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5. Rhodomyrtone decreases Staphylococcus aureus SigB activity during exponentially growing phase and inhibits haemolytic activity within membrane vesicles

Author

Jover, A., Barcenilla, F., García, M., Pujol, M., Gasch, O., Domínguez, M.A., Camoez, M., Dueñas, C., Ojeda, E., Martínez, J.A., Marco, F., Chaves, F., Lagarde, M., López-Medrano, F., Montejo, J.M., Bereciertua, E., Hernández, J.L., von Wichmann, M.Á., Goenaga, A., García-Arenzana, J.M., Padilla, B., Padilla, C., Cercenado, E., García-Prado, G., Tapiol, J., Horcajada, J.P., Montero, M., Salvadó, M., Arnáiz, A., Fernández, C., Calbo, E., Xercavins, M., Granados, A., Fontanals, D., Pintado, V., Loza, E., Torre-Cisneros, J., Lara, R., Rodríguez-López, F., Natera, C., Blanco, J.R., Olarte, I., Benito, N., Mirelis, B., Murillas, J., Ruiz de Gopegui, E., Espejo, H., Morera, M.A., Rodríguez-Baño, J., López-Cortés, L.E., Pascual, A., Martín, C., Lepe, J.A., Molina, J., Sordé, R., Almirante, B., Larrosa, N., Mitsuwan, Watcharapong, Jiménez-Munguía, Irene, Visutthi, Monton, Sianglum, Wipawadee, Rodríguez-Ortega, Manuel J., and Voravuthikunchai, Supayang P.

Published
2019
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6. Plasma inducible degrader of the LDLR, soluble low-density lipoprotein receptor, and proprotein convertase subtilisin/kexin type 9 levels as potential biomarkers of familial hypercholesterolemia in children

Author

Amigó, E., Andrés, P., Barrio, M., Bilbao, J.Á., Bosch, M., Cabedo, J.L., Calvo, J., Campillo, C., Castejón, E., Castillejo, G., Castro, M., Cliville, R., De Gotardo, E., Domènech, V., Domínguez, D., Escolà, M., Fernández, M., García, J., Girona, R., Guijarro, E., Gutiérrez, M.A., Iglesias, D., Salsas, J.M., Luque, V., Machado, P., Maixé, J., Mallafré, M., Martin, R., Jiménez, M., Monne, R., Morillo, S., Naranjo, À., Pérez, C., Planelles, M., Querol, C., Rabadà, M.J., Remedi, A., Riquelme, C., Rodríguez, N., Rosell, L., Salvado, M., Salvador, O., Santos, A., Sanz, N., Segura, S., Subirana, G., Tarrades, P., Vendrell, M., Vilella, M., Zabala, E., Girona, Josefa, Rodríguez-Borjabad, Cèlia, Ibarretxe, Daiana, Heras, Mercedes, Amigo, Nuria, Feliu, Albert, Masana, Luis, and Plana, Nuria

Published
2018
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18. Healthcare delivery for HIV-positive people with tuberculosis in Europe

Author

Bentzon, A, Panteleev, A, Mitsura, V, Borodulina, E, Skrahina, A, Denisova, E, Tetradov, S, Podlasin, R, Riekstina, V, Kancauskiene, Z, Paduto, D, Mocroft, A, Trofimova, T, Miller, R, Post, F, Grezesczuk, A, Lundgren, J, Inglot, M, Podlekareva, D, Bolokadze, N, Kirk, O, Karpov, I, Vassilenko, A, Klimuk, D, Skrahin, A, Kondratenko, O, Zalutskaya, A, Bondarenko, V, Kozorez, E, Tumash, O, Suetnov, O, Iljina, V, Kummik, T, Mshvidobadze, K, Lanchava, N, Goginashvili, L, Mikiashvili, L, Bablishvili, N, Rozentale, B, Zeltina, I, Janushkevich, I, Caplinskiene, I, Caplinskas, S, Wiercinska-Drapalo, A, Thompson, M, Kozlowska, J, Bura, M, Knysz, B, Garlicki, A, Loster, J, Duiculescu, D, Rakhmanova, A, Panteleeva, O, Yakovlev, A, Kozlov, A, Tyukalova, A, Vlasova, Y, Trofimov, T, Kyselyova, G, Obel, N, Gerstoft, J, Kronborg, G, Payen, M, Kabeya, K, Necsoi, C, Dabis, F, Tsaranazy, A, Cazanave, C, Furrer, H, Sagette, M, Rickenbach, M, Elzi, L, Battegay, M, Sculier, D, Calmy, A, Cavassini, M, Bruno, A, Bernasconi, E, Hoffmann, M, Vernazza, P, Fehr, J, Weber, R, Vora, N, Cooke, G, Mullaney, S, Wilkins, E, George, V, Collini, P, Dockrell, D, Campbell, L, Brum, R, Mabonga, E, Saigal, P, Kegg, S, Ainsworth, J, Waters, A, Dhar, J, Ellis, K, Spallanzani, O, Girardi, E, Rianda, A, Galati, V, Pinnetti, C, Tommasi, C, San Gerardo, A, Lapadula, G, Di Biagio, A, Parisini, A, Carbonara, S, Angarano, G, Purgatorio, M, Matteelli, A, Apostoli, A, Miro, J, Manzardo, C, Ligero, C, Gonzalez, J, Martinez-Martinez, J, Sanchez, F, Knobel, H, Salvado, M, Lopez-Colomes, J, Martinez-Lacasa, X, Cuchi, E, Falco, V, Curran, A, Tortola, M, Ocana, I, Vidal, R, Sambeat, M, Pomar, V, Coll, P, Pozamczer, D, Saumoy, M, Alcaide, F, Cayla, J, Moreno, A, Millet, J, Orcau, A, Fina, L, Romero, A, Roldan, L, Iribarren, J, Ibarguren, M, Moreno, S, Gonzalez, A, Miralles, P, Aldamiz-Echevarria, T, Losso, M, Toibaro, J, Gambardella, L, Ramos Mejia, J, Moreno Macias, L, Warley, E, Tavella, S, Garcia Messina, O, Gear, O, Laplume, H, Marson, C, Contarelia, J, Michaan, M, Scapellato, P, Bartoletti, B, Palmero, D, Elias, C, Cortes, C, Crabtree, B, Mosqueda Gomez, J, Villanueva, J, Gonzalez Hernandez, L, Badial, F, Bentzon A. K., Panteleev A., Mitsura V., Borodulina E., Skrahina A., Denisova E., Tetradov S., Podlasin R., Riekstina V., Kancauskiene Z., Paduto D., Mocroft A., Trofimova T., Miller R., Post F., Grezesczuk A., Lundgren J. D., Inglot M., Podlekareva D., Bolokadze N., Kirk O., Karpov I., Vassilenko A., Klimuk D., Skrahin A., Kondratenko O., Zalutskaya A., Bondarenko V., Kozorez E., Tumash O., Suetnov O., Iljina V., Kummik T., Mshvidobadze K., Lanchava N., Goginashvili L., Mikiashvili L., Bablishvili N., Rozentale B., Zeltina I., Janushkevich I., Caplinskiene I., Caplinskas S., Wiercinska-Drapalo A., Thompson M., Kozlowska J., Bura M., Knysz B., Garlicki A., Loster J., Duiculescu D., Rakhmanova A., Panteleeva O., Yakovlev A., Kozlov A., Tyukalova A., Vlasova Y., Trofimov T., Kyselyova G., Obel N., Gerstoft J., Kronborg G., Payen M. C., Kabeya K., Necsoi C., Dabis F., Tsaranazy A., Cazanave C., Furrer H., Sagette M., Rickenbach M., Elzi L., Battegay M., Sculier D., Calmy A., Cavassini M., Bruno A., Bernasconi E., Hoffmann M., Vernazza P., Fehr J., Weber R., Vora N., Cooke G., Mullaney S., Wilkins E., George V., Collini P., Dockrell D., Campbell L., Brum R., Mabonga E., Saigal P., Kegg S., Ainsworth J., Waters A., Dhar J., Ellis K., Spallanzani O. L., Girardi E., Rianda A., Galati V., Pinnetti C., Tommasi C., San Gerardo A. O., Lapadula G., Di Biagio A., Parisini A., Carbonara S., Angarano G., Purgatorio M., Matteelli A., Apostoli A., Miro J. M., Manzardo C., Ligero C., Gonzalez J., Martinez-Martinez J. A., Sanchez F., Knobel H., Salvado M., Lopez-Colomes J. L., Martinez-Lacasa X., Cuchi E., Falco V., Curran A., Tortola M. T., Ocana I., Vidal R., Sambeat M. A., Pomar V., Coll P., Pozamczer D., Saumoy M., Alcaide F., Cayla J., Moreno A., Millet J. P., Orcau A., Fina L., Romero A., Roldan L. L., Iribarren J. A., Ibarguren M., Moreno S., Gonzalez A., Miralles P., Aldamiz-Echevarria T., Losso M., Toibaro J., Gambardella L., Ramos Mejia J. M., Moreno Macias L., Warley E., Tavella S., Garcia Messina O., Gear O., Laplume H., Marson C., Contarelia J., Michaan M., Scapellato P., Bartoletti B., Palmero D., Elias C., Cortes C., Crabtree B., Mosqueda Gomez J. L., Villanueva J. A., Gonzalez Hernandez L. A., Badial F., Bentzon, A, Panteleev, A, Mitsura, V, Borodulina, E, Skrahina, A, Denisova, E, Tetradov, S, Podlasin, R, Riekstina, V, Kancauskiene, Z, Paduto, D, Mocroft, A, Trofimova, T, Miller, R, Post, F, Grezesczuk, A, Lundgren, J, Inglot, M, Podlekareva, D, Bolokadze, N, Kirk, O, Karpov, I, Vassilenko, A, Klimuk, D, Skrahin, A, Kondratenko, O, Zalutskaya, A, Bondarenko, V, Kozorez, E, Tumash, O, Suetnov, O, Iljina, V, Kummik, T, Mshvidobadze, K, Lanchava, N, Goginashvili, L, Mikiashvili, L, Bablishvili, N, Rozentale, B, Zeltina, I, Janushkevich, I, Caplinskiene, I, Caplinskas, S, Wiercinska-Drapalo, A, Thompson, M, Kozlowska, J, Bura, M, Knysz, B, Garlicki, A, Loster, J, Duiculescu, D, Rakhmanova, A, Panteleeva, O, Yakovlev, A, Kozlov, A, Tyukalova, A, Vlasova, Y, Trofimov, T, Kyselyova, G, Obel, N, Gerstoft, J, Kronborg, G, Payen, M, Kabeya, K, Necsoi, C, Dabis, F, Tsaranazy, A, Cazanave, C, Furrer, H, Sagette, M, Rickenbach, M, Elzi, L, Battegay, M, Sculier, D, Calmy, A, Cavassini, M, Bruno, A, Bernasconi, E, Hoffmann, M, Vernazza, P, Fehr, J, Weber, R, Vora, N, Cooke, G, Mullaney, S, Wilkins, E, George, V, Collini, P, Dockrell, D, Campbell, L, Brum, R, Mabonga, E, Saigal, P, Kegg, S, Ainsworth, J, Waters, A, Dhar, J, Ellis, K, Spallanzani, O, Girardi, E, Rianda, A, Galati, V, Pinnetti, C, Tommasi, C, San Gerardo, A, Lapadula, G, Di Biagio, A, Parisini, A, Carbonara, S, Angarano, G, Purgatorio, M, Matteelli, A, Apostoli, A, Miro, J, Manzardo, C, Ligero, C, Gonzalez, J, Martinez-Martinez, J, Sanchez, F, Knobel, H, Salvado, M, Lopez-Colomes, J, Martinez-Lacasa, X, Cuchi, E, Falco, V, Curran, A, Tortola, M, Ocana, I, Vidal, R, Sambeat, M, Pomar, V, Coll, P, Pozamczer, D, Saumoy, M, Alcaide, F, Cayla, J, Moreno, A, Millet, J, Orcau, A, Fina, L, Romero, A, Roldan, L, Iribarren, J, Ibarguren, M, Moreno, S, Gonzalez, A, Miralles, P, Aldamiz-Echevarria, T, Losso, M, Toibaro, J, Gambardella, L, Ramos Mejia, J, Moreno Macias, L, Warley, E, Tavella, S, Garcia Messina, O, Gear, O, Laplume, H, Marson, C, Contarelia, J, Michaan, M, Scapellato, P, Bartoletti, B, Palmero, D, Elias, C, Cortes, C, Crabtree, B, Mosqueda Gomez, J, Villanueva, J, Gonzalez Hernandez, L, Badial, F, Bentzon A. K., Panteleev A., Mitsura V., Borodulina E., Skrahina A., Denisova E., Tetradov S., Podlasin R., Riekstina V., Kancauskiene Z., Paduto D., Mocroft A., Trofimova T., Miller R., Post F., Grezesczuk A., Lundgren J. D., Inglot M., Podlekareva D., Bolokadze N., Kirk O., Karpov I., Vassilenko A., Klimuk D., Skrahin A., Kondratenko O., Zalutskaya A., Bondarenko V., Kozorez E., Tumash O., Suetnov O., Iljina V., Kummik T., Mshvidobadze K., Lanchava N., Goginashvili L., Mikiashvili L., Bablishvili N., Rozentale B., Zeltina I., Janushkevich I., Caplinskiene I., Caplinskas S., Wiercinska-Drapalo A., Thompson M., Kozlowska J., Bura M., Knysz B., Garlicki A., Loster J., Duiculescu D., Rakhmanova A., Panteleeva O., Yakovlev A., Kozlov A., Tyukalova A., Vlasova Y., Trofimov T., Kyselyova G., Obel N., Gerstoft J., Kronborg G., Payen M. C., Kabeya K., Necsoi C., Dabis F., Tsaranazy A., Cazanave C., Furrer H., Sagette M., Rickenbach M., Elzi L., Battegay M., Sculier D., Calmy A., Cavassini M., Bruno A., Bernasconi E., Hoffmann M., Vernazza P., Fehr J., Weber R., Vora N., Cooke G., Mullaney S., Wilkins E., George V., Collini P., Dockrell D., Campbell L., Brum R., Mabonga E., Saigal P., Kegg S., Ainsworth J., Waters A., Dhar J., Ellis K., Spallanzani O. L., Girardi E., Rianda A., Galati V., Pinnetti C., Tommasi C., San Gerardo A. O., Lapadula G., Di Biagio A., Parisini A., Carbonara S., Angarano G., Purgatorio M., Matteelli A., Apostoli A., Miro J. M., Manzardo C., Ligero C., Gonzalez J., Martinez-Martinez J. A., Sanchez F., Knobel H., Salvado M., Lopez-Colomes J. L., Martinez-Lacasa X., Cuchi E., Falco V., Curran A., Tortola M. T., Ocana I., Vidal R., Sambeat M. A., Pomar V., Coll P., Pozamczer D., Saumoy M., Alcaide F., Cayla J., Moreno A., Millet J. P., Orcau A., Fina L., Romero A., Roldan L. L., Iribarren J. A., Ibarguren M., Moreno S., Gonzalez A., Miralles P., Aldamiz-Echevarria T., Losso M., Toibaro J., Gambardella L., Ramos Mejia J. M., Moreno Macias L., Warley E., Tavella S., Garcia Messina O., Gear O., Laplume H., Marson C., Contarelia J., Michaan M., Scapellato P., Bartoletti B., Palmero D., Elias C., Cortes C., Crabtree B., Mosqueda Gomez J. L., Villanueva J. A., Gonzalez Hernandez L. A., and Badial F.

Abstract

Background: In a 2013 survey, we reported distinct discrepancies in delivery of tuberculosis (TB) and HIV services in eastern Europe (EE) vs. western Europe (WE). Objectives: To verify the differences in TB and HIV services in EE vs. WE. Methods: Twenty-three sites completed a survey in 2018 (EE, 14; WE, nine; 88% response rate). Results were compared across as well as within the two regions. When possible, results were compared with the 2013 survey. Results: Delivery of healthcare was significantly less integrated in EE: provision of TB and HIV services at one site (36% in EE vs. 89% in WE; P = 0.034), and continued TB follow-up in one location (42% vs. 100%; P = 0.007). Although access to TB diagnostics, standard TB and HIV drugs was generally good, fewer sites in EE reported unlimited access to rifabutin/multi-drug-resistant TB (MDR-TB) drugs, HIV integrase inhibitors and opioid substitution therapy (OST). Compared with 2013, routine usage of GeneXpert was more common in EE in 2018 (54% vs. 92%; P = 0.073), as was access to moxifloxacin (46% vs. 91%; P = 0.033), linezolid (31% vs. 64%; P = 0.217), and bedaquiline (0% vs. 25%; P = 0.217). Integration of TB and HIV services (46% vs. 39%; P = 1.000) and provision of OST to patients with opioid dependency (54% vs. 46%; P = 0.695) remained unchanged. Conclusion: Delivery of TB and HIV healthcare, including integration of TB and HIV care and access to MDR-TB drugs, still differs between WE and EE, as well as between individual EE sites.

Published
2021

19. Delayed diagnosis of tuberculosis in persons living with HIV in Eastern Europe: associated factors and effect on mortality—a multicentre prospective cohort study

Author

Kraef, C, Bentzon, A, Panteleev, A, Skrahina, A, Bolokadze, N, Tetradov, S, Podlasin, R, Karpov, I, Borodulina, E, Denisova, E, Azina, I, Lundgren, J, Johansen, I, Mocroft, A, Podlekareva, D, Kirk, O, Vassilenko, A, Klimuk, D, Kondratenko, O, Zalutskaya, A, Bondarenko, V, Mitsura, V, Kozorez, E, Tumash, O, Suetnov, O, Paduto, D, Iljina, V, Kummik, T, Mshvidobadze, K, Lanchava, N, Goginashvili, L, Mikiashvili, L, Bablishvili, N, Rozentale, B, Zeltina, I, Janushkevich, I, Caplinskiene, I, Caplinskas, S, Kancauskiene, Z, Wiercinska-Drapalo, A, Thompson, M, Kozlowska, J, Grezesczuk, A, Bura, M, Knysz, B, Inglot, M, Garlicki, A, Loster, J, Uiculescu, D, Rakhmanova, A, Panteleev, O, Yakovlev, A, Kozlov, A, Tyukalova, A, Vlasova, Y, Rofimov, T, Kyselyova, G, Obel, N, Gerstoft, J, Kronborg, G, Payen, M, Abeya, K, Necsoi, C, Dabis, F, Tsaranazy, A, Cazanave, C, Furrer, H, Sagette, M, Rickenbach, M, Sculier, D, Calmy, A, Cavassini, M, Bruno, A, Bernasconi, E, Hoffmann, M, Vernazza, P, Fehr, J, Weber, R, Miller, R, Vora, N, Cooke, G, Mullaney, S, Wilkins, E, George, V, Collini, P, Dockrell, D, Post, F, Campbell, L, Brum, R, Mabonga, E, Saigal, P, Kegg, S, Ainsworth, J, Waters, A, Dhar, J, Ellis, K, Girardi, E, Rianda, A, Galati, V, Pinnetti, C, Tommasi, C, Lapadula, G, Di Biagio, A, Parisini, A, Carbonara, S, Angarano, G, Purgatorio, M, Matteelli, A, Apostoli, A, Miro, J, Manzardo, C, Ligero, C, Gonzalez, J, Martinez-Martinez, J, Sanchez, F, Knobel, H, Salvado, M, Lopez-Colomes, J, Martinez-Lacasa, X, Cuchi, E, Falco, V, Curran, A, Tortola, M, Ocana, I, Vidal, R, Sambeat, M, Pomar, V, Coll, P, Pozamczer, D, Saumoy, M, Alcaide, F, Cayla, J, Moreno, A, Millet, J, Orcau, A, Fina, L, Romero, A, Roldan, L, Iribarren, J, Ibarguren, M, Moreno, S, Gonzalez, A, Miralles, P, Aldamiz-Echevarria, T, Losso, M, Toibaro, J, Gambardella, L, Moreno Macias, L, Warley, E, Tavella, S, Garcia Messina, O, Gear, O, Laplume, H, Marson, C, Contarelia, J, Michaan, M, Scapellato, P, Bartoletti, B, Palmero, D, Elias, C, Cortes, C, Crabtree, B, Mosqueda Gomez, J, Villanueva, J, Gonzalez Hernandez, L, Badial, F, Kraef C., Bentzon A., Panteleev A., Skrahina A., Bolokadze N., Tetradov S., Podlasin R., Karpov I., Borodulina E., Denisova E., Azina I., Lundgren J., Johansen I. S., Mocroft A., Podlekareva D., Kirk O., Vassilenko A., Klimuk D., Kondratenko O., Zalutskaya A., Bondarenko V., Mitsura V., Kozorez E., Tumash O., Suetnov O., Paduto D., Iljina V., Kummik T., Mshvidobadze K., Lanchava N., Goginashvili L., Mikiashvili L., Bablishvili N., Rozentale B., Zeltina I., Janushkevich I., Caplinskiene I., Caplinskas S., Kancauskiene Z., Wiercinska-Drapalo A., Thompson M., Kozlowska J., Grezesczuk A., Bura M., Knysz B., Inglot M., Garlicki A., Loster J., uiculescu D. D., Rakhmanova A., Panteleev O., Yakovlev A., Kozlov A., Tyukalova A., Vlasova Y., rofimov T. T., Kyselyova G., Obel N., Gerstoft J., Kronborg G., Payen M. C., abeya K. K., Necsoi C., Dabis F., Tsaranazy A., Cazanave C., Furrer H., Sagette M., Rickenbach M., Sculier D., Calmy A., Cavassini M., Bruno A., Bernasconi E., Hoffmann M., Vernazza P., Fehr J., Weber R., Miller R., Vora N., Cooke G., Mullaney S., Wilkins E., George V., Collini P., Dockrell D., Post F., Campbell L., Brum R., Mabonga E., Saigal P., Kegg S., Ainsworth J., Waters A., Dhar J., Ellis K., Girardi E., Rianda A., Galati V., Pinnetti C., Tommasi C., Lapadula G., Di Biagio A., Parisini A., Carbonara S., Angarano G., Purgatorio M., Matteelli A., Apostoli A., Miro J. M., Manzardo C., Ligero C., Gonzalez J., Martinez-Martinez J. A., Sanchez F., Knobel H., Salvado M., Lopez-Colomes J. L., Martinez-Lacasa X., Cuchi E., Falco V., Curran A., Tortola M. T., Ocana I., Vidal R., Sambeat M. A., Pomar V., Coll P., Pozamczer D., Saumoy M., Alcaide F., Cayla J., Moreno A., Millet J. P., Orcau A., Fina L., Romero A., Roldan L. L., Iribarren J. A., Ibarguren M., Moreno S., Gonzalez A., Miralles P., Aldamiz-Echevarria T., Losso M., Toibaro J., Gambardella L., Moreno Macias L., Warley E., Tavella S., Garcia Messina O., Gear O., Laplume H., Marson C., Contarelia J., Michaan M., Scapellato P., Bartoletti B., Palmero D., Elias C., Cortes C., Crabtree B., Mosqueda Gomez J. L., Villanueva J. A., Gonzalez Hernandez L. A., Badial F., Kraef, C, Bentzon, A, Panteleev, A, Skrahina, A, Bolokadze, N, Tetradov, S, Podlasin, R, Karpov, I, Borodulina, E, Denisova, E, Azina, I, Lundgren, J, Johansen, I, Mocroft, A, Podlekareva, D, Kirk, O, Vassilenko, A, Klimuk, D, Kondratenko, O, Zalutskaya, A, Bondarenko, V, Mitsura, V, Kozorez, E, Tumash, O, Suetnov, O, Paduto, D, Iljina, V, Kummik, T, Mshvidobadze, K, Lanchava, N, Goginashvili, L, Mikiashvili, L, Bablishvili, N, Rozentale, B, Zeltina, I, Janushkevich, I, Caplinskiene, I, Caplinskas, S, Kancauskiene, Z, Wiercinska-Drapalo, A, Thompson, M, Kozlowska, J, Grezesczuk, A, Bura, M, Knysz, B, Inglot, M, Garlicki, A, Loster, J, Uiculescu, D, Rakhmanova, A, Panteleev, O, Yakovlev, A, Kozlov, A, Tyukalova, A, Vlasova, Y, Rofimov, T, Kyselyova, G, Obel, N, Gerstoft, J, Kronborg, G, Payen, M, Abeya, K, Necsoi, C, Dabis, F, Tsaranazy, A, Cazanave, C, Furrer, H, Sagette, M, Rickenbach, M, Sculier, D, Calmy, A, Cavassini, M, Bruno, A, Bernasconi, E, Hoffmann, M, Vernazza, P, Fehr, J, Weber, R, Miller, R, Vora, N, Cooke, G, Mullaney, S, Wilkins, E, George, V, Collini, P, Dockrell, D, Post, F, Campbell, L, Brum, R, Mabonga, E, Saigal, P, Kegg, S, Ainsworth, J, Waters, A, Dhar, J, Ellis, K, Girardi, E, Rianda, A, Galati, V, Pinnetti, C, Tommasi, C, Lapadula, G, Di Biagio, A, Parisini, A, Carbonara, S, Angarano, G, Purgatorio, M, Matteelli, A, Apostoli, A, Miro, J, Manzardo, C, Ligero, C, Gonzalez, J, Martinez-Martinez, J, Sanchez, F, Knobel, H, Salvado, M, Lopez-Colomes, J, Martinez-Lacasa, X, Cuchi, E, Falco, V, Curran, A, Tortola, M, Ocana, I, Vidal, R, Sambeat, M, Pomar, V, Coll, P, Pozamczer, D, Saumoy, M, Alcaide, F, Cayla, J, Moreno, A, Millet, J, Orcau, A, Fina, L, Romero, A, Roldan, L, Iribarren, J, Ibarguren, M, Moreno, S, Gonzalez, A, Miralles, P, Aldamiz-Echevarria, T, Losso, M, Toibaro, J, Gambardella, L, Moreno Macias, L, Warley, E, Tavella, S, Garcia Messina, O, Gear, O, Laplume, H, Marson, C, Contarelia, J, Michaan, M, Scapellato, P, Bartoletti, B, Palmero, D, Elias, C, Cortes, C, Crabtree, B, Mosqueda Gomez, J, Villanueva, J, Gonzalez Hernandez, L, Badial, F, Kraef C., Bentzon A., Panteleev A., Skrahina A., Bolokadze N., Tetradov S., Podlasin R., Karpov I., Borodulina E., Denisova E., Azina I., Lundgren J., Johansen I. S., Mocroft A., Podlekareva D., Kirk O., Vassilenko A., Klimuk D., Kondratenko O., Zalutskaya A., Bondarenko V., Mitsura V., Kozorez E., Tumash O., Suetnov O., Paduto D., Iljina V., Kummik T., Mshvidobadze K., Lanchava N., Goginashvili L., Mikiashvili L., Bablishvili N., Rozentale B., Zeltina I., Janushkevich I., Caplinskiene I., Caplinskas S., Kancauskiene Z., Wiercinska-Drapalo A., Thompson M., Kozlowska J., Grezesczuk A., Bura M., Knysz B., Inglot M., Garlicki A., Loster J., uiculescu D. D., Rakhmanova A., Panteleev O., Yakovlev A., Kozlov A., Tyukalova A., Vlasova Y., rofimov T. T., Kyselyova G., Obel N., Gerstoft J., Kronborg G., Payen M. C., abeya K. K., Necsoi C., Dabis F., Tsaranazy A., Cazanave C., Furrer H., Sagette M., Rickenbach M., Sculier D., Calmy A., Cavassini M., Bruno A., Bernasconi E., Hoffmann M., Vernazza P., Fehr J., Weber R., Miller R., Vora N., Cooke G., Mullaney S., Wilkins E., George V., Collini P., Dockrell D., Post F., Campbell L., Brum R., Mabonga E., Saigal P., Kegg S., Ainsworth J., Waters A., Dhar J., Ellis K., Girardi E., Rianda A., Galati V., Pinnetti C., Tommasi C., Lapadula G., Di Biagio A., Parisini A., Carbonara S., Angarano G., Purgatorio M., Matteelli A., Apostoli A., Miro J. M., Manzardo C., Ligero C., Gonzalez J., Martinez-Martinez J. A., Sanchez F., Knobel H., Salvado M., Lopez-Colomes J. L., Martinez-Lacasa X., Cuchi E., Falco V., Curran A., Tortola M. T., Ocana I., Vidal R., Sambeat M. A., Pomar V., Coll P., Pozamczer D., Saumoy M., Alcaide F., Cayla J., Moreno A., Millet J. P., Orcau A., Fina L., Romero A., Roldan L. L., Iribarren J. A., Ibarguren M., Moreno S., Gonzalez A., Miralles P., Aldamiz-Echevarria T., Losso M., Toibaro J., Gambardella L., Moreno Macias L., Warley E., Tavella S., Garcia Messina O., Gear O., Laplume H., Marson C., Contarelia J., Michaan M., Scapellato P., Bartoletti B., Palmero D., Elias C., Cortes C., Crabtree B., Mosqueda Gomez J. L., Villanueva J. A., Gonzalez Hernandez L. A., and Badial F.

Abstract

Background: Early diagnosis of tuberculosis (TB) is important to reduce transmission, morbidity and mortality in people living with HIV (PLWH). Methods: PLWH with a diagnosis of TB were enrolled from HIV and TB clinics in Eastern Europe and followed until 24 months. Delayed diagnosis was defined as duration of TB symptoms (cough, weight-loss or fever) for ≥ 1 month before TB diagnosis. Risk factors for delayed TB diagnosis were assessed using multivariable logistic regression. The effect of delayed diagnosis on mortality was assessed using Kaplan–Meier estimates and Cox models. Findings: 480/740 patients (64.9%; 95% CI 61.3–68.3%) experienced a delayed diagnosis. Age ≥ 50 years (vs. < 50 years, aOR = 2.51; 1.18–5.32; p = 0.016), injecting drug use (IDU) (vs. non-IDU aOR = 1.66; 1.21–2.29; p = 0.002), being ART naïve (aOR = 1.77; 1.24–2.54; p = 0.002), disseminated TB (vs. pulmonary TB, aOR = 1.56, 1.10–2.19, p = 0.012), and presenting with weight loss (vs. no weight loss, aOR = 1.63; 1.18–2.24; p = 0.003) were associated with delayed diagnosis. PLWH with a delayed diagnosis were at 36% increased risk of death (hazard ratio = 1.36; 1.04–1.77; p = 0.023, adjusted hazard ratio 1.27; 0.95–1.70; p = 0.103). Conclusion: Nearly two thirds of PLWH with TB in Eastern Europe had a delayed TB diagnosis, in particular those of older age, people who inject drugs, ART naïve, with disseminated disease, and presenting with weight loss. Patients with delayed TB diagnosis were subsequently at higher risk of death in unadjusted analysis. There is a need for optimisation of the current TB diagnostic cascade and HIV care in PLWH in Eastern Europe.

Published
2021

37. Healthcare delivery for HIV-positive people with tuberculosis in Europe

Author

Bentzon, A. K., Panteleev, A., Mitsura, V., Borodulina, E., Skrahina, A., Denisova, E., Tetradov, S., Podlasin, R., Riekstina, V., Kancauskiene, Z., Paduto, D., Mocroft, A., Trofimova, T., Miller, R., Post, F., Grezesczuk, A., Lundgren, J. D., Inglot, M., Podlekareva, D., Bolokadze, N., Kirk, O., Karpov, I., Vassilenko, A., Klimuk, D., Skrahin, A., Kondratenko, O., Zalutskaya, A., Bondarenko, V., Kozorez, E., Tumash, O., Suetnov, O., Iljina, V., Kummik, T., Mshvidobadze, K., Lanchava, N., Goginashvili, L., Mikiashvili, L., Bablishvili, N., Rozentale, B., Zeltina, I., Janushkevich, I., Caplinskiene, I., Caplinskas, S., Wiercinska-Drapalo, A., Thompson, M., Kozlowska, J., Bura, M., Knysz, B., Garlicki, A., Loster, J., Duiculescu, D., Rakhmanova, A., Panteleeva, O., Yakovlev, A., Kozlov, A., Tyukalova, A., Vlasova, Y., Trofimov, T., Kyselyova, G., Obel, N., Gerstoft, J., Kronborg, G., Payen, M. C., Kabeya, K., Necsoi, C., Dabis, F., Tsaranazy, A., Cazanave, C., Furrer, H., Sagette, M., Rickenbach, M., Elzi, L., Battegay, M., Sculier, D., Calmy, A., Cavassini, M., Bruno, A., Bernasconi, E., Hoffmann, M., Vernazza, P., Fehr, J., Weber, R., Vora, N., Cooke, G., Mullaney, S., Wilkins, E., George, V., Collini, P., Dockrell, D., Campbell, L., Brum, R., Mabonga, E., Saigal, P., Kegg, S., Ainsworth, J., Waters, A., Dhar, J., Ellis, K., Spallanzani, O. L., Girardi, E., Rianda, A., Galati, V., Pinnetti, C., Tommasi, C., San Gerardo, A. O., Lapadula, G., Di Biagio, A., Parisini, A., Carbonara, S., Angarano, G., Purgatorio, M., Matteelli, A., Apostoli, A., Miro, J. M., Manzardo, C., Ligero, C., Gonzalez, J., Martinez-Martinez, J. A., Sanchez, F., Knobel, H., Salvado, M., Lopez-Colomes, J. L., Martinez-Lacasa, X., Cuchi, E., Falco, V., Curran, A., Tortola, M. T., Ocana, I., Vidal, R., Sambeat, M. A., Pomar, V., Coll, P., Pozamczer, D., Saumoy, M., Alcaide, F., Cayla, J., Moreno, A., Millet, J. P., Orcau, A., Fina, L., Romero, A., Roldan, L. L., Iribarren, J. A., Ibarguren, M., Moreno, S., Gonzalez, A., Miralles, P., Aldamiz-Echevarria, T., Losso, M., Toibaro, J., Gambardella, L., Ramos Mejia, J. M., Moreno Macias, L., Warley, E., Tavella, S., Garcia Messina, O., Gear, O., Laplume, H., Marson, C., Contarelia, J., Michaan, M., Scapellato, P., Bartoletti, B., Palmero, D., Elias, C., Cortes, C., Crabtree, B., Mosqueda Gomez, J. L., Villanueva, J. A., Gonzalez Hernandez, L. A., and Badial, F.

Subjects
0301 basic medicine, medicine.medical_specialty, Rifabutin, Tuberculosis, Tuberculosi, Epidemiology, Antitubercular Agents, HIV Infections, Article, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Moxifloxacin, Internal medicine, medicine, clinical management, VIH (Virus), Humans, Pharmacology (medical), 030212 general & internal medicine, Epidemiologia, coinfection, eastern Europe, HIV, tuberculosis, western Europe, Response rate (survey), GeneXpert MTB/RIF, business.industry, HIV (Viruses), Health Policy, medicine.disease, 030112 virology, Europe, Infectious Diseases, HIV-positive people, chemistry, Coinfection, Bedaquiline, business, Europa, Delivery of Health Care, medicine.drug
Abstract

Background: In a 2013 survey, we reported distinct discrepancies in delivery of tuberculosis (TB) and HIV services in eastern Europe (EE) vs. western Europe (WE). Objectives: To verify the differences in TB and HIV services in EE vs. WE. Methods: Twenty-three sites completed a survey in 2018 (EE, 14; WE, nine; 88% response rate). Results were compared across as well as within the two regions. When possible, results were compared with the 2013 survey. Results: Delivery of healthcare was significantly less integrated in EE: provision of TB and HIV services at one site (36% in EE vs. 89% in WE; P = 0.034), and continued TB follow-up in one location (42% vs. 100%; P = 0.007). Although access to TB diagnostics, standard TB and HIV drugs was generally good, fewer sites in EE reported unlimited access to rifabutin/multi-drug-resistant TB (MDR-TB) drugs, HIV integrase inhibitors and opioid substitution therapy (OST). Compared with 2013, routine usage of GeneXpert was more common in EE in 2018 (54% vs. 92%; P = 0.073), as was access to moxifloxacin (46% vs. 91%; P = 0.033), linezolid (31% vs. 64%; P = 0.217), and bedaquiline (0% vs. 25%; P = 0.217). Integration of TB and HIV services (46% vs. 39%; P = 1.000) and provision of OST to patients with opioid dependency (54% vs. 46%; P = 0.695) remained unchanged. Conclusion: Delivery of TB and HIV healthcare, including integration of TB and HIV care and access to MDR-TB drugs, still differs between WE and EE, as well as between individual EE sites.

Published
2020
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38. A Mix of Natural Bioactive Compounds Reduces Fat Accumulation and Modulates Gene Expression in the Adipose Tissue of Obese Rats Fed a Cafeteria Diet

Author

Universitat Rovira i Virgili, Gibert-Ramos, Albert; Martin-Gonzalez, Miguel Z.; Crescenti, Anna; Salvado, M. Josepa, Universitat Rovira i Virgili, and Gibert-Ramos, Albert; Martin-Gonzalez, Miguel Z.; Crescenti, Anna; Salvado, M. Josepa

Abstract

Scientists are focusing on bioactive ingredients to counteract obesity. We evaluated whether a mix containing grape seed proanthocyanidin extract (GSPE), anthocyanins, conjugated linoleic acid (CLA), and chicken feet hydrolysate (CFH) could reduce body fat mass and also determined which mechanisms in the white adipose tissue (WAT) and the brown adipose tissue (BAT) were affected by the treatment. The mix or vehicle (VH) were administered for three weeks to obese rats fed a cafeteria (CAF) diet. Biometric measures, indirect calorimetry, and gene expression in WAT and BAT were analyzed as was the histology of the inguinal WAT (IWAT). The individual compounds were also tested in the 3T3-L1 cell line. The mix treatment resulted in a significant 15% reduction in fat (25.01 +/- 0.91 g) compared to VH treatment (21.19 +/- 1.59 g), and the calorimetry results indicated a significant increase in energy expenditure and fat oxidation. We observed a significant downregulation of Fasn mRNA and an upregulation of Atgl and Hsl mRNA in adipose depots in the group treated with the mix. The IWAT showed a tendency of reduction in the number of adipocytes, although no differences in the total adipocyte area were found. GSPE and anthocyanins modulated the lipid content and downregulated the gene and protein levels of Fasn compared to the untreated group in 3T3-L1 cells. In conclusion, this mix is a promising treatment against obesity, reducing the WAT of obese rats fed a CAF diet, increasing energy expenditure and fat oxidation, and modifying the expression of genes involved in lipid metabolism of the adipose tissue.

Published
2020

39. Recent improvement in long-term survival after a COPD hospitalisation

Author

Almagro, Pere, Salvado, M., Garcia-Vidal, C., Rodriguez-Carballeira, M., Delgado, M., Barreiro, B., Heredia, J.L., and Soriano, Joan B.

Subjects
Lung diseases, Obstructive -- Care and treatment, Lung diseases, Obstructive -- Patient outcomes, Lung diseases, Obstructive -- Research, Mortality -- Spain, Mortality -- Research, Hospitals -- Admission and discharge, Hospitals -- Research, Health
Published
2010

42. Long-term safety and efficacy of subcutaneous immunoglobulin IgPro20 in CIDP: PATH extension study

Author

van Schaik, Ivo N, Mielke, Orell, Bril, Vera, van Geloven, Nan, Hartung, Hans-Peter, Lewis, Richard A, Sobue, Gen, Lawo, John-Philip, Praus, Michaela, Durn, Billie L, Cornblath, David R, Merkies, Ingemar SJ, Sabet, A, George, K, Roberts, L, Carne, R, Blum, S, Henderson, R, Van Damme, P, Demeestere, J, Larue, S, D'Amour, C, Bril, V, Breiner, A, Kunc, P, Michal, V, Sussova, J, Tomas, K, Talab, R, Michal, B, Toomsoo, T, Rubanovits, I, Gross-Paju, K, Sorro, U, Saarela, M, Auranen, M, Pouget, J, Attarian, S, Le Masson, G, Wielanek-Bachelet, A, Desnuelle, C, Delmont, E, Clavelou, P, Aufauvre, D, Schmidt, J, Zschumtszsch, J, Sommer, C, Kramer, D, Hoffmann, O, Goerlitz, C, Haas, J, Chatzopoulos, M, Yoon, R, Gold, R, Berlit, P, Jaspert-Grehl, A, Liebetanz, D, Kutschenko, A, Stangel, M, Trebst, C, Baum, P, Bergh, F, Klehmet, J, Meisel, A, Klostermann, F, Oechtering, J, Lehmann, H, Schroeter, M, Hagenacker, T, Mueller, D, Sperfeld, A, Bethke, F, Drory, V, Algom, A, Yarnitsky, D, Murinson, B, Di Muzio, A, Ciccocioppo, F, Sorbi, S, Mata, S, Schenone, A, Grandis, M, Lauria, G, Cazzato, D, Antonini, G, Morino, S, Cocito, D, Zibetti, M, Yokota, T, Ohkubo, T, Kanda, T, Kawai, M, Kaida, K, Onoue, H, Kuwabara, S, Mori, M, Iijima, M, Ohyama, K, Baba, M, Tomiyama, M, Nishiyama, K, Akutsu, T, Yokoyama, K, Kanai, K, van Schaik, IN, Eftimov, F, Notermans, NC, Visser, N, Faber, C, Hoeijmakers, J, Rejdak, K, Chyrchel-Paszkiewicz, U, Casanovas Pons, C, Antonia, M, Gamez, J, Salvado, M, Marquez Infante, C, Benitez, S, Lunn, M, Morrow, J, Gosal, D, Lavin, T, Melamed, I, Testori, A, Ajroud-Driss, S, Menichella, D, Simpson, E, Lai, E Chi-Ho, Dimachkie, M, Barohn, RJ, Beydoun, S, Johl, H, Lange, D, Shtilbans, A, Muley, S, Ladha, S, Freimer, M, Kissel, J, Latov, N, Chin, R, Ubogu, E, Mumfrey, S, Rao, T, MacDonald, P, Sharma, K, Gonzalez, G, Allen, J, Walk, D, Hobson-Webb, L, Gable, K, Klinische Neurowetenschappen, MUMC+: MA Med Staf Spec Neurologie (9), RS: MHeNs - R1 - Cognitive Neuropsychiatry and Clinical Neuroscience, Hagenacker, Tim (Beitragende*r), HUS Neurocenter, Neurologian yksikkö, Clinicum, Department of Neurosciences, Academic Medical Center, and CSL Behring

Subjects
Adult, Male, medicine.medical_specialty, Time Factors, Injections, Subcutaneous, Medizin, Chronic inflammatory demyelinating polyneuropathy, Subcutaneous immunoglobulin, INFLAMMATORY DEMYELINATING POLYNEUROPATHY, Gastroenterology, 3124 Neurology and psychiatry, law.invention, 03 medical and health sciences, MUSCLE STRENGTH, 0302 clinical medicine, Randomized controlled trial, law, Internal medicine, Humans, Medicine, Prospective Studies, Dosing, Adverse effect, Prospective cohort study, Aged, 030304 developmental biology, 0303 health sciences, MMN, business.industry, Extension study, 3112 Neurosciences, Immunoglobulins, Intravenous, Polyradiculoneuropathy, Middle Aged, medicine.disease, 3. Good health, Treatment Outcome, Polyradiculoneuropathy, Chronic Inflammatory Demyelinating, Neurology, Immunoglobulin G, Female, Neurology (clinical), business, 030217 neurology & neurosurgery, Follow-Up Studies
Abstract

PATH study group., [Objective] To investigate the long-term safety and efficacy of weekly subcutaneous IgPro20 (Hizentra, CSL Behring) in chronic inflammatory demyelinating polyneuropathy (CIDP)., [Methods] In a 48-week open-label prospective extension study to the PATH study, patients were initially started on 0.2 g/kg or on 0.4 g/kg weekly and—if clinically stable—switched to 0.2 g/kg weekly after 24 weeks. Upon CIDP relapse on the 0.2 g/kg dose, 0.4 g/kg was (re)initiated. CIDP relapse was defined as a deterioration by at least 1 point in the total adjusted Inflammatory Neuropathy Cause and Treatment score., [Results] Eighty-two patients were enrolled. Sixty-two patients initially received 0.4 g/kg, 20 patients 0.2 g/kg weekly. Seventy-two received both doses during the study. Sixty-six patients (81%) completed the 48-week study duration. Overall relapse rates were 10% in 0.4 g/kg–treated patients and 48% in 0.2 g/kg–treated patients. After dose reduction from 0.4 to 0.2 g/kg, 51% (27/53) of patients relapsed, of whom 92% (24 of 26) improved after reinitiation of the 0.4 g/kg dose. Two-thirds of patients (19/28) who completed the PATH study without relapse remained relapse-free on the 0.2 g/kg dose after dose reduction in the extension study. Sixty-two patients had adverse events (AEs) (76%), of which most were mild or moderate with no related serious AEs., [Conclusions] Subcutaneous treatment with IgPro20 provided long-term benefit at both 0.4 and 0.2 g/kg weekly doses with lower relapse rates on the higher dose. Long-term dosing should be individualized to find the most appropriate dose in a given patient. Classification of evidence This study provides Class IV evidence that for patients with CIDP, long-term treatment with SCIG beyond 24 weeks is safe and efficacious., This study was supported by CSL Behring.

Published
2019
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43. Correction to: Eculizumab improves fatigue in refractory generalized myasthenia gravis (Quality of Life Research, (2019), 28, 8, (2247-2254), 10.1007/s11136-019-02148-2)

Author

Andersen, H., Mantegazza, R., Wang, J. J., O'Brien, F., Patra, K., Howard, J. F., Mazia, C. G., Wilken, M., Barroso, F., Saba, J., Rugiero, M., Bettini, M., Chaves, M., Vidal, G., Garcia, A. D., Debleecker, J., Van denAbeele, G., Dekoning, K., Demey, K., Mercelis, R., Mahieu, D., Wagemaekers, L., Vandamme, P., Depreitere, A., Schotte, C., Smetcoren, C., Stevens, O., Vandaele, S., Vandenbussche, N., Vanhee, A., Verjans, S., Vynckier, J., D'Hondt, A., Tilkin, P., AlvesdeSiqueira Carvalho, A., Diasbrockhausen, I., Feder, D., Ambrosio, D., Cesar, P., Melo, A. P., Martinsribeiro, R., Rocha, R., Bezerrarosa, B., Veiga, T., Dasilva, L. A., Santosengel, M., Goncalvesgeraldo, J., daPenha AnaniasMorita, M., Nogueiracoelho, E., Paiva, G., Pozo, M., Prando, N., Martinelitorres, D. D., Butinhao, C. F., Duran, G., Gomes daSilva, T. C., Otavio MaiaGoncalves, L., Pazetto, L. E., Fialho, T. A. S., Renata CubasVolpe, L., Souzaduca, L., Ghellerfriedrich, M. A., Guerreiro, A., Mohr, H., Pereiramartins, M., daCruz Pacheco, D., Ferreira, L., Macagnan, A. P., Pinto, G., deCassia Santos, A., Souza BulleOliveira, A., Amaralandrade, A. C., Annes, M., Duarte Silva, L., Cavalcantelino, V., Pinto, W., Assis, N., Carrara, F., Miranda, C., Souza, I., Fernandes, P., Siddiqi, Z., Phan, C., Narayan, J., Blackmore, D., Mallon, A., Roderus, R., Watt, E., Vohanka, S., Bednarik, J., Chmelikova, M., Cierny, M., Toncrova, S., Junkerova, J., Kurkova, B., Reguliova, K., Zapletalova, O., Pitha, J., Novakova, I., Tyblova, M., Jurajdova, I., Wolfova, M., Harbo, T., Vinge, L., Krogh, S., Mogensen, A., Vissing, J., Hojgaard, J., Witting, N., Ostergaardautzen, A., Pedersen, J., Eralinna, J. -P., Laaksonen, M., Oksaranta, O., Harrison, T., Eriksson, J., Rozsa, C., Horvath, M., Lovas, G., Matolcsi, J., Szabo, G., Jakab, G., Szabadosne, B., Vecsei, L., Dezsi, L., Varga, E., Konyane, M., Antonini, G., Dipasquale, A., Garibaldi, M., Morino, S., Troili, F., Fionda, L., Filla, A., Costabile, T., Marano, E., Sacca, F., Fasanaro, A., Marsili, A., Puorro, G., Antozzi, C., Bonanno, S., Camera, G., Locatelli, A., Maggi, L., Pasanisi, M., Campanella, A., Evoli, A., Alboini, P. E., D'Amato, V., Iorio, R., Inghilleri, M., Frasca, V., Giacomelli, E., Gori, M., Lopergolo, D., Onesti, E., Gabriele, M., Uzawa, A., Kanai, T., Kawaguchi, N., Mori, M., Kaneko, Y., Kanzaki, A., Kobayashi, E., Murai, H., Masaki, K., Matsuse, D., Matsushita, T., Uehara, T., Shimpo, M., Jingu, M., Kikutake, K., Nakamura, Y., Sano, Y., Utsugisawa, K., Nagane, Y., Kamegamori, I., Tsuda, T., Fujii, Y., Futono, K., Ozawa, Y., Mizugami, A., Saito, Y., Suzuki, H., Morikawa, M., Samukawa, M., Kamakura, S., Miyawaki, E., Shiraishi, H., Mitazaki, T., Motomura, M., Mukaino, A., Yoshimura, S., Asada, S., Yoshida, S., Amamoto, S., Kobashikawa, T., Koga, M., Maeda, Y., Takada, K., Takada, M., Tsurumaru, M., Yamashita, Y., Suzuki, Y., Akiyama, T., Narikawa, K., Tano, O., Tsukita, K., Kurihara, R., Meguro, F., Fukuda, Y., Sato, M., Okumura, M., Funaka, S., Kawamura, T., Makamori, M., Takahashi, M., Taichi, N., Hasuike, T., Higuchi, E., Kobayashi, H., Osakada, K., Imai, T., Tsuda, E., Shimohama, S., Hayashi, T., Hisahara, S., Kawamata, J., Murahara, T., Saitoh, M., Suzuki, S., Yamamoto, D., Ishiyama, Y., Ishiyama, N., Noshiro, M., Takeyama, R., Uwasa, K., Yasuda, I., van derKooi, A., Devisser, M., Gibson, T., Kim, B. -J., Lee, C. N., Koo, Y. S., Seok, H. Y., Kang, H. N., H. J., Ra, Kim, B. J., Cho, E. B., Choi, M. S., Lee, H. L., Min, J. -H., Seok, J., Lee, J. E., Koh, D. Y., Kwon, J. Y., Park, S. A., Choi, E. H., Hong, Y. -H., Ahn, S. -H., Koo, D. L., Lim, J. -S., Shin, C. W., Hwang, J. Y., Kim, M., Kim, S. M., Jeong, H. -N., Jung, J. W., Kim, Y. -H., Lee, H. S., Shin, H. Y., Hwang, E. B., Shin, M., Casasnovas, C., Albertiaguilo, M. A., Homedes-Pedret, C., Juliapalacios, N., Diezporras, L., Velezsantamaria, V., Lazaro, A., Dieztejedor, E., Gomez Salcedo, P., Fernandez-Fournier, M., Lopezruiz, P., Rodriguez deRivera, F. J., Sastre, M., Gamez, J., Sune, P., Salvado, M., Gili, G., Mazuela, G., Illa, I., Cortesvicente, E., Diaz-Manera, J., Querolgutierrez, L. A., Rojasgarcia, R., Vidal, N., Arribas-Ibar, E., Piehl, F., Hietala, A., Bjarbo, L., Sengun, I., Meherremova, A., Ozcelik, P., Balkan, B., Tuga, C., Ugur, M., Erdem-Ozdamar, S., Bekircan-Kurt, C. E., Acar, N. P., Yilmaz, E., Caliskan, Y., Orsel, G., Efendi, H., Aydinlik, S., Cavus, H., Kutlu, A., Becerikli, G., Semiz, C., Tun, O., Terzi, M., Dogan, B., Onar, M. K., Sen, S., Kirbascavdar, T., Veske, A., Norwood, F., Dimitriou, A., Gollogly, J., Mahdi-Rogers, M., Seddigh, A., Sokratous, G., Maier, G., Sohail, F., Jacob, S., Sadalage, G., Torane, P., Brown, C., Shah, A., Sathasivam, S., Arndt, H., Davies, D., Watling, D., Amato, A., Cochrane, T., Salajegheh, M., Roe, K., Amato, K., Toska, S., Wolfe, G., Silvestri, N., Patrick, K., Zakalik, K., Katz, J., Miller, R., Engel, M., Forshew, D., Bravver, E., Brooks, B., Plevka, S., Burdette, M., Cunningham, S., Sanjak, M., Kramer, M., Nemeth, J., Schommer, C., Tierney, S., Juel, V., Guptill, J., Hobson-Webb, L., Massey, J., Beck, K., Carnes, D., Loor, J., Anderson, A., Pascuzzi, R., Bodkin, C., Kincaid, J., Snook, R., Guingrich, S., Micheels, A., Chaudhry, V., Corse, A., Mosmiller, B., Kelley, A., Ho, D., Srinivasan, J., Vytopil, M., Jara, J., Ventura, N., Scala, S., Carter, C., Donahue, C., Herbert, C., Weiner, E., Alam, S., Mckinnon, J., Haar, L., Mckinnon, N., Alcon, K., Mckenna, K., Sattar, N., Daniels, K., Jeffery, D., Kissel, J., Freimer, M., Hoyle, J. C., Agriesti, J., Chelnick, S., Mezache, L., Pineda, C., Muharrem, F., Karam, C., Khoury, J., Marburger, T., Kaur, H., Dimitrova, D., Gilchrist, J., Agrawal, B., Elsayed, M., Kohlrus, S., Andoin, A., Darnell, T., Golden, L., Lokaitis, B., Seelback, J., Muppidi, S., Goyal, N., Sakamuri, S., Y. T., So, Paulose, S., Pol, S., Welsh, L., Bhavaraju-Sanka, R., Tobongonzales, A., Dishman, L., Jones, F., Gonzalez, A., Padilla, P., Saklad, A., Silva, M., Nations, S., Trivedi, J., Hopkins, S., Kazamel, M., Alsharabati, M., Lu, L., Nozaki, K., Mumfrey-Thomas, S., Woodall, A., Mozaffar, T., Cash, T., Roy, G., Mathew, V., Maqsood, F., Minton, B., Jones, H. J., Rosenfeld, J., Garcia, R., Echevarria, L., Garcia, S., Pulley, M., Aranke, S., Berger, A. R., Shah, J., Shabbir, Y., Smith, L., Varghese, M., Gutmann, L., Jerath, N., Nance, C., Swenson, A., Olalde, H., Kressin, N., Sieren, J., Barohn, R., Dimachkie, M., Glenn, M., Mcvey, A., Pasnoor, M., Statland, J., Wang, J., Liu, T., Emmons, K., Jenci, N., Locheke, J., Fondaw, A., Johns, K., Rico, G., Walsh, M., Herbelin, L., Hafer-Macko, C., Kwan, J., Zilliox, L., Callison, K., Young, V., Disanzo, B., Naunton, K., Benatar, M., Bilsker, M., Sharma, K., Cooley, A., Reyes, E., Michon, S. -C., Sheldon, D., Steele, J., Chopra, M., Traub, R., Vu, T., Katzin, L., Mcclain, T., Harvey, B., Hart, A., Huynh, K., Beydoun, S., Chilingaryan, A., Doan, V., Droker, B., Gong, H., Karimi, S., Lin, F., Pokala, K., Tran, A., Akhter, S., Malekniazi, A., Tandan, R., Hehir, M., Waheed, W., Lucy, S., Weiss, M., Distad, J., Strom, S., Downing, S., Kim, B., Bertorini, T., Arnold, T., Hendersen, K., Pillai, R., Liu, Y., Wheeler, L., Hewlett, J., Vanderhook, M., Nowak, R., Dicapua, D., Keung, B., Kumar, A., Patwa, H., Robeson, K., Yang, I., Nye, J., and Vu, H.

Subjects
myasthenia gravis, eculizumab
Published
2019

46. Restabilization treatment after intravenous immunoglobulin withdrawal in chronic inflammatory demyelinating polyneuropathy: Results from the pre-randomization phase of the Polyneuropathy And Treatment with Hizentra study

Author

Mielke, Orell, Bril, Vera, Cornblath, David R., Lawo, John-Philip, van Geloven, Nan, Hartung, Hans-Peter, Lewis, Richard A., Merkies, Ingemar S. J., Sobue, Gen, Durn, Billie, Shebl, Amgad, van Schaik, Ivo N., Sabet, A., George, K., Roberts, L., Carne, R., Blum, S., Henderson, R., Van Damme, P., Demeestere, J., Larue, S., D'Amour, C., Kunc, P., Valis, M., Sussova, J., Kalous, T., Talab, R., Bednar, M., Toomsoo, T., Rubanovits, I., Gross-Paju, K., Sorro, U., Saarela, M., Auranen, M., Pouget, J., Attarian, S., Le Masson, G., Wielanek-Bachelet, A., Desnuelle, C., Delmont, E., Clavelou, P., Aufauvre, D., Schmidt, J., Zschuentzsch, J., Sommer, C., Kramer, D., Hoffmann, O., Goerlitz, C., Haas, J., Chatzopoulos, M., Yoon, R., Gold, R., Berlit, P., Jaspert-Grehl, A., Liebetanz, D., Kutschenko, A., Stangel, M., Trebst, C., Baum, P., Bergh, F., Klehmet, J., Meisel, A., Klostermann, F., Oechtering, J., Lehmann, H., Schroeter, M., Hagenacker, T., Mueller, D., Sperfeld, A., Bethke, F., Drory, V., Algom, A., Yarnitsky, D., Murinson, B., Di Muzio, A., Ciccocioppo, F., Sorbi, S., Mata, S., Schenone, A., Grandis, M., Lauria, G., Cazzato, D., Antonini, G., Morino, S., Cocito, D., Zibetti, M., Yokota, T., Ohkubo, T., Kanda, T., Kawai, M., Kaida, K., Onoue, H., Kuwabara, S., Mori, M., Iijima, M., Ohyama, K., Baba, M., Tomiyama, M., Nishiyama, K., Akutsu, T., Yokoyama, K., Kanai, K., van Schaik, I. N., Eftimov, F., Notermans, N. C., Visser, N., Faber, C., Hoeijmakers, J., Rejdak, K., Chyrchel-Paszkiewicz, U., Casanovas Pons, C., Antonia, M., Gamez, J., Salvado, M., Marquez Infante, C., Benitez, S., Lunn, M., Morrow, J., Gosal, D., Lavin, T., Melamed, I., Testori, A., Ajroud-Driss, S., Menichella, D., Simpson, E., Lai, E. Chi-Ho, Dimachkie, M., Barohn, R. J., Beydoun, S., Johl, H., Lange, D., Shtilbans, A., Muley, S., Ladha, S., Freimer, M., Kissel, J., Latov, N., Chin, R., Ubogu, E., Mumfrey, S., Rao, T., MacDonald, P., Sharma, K., Gonzalez, G., Allen, J., Walk, D., Hobson-Webb, L., Gable, K., Mielke, Orell, Bril, Vera, Cornblath, David R., Lawo, John-Philip, van Geloven, Nan, Hartung, Hans-Peter, Lewis, Richard A., Merkies, Ingemar S. J., Sobue, Gen, Durn, Billie, Shebl, Amgad, van Schaik, Ivo N., Sabet, A., George, K., Roberts, L., Carne, R., Blum, S., Henderson, R., Van Damme, P., Demeestere, J., Larue, S., D'Amour, C., Kunc, P., Valis, M., Sussova, J., Kalous, T., Talab, R., Bednar, M., Toomsoo, T., Rubanovits, I., Gross-Paju, K., Sorro, U., Saarela, M., Auranen, M., Pouget, J., Attarian, S., Le Masson, G., Wielanek-Bachelet, A., Desnuelle, C., Delmont, E., Clavelou, P., Aufauvre, D., Schmidt, J., Zschuentzsch, J., Sommer, C., Kramer, D., Hoffmann, O., Goerlitz, C., Haas, J., Chatzopoulos, M., Yoon, R., Gold, R., Berlit, P., Jaspert-Grehl, A., Liebetanz, D., Kutschenko, A., Stangel, M., Trebst, C., Baum, P., Bergh, F., Klehmet, J., Meisel, A., Klostermann, F., Oechtering, J., Lehmann, H., Schroeter, M., Hagenacker, T., Mueller, D., Sperfeld, A., Bethke, F., Drory, V., Algom, A., Yarnitsky, D., Murinson, B., Di Muzio, A., Ciccocioppo, F., Sorbi, S., Mata, S., Schenone, A., Grandis, M., Lauria, G., Cazzato, D., Antonini, G., Morino, S., Cocito, D., Zibetti, M., Yokota, T., Ohkubo, T., Kanda, T., Kawai, M., Kaida, K., Onoue, H., Kuwabara, S., Mori, M., Iijima, M., Ohyama, K., Baba, M., Tomiyama, M., Nishiyama, K., Akutsu, T., Yokoyama, K., Kanai, K., van Schaik, I. N., Eftimov, F., Notermans, N. C., Visser, N., Faber, C., Hoeijmakers, J., Rejdak, K., Chyrchel-Paszkiewicz, U., Casanovas Pons, C., Antonia, M., Gamez, J., Salvado, M., Marquez Infante, C., Benitez, S., Lunn, M., Morrow, J., Gosal, D., Lavin, T., Melamed, I., Testori, A., Ajroud-Driss, S., Menichella, D., Simpson, E., Lai, E. Chi-Ho, Dimachkie, M., Barohn, R. J., Beydoun, S., Johl, H., Lange, D., Shtilbans, A., Muley, S., Ladha, S., Freimer, M., Kissel, J., Latov, N., Chin, R., Ubogu, E., Mumfrey, S., Rao, T., MacDonald, P., Sharma, K., Gonzalez, G., Allen, J., Walk, D., Hobson-Webb, L., and Gable, K.

Abstract

In patients with chronic inflammatory demyelinating polyneuropathy (CIDP), intravenous immunoglobulin (IVIG) is recommended to be periodically reduced to assess the need for ongoing therapy. However, little is known about the effectiveness of restabilization with IVIG in patients who worsen after IVIG withdrawal. In the Polyneuropathy And Treatment with Hizentra (PATH) study, the pre-randomization period included sudden stopping of IVIG followed by 12 weeks of observation. Those deteriorating were then restabilized with IVIG. Of 245 subjects who stopped IVIG, 28 did not show signs of clinical deterioration within 12 weeks. Two hundred and seven received IVIG restabilization with an induction dose of 2 g/kg bodyweight (bw) IgPro10 (Privigen, CSL Behring, King of Prussia, Pennsylvania) and maintenance doses of 1 g/kg bw every 3 weeks for up to 13 weeks. Signs of clinical improvement were seen in almost all (n = 188; 91%) subjects. During IVIG restabilization, 35 subjects either did not show CIDP stability (n = 21, analyzed as n = 22 as an additional subject was randomized in error) or withdrew for other reasons (n = 14). Of the 22 subjects who did not achieve clinical stability, follow-up information in 16 subjects after an additional 4 weeks was obtained. Nine subjects were reported to have improved, leaving a maximum of 27 subjects (13%) who either showed no signs of clinical improvement during the restabilization phase and 4 weeks post-study or withdrew for other reasons. In conclusion, sudden IVIG withdrawal was effective in detecting ongoing immunoglobulin G dependency with a small risk for subjects not returning to their baseline 17 weeks after withdrawal.

Published
2019

47. Efficacy and safety of IVIG in CIDP: Combined data of the PRIMA and PATH studies

Author

Merkies, Ingemar S. J., van Schaik, Ivo N., Leger, Jean-Marc, Bril, Vera, van Geloven, Nan, Hartung, Hans-Peter, Lewis, Richard A., Sobue, Gen, Lawo, John-Philip, Durn, Billie L., Cornblath, David R., De Bleecker, Jan L., Sommer, Claudia, Robberecht, Wim, Saarela, Mika, Kamienowski, Jerzy, Stelmasiak, Zbigniew, Tackenberg, Bjoern, Mielke, Orell, Sabet, A., George, K., Roberts, L., Carne, R., Blum, S., Henderson, R., Van Damme, P., Demeestere, J., Larue, S., D'Amour, C., Kunc, P., Valis, M., Sussova, J., Kalous, T., Talab, R., Bednar, M., Toomsoo, T., Rubanovits, I., Gross-Paju, K., Sorro, U., Saarela, M., Auranen, M., Pouget, J., Attarian, S., Le Masson, G., Wielanek-Bachelet, A., Desnuelle, C., Delmont, E., Clavelou, P., Aufauvre, D., Schmidt, J., Zschuentzsch, J., Sommer, C., Kramer, D., Hoffmann, O., Goerlitz, C., Haas, J., Chatzopoulos, M., Yoon, R., Gold, R., Berlit, P., Jaspert-Grehl, A., Liebetanz, D., Kutschenko, A., Stangel, M., Trebst, C., Baum, P., Bergh, F., Klehmet, J., Meisel, A., Klostermann, F., Oechtering, J., Lehmann, H., Schroeter, M., Hagenacker, T., Mueller, D., Sperfeld, A., Bethke, F., Drory, V., Algom, A., Yarnitsky, D., Murinson, B., Di Muzio, A., Ciccocioppo, F., Sorbi, S., Mata, S., Schenone, A., Grandis, M., Lauria, G., Cazzato, D., Antonini, G., Morino, S., Cocito, D., Zibetti, M., Yokota, T., Ohkubo, T., Kanda, T., Kawai, M., Kaida, K., Onoue, H., Kuwabara, S., Mori, M., Iijima, M., Ohyama, K., Baba, M., Tomiyama, M., Nishiyama, K., Akutsu, T., Yokoyama, K., Kanai, K., van Schaik, I. N., Eftimov, F., Notermans, N. C., Visser, N., Faber, C., Hoeijmakers, J., Rejdak, K., Chyrchel-Paszkiewicz, U., Casanovas Pons, C., Antonia, M., Gamez, J., Salvado, M., Marquez Infante, C., Benitez, S., Lunn, M., Morrow, J., Gosal, D., Lavin, T., Melamed, I., Testori, A., Ajroud-Driss, S., Menichella, D., Lai, E. Chi-Ho, Dimachkie, M., Barohn, R. J., Beydoun, S., Johl, H., Lange, D., Shtilbans, A., Muley, S., Ladha, S., Freimer, M., Kissel, J., Latov, N., Chin, R., Ubogu, E., Mumfrey, S., Rao, T., MacDonald, P., Sharma, K., Gonzalez, G., Allen, J., Walk, D., Hobson-Webb, L., Gable, K., De Bleecker, J. L., Franques, J., Leger, J. -M., Morales, R. Juntas, Nguento, A., Schrey, Ch., Kamienowski, J., Stelmasiak, Z., Zwolinska, G., Merkies, Ingemar S. J., van Schaik, Ivo N., Leger, Jean-Marc, Bril, Vera, van Geloven, Nan, Hartung, Hans-Peter, Lewis, Richard A., Sobue, Gen, Lawo, John-Philip, Durn, Billie L., Cornblath, David R., De Bleecker, Jan L., Sommer, Claudia, Robberecht, Wim, Saarela, Mika, Kamienowski, Jerzy, Stelmasiak, Zbigniew, Tackenberg, Bjoern, Mielke, Orell, Sabet, A., George, K., Roberts, L., Carne, R., Blum, S., Henderson, R., Van Damme, P., Demeestere, J., Larue, S., D'Amour, C., Kunc, P., Valis, M., Sussova, J., Kalous, T., Talab, R., Bednar, M., Toomsoo, T., Rubanovits, I., Gross-Paju, K., Sorro, U., Saarela, M., Auranen, M., Pouget, J., Attarian, S., Le Masson, G., Wielanek-Bachelet, A., Desnuelle, C., Delmont, E., Clavelou, P., Aufauvre, D., Schmidt, J., Zschuentzsch, J., Sommer, C., Kramer, D., Hoffmann, O., Goerlitz, C., Haas, J., Chatzopoulos, M., Yoon, R., Gold, R., Berlit, P., Jaspert-Grehl, A., Liebetanz, D., Kutschenko, A., Stangel, M., Trebst, C., Baum, P., Bergh, F., Klehmet, J., Meisel, A., Klostermann, F., Oechtering, J., Lehmann, H., Schroeter, M., Hagenacker, T., Mueller, D., Sperfeld, A., Bethke, F., Drory, V., Algom, A., Yarnitsky, D., Murinson, B., Di Muzio, A., Ciccocioppo, F., Sorbi, S., Mata, S., Schenone, A., Grandis, M., Lauria, G., Cazzato, D., Antonini, G., Morino, S., Cocito, D., Zibetti, M., Yokota, T., Ohkubo, T., Kanda, T., Kawai, M., Kaida, K., Onoue, H., Kuwabara, S., Mori, M., Iijima, M., Ohyama, K., Baba, M., Tomiyama, M., Nishiyama, K., Akutsu, T., Yokoyama, K., Kanai, K., van Schaik, I. N., Eftimov, F., Notermans, N. C., Visser, N., Faber, C., Hoeijmakers, J., Rejdak, K., Chyrchel-Paszkiewicz, U., Casanovas Pons, C., Antonia, M., Gamez, J., Salvado, M., Marquez Infante, C., Benitez, S., Lunn, M., Morrow, J., Gosal, D., Lavin, T., Melamed, I., Testori, A., Ajroud-Driss, S., Menichella, D., Lai, E. Chi-Ho, Dimachkie, M., Barohn, R. J., Beydoun, S., Johl, H., Lange, D., Shtilbans, A., Muley, S., Ladha, S., Freimer, M., Kissel, J., Latov, N., Chin, R., Ubogu, E., Mumfrey, S., Rao, T., MacDonald, P., Sharma, K., Gonzalez, G., Allen, J., Walk, D., Hobson-Webb, L., Gable, K., De Bleecker, J. L., Franques, J., Leger, J. -M., Morales, R. Juntas, Nguento, A., Schrey, Ch., Kamienowski, J., Stelmasiak, Z., and Zwolinska, G.

Abstract

Intravenous immunoglobulin (IVIG) is a potential therapy for chronic inflammatory demyelinating polyneuropathy (CIDP). To investigate the efficacy and safety of the IVIG IgPro10 (Privigen) for treatment of CIDP, results from Privigen Impact on Mobility and Autonomy (PRIMA), a prospective, open-label, single-arm study of IVIG in immunoglobulin (Ig)-naive or IVIG pre-treated subjects (NCT01184846, n = 28) and Polyneuropathy And Treatment with Hizentra (PATH), a double-blind, randomized study including an open-label, single-arm IVIG phase in IVIG pre-treated subjects (NCT01545076, IVIG restabilization phase n = 207) were analyzed separately and together (n = 235). Efficacy assessments included change in adjusted inflammatory neuropathy cause and treatment (INCAT) score, grip strength and Medical Research Council (MRC) sum score. Adverse drug reactions (ADRs) and ADRs/infusion were recorded. Adjusted INCAT response rate was 60.7% in all PRIMA subjects at Week 25 (76.9% in IVIG pre-treated subjects) and 72.9% in PATH. In the pooled cohort (n = 235), INCAT response rate was 71.5%; median time to INCAT improvement was 4.3 weeks. No clear demographic differences were noticed between early (responding before Week 7, n = 148) and late responders (n = 21). In the pooled cohort, median change from baseline to last observation was -1.0 (interquartile range -2.0; 0.0) point for INCAT score; +8.0 (0.0; 20.0) kPa for maximum grip strength; +3.0 (1.0; 7.0) points for MRC sum score. In the pooled cohort, 271 ADRs were reported in 105 subjects (44.7%), a rate of 0.144 ADRs per infusion. This analysis confirms the efficacy and safety of IgPro10, a recently FDA-approved IVIG for CIDP, in a population of mainly pre-treated subjects with CIDP [Correction added on 14 March 2019 after first online publication: the INCAT response rate has been corrected.].

Published
2019

48. Long-term safety and efficacy of subcutaneous immunoglobulin IgPro20 in CIDP PATH extension study

Author

van Schaik, Ivo N., Mielke, Orell, Bril, Vera, van Geloven, Nan, Hartung, Hans-Peter, Lewis, Richard A., Sobue, Gen, Lawo, John-Philip, Praus, Michaela, Durn, Billie L., Cornblath, David R., Merkies, Ingemar S. J., Sabet, A., George, K., Roberts, L., Carne, R., Blum, S., Henderson, R., Van Damme, P., Demeestere, J., Larue, S., D'Amour, C., Bril, V, Breiner, A., Kunc, P., Michal, V, Sussova, J., Tomas, K., Talab, R., Michal, B., Toomsoo, T., Rubanovits, I, Gross-Paju, K., Sorro, U., Saarela, M., Auranen, M., Pouget, J., Attarian, S., Le Masson, G., Wielanek-Bachelet, A., Desnuelle, C., Delmont, E., Clavelou, P., Aufauvre, D., Schmidt, J., Zschumtszsch, J., Sommer, C., Kramer, D., Hoffmann, O., Goerlitz, C., Haas, J., Chatzopoulos, M., Yoon, R., Gold, R., Berlit, P., Jaspert-Grehl, A., Liebetanz, D., Kutschenko, A., Stangel, M., Trebst, C., Baum, P., Bergh, F., Klehmet, J., Meisel, A., Klostermann, F., Oechtering, J., Lehmann, H., Schroeter, M., Hagenacker, T., Mueller, D., Sperfeld, A., Bethke, F., Drory, V, Algom, A., Yarnitsky, D., Murinson, B., Di Muzio, A., Ciccocioppo, F., Sorbi, S., Mata, S., Schenone, A., Grandis, M., Lauria, G., Cazzato, D., Antonini, G., Morino, S., Cocito, D., Zibetti, M., Yokota, T., Ohkubo, T., Kanda, T., Kawai, M., Kaida, K., Onoue, H., Kuwabara, S., Mori, M., Iijima, M., Ohyama, K., Baba, M., Tomiyama, M., Nishiyama, K., Akutsu, T., Yokoyama, K., Kanai, K., van Schaik, I. N., Eftimov, F., Notermans, N. C., Visser, N., Faber, C., Hoeijmakers, J., Rejdak, K., Chyrchel-Paszkiewicz, U., Casanovas Pons, C., Antonia, M., Gamez, J., Salvado, M., Marquez Infante, C., Benitez, S., Lunn, M., Morrow, J., Gosal, D., Lavin, T., Melamed, I, Testori, A., Ajroud-Driss, S., Menichella, D., Simpson, E., Lai, E. Chi-Ho, Dimachkie, M., Barohn, R. J., Beydoun, S., Johl, H., Lange, D., Shtilbans, A., Muley, S., Ladha, S., Freimer, M., Kissel, J., Latov, N., Chin, R., Ubogu, E., Mumfrey, S., Rao, T., MacDonald, P., Sharma, K., Gonzalez, G., Allen, J., Walk, D., Hobson-Webb, L., Gable, K., van Schaik, Ivo N., Mielke, Orell, Bril, Vera, van Geloven, Nan, Hartung, Hans-Peter, Lewis, Richard A., Sobue, Gen, Lawo, John-Philip, Praus, Michaela, Durn, Billie L., Cornblath, David R., Merkies, Ingemar S. J., Sabet, A., George, K., Roberts, L., Carne, R., Blum, S., Henderson, R., Van Damme, P., Demeestere, J., Larue, S., D'Amour, C., Bril, V, Breiner, A., Kunc, P., Michal, V, Sussova, J., Tomas, K., Talab, R., Michal, B., Toomsoo, T., Rubanovits, I, Gross-Paju, K., Sorro, U., Saarela, M., Auranen, M., Pouget, J., Attarian, S., Le Masson, G., Wielanek-Bachelet, A., Desnuelle, C., Delmont, E., Clavelou, P., Aufauvre, D., Schmidt, J., Zschumtszsch, J., Sommer, C., Kramer, D., Hoffmann, O., Goerlitz, C., Haas, J., Chatzopoulos, M., Yoon, R., Gold, R., Berlit, P., Jaspert-Grehl, A., Liebetanz, D., Kutschenko, A., Stangel, M., Trebst, C., Baum, P., Bergh, F., Klehmet, J., Meisel, A., Klostermann, F., Oechtering, J., Lehmann, H., Schroeter, M., Hagenacker, T., Mueller, D., Sperfeld, A., Bethke, F., Drory, V, Algom, A., Yarnitsky, D., Murinson, B., Di Muzio, A., Ciccocioppo, F., Sorbi, S., Mata, S., Schenone, A., Grandis, M., Lauria, G., Cazzato, D., Antonini, G., Morino, S., Cocito, D., Zibetti, M., Yokota, T., Ohkubo, T., Kanda, T., Kawai, M., Kaida, K., Onoue, H., Kuwabara, S., Mori, M., Iijima, M., Ohyama, K., Baba, M., Tomiyama, M., Nishiyama, K., Akutsu, T., Yokoyama, K., Kanai, K., van Schaik, I. N., Eftimov, F., Notermans, N. C., Visser, N., Faber, C., Hoeijmakers, J., Rejdak, K., Chyrchel-Paszkiewicz, U., Casanovas Pons, C., Antonia, M., Gamez, J., Salvado, M., Marquez Infante, C., Benitez, S., Lunn, M., Morrow, J., Gosal, D., Lavin, T., Melamed, I, Testori, A., Ajroud-Driss, S., Menichella, D., Simpson, E., Lai, E. Chi-Ho, Dimachkie, M., Barohn, R. J., Beydoun, S., Johl, H., Lange, D., Shtilbans, A., Muley, S., Ladha, S., Freimer, M., Kissel, J., Latov, N., Chin, R., Ubogu, E., Mumfrey, S., Rao, T., MacDonald, P., Sharma, K., Gonzalez, G., Allen, J., Walk, D., Hobson-Webb, L., and Gable, K.

Abstract

Objective To investigate the long-term safety and efficacy of weekly subcutaneous IgPro20 (Hizentra, CSL Behring) in chronic inflammatory demyelinating polyneuropathy (CIDP). Methods In a 48-week open-label prospective extension study to the PATH study, patients were initially started on 0.2 g/kg or on 0.4 g/kg weekly and-if clinically stable-switched to 0.2 g/kg weekly after 24 weeks. Upon CIDP relapse on the 0.2 g/kg dose, 0.4 g/kg was (re)initiated. CIDP relapse was defined as a deterioration by at least 1 point in the total adjusted Inflammatory Neuropathy Cause and Treatment score. Results Eighty-two patients were enrolled. Sixty-two patients initially received 0.4 g/kg, 20 patients 0.2 g/kg weekly. Seventy-two received both doses during the study. Sixty-six patients (81%) completed the 48-week study duration. Overall relapse rates were 10% in 0.4 g/kg-treated patients and 48% in 0.2 g/kg-treated patients. After dose reduction from 0.4 to 0.2 g/kg, 51% (27/53) of patients relapsed, of whom 92% (24 of 26) improved after reinitiation of the 0.4 g/kg dose. Two-thirds of patients (19/28) who completed the PATH study without relapse remained relapse-free on the 0.2 g/kg dose after dose reduction in the extension study. Sixty-two patients had adverse events (AEs) (76%), of which most were mild or moderate with no related serious AEs. Conclusions Subcutaneous treatment with IgPro20 provided long-term benefit at both 0.4 and 0.2 g/kg weekly doses with lower relapse rates on the higher dose. Long-term dosing should be individualized to find the most appropriate dose in a given patient. Classification of evidence This study provides Class IV evidence that for patients with CIDP, long-term treatment with SCIG beyond 24 weeks is safe and efficacious.

Published
2019

49. Efficacy and safety of IVIG in CIDP: Combined data of the PRIMA and PATH studies

Author

Merkies, ISJ, van Schaik, IN, Leger, J-M, Bril, V, van Geloven, N, Hartung, H-P, Lewis, RA, Sobue, G, Lawo, J-P, Durn, BL, Cornblath, DR, De Bleecker, JL, Sommer, C, Robberecht, W, Saarela, M, Kamienowski, J, Stelmasiak, Z, Tackenberg, B, Mielke, O, Sabet, A, George, K, Roberts, L, Carne, R, Blum, S, Henderson, R, Van Damme, P, Demeestere, J, Larue, S, D'Amour, C, Kunc, P, Valis, M, Sussova, J, Kalous, T, Talab, R, Bednar, M, Toomsoo, T, Rubanovits, I, Gross-Paju, K, Sorro, U, Auranen, M, Pouget, J, Attarian, S, Le Masson, G, Wielanek-Bachelet, A, Desnuelle, C, Delmont, E, Clavelou, P, Aufauvre, D, Schmidt, J, Zschuentzsch, J, Kramer, D, Hoffmann, O, Goerlitz, C, Haas, J, Chatzopoulos, M, Yoon, R, Gold, R, Berlit, P, Jaspert-Grehl, A, Liebetanz, D, Kutschenko, A, Stangel, M, Trebst, C, Baum, P, Bergh, F, Klehmet, J, Meisel, A, Klostermann, F, Oechtering, J, Lehmann, H, Schroeter, M, Hagenacker, T, Mueller, D, Sperfeld, A, Bethke, F, Drory, V, Algom, A, Yarnitsky, D, Murinson, B, Di Muzio, A, Ciccocioppo, F, Sorbi, S, Mata, S, Schenone, A, Grandis, M, Lauria, G, Cazzato, D, Antonini, G, Morino, S, Cocito, D, Zibetti, M, Yokota, T, Ohkubo, T, Kanda, T, Kawai, M, Kaida, K, Onoue, H, Kuwabara, S, Mori, M, Iijima, M, Ohyama, K, Baba, M, Tomiyama, M, Nishiyama, K, Akutsu, T, Yokoyama, K, Kanai, K, Eftimov, F, Notermans, NC, Visser, N, Faber, C, Hoeijmakers, J, Rejdak, K, Chyrchel-Paszkiewicz, U, Casanovas Pons, C, Antonia, M, Gamez, J, Salvado, M, Marquez Infante, C, Benitez, S, Lunn, M, Morrow, J, Gosal, D, Lavin, T, Melamed, I, Testori, A, Ajroud-Driss, S, Menichella, D, Simpson, Lai, EC-H, Dimachkie, M, Barohn, RJ, Beydoun, S, Johl, H, Lange, D, Shtilbans, A, Muley, S, Ladha, S, Freimer, M, Kissel, J, Latov, N, Chin, R, Ubogu, E, Mumfrey, S, Rao, T, MacDonald, P, Sharma, K, Gonzalez, G, Allen, J, Walk, D, Hobson-Webb, L, Gable, K, Franques, J, Morales, RJ, Nguento, A, Schrey, C, Zwolinska, G, Merkies, ISJ, van Schaik, IN, Leger, J-M, Bril, V, van Geloven, N, Hartung, H-P, Lewis, RA, Sobue, G, Lawo, J-P, Durn, BL, Cornblath, DR, De Bleecker, JL, Sommer, C, Robberecht, W, Saarela, M, Kamienowski, J, Stelmasiak, Z, Tackenberg, B, Mielke, O, Sabet, A, George, K, Roberts, L, Carne, R, Blum, S, Henderson, R, Van Damme, P, Demeestere, J, Larue, S, D'Amour, C, Kunc, P, Valis, M, Sussova, J, Kalous, T, Talab, R, Bednar, M, Toomsoo, T, Rubanovits, I, Gross-Paju, K, Sorro, U, Auranen, M, Pouget, J, Attarian, S, Le Masson, G, Wielanek-Bachelet, A, Desnuelle, C, Delmont, E, Clavelou, P, Aufauvre, D, Schmidt, J, Zschuentzsch, J, Kramer, D, Hoffmann, O, Goerlitz, C, Haas, J, Chatzopoulos, M, Yoon, R, Gold, R, Berlit, P, Jaspert-Grehl, A, Liebetanz, D, Kutschenko, A, Stangel, M, Trebst, C, Baum, P, Bergh, F, Klehmet, J, Meisel, A, Klostermann, F, Oechtering, J, Lehmann, H, Schroeter, M, Hagenacker, T, Mueller, D, Sperfeld, A, Bethke, F, Drory, V, Algom, A, Yarnitsky, D, Murinson, B, Di Muzio, A, Ciccocioppo, F, Sorbi, S, Mata, S, Schenone, A, Grandis, M, Lauria, G, Cazzato, D, Antonini, G, Morino, S, Cocito, D, Zibetti, M, Yokota, T, Ohkubo, T, Kanda, T, Kawai, M, Kaida, K, Onoue, H, Kuwabara, S, Mori, M, Iijima, M, Ohyama, K, Baba, M, Tomiyama, M, Nishiyama, K, Akutsu, T, Yokoyama, K, Kanai, K, Eftimov, F, Notermans, NC, Visser, N, Faber, C, Hoeijmakers, J, Rejdak, K, Chyrchel-Paszkiewicz, U, Casanovas Pons, C, Antonia, M, Gamez, J, Salvado, M, Marquez Infante, C, Benitez, S, Lunn, M, Morrow, J, Gosal, D, Lavin, T, Melamed, I, Testori, A, Ajroud-Driss, S, Menichella, D, Simpson, Lai, EC-H, Dimachkie, M, Barohn, RJ, Beydoun, S, Johl, H, Lange, D, Shtilbans, A, Muley, S, Ladha, S, Freimer, M, Kissel, J, Latov, N, Chin, R, Ubogu, E, Mumfrey, S, Rao, T, MacDonald, P, Sharma, K, Gonzalez, G, Allen, J, Walk, D, Hobson-Webb, L, Gable, K, Franques, J, Morales, RJ, Nguento, A, Schrey, C, and Zwolinska, G

Abstract

Intravenous immunoglobulin (IVIG) is a potential therapy for chronic inflammatory demyelinating polyneuropathy (CIDP). To investigate the efficacy and safety of the IVIG IgPro10 (Privigen) for treatment of CIDP, results from Privigen Impact on Mobility and Autonomy (PRIMA), a prospective, open-label, single-arm study of IVIG in immunoglobulin (Ig)-naïve or IVIG pre-treated subjects (NCT01184846, n = 28) and Polyneuropathy And Treatment with Hizentra (PATH), a double-blind, randomized study including an open-label, single-arm IVIG phase in IVIG pre-treated subjects (NCT01545076, IVIG restabilization phase n = 207) were analyzed separately and together (n = 235). Efficacy assessments included change in adjusted inflammatory neuropathy cause and treatment (INCAT) score, grip strength and Medical Research Council (MRC) sum score. Adverse drug reactions (ADRs) and ADRs/infusion were recorded. Adjusted INCAT response rate was 60.7% in all PRIMA subjects at Week 25 (76.9% in IVIG pre-treated subjects) and 72.9% in PATH. In the pooled cohort (n = 235), INCAT response rate was 71.5%; median time to INCAT improvement was 4.3 weeks. No clear demographic differences were noticed between early (responding before Week 7, n = 148) and late responders (n = 21). In the pooled cohort, median change from baseline to last observation was -1.0 (interquartile range -2.0; 0.0) point for INCAT score; +8.0 (0.0; 20.0) kPa for maximum grip strength; +3.0 (1.0; 7.0) points for MRC sum score. In the pooled cohort, 271 ADRs were reported in 105 subjects (44.7%), a rate of 0.144 ADRs per infusion. This analysis confirms the efficacy and safety of IgPro10, a recently FDA-approved IVIG for CIDP, in a population of mainly pre-treated subjects with CIDP [Correction added on 14 March 2019 after first online publication: the INCAT response rate has been corrected.].

Published
2019

50. Restabilization treatment after intravenous immunoglobulin withdrawal in chronic inflammatory demyelinating polyneuropathy: Results from the pre-randomization phase of the Polyneuropathy And Treatment with Hizentra study

Author

Mielke, O, Bril, V, Cornblath, DR, Lawo, J-P, van Geloven, N, Hartung, H-P, Lewis, RA, Merkies, ISJ, Sobue, G, Durn, B, Shebl, A, van Schaik, IN, Sabet, A, George, K, Roberts, L, Carne, R, Blum, S, Henderson, R, Van Damme, P, Demeestere, J, Larue, S, D'Amour, C, Kunc, P, Valis, M, Sussova, J, Kalous, T, Talab, R, Bednar, M, Toomsoo, T, Rubanovits, I, Gross-Paju, K, Sorro, U, Saarela, M, Auranen, M, Pouget, J, Attarian, S, Le Masson, G, Wielanek-Bachelet, A, Desnuelle, C, Delmont, E, Clavelou, P, Aufauvre, D, Schmidt, J, Zschuentzsch, J, Sommer, C, Kramer, D, Hoffmann, O, Goerlitz, C, Haas, J, Chatzopoulos, M, Yoon, R, Gold, R, Berlit, P, Jaspert-Grehl, A, Liebetanz, D, Kutschenko, A, Stangel, M, Trebst, C, Baum, P, Bergh, F, Klehmet, J, Meisel, A, Klostermann, F, Oechtering, J, Lehmann, H, Schroeter, M, Hagenacker, T, Mueller, D, Sperfeld, A, Bethke, F, Drory, V, Algom, A, Yarnitsky, D, Murinson, B, Di Muzio, A, Ciccocioppo, F, Sorbi, S, Mata, S, Schenone, A, Grandis, M, Lauria, G, Cazzato, D, Antonini, G, Morino, S, Cocito, D, Zibetti, M, Yokota, T, Ohkubo, T, Kanda, T, Kawai, M, Kaida, K, Onoue, H, Kuwabara, S, Mori, M, Iijima, M, Ohyama, K, Baba, M, Tomiyama, M, Nishiyama, K, Akutsu, T, Yokoyama, K, Kanai, K, Eftimov, F, Notermans, NC, Visser, N, Faber, C, Hoeijmakers, J, Rejdak, K, Chyrchel-Paszkiewicz, U, Casanovas Pons, C, Antonia, M, Gamez, J, Salvado, M, Marquez Infante, C, Benitez, S, Lunn, M, Morrow, J, Gosal, D, Lavin, T, Melamed, I, Testori, A, Ajroud-Driss, S, Menichella, D, Simpson, E, Lai, EC-H, Dimachkie, M, Barohn, RJ, Beydoun, S, Johl, H, Lange, D, Shtilbans, A, Muley, S, Ladha, S, Freimer, M, Kissel, J, Latov, N, Chin, R, Ubogu, E, Mumfrey, S, Rao, T, MacDonald, P, Sharma, K, Gonzalez, G, Allen, J, Walk, D, Hobson-Webb, L, Gable, K, Mielke, O, Bril, V, Cornblath, DR, Lawo, J-P, van Geloven, N, Hartung, H-P, Lewis, RA, Merkies, ISJ, Sobue, G, Durn, B, Shebl, A, van Schaik, IN, Sabet, A, George, K, Roberts, L, Carne, R, Blum, S, Henderson, R, Van Damme, P, Demeestere, J, Larue, S, D'Amour, C, Kunc, P, Valis, M, Sussova, J, Kalous, T, Talab, R, Bednar, M, Toomsoo, T, Rubanovits, I, Gross-Paju, K, Sorro, U, Saarela, M, Auranen, M, Pouget, J, Attarian, S, Le Masson, G, Wielanek-Bachelet, A, Desnuelle, C, Delmont, E, Clavelou, P, Aufauvre, D, Schmidt, J, Zschuentzsch, J, Sommer, C, Kramer, D, Hoffmann, O, Goerlitz, C, Haas, J, Chatzopoulos, M, Yoon, R, Gold, R, Berlit, P, Jaspert-Grehl, A, Liebetanz, D, Kutschenko, A, Stangel, M, Trebst, C, Baum, P, Bergh, F, Klehmet, J, Meisel, A, Klostermann, F, Oechtering, J, Lehmann, H, Schroeter, M, Hagenacker, T, Mueller, D, Sperfeld, A, Bethke, F, Drory, V, Algom, A, Yarnitsky, D, Murinson, B, Di Muzio, A, Ciccocioppo, F, Sorbi, S, Mata, S, Schenone, A, Grandis, M, Lauria, G, Cazzato, D, Antonini, G, Morino, S, Cocito, D, Zibetti, M, Yokota, T, Ohkubo, T, Kanda, T, Kawai, M, Kaida, K, Onoue, H, Kuwabara, S, Mori, M, Iijima, M, Ohyama, K, Baba, M, Tomiyama, M, Nishiyama, K, Akutsu, T, Yokoyama, K, Kanai, K, Eftimov, F, Notermans, NC, Visser, N, Faber, C, Hoeijmakers, J, Rejdak, K, Chyrchel-Paszkiewicz, U, Casanovas Pons, C, Antonia, M, Gamez, J, Salvado, M, Marquez Infante, C, Benitez, S, Lunn, M, Morrow, J, Gosal, D, Lavin, T, Melamed, I, Testori, A, Ajroud-Driss, S, Menichella, D, Simpson, E, Lai, EC-H, Dimachkie, M, Barohn, RJ, Beydoun, S, Johl, H, Lange, D, Shtilbans, A, Muley, S, Ladha, S, Freimer, M, Kissel, J, Latov, N, Chin, R, Ubogu, E, Mumfrey, S, Rao, T, MacDonald, P, Sharma, K, Gonzalez, G, Allen, J, Walk, D, Hobson-Webb, L, and Gable, K

Abstract

In patients with chronic inflammatory demyelinating polyneuropathy (CIDP), intravenous immunoglobulin (IVIG) is recommended to be periodically reduced to assess the need for ongoing therapy. However, little is known about the effectiveness of restabilization with IVIG in patients who worsen after IVIG withdrawal. In the Polyneuropathy And Treatment with Hizentra (PATH) study, the pre-randomization period included sudden stopping of IVIG followed by 12 weeks of observation. Those deteriorating were then restabilized with IVIG. Of 245 subjects who stopped IVIG, 28 did not show signs of clinical deterioration within 12 weeks. Two hundred and seven received IVIG restabilization with an induction dose of 2 g/kg bodyweight (bw) IgPro10 (Privigen, CSL Behring, King of Prussia, Pennsylvania) and maintenance doses of 1 g/kg bw every 3 weeks for up to 13 weeks. Signs of clinical improvement were seen in almost all (n = 188; 91%) subjects. During IVIG restabilization, 35 subjects either did not show CIDP stability (n = 21, analyzed as n = 22 as an additional subject was randomized in error) or withdrew for other reasons (n = 14). Of the 22 subjects who did not achieve clinical stability, follow-up information in 16 subjects after an additional 4 weeks was obtained. Nine subjects were reported to have improved, leaving a maximum of 27 subjects (13%) who either showed no signs of clinical improvement during the restabilization phase and 4 weeks post-study or withdrew for other reasons. In conclusion, sudden IVIG withdrawal was effective in detecting ongoing immunoglobulin G dependency with a small risk for subjects not returning to their baseline 17 weeks after withdrawal.

Published
2019

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