog, H., West, R. L., Kuipers, E. J., Zelinkova, Z., and Janneke van der Woude, C.
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CROHN'S disease ,DOSAGE forms of drugs ,BODY mass index ,INFLIXIMAB ,DRUG efficacy ,MONOCLONAL antibodies ,PATIENTS - Abstract
Summary Background Adalimumab is effective for the induction and maintenance of remission in Crohn's disease (CD)-patients. Aim To find predictors for adalimumab dose escalation at initiation of adalimumab. Methods Crohn's disease patients in a single tertiary referral centre who started adalimumab between July 2007 and March 2010 at an induction dose (week 0 160 mg subcutaneously (sc), week 2 80 mg sc) and maintenance dose of 40 mg sc thereafter every other week were followed prospectively. Patients on adalimumab for at least 3 months were included. The number of patients needing dose escalation was assessed. Patients that needed dose escalation were compared with patients that did not need dose escalation. Results Of 199 CD patients treated with adalimumab and followed prospectively, 122 patients (M/F 54/68, median age 35 years, range 18-66 years, median CDAI 164, range 6-468) were treated for 3 months. In total 38% of these patients (46/122) needed a dose escalation within a median time of 21 weeks after adalimumab introduction (range 4-105). Body mass index (BMI) ( P < 0.03) and secondary non-response to infliximab (IFX) ( P < 0.06) were identified as predictors for dose escalation. Concomitant use of immunomodulators at initiation of adalimumab and the presence of autoantibodies to IFX did not predict dose escalation. Conclusions Over one-third adalimumab-treated patients are dose escalated within a median of 5 months. Higher BMI and secondary non-response to IFX treatment are predictive for a dose escalation during adalimumab treatment. [ABSTRACT FROM AUTHOR]
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- 2012
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36. Defective ATG16L1-mediated removal of IRE1α drives Crohn's disease-like ileitis
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Tschurtschenthaler, M, Adolph, TE, Ashcroft, JW, Niederreiter, L, Bharti, R, Saveljeva, S, Bhattacharyya, J, Flak, MB, Shih, DQ, Fuhler, GM, Parkes, M, Kohno, K, Iwawaki, T, Janneke Van Der Woude, C, Harding, HP, Smith, AM, Peppelenbosch, MP, Targan, Ron, D, Rosenstiel, P, Blumberg, RS, and Kaser, A
- Subjects
Microbiota ,Age Factors ,Autophagy-Related Proteins ,Membrane Proteins ,Ileitis ,Protein Serine-Threonine Kinases ,Endoplasmic Reticulum Stress ,digestive system ,3. Good health ,Mice, Inbred C57BL ,Mice ,Crohn Disease ,Endoribonucleases ,Autophagy ,Animals - Abstract
ATG16L1$^{T300A}$, a major risk polymorphism in Crohn's disease (CD), causes impaired autophagy, but it has remained unclear how this predisposes to CD. In this study, we report that mice with Atg16l1 deletion in intestinal epithelial cells (IECs) spontaneously develop transmural ileitis phenocopying ileal CD in an age-dependent manner, driven by the endoplasmic reticulum (ER) stress sensor IRE1α. IRE1α accumulates in Paneth cells of Atg16l1$^{ΔIEC}$ mice, and humans homozygous for ATG16L1$^{T300A}$ exhibit a corresponding increase of IRE1α in intestinal epithelial crypts. In contrast to a protective role of the IRE1β isoform, hyperactivated IRE1α also drives a similar ileitis developing earlier in life in Atg16l1;Xbp1$^{ΔIEC}$ mice, in which ER stress is induced by deletion of the unfolded protein response transcription factor XBP1. The selective autophagy receptor optineurin interacts with IRE1α, and optineurin deficiency amplifies IRE1α levels during ER stress. Furthermore, although dysbiosis of the ileal microbiota is present in Atg16l1;Xbp1$^{ΔIEC}$ mice as predicted from impaired Paneth cell antimicrobial function, such structural alteration of the microbiota does not trigger ileitis but, rather, aggravates dextran sodium sulfate-induced colitis. Hence, we conclude that defective autophagy in IECs may predispose to CD ileitis via impaired clearance of IRE1α aggregates during ER stress at this site.
37. Discontinuation of Anti-Tumour Necrosis Factor Therapy in Patients with Perianal Fistulizing Crohn's Disease: Individual Participant Data Meta-Analysis of 309 Patients from 12 Studies.
- Author
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Ten Bokkel Huinink S, Thomassen D, Steyerberg EW, Pauwels RWM, Casanova MJ, Bouguen G, Mak JWY, Molnár T, Lobo AJ, Seidelin JB, Amiot A, D'Haens G, Rivière P, Guidi L, Bor R, Lin WC, Peyrin-Biroulet L, Gisbert JP, Janneke van der Woude C, and de Vries AC
- Subjects
- Humans, Adolescent, Infliximab therapeutic use, Tumor Necrosis Factor-alpha, Tumor Necrosis Factor Inhibitors therapeutic use, Recurrence, Necrosis complications, Treatment Outcome, Retrospective Studies, Crohn Disease complications, Crohn Disease drug therapy, Rectal Fistula etiology, Rectal Fistula complications
- Abstract
Background: The risk of relapse after anti-tumour necrosis factor [TNF] therapy discontinuation in Crohn's disease patients with perianal fistulas [pCD] is unclear. We aimed to assess this risk., Methods: A systematic literature search was conducted to identify cohort studies on the incidence of relapse following anti-TNF discontinuation in pCD patients. Individual participant data were requested from the original study cohorts. Inclusion criteria were age ≥16 years, pCD as a (co)indication for start of anti-TNF therapy, more than three doses, and remission of luminal and pCD at anti-TNF discontinuation. The primary outcome was the cumulative incidence of CD relapse using Kaplan-Meier estimates. Secondary outcomes included response to re-treatment and risk factors associated with relapse as assessed by Cox regression analysis., Results: In total, 309 patients from 12 studies in ten countries were included. The median duration of anti-TNF treatment was 14 months [interquartile range 5.8-32.5]. Most patients were treated for pCD without active luminal disease [89%], received first-line anti-TNF therapy [87%], and continued immunomodulatory therapy following anti-TNF discontinuation [78%]. The overall cumulative incidence of relapse was 36% (95% confidence interval [CI] 25-48%) and 42% [95% CI 32-53%] at 1 and 2 years after anti-TNF discontinuation, respectively. Risk factors for relapse included smoking (hazard ratio [HR] 1.5 [1.0, 2.1]) and history of proctitis (HR 1.7 [1.1, 2.5]). The overall re-treatment response rate was 82%., Conclusions: This individual participant data meta-analysis, on predominantly patients with pCD without active luminal disease and first-line anti-TNF therapy, shows that over half of patients remain in remission 2 years after anti-TNF discontinuation. Therefore, anti-TNF discontinuation may be considered in this subgroup., (© The Author(s) 2023. Published by Oxford University Press on behalf of European Crohn’s and Colitis Organisation.)
- Published
- 2024
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38. Timing of Live Attenuated Vaccination in Infants Exposed to Infliximab or Adalimumab in Utero: A Prospective Cohort Study in 107 Children.
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Liu Z, Julsgaard M, Zhu X, Martin J, Barclay ML, Cranswick N, Gibson PR, Gearry RB, van der Giessen J, Connor SJ, Rosella O, Grosen A, Toong C, Flanagan E, Wieringa JW, Janneke van der Woude C, and Bell SJ
- Subjects
- Child, Female, Humans, Infant, Infant, Newborn, Pregnancy, Bayes Theorem, Prospective Studies, Tumor Necrosis Factor Inhibitors therapeutic use, Vaccination, Maternal Exposure, Adalimumab therapeutic use, Inflammatory Bowel Diseases drug therapy, Infliximab therapeutic use, Vaccines, Attenuated administration & dosage
- Abstract
Background and Aims: For infants exposed in utero to anti-tumour necrosis factor-α [TNF] medications, it is advised that live-attenuated vaccinations be postponed until the drug is cleared, but little is known about time to clearance. To minimize delays before live-attenuated vaccination can be given, we aimed to develop a pharmacokinetic model to predict time-to-clearance in infants exposed during pregnancy., Methods: We prospectively followed in utero infliximab/adalimumab-exposed infants of mothers with inflammatory bowel disease across four countries between 2011 and 2018. Infants with a detectable anti-TNF umbilical-cord level and at least one other blood sample during the first year of life were included., Results: Overall, 107 infants were enrolled, including 166 blood samples from 71 infliximab-exposed infants and 77 samples from 36 adalimumab-exposed infants. Anti-TNF was detectable in 23% [n = 25] of infants at 6 months. At 12 months, adalimumab was not detected but 4% [n = 3] had detectable infliximab. A Bayesian forecasting method was developed using a one-compartment pharmacokinetic model. Model validation showed that the predicted clearing time was in accordance with the measured observations. A clinician-friendly online calculator was developed for calculating full anti-TNF clearing time: https://xiaozhu.shinyapps.io/antiTNFcalculator2/., Conclusions: Almost one-quarter of infants born to mothers receiving anti-TNF during pregnancy have detectable anti-TNF at 6 months. To limit the time to live-attenuated vaccination in infants of mothers receiving anti-TNF during pregnancy, the results of a cord drug level at birth and a second sample ≥ 1 month thereafter can be used to estimate the time for full anti-TNF clearance in these children., (© The Author(s) 2022. Published by Oxford University Press on behalf of European Crohn’s and Colitis Organisation. All rights reserved. For permissions, please email: journals.permissions@oup.com.)
- Published
- 2022
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39. Steroid-Free Deep Remission at One Year Does Not Prevent Crohn's Disease Progression: Long-Term Data From the TAILORIX Trial.
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Laharie D, D'Haens G, Nachury M, Lambrecht G, Bossuyt P, Bouhnik Y, Louis E, Janneke van der Woude C, Buisson A, Van Hootegem P, Allez M, Filippi J, Brixi H, Gilletta C, Picon L, Baert F, Vermeire S, Duveau N, and Peyrin-Biroulet L
- Subjects
- Disease Progression, Follow-Up Studies, Humans, Infliximab, Prospective Studies, Remission Induction, Steroids, Treatment Outcome, Crohn Disease
- Abstract
Background & Aims: Crohn's disease (CD) patients included in the Tailored Treatment With Infliximab for Active Crohn's Disease (TAILORIX) trial started infliximab in combination with an immunosuppressant for 1 year. The aim of the present study was to determine the long-term disease course beyond the study period., Methods: We compared the outcomes of patients who did or did not reach the primary end point of the TAILORIX trial, defined as sustained corticosteroid-free clinical remission from weeks 22 through 54, with no ulcers on ileocolonoscopy at week 54. The primary outcome of this follow-up study was the progression-free survival of CD defined by anal or major abdominal surgery, CD-related hospitalization, or the need for a new systemic CD treatment., Results: The 95 patients (median disease duration, 4.5 mo; interquartile range, 1.0-56.6 mo) analyzed, including 45 (47%) who achieved the primary end point, were followed up for a median duration of 64.2 months (interquartile range, 57.6-69.9 mo) after the end of the study period. There was no significant difference in CD progression-free survival at 1, 3, and 5 years between patients who achieved the TAILORIX primary end point and patients who did not (P = .64). No difference was observed between both groups for each component of CD progression: anal surgery, major abdominal surgery, CD-related hospitalization, or the need for a new systemic CD treatment., Conclusions: Achieving a sustained clinical remission off steroids with complete endoscopic remission in this cohort of 95 patients with early CD was not associated with less disease progression. Prospective trials to define the therapeutic goals that change the natural history of CD and prevent complications are needed., (Copyright © 2022 AGA Institute. Published by Elsevier Inc. All rights reserved.)
- Published
- 2022
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40. No Superiority of Tacrolimus Suppositories vs Beclomethasone Suppositories in a Randomized Trial of Patients With Refractory Ulcerative Proctitis.
- Author
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Lie MRKL, Kreijne JE, Dijkstra G, Löwenberg M, van Assche G, West RL, van Noord D, van der Meulen-de Jong AE, Oldenburg B, Zaal RJ, Hansen BE, de Vries AC, and Janneke van der Woude C
- Subjects
- Anti-Inflammatory Agents, Non-Steroidal therapeutic use, Beclomethasone adverse effects, Female, Humans, Male, Mesalamine adverse effects, Quality of Life, Suppositories, Tacrolimus adverse effects, Colitis, Ulcerative drug therapy, Proctitis drug therapy
- Abstract
Background & Aims: Ulcerative proctitis (UP) refractory to 5-aminosalicylic acid (5-ASA) suppositories is a challenge to treat, often requiring step up to immunomodulator or biological therapy. Topical tacrolimus is effective and safe in patients with refractory UP. However, it is not clear how tacrolimus suppositories fit into in the treatment algorithm of UP., Methods: We performed a randomized controlled, double-blind study at 8 hospitals in the Netherlands and Belgium from 2014 through 2017. Eighty-five patients with refractory UP (65% women) were randomly assigned to groups given once daily tacrolimus suppositories (2 mg; n = 43) or beclomethasone (3 mg; n = 42) for 4 weeks. The primary outcome was clinical response (decrease in Mayo score of 3 or more). Secondary outcomes included clinical remission, endoscopic response and remission, adverse events and quality of life. Outcomes were compared using Fisher's exact test and Mann-Whitney U test., Results: Proportions of patients with clinical responses were 63% in the tacrolimus group and 59% in the beclomethasone group (P = .812); proportions of patients in clinical remission were 46% and 38%, respectively (P = .638). Proportions of patients with an endoscopic response were 68% and 60% in the tacrolimus group and in the beclomethasone group (P = .636); proportions in endoscopic remission rates were 30% and 13%, respectively (P = .092) Median increases in the inflammatory bowel disease questionnaire score were 18.0 in the tacrolimus group and 20.5 in the beclomethasone group (P = .395). Adverse event rates did not differ significantly between groups., Conclusions: In a 4-week randomized controlled trial, tacrolimus and beclomethasone suppositories induce comparable clinical and endoscopic responses in patients with UP refractory to 5-ASA. There were no significant differences in adverse events rates. Tacrolimus and beclomethasone suppositories are therefore each safe and effective treatment options for 5-ASA refractory disease. EUDRACT 2013-001259-11; Netherlands Trial Register NL4205/NTR4416., (Copyright © 2020 AGA Institute. Published by Elsevier Inc. All rights reserved.)
- Published
- 2020
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41. Extracorporeal photopheresis (ECP) in patients with steroid-dependent Crohn's disease: an open-label, multicenter, prospective trial.
- Author
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Reinisch W, Knobler R, Rutgeerts PJ, Ochsenkühn T, Anderson F, von Tirpitz C, Kaatz M, Janneke van der Woude C, Parenti D, and Mannon PJ
- Subjects
- Adolescent, Adult, Aged, Aged, 80 and over, Drug Administration Schedule, Drug Therapy, Combination, Female, Humans, Induction Chemotherapy, Intention to Treat Analysis, Maintenance Chemotherapy, Male, Middle Aged, Prospective Studies, Treatment Outcome, Young Adult, Crohn Disease drug therapy, Glucocorticoids therapeutic use, Photopheresis, Prednisone therapeutic use
- Abstract
Background: Extracorporeal photopheresis (ECP) involves ex vivo leukocyte treatment with methoxsalen and UVA light to generate a tolerogenic response. A previous trial demonstrated that ECP permits corticosteroid withdrawal in steroid-dependent Crohn's disease (CD) patients who were in clinical remission. We studied the effect of ECP on steroid withdrawal in steroid-dependent CD., Methods: Patients with CD for ≥ 6 months, in remission at baseline while on steroids, but who had failed at ≥ 1 steroid withdrawal were included. Patients received two ECP treatments every 2 weeks for the 24-week steroid tapering period and underwent steroid-tapering. Patients completing steroid tapering could receive maintenance ECP (two treatments/week) every month for 24 weeks., Results: Thirty-one patients (Crohn's Disease Activity Index [CDAI] score 91; Inflammatory Bowel Disease Questionnaire [IBDQ] 172.5) were enrolled (baseline corticosteroid dose, 20 mg/day); 65% were refractory to/intolerant of anti-tumor necrosis factor (TNF) agents or immunosuppressants. After 24 weeks of ECP, 7 of 31 (22.6%) patients discontinued steroids while maintaining a CDAI of <150. At week 24, the steroid dose for the remaining patients on corticosteroids was 10 mg (P < 0.003 vs. baseline) with a CDAI of 110 and an IBDQ of 179. Following maintenance treatment, three patients remained in steroid-free remission. The 10 patients in the study and receiving ECP at week 48 had a steroid dose of 3.5 mg with a CDAI of 40 and an IBDQ of 188., Conclusions: ECP permitted discontinuation or reduction of steroids in a population of refractory steroid-dependent CD patients. ECP may be useful in permitting steroid withdrawal in selected steroid-dependent CD patients. Ideally, these results need to be confirmed in a "sham-controlled clinical trial.
- Published
- 2013
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