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8. High- Q Magnetic Levitation and Control of Superconducting Microspheres at Millikelvin Temperatures

Author

Hofer, J., primary, Gross, R., additional, Higgins, G., additional, Huebl, H., additional, Kieler, O. F., additional, Kleiner, R., additional, Koelle, D., additional, Schmidt, P., additional, Slater, J. A., additional, Trupke, M., additional, Uhl, K., additional, Weimann, T., additional, Wieczorek, W., additional, and Aspelmeyer, M., additional

Published
2023
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11. Glioblastoma and the search for non-hypothesis driven combination therapeutics in academia

Author

Johanssen, T, McVeigh, L, Erridge, S, Higgins, G, Straehla, J, Frame, M, Aittokallio, T, Carragher, NO, Ebner, D, Helsinki Institute for Information Technology, Tero Aittokallio / Principal Investigator, Bioinformatics, Institute for Molecular Medicine Finland, University of Helsinki, Research Programs Unit, and Helsinki Institute of Life Science HiLIFE

Subjects
Cancer Research, Temozolamide, glioblastoma stem cell, Radiotherapy, drug targer combination, hypoxia, high throughput screening (HTS), 3122 Cancers, glioblastoma, radiothereapy, Oncology, temozolamide, Glioblastoma stem cell, Glioblastoma, Hypoxia, Drug target combination
Abstract

Glioblastoma (GBM) remains a cancer of high unmet clinical need. Currentstandard of care for GBM, consisting of maximal surgical resection, followed byionisation radiation (IR) plus concomitant and adjuvant temozolomide (TMZ),provides less than 15-month survival benefit. Efforts by conventional drugdiscovery to improve overall survival have failed to overcome challengespresented by inherent tumor heterogeneity, therapeutic resistance attributed toGBM stem cells, and tumor niches supporting self-renewal. In this review wedescribe the steps academic researchers are taking to address these limitations in high throughput screening programs to identify novel GBM combinatorial targets.We detail how they are implementing more physiologically relevant phenotypicassays which better recapitulate key areas of disease biology coupled with morefocussed libraries of small compounds, such as drug repurposing, target discovery, pharmacologically active and novel, more comprehensive anti-cancer targetannotated compound libraries. Herein, we discuss the rationale for current GBM combination trials and the need for more systematic and transparent strategies for identification, validation and prioritisation of combinations that lead to clinical trials. Finally, we make specific recommendations to the preclinical, small compound screening paradigm that could increase the likelihood of identifying tractable, combinatorial, small molecule inhibitors and better drug targets specific to GBM.

Published
2023
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15. Predictive modelling and optimization of HVAC systems using neural network and particle swarm optimization algorithm

Author

Afroz, Z, Shafiullah, GM, Urmee, T, Shoeb, MA, Higgins, G, Afroz, Z, Shafiullah, GM, Urmee, T, Shoeb, MA, and Higgins, G

Abstract

The concept of maintaining indoor environmental quality comprising building indoor temperature, relative humidity, CO2, and volatile organic compound (VOC) level poses new challenges to the optimal operation of heating, ventilation and air-conditioning (HVAC) systems. While existing case studies demonstrate the energy-saving potentials for efficient HVAC operation, there is a lack of studies quantifying energy savings whilst considering indoor environmental conditions. This study proposes a state-of-the-art modelling and optimization approach to minimize the energy consumption of the HVAC systems without compromising indoor environmental quality. While the primary objective of ensuring optimal operation of HVAC systems is to minimize energy consumption, controlling indoor environmental parameters to remain within the acceptable range imposes excess energy use. These two conflicting objectives constitute a multi-variable constrained optimization problem that has been solved using a particle swarm optimization (PSO) algorithm. Real-time predictive models are developed for the individual indoor environmental parameters and HVAC energy consumption using a Nonlinear Autoregressive Exogenous (NARX) neural network (NN). During model development, models' performance is optimized in terms of complexity, predictive accuracy, and ease of application to a real system. The proposed predictive models are then optimized to provide an optimal control setting for the HVAC systems considering seasonal variations. The results indicate that it is possible to reduce 7.8% of total energy, without negotiating indoor environmental conditions, e.g., air temperature 19.60–28.20°C and relative humidity 30–65% as per ASHRAE Standard 55, and CO2 ≤ 800 ppm and VOC ≤1000 ppm as per AS 1668.2.

Published
2022

16. Seroprevalence of Severe Acute Respiratory Syndrome Coronavirus 2-Specific Antibodies in Australia After the First Epidemic Wave in 2020: A National Survey

Author

Vette, KM, Machalek, DA, Gidding, HF, Nicholson, S, O'Sullivan, MVN, Carlin, JB, Downes, M, Armstrong, L, Beard, FH, Dwyer, DE, Gibb, R, Gosbell, IB, Hendry, AJ, Higgins, G, Hirani, R, Hueston, L, Irving, DO, Quinn, HE, Shilling, H, Smith, D, Kaldor, JM, Macartney, K, Vette, KM, Machalek, DA, Gidding, HF, Nicholson, S, O'Sullivan, MVN, Carlin, JB, Downes, M, Armstrong, L, Beard, FH, Dwyer, DE, Gibb, R, Gosbell, IB, Hendry, AJ, Higgins, G, Hirani, R, Hueston, L, Irving, DO, Quinn, HE, Shilling, H, Smith, D, Kaldor, JM, and Macartney, K

Abstract

BACKGROUND: As of mid-2021, Australia's only nationwide coronavirus disease 2019 (COVID-19) epidemic occurred in the first 6 months of the pandemic. Subsequently, there has been limited transmission in most states and territories. Understanding community spread during the first wave was hampered by initial limitations on testing and surveillance. To characterize the prevalence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-specific antibody seroprevalence generated during this time, we undertook Australia's largest national SARS-CoV-2 serosurvey. METHODS: Between June 19 and August 6, 2020, residual specimens were sampled from people undergoing general pathology testing (all ages), women attending antenatal screening (20-39 years), and blood donors (20-69 years) based on the Australian population's age and geographic distributions. Specimens were tested by Wantai total SARS-CoV-2-antibody assay. Seroprevalence estimates adjusted for test performance were produced. The SARS-CoV-2 antibody-positive specimens were characterized with microneutralization assays. RESULTS: Of 11 317 specimens (5132 general pathology; 2972 antenatal; 3213 blood-donors), 71 were positive for SARS-CoV-2-specific antibodies. Seroprevalence estimates were 0.47% (95% credible interval [CrI], 0.04%-0.89%), 0.25% (CrI, 0.03%-0.54%), and 0.23% (CrI, 0.04%-0.54%), respectively. No seropositive specimens had neutralizing antibodies. CONCLUSIONS: Australia's seroprevalence was extremely low (<0.5%) after the only national COVID-19 wave thus far. These data and the subsequent limited community transmission highlight the population's naivety to SARS-CoV-2 and the urgency of increasing vaccine-derived protection.

Published
2022

17. Predictive modelling and optimization of HVAC systems using neural network and particle swarm optimization algorithm

Author

Afroz, Z., Shafiullah, GM., Urmee, T., Shoeb, M.A., Higgins, G., Afroz, Z., Shafiullah, GM., Urmee, T., Shoeb, M.A., and Higgins, G.

Abstract

The concept of maintaining indoor environmental quality comprising building indoor temperature, relative humidity, CO2, and volatile organic compound (VOC) level poses new challenges to the optimal operation of heating, ventilation and air-conditioning (HVAC) systems. While existing case studies demonstrate the energy-saving potentials for efficient HVAC operation, there is a lack of studies quantifying energy savings whilst considering indoor environmental conditions. This study proposes a state-of-the-art modelling and optimization approach to minimize the energy consumption of the HVAC systems without compromising indoor environmental quality. While the primary objective of ensuring optimal operation of HVAC systems is to minimize energy consumption, controlling indoor environmental parameters to remain within the acceptable range imposes excess energy use. These two conflicting objectives constitute a multi-variable constrained optimization problem that has been solved using a particle swarm optimization (PSO) algorithm. Real-time predictive models are developed for the individual indoor environmental parameters and HVAC energy consumption using a Nonlinear Autoregressive Exogenous (NARX) neural network (NN). During model development, models' performance is optimized in terms of complexity, predictive accuracy, and ease of application to a real system. The proposed predictive models are then optimized to provide an optimal control setting for the HVAC systems considering seasonal variations. The results indicate that it is possible to reduce 7.8% of total energy, without negotiating indoor environmental conditions, e.g., air temperature 19.60–28.20°C and relative humidity 30–65% as per ASHRAE Standard 55, and CO2 ≤ 800 ppm and VOC ≤1000 ppm as per AS 1668.2.

Published
2022

19. OC-0428 Development of DNA polymerase theta inhibitors as tumour specific radiosensitisers

Author

Prevo, R., primary, Ranzani, M., additional, Puliyadi, R., additional, Rodriguez-Berriguete, G., additional, Robinson, H., additional, Rajendra, E., additional, Grinkevich, V., additional, Boursier, M., additional, Cicconi, A., additional, Piscitello, D., additional, Cerutti, A., additional, Majithiya, J., additional, Heald, R., additional, Stockley, M., additional, Smith, G., additional, and Higgins, G., additional

Published
2022
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21. Long-term outcomes in patients with polyarticular juvenile idiopathic arthritis receiving adalimumab with or without methotrexate

Author

Lovell, D, Brunner, H, Reiff, A, Jung, L, Jarosova, K, Němcová, D, Mouy, R, Sandborg, C, Bohnsack, J, Elewaut, D, Gabriel, C, Higgins, G, Kone-Paut, I, Jones, O, Vargová, V, Chalom, E, Wouters, C, Lagunes, I, Song, Y, Martini, A, Ruperto, N, Lovell DJ, Brunner HI, Reiff AO, Jung L, Jarosova K, Němcová D, Mouy R, Sandborg C, Bohnsack JF, Elewaut D, Gabriel C, Higgins G, Kone-Paut I, Jones OY, Vargová V, Chalom E, Wouters C, Lagunes I, Song Y, Martini A, Ruperto N, Lovell, D, Brunner, H, Reiff, A, Jung, L, Jarosova, K, Němcová, D, Mouy, R, Sandborg, C, Bohnsack, J, Elewaut, D, Gabriel, C, Higgins, G, Kone-Paut, I, Jones, O, Vargová, V, Chalom, E, Wouters, C, Lagunes, I, Song, Y, Martini, A, Ruperto, N, Lovell DJ, Brunner HI, Reiff AO, Jung L, Jarosova K, Němcová D, Mouy R, Sandborg C, Bohnsack JF, Elewaut D, Gabriel C, Higgins G, Kone-Paut I, Jones OY, Vargová V, Chalom E, Wouters C, Lagunes I, Song Y, Martini A, and Ruperto N

Abstract

Objectives Long-term safety and efficacy of adalimumab among patients with juvenile idiopathic arthritis (JIA) was evaluated through 6 years of treatment. Methods Children aged 4-17 years with polyarticular JIA were enrolled in a phase III, randomised-withdrawal, double-blind, placebo-controlled trial consisting of a 16-week open-label lead-in period, 32-week randomised double-blind period and 360-week long-term extension. Patients were stratified by baseline methotrexate use. Adverse events (AEs) were monitored, and efficacy assessments included JIA American College of Rheumatology (JIA ACR) 30%, 50%, 70% or 90% responses and the proportions of patients achieving 27-joint Juvenile Arthritis Disease Activity Score (JADAS27) low disease activity (LDA, ≤3.8) and inactive disease (ID, ≤1). Results Of 171 patients enrolled, 62 (36%) completed the long-term extension. Twelve serious infections in 11 patients were reported through 592.8 patient-years of exposure. No cases of congestive heart failure-related AEs, demyelinating disease, lupus-like syndrome, malignancies, tuberculosis or deaths were reported. JIA ACR 30/50/70/90 responses and JADAS27 LDA were achieved in 66% to 96% of patients at week 104, and 63 (37%) patients achieved clinical remission (JADAS27 ID sustained for ≥6 continuous months) during the study. Attainment of JIA ACR 50 or higher and JADAS27 LDA or ID in the initial weeks were the best predictors of clinical remission. Mean JADAS27 decreased from baseline, 22.5 (n=170), to 2.5 (n=30) at week 312 (observed analysis). Conclusions Through 6 years of exposure, adalimumab was well tolerated with significant clinical response (up to clinical remission) and a relatively low retention rate.

Published
2020

26. Nerve Growth Factor Function in the Central Nervous System

Author

Gage, F. H., Tuszynski, M. H., Chen, K. S., Fagan, A. M., Higgins, G. A., Compans, R. W., editor, Cooper, M., editor, Koprowski, H., editor, McConnell, I., editor, Melchers, F., editor, Nussenzweig, V., editor, Oldstone, M., editor, Olsnes, S., editor, Potter, M., editor, Saedler, H., editor, Vogt, P. K., editor, Wagner, H., editor, Wilson, I., editor, and Bothwell, Mark, editor

Published
1991
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28. Exploring mathematical reasoning and math-talk through Izak9

Author

Higgins, G., Kingston, M., and Grimes, P.

Abstract

This paper focuses on the use of Izak9 in promoting the development of mathematical reasoning and Math-Talk in an Irish classroom. Recent national and international assessments have shown many positive results in relation to the mathematical learning of Irish pupils (Shiel et al., 2014; Perkins & Clerkin, 2020). However, the skill of reasoning is a relative weakness among this cohort (Perkins & Clerkin, 2020). Reasoning is highlighted as one of the four ‘elements’ of the proposed new Primary Mathematics Curriculum (PMC), which is currently under development (National Council for Curriculum and Assessment (NCCA), 2016; NCCA, 2017). This study was qualitative in nature. The research methods utilised were focus group interviews and observations of mathematics lessons. Findings of this study demonstrated that mathematical reasoning skills were promoted in Izak9 lessons, specifically the exploration of patterns and the justification of mathematical processes and solutions. In addition, a Math-Talk environment was also supported through the use of the resource.

Published
2021
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35. Targeting TOPK 1 sensitises tumour cells to radiation-induced damage by enhancing replication stress

Author

Herbert, K, Puliyadi, R, Prevo, R, Rodriguez Berriguete, G, Ryan, A, Ramadan, K, and Higgins, G

Abstract

T-LAK-originated protein kinase (TOPK) overexpression is a feature of multiple cancers, yet is absent from most phenotypically normal tissues. As such, TOPK expression profiling and the development of TOPK-targeting pharmaceutical agents have raised hopes for its future potential in the development of targeted therapeutics. Results presented in this paper confirm the value of TOPK as a potential target for the treatment of solid tumours, and demonstrate the efficacy of a TOPK inhibitor (OTS964) when used in combination with radiation treatment. Using H460 and Calu-6 lung cancer xenograft models, we show that pharmaceutical inhibition of TOPK potentiates the efficacy of fractionated irradiation. Furthermore, we provide in vitro evidence that TOPK plays a hitherto unknown role during S phase, showing that TOPK depletion increases fork stalling and collapse under conditions of replication stress and exogenous DNA damage. Transient knockdown of TOPK was shown to impair recovery from fork stalling and to increase the formation of replication-associated single-stranded DNA foci in H460 lung cancer cells. We also show that TOPK interacts directly with CHK1 and Cdc25c, two key players in the checkpoint signalling pathway activated after replication fork collapse. This study thus provides novel insights into the mechanism by which TOPK activity supports the survival of cancer cells, facilitating checkpoint signalling in response to replication stress and DNA damage.

Published
2020

36. Tapering Canakinumab Monotherapy in Patients with Systemic Juvenile Idiopathic Arthritis in Clinical Remission: Results from an Open‐label, Randomized Phase IIIb/IV Study

Author

Quartier, P, Alexeeva, E, Tamàs, C, Chasnyk, V, Wulffraat, N, Palmblad, K, Wouters, C, Brunner, H, Marzan, K, Schneider, R, Horneff, G, Martini, A, Anton, J, Wei, X, Slade, A, Ruperto, N, Abrams, K, Emminger, W, Ulbrich, A, Fodor, S, Desomer, L, Lauwerys, B, Brichard, B, Boulanger, C, Levy, G, Goffin, L, Quoc Le, P, Bandeira, M, Feitosa Pelajo, C, Knupp Feitosa, S, Costa, C, Cristine Felix Rodrigues, M, Artur Almeida da Silva, C, Maria Mattei de, L, Kozu, K, Laxer, R, Houghton, K, Tucker, L, Morishita, K, Mogenet, A, Mouy, R, Bader Meunier, B, Meyzer, C, Semeraro, M, Ben‐brahim, O, Kone‐paut, I, Galeotti, C, Rossi, L, Dusser, P, Cherquaoui, B, Belot, A, Duquesne, A, Caroline, F, Audrey, L, Desjonqueres, M, Foeldvari, I, Kienast, A, Willig, B, Barthel, D, Peitz, J, Wintrich, S, Felix Geikowski, T, Carina Schulz, A, Hufnagel, M, Hirdes, M, Kubicki, R, Kirschner, J, Janda, A, Jacob, A, Emerich, C, Raab, A, Ngoumou, G, Minden, K, Lieber, M, von Stuckrad, S, Kuemmerle Deschner, J, Hansmann, S, Schleich, T, Maria Magunia, I, Riethmuller, J, Anders, N, Lehmann, H, de Laffolie, J, Lutz, T, Grulich‐henn, J, Pfeil, J, Helling‐bakki, A, Trauzeddel, R, Haselbusch, D, Kolbeck, H, Weissbarth‐riedel, E, Froehlich, A, Ponyi, A, Garan, D, Orban, I, Sevcic, K, Butbul, Y, Brik, R, Hashkes, P, Toker, O, Haviv, R, Uziel, Y, Moshe, V, Rothschild, M, Harel, L, Amarilyo, G, Tal, R, Hamad Said, M, Tirosh, I, Spielman, S, Gerstein, M, Ravelli, A, Schiappapietra, B, Camilla Varnier, G, Finetti, M, Marasini, M, Caorsi, R, Rosina, S, Federici, S, Pontikaki, I, Luigi Meroni, P, Gerloni, V, Ughi, N, Ubiali, T, Alessio, M, Della Casa, R, Jozef Vastert, S, Frans Swart, J, van Royen‐Kerhof, A, Schatorje, E, Van Iperen‐Schutte, G, Rutkowska‐sak, L, Szczygielska, I, Kwiatkowska, M, Marusak‐banacka, M, Gietka, P, Isaeva, K, Denisova, R, Snegireva, L, Dubko, M, Kostik, M, Buchinskaia, N, Kalashnikova, O, Avrusin, S, Masalova, V, Nunez Cuadros, E, Diez, G, Galindo Zavala, R, Bou Torrent, R, Iglesias, E, Calzada, J, Bittermann, V, Lucica Boteanu, A, Luz Gamir, M, Calvo, I, Lopez, B, Gonzalez, I, Fernandez, L, Clemente Garulo, D, Carlos Lopez Robledillo, J, Merino, R, Alcobendas, R, Remesal, A, Murias, S, Magnusson, B, Kasapcopur, O, Barut, K, Adrovic, A, Sahin, S, Erguven, M, Gozdenur Savci, R, Ozen, S, Demir, S, Bilginer, Y, Serap Avci, Z, Deriz Batu, E, Reiff, A, Ramanatham, A, Brown, D, Shaham, B, Parks, S, Cidon, M, Higgins, G, Spencer, C, Rossette, J, Jones, K, Bout Tabaku, S, Farley, S, Akoghlanian, S, Pierre Quartier, Ekaterina Alexeeva, Constantin Tamàs, Vyacheslav Chasnyk, Nico Wulffraat, Karin Palmblad, Carine Wouters, Hermine Brunner, Katherine Marzan, Rayfel Schneider, Gerd Horneff, Alberto Martini, Jordi Anton, Xiaoling Wei, Alan Slade, Nicolino Ruperto, Ken Abrams, Wolfgang Emminger, Andrea Ulbrich, Sugarka Fodor, Lien Desomer, Bernard Lauwerys, Bénédicte Brichard, Cécile Boulanger, Gabriel Levy, Laurence Goffin, Phu Quoc Le, Marcia Bandeira, Christina Feitosa Pelajo, Sheila Knupp Feitosa, Christianne Costa, Marta Cristine Felix Rodrigues, Clovis Artur Almeida da Silva, Lucia Maria Mattei de, Katia Kozu, Ronald Laxer, Kristin Houghton, Lori Tucker, Kimberly Morishita, Agnes Mogenet, Richard Mouy, Brigitte Bader Meunier, Candice Meyzer, Michaela Semeraro, Ouafa Ben‐Brahim, Isabelle Kone‐Paut, Caroline Galeotti, Linda Rossi, Perrine Dusser, Bilade Cherquaoui, Alexandre Belot, Agnes Duquesne, Freychet Caroline, Laurent Audrey, Marine Desjonqueres, Ivan Foeldvari, Antonia Kienast, Barbara Willig, Deborah Barthel, Joachim Peitz, Stefanie Wintrich, Tilman Felix Geikowski, Anna Carina Schulz, Markus Hufnagel, Marc Hirdes, Rouven Kubicki, Janbernd Kirschner, Ales Janda, Andre Jacob, Cornelia Emerich, Anna Raab, Gonza Ngoumou, Kirsten Minden, Mareike Lieber, Sae‐Lim von Stuckrad, Jasmin Kuemmerle Deschner, Sandra Hansmann, Tom Schleich, Ines Maria Magunia, Joachim Riethmuller, Nicole Anders, Hartwig Lehmann, Jan de Laffolie, Thomas Lutz, Juergen Grulich‐Henn, Johannes Pfeil, Astrid Helling‐Bakki, Ralf Trauzeddel, Daniel Haselbusch, Henryk Kolbeck, Elisabeth Weissbarth‐Riedel, Anja Froehlich, Andrea Ponyi, Diana Garan, Ilonka Orban, Krisztina Sevcic, Yonatan Butbul, Riva Brik, Philip Hashkes, Ori Toker, Ruby Haviv, Yosef Uziel, Rubi Haviv, Veronica Moshe, Michal Rothschild, Liora Harel, Gil Amarilyo, Rotem Tal, Mohamad Hamad Said, Irit Tirosh, Shiri Spielman, Maya Gerstein, Angelo Ravelli, Benedetta Schiappapietra, Giulia Camilla Varnier, Martina Finetti, Maurizio Marasini, Roberta Caorsi, Silvia Rosina, Silvia Federici, Irene Pontikaki, Pier Luigi Meroni, Valeri Gerloni, Nicola Ughi, Tania Ubiali, Maria Alessio, Roberto Della Casa, Sebastiaan Jozef Vastert, Joost Frans Swart, A. van Royen‐Kerhof, Ellen Schatorje, G. Van Iperen‐Schutte, Lidia Rutkowska‐Sak, Izabela Szczygielska, Malgorzata Kwiatkowska, Maria Marusak‐Banacka, Piotr Gietka, Kseniya Isaeva, Rina Denisova, Ludmila Snegireva, Margarita Dubko, Mikhail Kostik, Natalia Buchinskaia, Olga Kalashnikova, Sergey Avrusin, Vera Masalova, Esmeralda Nunez Cuadros, Gisela Diez, Rocio Galindo Zavala, Rosa Bou Torrent, Estibaliz Iglesias, Joan Calzada, Violeta Bittermann, Alina Lucica Boteanu, Maria Luz Gamir, Inmaculada Calvo, Berta Lopez, Isabel Gonzalez, Laura Fernandez, Daniel Clemente Garulo, Juan Carlos Lopez Robledillo, Rosa Merino, Rosa Alcobendas, Agustin Remesal, Sara Murias, Bo Magnusson, Ozgur Kasapcopur, Kenan Barut, Amra Adrovic, Sezgin Sahin, Muferet Erguven, Refia Gozdenur Savci, Seza Ozen, Selcan Demir, Yelda Bilginer, Zehra Serap Avci, Ezgi Deriz Batu, Andreas Reiff, Anusha Ramanatham, Diana Brown, Bracha Shaham, Shirley Parks, Michal Cidon, Gloria Higgins, Charles Spencer, Jenny Rossette, Karla Jones, Sharon Bout Tabaku, Shelli Farley, Shoghik Akoghlanian, Quartier, P, Alexeeva, E, Tamàs, C, Chasnyk, V, Wulffraat, N, Palmblad, K, Wouters, C, Brunner, H, Marzan, K, Schneider, R, Horneff, G, Martini, A, Anton, J, Wei, X, Slade, A, Ruperto, N, Abrams, K, Emminger, W, Ulbrich, A, Fodor, S, Desomer, L, Lauwerys, B, Brichard, B, Boulanger, C, Levy, G, Goffin, L, Quoc Le, P, Bandeira, M, Feitosa Pelajo, C, Knupp Feitosa, S, Costa, C, Cristine Felix Rodrigues, M, Artur Almeida da Silva, C, Maria Mattei de, L, Kozu, K, Laxer, R, Houghton, K, Tucker, L, Morishita, K, Mogenet, A, Mouy, R, Bader Meunier, B, Meyzer, C, Semeraro, M, Ben‐brahim, O, Kone‐paut, I, Galeotti, C, Rossi, L, Dusser, P, Cherquaoui, B, Belot, A, Duquesne, A, Caroline, F, Audrey, L, Desjonqueres, M, Foeldvari, I, Kienast, A, Willig, B, Barthel, D, Peitz, J, Wintrich, S, Felix Geikowski, T, Carina Schulz, A, Hufnagel, M, Hirdes, M, Kubicki, R, Kirschner, J, Janda, A, Jacob, A, Emerich, C, Raab, A, Ngoumou, G, Minden, K, Lieber, M, von Stuckrad, S, Kuemmerle Deschner, J, Hansmann, S, Schleich, T, Maria Magunia, I, Riethmuller, J, Anders, N, Lehmann, H, de Laffolie, J, Lutz, T, Grulich‐henn, J, Pfeil, J, Helling‐bakki, A, Trauzeddel, R, Haselbusch, D, Kolbeck, H, Weissbarth‐riedel, E, Froehlich, A, Ponyi, A, Garan, D, Orban, I, Sevcic, K, Butbul, Y, Brik, R, Hashkes, P, Toker, O, Haviv, R, Uziel, Y, Moshe, V, Rothschild, M, Harel, L, Amarilyo, G, Tal, R, Hamad Said, M, Tirosh, I, Spielman, S, Gerstein, M, Ravelli, A, Schiappapietra, B, Camilla Varnier, G, Finetti, M, Marasini, M, Caorsi, R, Rosina, S, Federici, S, Pontikaki, I, Luigi Meroni, P, Gerloni, V, Ughi, N, Ubiali, T, Alessio, M, Della Casa, R, Jozef Vastert, S, Frans Swart, J, van Royen‐Kerhof, A, Schatorje, E, Van Iperen‐Schutte, G, Rutkowska‐sak, L, Szczygielska, I, Kwiatkowska, M, Marusak‐banacka, M, Gietka, P, Isaeva, K, Denisova, R, Snegireva, L, Dubko, M, Kostik, M, Buchinskaia, N, Kalashnikova, O, Avrusin, S, Masalova, V, Nunez Cuadros, E, Diez, G, Galindo Zavala, R, Bou Torrent, R, Iglesias, E, Calzada, J, Bittermann, V, Lucica Boteanu, A, Luz Gamir, M, Calvo, I, Lopez, B, Gonzalez, I, Fernandez, L, Clemente Garulo, D, Carlos Lopez Robledillo, J, Merino, R, Alcobendas, R, Remesal, A, Murias, S, Magnusson, B, Kasapcopur, O, Barut, K, Adrovic, A, Sahin, S, Erguven, M, Gozdenur Savci, R, Ozen, S, Demir, S, Bilginer, Y, Serap Avci, Z, Deriz Batu, E, Reiff, A, Ramanatham, A, Brown, D, Shaham, B, Parks, S, Cidon, M, Higgins, G, Spencer, C, Rossette, J, Jones, K, Bout Tabaku, S, Farley, S, Akoghlanian, S, Pierre Quartier, Ekaterina Alexeeva, Constantin Tamàs, Vyacheslav Chasnyk, Nico Wulffraat, Karin Palmblad, Carine Wouters, Hermine Brunner, Katherine Marzan, Rayfel Schneider, Gerd Horneff, Alberto Martini, Jordi Anton, Xiaoling Wei, Alan Slade, Nicolino Ruperto, Ken Abrams, Wolfgang Emminger, Andrea Ulbrich, Sugarka Fodor, Lien Desomer, Bernard Lauwerys, Bénédicte Brichard, Cécile Boulanger, Gabriel Levy, Laurence Goffin, Phu Quoc Le, Marcia Bandeira, Christina Feitosa Pelajo, Sheila Knupp Feitosa, Christianne Costa, Marta Cristine Felix Rodrigues, Clovis Artur Almeida da Silva, Lucia Maria Mattei de, Katia Kozu, Ronald Laxer, Kristin Houghton, Lori Tucker, Kimberly Morishita, Agnes Mogenet, Richard Mouy, Brigitte Bader Meunier, Candice Meyzer, Michaela Semeraro, Ouafa Ben‐Brahim, Isabelle Kone‐Paut, Caroline Galeotti, Linda Rossi, Perrine Dusser, Bilade Cherquaoui, Alexandre Belot, Agnes Duquesne, Freychet Caroline, Laurent Audrey, Marine Desjonqueres, Ivan Foeldvari, Antonia Kienast, Barbara Willig, Deborah Barthel, Joachim Peitz, Stefanie Wintrich, Tilman Felix Geikowski, Anna Carina Schulz, Markus Hufnagel, Marc Hirdes, Rouven Kubicki, Janbernd Kirschner, Ales Janda, Andre Jacob, Cornelia Emerich, Anna Raab, Gonza Ngoumou, Kirsten Minden, Mareike Lieber, Sae‐Lim von Stuckrad, Jasmin Kuemmerle Deschner, Sandra Hansmann, Tom Schleich, Ines Maria Magunia, Joachim Riethmuller, Nicole Anders, Hartwig Lehmann, Jan de Laffolie, Thomas Lutz, Juergen Grulich‐Henn, Johannes Pfeil, Astrid Helling‐Bakki, Ralf Trauzeddel, Daniel Haselbusch, Henryk Kolbeck, Elisabeth Weissbarth‐Riedel, Anja Froehlich, Andrea Ponyi, Diana Garan, Ilonka Orban, Krisztina Sevcic, Yonatan Butbul, Riva Brik, Philip Hashkes, Ori Toker, Ruby Haviv, Yosef Uziel, Rubi Haviv, Veronica Moshe, Michal Rothschild, Liora Harel, Gil Amarilyo, Rotem Tal, Mohamad Hamad Said, Irit Tirosh, Shiri Spielman, Maya Gerstein, Angelo Ravelli, Benedetta Schiappapietra, Giulia Camilla Varnier, Martina Finetti, Maurizio Marasini, Roberta Caorsi, Silvia Rosina, Silvia Federici, Irene Pontikaki, Pier Luigi Meroni, Valeri Gerloni, Nicola Ughi, Tania Ubiali, Maria Alessio, Roberto Della Casa, Sebastiaan Jozef Vastert, Joost Frans Swart, A. van Royen‐Kerhof, Ellen Schatorje, G. Van Iperen‐Schutte, Lidia Rutkowska‐Sak, Izabela Szczygielska, Malgorzata Kwiatkowska, Maria Marusak‐Banacka, Piotr Gietka, Kseniya Isaeva, Rina Denisova, Ludmila Snegireva, Margarita Dubko, Mikhail Kostik, Natalia Buchinskaia, Olga Kalashnikova, Sergey Avrusin, Vera Masalova, Esmeralda Nunez Cuadros, Gisela Diez, Rocio Galindo Zavala, Rosa Bou Torrent, Estibaliz Iglesias, Joan Calzada, Violeta Bittermann, Alina Lucica Boteanu, Maria Luz Gamir, Inmaculada Calvo, Berta Lopez, Isabel Gonzalez, Laura Fernandez, Daniel Clemente Garulo, Juan Carlos Lopez Robledillo, Rosa Merino, Rosa Alcobendas, Agustin Remesal, Sara Murias, Bo Magnusson, Ozgur Kasapcopur, Kenan Barut, Amra Adrovic, Sezgin Sahin, Muferet Erguven, Refia Gozdenur Savci, Seza Ozen, Selcan Demir, Yelda Bilginer, Zehra Serap Avci, Ezgi Deriz Batu, Andreas Reiff, Anusha Ramanatham, Diana Brown, Bracha Shaham, Shirley Parks, Michal Cidon, Gloria Higgins, Charles Spencer, Jenny Rossette, Karla Jones, Sharon Bout Tabaku, Shelli Farley, and Shoghik Akoghlanian

Abstract

Objective: To evaluate the efficacy and safety of 2 canakinumab monotherapy tapering regimens in order to maintain complete clinical remission in children with systemic juvenile idiopathic arthritis (JIA). Methods: The study was designed as a 2-part phase IIIb/IV open-label, randomized trial. In the first part, patients received 4 mg/kg of canakinumab subcutaneously every 4 weeks and discontinued glucocorticoids and/or methotrexate as appropriate. Patients in whom clinical remission was achieved (inactive disease for at least 24 weeks) with canakinumab monotherapy were entered into the second part of the trial, in which they were randomized 1:1 into 1 of 2 treatment arms. In arm 1, the dose of canakinumab was reduced from 4 mg/kg to 2 mg/kg and then to 1 mg/kg, followed by discontinuation. In arm 2, the 4 mg/kg dose interval was prolonged from every 4 weeks, to every 8 weeks, and then to every 12 weeks, followed by discontinuation. In both arms, canakinumab exposure could be reduced provided systemic JIA remained in clinical remission for 24 weeks with each step. The primary objective was to assess whether >40% of randomized patients in either arm maintained clinical remission of systemic JIA for 24 weeks in the first part of the study. Results: In part 1 of the study, 182 patients were enrolled, with 75 of those patients randomized before entering part 2 of the trial. Among the 75 randomized patients, clinical remission was maintained for 24 weeks in 27 (71%) of 38 patients in arm 1 (2 mg/kg every 4 weeks) and 31 (84%) of 37 patients in arm 2 (4 mg/kg every 8 weeks) (P ≤ 0.0001 for arm 1 versus arm 2 among those meeting the 40% threshold). Overall, 25 (33%) of 75 patients discontinued canakinumab, and clinical remission was maintained for at least 24 weeks in all 25 of these patients. No new safety signals were identified. Conclusion: Reduction of canakinumab exposure may be feasible in patients who have achieved clinical remission of systemic JIA, but consisten

Published
2021

48. Use of atorvastatin in systemic lupus erythematosus in children and adolescents

Author

Schanberg, L. E., Sandborg, C., Barnhart, H. X., Ardoin, S. P., Yow, E., Evans, G. W., Mieszkalski, K. L., Ilowite, N. T., Eberhard, A., Imundo, L. F., Kimura, Y., von Scheven, E., Silverman, E., Bowyer, S. L., Punaro, M., Singer, N. G., Sherry, D. D., McCurdy, D., Klein-Gitelman, M., Wallace, C., Silver, R., Wagner-Weiner, L., Higgins, G. C., Brunner, H. I., Jung, L., Soep, J. B., Reed, A. M., Provenzale, J., and Thompson, S. D.

Published
2012
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