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11 results on '"Pulka G"'

1. Safety and Tolerability of Bilastine 0.6% Ophthalmic Solution: An 8-Weeks Phase III Study

Author

Kuna P, Jutel M, Pulka G, Tokarski S, Arranz P, Hernández G, and Fernández Hernando N

Subjects
h1-antihistamine, bilastine, safety, allergic conjunctivitis, ocular allergy, ophthalmic solution, Ophthalmology, RE1-994
Abstract

Piotr Kuna,1 Marek Jutel,2,3 Grazyna Pulka,4 Slawomir Tokarski,5 Paula Arranz,6 Gonzalo Hernández,6 Nieves Fernández Hernando6 1Department of Internal Medicine, Asthma and Allergy, Medical University of Lodz, Lodz, Poland; 2Department of Clinical Immunology, Wroclaw Medical University, Wrocław, Poland; 3All-Med Medical Research Institute, Wrocław, Poland; 4Centrum Medyczne All-Med, Krakòw, Poland; 5Institute of Medical Sciences, Medical College of Rzeszow University, Rzeszow, Poland; 6Department of Research, Development and Innovation, FAES FARMA, Leioa, Bizkaia, SpainCorrespondence: Nieves Fernández Hernando, FAES FARMA, S.A, Av. Autonomía 10, Leioa, Bizkaia, 48940, Spain, Tel +34 94 481 83 00, Email nfernandez@faes.esPurpose: The objective of this study was to assess the safety and tolerability of preservative-free bilastine 0.6% ophthalmic solution after 8 weeks of once-daily administration in patients with allergic conjunctivitis (AC).Patients and Methods: Multi-center, international, randomized, double blind, placebo-controlled, parallel-group, phase III study of adult patients with seasonal or perennial AC. The study was conducted in 26 centers of 5 European countries. Duration of daily treatment with bilastine 0.6% ophthalmic solution or placebo was 8 weeks. Safety was evaluated by analyzing incidence of ocular treatment-emergent adverse events (TEAEs); additionally, and as secondary parameters, ocular tolerability was assessed, in addition efficacy was also assessed by the average daily total eye symptoms score (TESS).Results: A total of 333 randomized patients with AC were included (bilastine, N=218; placebo, N=115). Mean (SD) age of the patients was 39.9 (13.7) and were 63.7% female. Overall, the percentage of ocular related TEAEs was low, and the percentage of patients with ocular related TEAEs was lower in the bilastine ophthalmic solution group (2.8%) than in the placebo group (4.3%). No severe TEAEs were reported. The ocular symptoms and TESS improved during the trial in both treatment groups. Statistically significant treatment differences were observed at Week 8 for the TESS and all individual ocular symptoms, being significantly better in the bilastine ophthalmic solution group than in placebo group.Conclusion: Bilastine 0.6% ophthalmic solution revealed no safety concerns in patients with AC after 8 weeks of once-daily administration. Bilastine was effective in reducing ocular symptoms associated with AC in response to both seasonal and perennial allergens.Keywords: H1-antihistamine, bilastine, safety, allergic conjunctivitis, ocular allergy, ophthalmic solution

Published
2023

2. Nintedanib for Systemic Sclerosis-Associated Interstitial Lung Disease

Author

Distler, O, Highland, Kb, Gahlemann, M, Azuma, A, Fischer, A, Mayes, Md, Raghu, G, Sauter, W, Girard, M, Alves, M, Clerisme-Beaty, E, Stowasser, S, Tetzlaff, K, Kuwana, M, Maher, Tm, Bergna, M, Casado, G, Mannucci Walter, P, Proudman, S, Stevens, W, Thakkar, V, Troy, L, Loeffler-Ragg, J, Olschewski, H, Bondue, B, Houssiau, F, Smith, V, Wuyts, W, Johnson, S, Keystone, E, Khalidi, N, Levesque, M, Maturana Rozas, R, Silva Orellana, A, Huang, C, Li, J, Jiang, Z, Liu, Y, Xiao, W, Xu, J, Zeng, X, Zheng, Y, Zou, H, Becvar, R, Madsen, H, Søndergaard, K, Kilpeläinen, M, Myllärniemi, M, Agard, C, Allanore, Y, Bourdin, A, Cottin, V, Crestani, B, Diot, E, Dominique, S, Hachulla, E, Jouneau, S, Leroy, S, Nunes, H, Prevot, G, Wallaert, B, Wemeau, L, Aringer, M, Bewig, B, Blaas, S, Distler, J, Ehrchen, J, Ewert, R, Gläser, S, Henes, J, Hunzelmann, N, König, R, Kötter, I, Kreuter, M, Prasse, A, Schulze-Koops, H, Sfikakis, P, Vlachoyiannopoulos, P, Losonczy, G, Behera, D, Gayathri Devi HJ, Kadel, J, Kawedia, M, Kumar, D, Kumar, U, Lokhande, R, Malpani, A, Mohan, M, Nalawade, A, Parakh, U, Swarnakar, R, Shobha, V, Thangakunam, B, Udwadia, Z, Henry, M, O'Reilly, K, Balbir-Gurman, A, Kramer, M, Litinsky, I, Rosner, I, Cutolo, M, Gabrielli, A, Iaccarino, L, Pesci, A, Riccieri, V, Vettori, S, Funakubo, Y, Inoue, Y, Kawakami, A, Kawaguchi, Y, Kawamura, T, Kondoh, Y, Nanki, T, Nishioka, Y, Nozawa, K, Oguragawa, T, Okamoto, M, Sano, H, Sasai, R, Sasaki, N, Suda, T, Takahashi, H, Takeuchi, T, Tanaka, S, Yamasaki, Y, Ch'Ng, Ss, Cheah, C, Kan, S, Raja Mohamed RB, Selman, M, de Vries-Bouwstra JK, van den Toorn, L, Vonken, M, Voskuyl, Ae, Hoffmann-Vold, Am, Seip, M, Dankiewicz-Fares, I, Olesiejuk, R, Pulka, G, Szepietowski, J, Alves, J, Bernardes, M, Cordeiro, A, Costa, J, Neves, S, Salvador, Mj, Alegre Sancho, J, Carreira Delgado, P, Castellví Barranco, I, Cifrián Martínez, J, Guillén Del Castillo, A, Ovalles, Jg, López-Longo, Fj, Rivera Gallego, A, Freire Dapena MC, Román Ivorra JA, Ekwall, Ah, Maurer, B, Mihai, Cm, Müller, R, Mahakkanukrauh, A, Nantiruj, K, Siripaitoon, B, Denton, Cp, Herrick, A, Madhok, R, West, A, Bascom, R, Criner, G, Csuka, Me, Dematte D'Amico, J, Ettinger, N, Gerbino, A, Gerke, A, Glassberg, M, Glazer, C, Golden, J, Gripaldo, R, Gupta, N, Hamblin, M, Highland, K, Ho, L, Huggins, Jt, Hummers, L, Jones, L, Kahaleh, M, Khanna, D, Kim, H, Lancaster, Lh, Luckhardt, T, Mayes, M, Mendoza Ballesteros, F, Mooney, J, Mohabir, P, Morrissey, B, Moua, T, Padilla, M, Patel, N, Perez, R, Roman, J, Rossman, M, Russell, T, Saketkoo, L, Shah, A, Shlobin, O, Scholand, Mb, Simmssetts, R, Spiera, R, Steen, V, Veeraraghavan, S, Weigt, S., Distler, O, Highland, Kb, Gahlemann, M, Azuma, A, Fischer, A, Mayes, Md, Raghu, G, Sauter, W, Girard, M, Alves, M, Clerisme-Beaty, E, Stowasser, S, Tetzlaff, K, Kuwana, M, Maher, Tm, SENSCIS Trial Investigators., Bergna M, Casado, G, Mannucci Walter, P, Proudman, S, Stevens, W, Thakkar, V, Troy, L, Loeffler-Ragg, J, Olschewski, H, Bondue, B, Houssiau, F, Smith, V, Wuyts, W, Johnson, S, Keystone, E, Khalidi, N, Levesque, M, Maturana Rozas, R, Silva Orellana, A, Huang, C, Li, J, Jiang, Z, Liu, Y, Xiao, W, Xu, J, Zeng, X, Zheng, Y, Zou, H, Becvar, R, Madsen, H, Søndergaard, K, Kilpeläinen, M, Myllärniemi, M, Agard, C, Allanore, Y, Bourdin, A, Cottin, V, Crestani, B, Diot, E, Dominique, S, Hachulla, E, Jouneau, S, Leroy, S, Nunes, H, Prevot, G, Wallaert, B, Wemeau, L, Aringer, M, Bewig, B, Blaas, S, Distler, J, Ehrchen, J, Ewert, R, Gläser, S, Henes, J, Hunzelmann, N, König, R, Kötter, I, Kreuter, M, Prasse, A, Schulze-Koops, H, Sfikakis, P, Vlachoyiannopoulos, P, Losonczy, G, Behera, D, Gayathri Devi, Hj, Kadel, J, Kawedia, M, Kumar, D, Kumar, U, Lokhande, R, Malpani, A, Mohan, M, Nalawade, A, Parakh, U, Swarnakar, R, Shobha, V, Thangakunam, B, Udwadia, Z, Henry, M, O'Reilly, K, Balbir-Gurman, A, Kramer, M, Litinsky, I, Rosner, I, Cutolo, M, Gabrielli, A, Iaccarino, Laura, Pesci, A, Riccieri, V, Vettori, S, Funakubo, Y, Inoue, Y, Kawakami, A, Kawaguchi, Y, Kawamura, T, Kondoh, Y, Nanki, T, Nishioka, Y, Nozawa, K, Oguragawa, T, Okamoto, M, Sano, H, Sasai, R, Sasaki, N, Suda, T, Takahashi, H, Takeuchi, T, Tanaka, S, Yamasaki, Y, Ch'Ng, S, Cheah, C, Kan, S, Raja Mohamed, Rb, Selman, M, de Vries-Bouwstra, Jk, van den Toorn, L, Vonken, M, Voskuyl, Ae, Hoffmann-Vold, Am, Seip, M, Dankiewicz-Fares, I, Olesiejuk, R, Pulka, G, Szepietowski, J, Alves, J, Bernardes, M, Cordeiro, A, Costa, J, Neves, S, Salvador, Mj, Alegre Sancho, J, Carreira Delgado, P, Castellví Barranco, I, Cifrián Martínez, J, Guillén Del Castillo, A, Ovalles, Jg, López-Longo, Fj, Rivera Gallego, A, Freire Dapena, Mc, Román Ivorra, Ja, Ekwall, Ah, Maurer, B, Mihai, Cm, Müller, R, Mahakkanukrauh, A, Nantiruj, K, Siripaitoon, B, Denton, Cp, Herrick, A, Madhok, R, West, A, Bascom, R, Criner, G, Csuka, Me, Dematte D'Amico, J, Ettinger, N, Gerbino, A, Gerke, A, Glassberg, M, Glazer, C, Golden, J, Gripaldo, R, Gupta, N, Hamblin, M, Highland, K, Ho, L, Huggins, Jt, Hummers, L, Jones, L, Kahaleh, M, Khanna, D, Kim, H, Lancaster, Lh, Luckhardt, T, Mayes, M, Mendoza Ballesteros, F, Mooney, J, Mohabir, P, Morrissey, B, Moua, T, Padilla, M, Patel, N, Perez, R, Roman, J, Rossman, M, Russell, T, Saketkoo, L, Shah, A, Shlobin, O, Scholand, Mb, Simmssetts, R, Spiera, R, Steen, V, Veeraraghavan, S, Weigt, S., National Institute for Health Research, British Lung Foundation, University of Zurich, and Distler, Oliver

Subjects
Male, Vital capacity, Indoles, Vital Capacity, Administration, Oral, 2700 General Medicine, 030204 cardiovascular system & hematology, Pulmonary function testing, law.invention, oral, Idiopathic pulmonary fibrosis, chemistry.chemical_compound, 0302 clinical medicine, Randomized controlled trial, law, SENSCIS Trial Investigators, CYCLOPHOSPHAMIDE, Clinical endpoint, scleroderma, 030212 general & internal medicine, Enzyme Inhibitors, 11 Medical and Health Sciences, lung diseases, Lung Diseases, Interstitial -- drug therapy -- etiology -- physiopathology, 10051 Rheumatology Clinic and Institute of Physical Medicine, General Medicine, respiratory system, Sciences bio-médicales et agricoles, Middle Aged, Protein-Tyrosine Kinases, MANIFESTATIONS, Disease Progression, Nintedanib, Female, TYROSINE KINASE INHIBITOR, Life Sciences & Biomedicine, CLINICAL-TRIALS, Adult, Diarrhea, medicine.medical_specialty, FIBROBLASTS, 610 Medicine & health, Placebo, administration, behavioral disciplines and activities, 03 medical and health sciences, FEV1/FVC ratio, Medicine, General & Internal, Double-Blind Method, Internal medicine, General & Internal Medicine, Enzyme Inhibitors -- adverse effects -- therapeutic use, SCORE, medicine, Humans, Indoles -- adverse effects -- therapeutic use, Scleroderma, Systemic -- complications -- drug therapy, Science & Technology, Scleroderma, Systemic, Protein-Tyrosine Kinases -- antagonists & inhibitors, business.industry, MORTALITY, interstitial, PULMONARY-FUNCTION, systemic, STANDARDIZATION, medicine.disease, EFFICACY, respiratory tract diseases, body regions, chemistry, adult, diarrhea, disease progression, double-blind method, enzyme inhibitors, female, humans, indoles, lung diseases, interstitial, male, middle aged, protein-tyrosine kinases, scleroderma, systemic, vital capacity, business, Lung Diseases, Interstitial, Diarrhea -- chemically induced
Abstract

Interstitial lung disease (ILD) is a common manifestation of systemic sclerosis and a leading cause of systemic sclerosis-related death. Nintedanib, a tyrosine kinase inhibitor, has been shown to have antifibrotic and antiinflammatory effects in preclinical models of systemic sclerosis and ILD., info:eu-repo/semantics/published

Published
2019

4. Rationale, design, and baseline characteristics in Evaluation of LIXisenatide in Acute Coronary Syndrome, a long-term cardiovascular end point trial of lixisenatide versus placebo

Author

UCL - SSS/IREC/CARD - Pôle de recherche cardiovasculaire, Bentley-Lewis, R., Aguilar, D., Riddle, M.C., Claggett, B., Diaz, R., Dickstein, K., Gerstein, H.C., Johnston, P., Køber, L.V., Lawson, F., Lewis, E.F., Maggioni, A.P., McMurray, J.J.V., Ping, L., Probstfield, J.L., Solomon, S.D., Tardif, J.-C., Wu, Y., Pfeffer, M.A., Barkoudah, E., Brahimi, A., Charytan, D., Finn, P., Flynn, A., Hartley, L.H., Henderson, G., Joseph, J., Odutayo, K., Rajesh, V., Vazir, A., Weinrauch, L., Del Prato, S., Petrie, J., Kaplan, A., Lieberman, P., Zuraw, B.L., O'Reilly, E., Patel, K., Allen, P., Scarpa, A., Schattner, M., Granger, C., Rouleau, J., DeMets, D., Chaturvedi, N., Raccah, D., Aizenberg, D., Alvarez, C., Alvarisqueta, A., Baccaro, C., Bartolacci, I., Bordonava, A., Bustamante Labarta, M., Caccavo, A., Calella, P., Cantero, M., Codutti, R., Commendatore, V., Costamagna, O., Cuello, J., Fernandez, A., Garcia Duran, R., Gomez Vilamajo, O., Gorban De Lapertosa, S., Grinfeld, D., Hermida, S., Lagrutta, M., Leon De La Fuente, R., Licheri, A., Luciardi, H., Mackinnon, I., Maffei, L., Marino, J., Montaña, O., Novaretto, L., Orio, S., Orlandini, A., Oviedo, A., Pérez Manghi, F., Patocchi, C., Ramos, H., Rolandi, F., Saa Zarandon, R., Saavedra, S.S., Schiavi, L., Schygiel, P., Trivi, M., Ulla, M., Urdiales, P., Vallejos, J., Vico, M., Waisman, F., Amerena, J., Paul, V., Sangla, K., Van Gaal, W., Yeap, B., Fasching, P., Pieber, T., Danilova, L., Mitkovskaya, N., Sudzhaeva, S., Mathieu, C., Pouleur, Anne-Catherine, Botelho, R.V., Cerqueira, M.J., Chacra, A., Dos Santos, F., Feitosa, G., Forti, A., Golbert, M., Halpern, A., Hissa, M., Lisboa, H., Moraes, J., Nery, M., Quadros, A., Raduan, R., Reis, G., Ribeiro Filho, F., Rollin, G., Rossi, P., Santos, E., Sgarbi, J., Souza, J., Souza, M.R., Delchev, A., Ivanov, V., Klyuchkova, N., Kyoleyan, M., Levterov, G., Lucheva, M., Raev, D., Shumkova, R., Tokmakova, M., Tzekova, M., Yordanov, V., Bailey, G., Bertrand, O., Bhargava, R., Burton, J., Campeau, J., Dumas, R., Filteau, P., Syan, G., Syan, R., Tsoukas, G., Warnica, J.W., Acuña, S., Araneda, G., Bunster, L., Cobos, L., Corbalán, R., Dussaillant, G., Eggers, G., Florenzano, F., Godoy, G., Huidobro, L.A., Lahsen, R., Lanas, F., Larenas, G., Manriquez, L., Medina, M., Palma, J.C., Perez, L., Potthoff, S., Raffo, C., Reyes, E., Saavedra, V., Sanhueza, P., Sepulveda, P., Solis, C.L., Soto, N., Torres, C., Westerberg, B., Yañez, M., Chen, L., Dong, Y., Du, J., Guo, X., Han, P., Hu, T., Jiang, B., Ke, Y., Li, Z., Lu, J., Ma, C., Peng, Y., Shi, Y., Su, G., Tang, B., Xu, B., Yang, J., Yang, Y., Accini, J.L., Arteaga, J.M., Botero, R., Castillo, G., Coronel, J., Cure, C., Garcia, H., Garcia, L., Gomez, C., Hernandez Triana, E., Hernandez, H., Lopez, M., Lopez, P., Manzur, F., Molina, D., Rodriguez, J., Sanchez Vallejo, G., Yupanqui, H., Bronnum-Schou, J., Kaiser Nielsen, P., Nielsen, H., Rønne, H., Rasmussen, S., Rungby, J., Skagen, K., Thomsen, K.K., Torp-Pedersen, C., Duarte-Vera, Y., Marmol Alvear, R., Peñaherrera-Patiño, C., Assaad, S., Shelbaya, S., Ambos, A., Jakovlev, U., Lubi, M., Märtsin, K., Rosenthal, S., Vides, H., Alanko, J., Korsoff, P., Koski, A.-M., Lahtela, J., Nelimarkka, L., Tuomilehto, J., Cariou, B., Catargi, B., Ducloux, R., Hadjadj, S., Kerlan, V., Malecot, J.-M., Petit, C., Rodier, M., Chumburidze, V., Glonti, S., Lominadze, Z., Todua, F., Contzen, C., Marck, C., Fischer, H., Hagenow, A., Himpel-Bönninghoff, A., Kihm, L., Killat, H., Kleinertz, K., Kosch, C., Kreutzmann, K., Lappo, M., Mertes, B., Piechatzek, R., Prohaska, M., Rinke, A., Schellenberg, D., Toursarkissian, N., Arango, J., Gonzalez, R., Granados, A., Herrera, M., Montenegro, P., Munoz, R., Rodriguez, E., Turcios, E., Villalobos, R., Wyss, F., Hatterjee, S., Chopda, M., Chopra, V., Deshpande, N., Dutta, R., Dwivedi, S., Gandhi, P., Gupta, S.K., Gupta, J.B., Gupta, S., Hiregouder, N., Jha, S., Joshi, A., Khan, N., Kumbla, M., Magdum, M., Murthy, K., Prabhu, M., Sahay, R., Sethuraman, S., Shah, N., Shamanna, P., Singh, K.S., Singh, P., Somasekharan, A., Sreenivasamurthy, L., Supe, P., Adawi, F., Atar, S., Cohen, O., Efrati, S., Karnieli, E., Klainman, E., Minuchin, O., Mosenzon, O., Stern, N., Turgeman, Y., Wainstein, J., Aimaretti, G., Berra, C., Ciardullo, A.V., Consoli, A., Cucinotta, D., Di Marco, S., Giorda, C., Giordano, C., Mannucci, E., Orsi, E., Piatti, P., Pontiroli, A., Ponzani, P., Pozzilli, P., Rivellese, A., Akahori, H., Eki, Y., Fujii, K., Hata, Y., Himeno, H., Hirayama, A., Kishimoto, I., Kobayashi, Y., Miyaoka, H., Niiya, T., Nishi, Y., Nozaki, A., Nunohiro, T., Saito, T., Satoh, Y., Takahashi, A., Takahashi, J., Takase, H., Takase, S., Tsuboko, Y., Tsujimoto, M., Tsujino, M., Tsuzuki, M., Watanabe, S., Yamada, T., Chung, W.J., Rim, S., Jang, H., Kim, U., Chung, C.H., Shin, S.-H., Kim, K., Kim, J., Rha, S., Lee, N.H., Kim, C.-J., Park, K.S., Amolina, I., Ducena, K., Helda, R., Konrade, I., Pirags, V., Sime, I., Sokolova, J., Kakariekiene, V., Kavaliauskiene, R., Petrulioniene, Z., Sakalyte, G., Urboniene, A., Zarankiene, R., Uribe, M., Garcia-Hernandez, P., Garza, J., Vazquez-Garcia, A., Gonzalez, J.G., Escalante, M., Zavala, A., Bayram, E., Hernandez-Muñuzuri, J., Ramos, Lopez, G.A., Lujan, J., Garcia-Soria, M., Velasco-Sanchez, R., Rodriguez, I., Jimenez, S., Galeana, C., Lara, S., Garcia-Castillo, A., Castro, M.G., Aguilar-Orozco, R., Lopez Rosas, E., Vidrio, M., Llamas, G., Stobschinski De Alba, C.A., Carranza-Madrigal, J., Cardosa-Torres, F., Cornel, J.H., Dekkers, P., Frederiks, J., Hermans, W., Lok, D., Meeder, J., Nierop, P., Cooper, J., Lappegård, K.T., Nedrebø, B.G., Castro, E., Gonzalez Castillo, B., Gonzalez, E., Nieto Ortega, R., Andrade, M., Calderon, J., Chavez, C., Correa Flores, R.M., Farfan, J., Lu, L., Luque, E., Manrique, H., Mogrovejo, W., Pariona-Javier, M., Pinto, M., Roldan, Y., Zubiate, C., Dans, A., Gomez, M.H., Panelo, A., Rey, N., Sulit, D.J., Sy, R.A., Timonera, M., Bednarski, J., Bijata-Bronisz, R., Bryniarski, L., Busz-Papiez, B., Czajkowska-Kaczmarek, E., Drzewiecka, A., Dulak, E., Gorska, M., Hamankiewicz, M., Janik, K., Kincel, K., Konieczny, M., Lubinski, A., Olszanecka-Glinianowicz, M., Ponikowski, P., Pulka, G., Rekosz, J., Skudlarski, D., Szymkowiak, K., Wilczewski, P., Bragança, N., Duarte, J., Monteiro, P., Rodrigues, E., Vinhas, M., Adina, P.-M., Avram, R.I., Cif, A., Creteanu, G., Dragomir, D., Ferariu, I.E., Iancu, A.-C., Istratoaie, O., Ivanica, G., Lichiardopol, R., Militaru, C., Minescu, B., Onaca, A., Pintilei, E., Podoleanu, C., Pop, L., Popa, B., Ranetti, A.E., Rosu, D., Tase, A., Tesloianu, D.N., Vinereanu, D., Ageev, F., Akhmedzhanov, N., Barbarash, O., Barbarich, V., Belousov, Y., Berns, S., Bokarev, I., Bolshakova, O., Boyarkin, M., Chumakova, G., Dmitry, P., Fitilev, S., Galyavich, A., Glezer, M., Ivanova, L., Kalashnikov, V., Kalashnikova, M., Karpov, Y., Khaisheva, L., Khalimov, Y., Kobalava, Z., Kosmachova, E., Kostenko, V., Koziolova, N., Kulibaba, E., Lesnov, V., Libov, I., Lyamina, N., Markov, V., Moiseev, V., Molchanova, O., Oleynikov, V., Orlikova, O., Panov, A., Rafalskiy, V., Rodionova, T., Samitin, V., Schokotov, V., Shilkina, N., Shogenov, Z., Shustov, S., Shvarts, Y., Sobolev, K., Stryuk, R., Suplotova, L., Viktorova, I., Vishnevsky, A., Vorokhobina, N., Yakusevich, V., Yakushin, S., Zadionchenko, V., Zalevskaya, A., Zalevsky, G., Zateyshchikova, A., Andjelic Jelic, M., Kocic, R., Komnenovic, S., Lalic, K., Lalic, N., Micic, D., Otasevic, P., Pesic, M., Seferovic, P., Stankovic, G., Arnold, S., Burgess, L., Coetzee, K., Dawood, S., Delport, E., Ebrahim, I., Ellis, G., Ismail, S., Kelbe, D., Naidoo, V., Ntsekhe, M., Sebastian, P.J., Siebert, M., Van Zyl, L., Venter, T., Lonso, E., Antorrena, I., Bodi, V., Botella, M., De La Fuente, J., Delgado, E., Duran Garcia, S., Elorza, J., Enciso, F., Gaztambide, S., Marin, F., Martin, V., Mauricio, D., Soto, A., Vida, M., Boberg, G., Jörneskog, G., Jendle, J., Mathiesen, U., Svensson, K.-A., Torstensson, I., Vasko, P., Moccetti, T., Chiang, C.-E., Chiu, Y.-W., Huang, T.-Y., Lu, C.-H., Pei, D., Shyu, K.-G., Ueng, K.-C., Wang, T.-D., Abid, M., Ben Abdallah, N., Haouala, H., Slimane, H., Zidi, B., Bascil Tutuncu, N., Camsari, A., Delibasi, T., Dinccag, N., Kultursay, H., Oto, A., Sahin, M., Saygili, F., Yigit, Z., Zorkun, C., Karpenko, O., Korpachev, V., Koval, O., Maslyanko, V., Perepelytsya, M., Pertseva, T., Petrosyan, O., Rudenko, L., Sychov, O., Synenko, V., Tseluyko, V., Zhuravleva, L., Al Mahmeed, W., Kaddaha, G.M., Andrews, R., Bain, S., Basu, A., Bhatnagar, D., Bickerton, A., Browne, D., Gibson, M., Hammond, P., Hanna, F., Issa, B., Jaap, A., Joseph, F., Jude, E., Kelly, C., Khan, A., Malik, R., Mukhopadhyay, B., O'Kane, M., Rayman, G., Robinson, A., Rooney, D., Sainsbury, C., Saravanan, P., Shakher, J., Singh, B., Turner, J., Whitelaw, D., Wilding, J., Wiles, P., Adenuga, B., Ahmad, Z., Akinboboye, O., Akright, L., Alappat, P., 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S., Webster, B., Weindorff, K., Welch, M., Welker, J., White, A., White, L., Williams, M., Wu, W.-C., Wynne, A., Yocono, M., and Yuen, K.

Abstract

Background: Cardiovascular (CV) disease is the leading cause of morbidity and mortality in patients with type 2 diabetes mellitus (T2DM). Furthermore, patients with T2DM and acute coronary syndrome (ACS) have a particularly high risk of CV events. The glucagonlike peptide 1 receptor agonist, lixisenatide, improves glycemia, but its effects on CV events have not been thoroughly evaluated. Methods: ELIXA (www.clinicaltrials.gov no. NCT01147250) is a randomized, double-blind, placebo-controlled, parallelgroup, multicenter study of lixisenatide in patients with T2DM and a recent ACS event. The primary aim is to evaluate the effects of lixisenatide on CV morbidity and mortality in a population at high CV risk. The primary efficacy end point is a composite of time to CV death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for unstable angina. Data are systematically collected for safety outcomes, including hypoglycemia, pancreatitis, and malignancy. Results: Enrollment began in July 2010 and ended in August 2013; 6,068 patients from 49 countries were randomized. Of these, 69% are men and 75% are white; at baseline, the mean ± SD age was 60.3 ± 9.7 years, body mass index was 30.2 ± 5.7 kg/m2, and duration of T2DM was 9.3±8.2 years. The qualifying ACS wasamyocardial infarctionin83% and unstableangina in 17%. The study will continue until the positive adjudication of the protocol-specified number of primary CV events. Conclusion: ELIXA will be the first trial to report the safety and efficacy of a glucagon-like peptide 1 receptor agonist in people with T2DM and high CV event risk. © 2015 Elsevier Inc. All rights reserved.

Published
2015

6. Biosimilar SB17 versus reference ustekinumab in moderate to severe plaque psoriasis after switching: phase 3 study results up to week 52.

Author

Feldman SR, Narbutt J, Girolomoni G, Brzezicki J, Reznichenko N, Zegadło-Mylik MA, Pulka G, Dmowska-Stecewicz M, Kłujszo E, Rekalov D, Rajzer L, Lee J, Lee M, and Rho YH

Subjects
Humans, Male, Female, Middle Aged, Adult, Treatment Outcome, Double-Blind Method, Injections, Subcutaneous, Psoriasis drug therapy, Psoriasis pathology, Ustekinumab therapeutic use, Ustekinumab administration & dosage, Biosimilar Pharmaceuticals therapeutic use, Biosimilar Pharmaceuticals administration & dosage, Biosimilar Pharmaceuticals adverse effects, Severity of Illness Index, Dermatologic Agents therapeutic use, Dermatologic Agents administration & dosage, Dermatologic Agents adverse effects, Drug Substitution
Abstract

Introduction: SB17 is a biosimilar to reference ustekinumab (UST). We compared the efficacy, safety, and immunogenicity of SB17 to UST up to Week 52, including switching from UST to SB17., Methods: Subjects were randomized to receive 45 mg of SB17 or UST subcutaneously up to Week 40. At Week 28, subjects from the UST treatment group were re-randomized to either switch to SB17 or continue UST. Efficacy, safety, and immunogenicity were assessed up to Week 52., Results: Among baseline randomized 503 subjects, 481 subjects were re-randomized at Week 28; continuing SB17 (SB17 + SB17, n  = 237), switching from UST to SB17 (UST+SB17, n  = 122) or continuing UST (UST+UST, n  = 122). The percent change from baseline in Psoriasis Area and Severity Index (PASI) was comparable between treatment groups up to Week 52 (SB17 + SB17: 95.8%, UST+SB17: 95.6%, UST+UST: 94.5% at Week 52). Other efficacy endpoints were also comparable. The incidence of treatment-emergent adverse events (SB17 + SB17: 16.5%, UST+SB17: 13.9%, UST+UST: 23.8%) and the overall incidence of anti-drug antibodies occurring after transition were comparable between treatment groups (SB17 + SB17: 5.6%, UST+SB17: 5.1%, and UST+UST: 6.7%)., Conclusion: SB17 demonstrated clinical biosimilarity to UST after switching from UST, and maintained long-term comparable efficacy and safety with UST up to Week 52.

Published
2024
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7. Phase 2b randomized trial of OX40 inhibitor telazorlimab for moderate-to-severe atopic dermatitis.

Author

Rewerska B, Sher LD, Alpizar S, Pauser S, Pulka G, Mozaffarian N, Salhi Y, Martinet C, Jabert W, Gudi G, Ca V, Gn S, Macoin J, Anstett V, Turrini R, Doucey MA, Blein S, Konto C, and Machkova M

Abstract

Background: Telazorlimab is a humanized anti-OX40 monoclonal antibody being studied for treatment of T-cell-mediated diseases., Objective: This randomized, placebo-controlled, phase 2b dose-range finding study investigated efficacy, safety, pharmacokinetics, and immunogenicity of telazorlimab in subjects with atopic dermatitis., Methods: In this 2-part study (NCT03568162), adults (≥18 years) with moderate-to-severe disease were randomized to various regimens of subcutaneous telazorlimab or placebo for 16 weeks' blinded treatment, followed by 38 weeks' open-label treatment and 12 weeks' drug-free follow-up. Telazorlimab treatment groups (following a loading dose) in part 1 were 300 mg every 2 weeks; 300 mg every 4 weeks; or 75 mg every 4 weeks. Part 2 evaluated telazorlimab 600 mg every 2 weeks. The primary end point was percentage change from baseline in Eczema Area and Severity Index (EASI) at week 16. Safety assessments included incidence of treatment-emergent adverse events., Results: The study randomized 313 subjects in part 1 and 149 in part 2. At 16 weeks, the least squares mean percentage change from baseline in EASI was significantly greater in subjects receiving telazorlimab 300 mg every 2 weeks (part 1) and 600 mg every 2 weeks (part 2) versus placebo (-54.4% vs -34.2% for part 1 and -59.0% vs -41.8% for part 2, P  = .008 for both). Telazorlimab was well tolerated, with similar distribution of adverse events between telazorlimab- and placebo-treated subjects in both part 1 and part 2., Conclusion: Telazorlimab, administered subcutaneously at 300 mg every 2 weeks or 600 mg every 2 weeks following a loading dose, was well tolerated and induced significant and progressive clinical improvement in adults with moderate-to-severe atopic dermatitis., Competing Interests: Supported by Ichnos Sciences (previously Glenmark Pharmaceuticals SA). The sponsor participated in study design; in the collection, analysis, and interpretation of data; in the writing of the report; and in the decision to submit the report for publication. Disclosure of potential conflict of interest: B. Rewerska, L. D. Sher, S. Alpizar, S. Pauser, G. Pulka, and M. Machkova have received research funding as principal investigators from Ichnos Sciences. V. CA, J. Macoin, V. Anstett, R. Turrini, and C. Konto are current employees of Ichnos Sciences. S. GN is a current employee of Glenmark Pharmaceuticals. N. Mozaffarian, Y. Salhi, W. Jabert, G. Gudi, S. Blein, and M.-A. Doucey are former employees of Ichnos Sciences (formerly Glenmark Pharmaceuticals). C. Martinet is an employee of Keyrus, a contractor for Ichnos Sciences., (© 2023 The Author(s).)

Published
2023
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8. Impaired fibrinolysis and lower levels of plasma α 2 -macroglobulin are associated with an increased risk of severe asthma exacerbations.

Author

Bazan-Socha S, Mastalerz L, Cybulska A, Zareba L, Kremers R, Zabczyk M, Pulka G, Iwaniec T, Bazan JG, Hemker C, and Undas A

Subjects
Female, Humans, Male, Middle Aged, Risk Assessment, Asthma pathology, Fibrinolysis, Plasma chemistry, Pregnancy-Associated alpha 2-Macroglobulins analysis
Abstract

Recently we have reported that asthma is associated with enhanced plasma thrombin formation, impaired fibrinolysis and platelet activation. In the present study we investigated whether described prothrombotic blood alterations might predispose to thromboembolic events or asthma exacerbations. In 164 adult asthmatics we assessed clinical events during 3-year follow-up and analyzed their associations with measured at baseline prothrombotic blood parameters. Data were obtained from 157 (95.7%) of the asthma patients. We documented 198 severe asthma exacerbations (64/year), which occurred in 53 subjects (34%). These patients were older (p = 0.004), had worse asthma control (p = 0.02) and lower spirometry values (p = 0.01), at baseline. Interestingly, this subgroup had longer clot lysis time (CLT), as well as lower α 2 -macroglobulin (p = 0.038 and p = 0.04, respectively, after adjustment for potential confounders). Increased CLT and lower α 2 -macroglobulin were demonstrated as independent predictors of asthma exacerbation in multiple regression model. Moreover, we documented two episodes of deep vein thrombosis (1.3%), and eight acute coronary syndromes (5.1%). Patients who experienced thromboembolic events (n = 10, 6.4%, 2.1%/year) had lower α 2 -macroglobulin (p = 0.04), without differences in efficiency of fibrinolysis and thrombin generation. Impaired fibrinolysis and lower levels of α 2 -macroglobulin might predispose to a higher rate of asthma exacerbations, suggesting new links between disturbed hemostasis and asthma.

Published
2017
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9. Evaluation of the quality of life in subjects with a history of severe anaphylactic reaction to the Hymenoptera venom.

Author

Nowak N, Bazan-Socha S, Pulka G, Pełka K, and Latra P

Subjects
Adult, Animals, Anxiety therapy, Female, Humans, Male, Middle Aged, Poland, Surveys and Questionnaires, Treatment Outcome, Anaphylaxis, Anxiety etiology, Bee Venoms, Desensitization, Immunologic, Quality of Life, Wasp Venoms
Abstract

Introduction: Sensitization to the Hymenoptera venom is one of the main causes of anaphylaxis in Poland. Venom immunotherapy is the only effective treatment in such cases. Comprehensive patient care includes also education. The aim of our study was to assess the state of knowledge and to evaluate the quality of life and the anxiety level in patients allergic to the Hymenoptera venom after anaphylactic reaction., Material and Methods: The survey was carried out in the period of the insects flight in 61 adult subjects (35 wasp and 26 bee allergic), using a validated Vespid Allergy Quality of Life Questionnaire (VQLQ), Hospital Anxiety and Depression Scale, and subjective assessment of anxiety level. The majority of respondents received venom immunotherapy., Results: Sensitized to the wasp venom had significantly impaired quality of life (VQLQ score) as compared to the bee venom allergic (p = 0.014). The intensity of anxiety decreased with the duration of immunotherapy (p = 0.01). The majority of subjects knew how to recognize and treat anaphylaxis, but only 8% employed an identification card and about 50% implemented rules of the pre-exposition prophylaxis., Conclusions: History of a severe anaphylaxis to the Hymenoptera venom affected the quality of life. Venom immunotherapy reduced anxiety. We hope that presented surveys and their results might be useful in qualifying for immunotherapy in clinically uncertain cases.

Published
2015
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10. [Measurement of bronchoconstrictive eicosanoids in chronic obstructive pulmonary disease].

Author

Gross-Sondej I, Soja J, Sładek K, Pulka G, Skucha W, and Niżankowska-Mogilnicka E

Subjects
Aged, Aged, 80 and over, Case-Control Studies, Female, Humans, Male, Middle Aged, Reference Values, Reproducibility of Results, Respiratory Function Tests, Risk Factors, Severity of Illness Index, Vital Capacity, Bronchoconstriction physiology, Leukotriene E4 blood, Leukotriene E4 urine, Prostaglandin D2 blood, Prostaglandin D2 urine, Pulmonary Disease, Chronic Obstructive metabolism
Abstract

Introduction: The aim of the study was the evaluation of the concentration of 9α11β prostaglandin F(2) - a stable metabolite of prostaglandin D(2) (PGD(2)) and leukotriene E(4) (LTE(4)) in stable and exacerbated COPD patients., Material and Methods: 29 COPD patients aged 73 ± 8.34, mean FEV1 = 48.64 ± 15.75% of predictive value and 29 healthy controls aged 57.48 ± 10.86, mean FEV1 = 97.17 ± 13.81% of predictive value participated in this study. Samples of urine and blood were taken from COPD patients during exacerbation and in stable state of the disease; LTE(4) was determined in urine using commercial enzyme immunoassay (EIA) and 9α11β prostaglandin F(2) (9α11βPGF(2)) - stable metabolite of PGD(2) was evaluated in blood and urine using GC/MS., Results: LTE(4) concentration in urine (677.15 vs. 436.4 pg/mg of creatinine; p = 0.035) and 9α11βPGF(2) in blood serum (5.35 vs. 3.07 pg/ml; p = 0.007) were significantly higher in exacerbated COPD patients than in control group. There was no difference in LTE(4) level in urine and 9α11βPGF2 in blood serum between exacerbated and stable COPD. The urinary 9α11βPGF(2) concentration did not differ between all studied groups. We found a positive correlation between smoking history and the urine LTE(4) level (r = 0.395; p = 0.002) as well as blood 9α11βPGF(2) concentration (r = 0.603; p = 0.001) in COPD patients., Conclusions: 9α11βPGF(2) and LTE(4) level in urine did not differ between the stable COPD group and the control group. We also did not find any difference between LTE4 level in urine and 9α11βPGF(2) in blood and urine between exacerbated and stable COPD. Finally, LTE(4) concentration in urine and 9α11βPGF(2) in blood occurred to be significantly higher in exacerbated COPD patients than in control group.

Published
2012

11. Efficacy and safety of fluticasone and formoterol in a single pressurized metered dose inhaler.

Author

Bodzenta-Lukaszyk A, Pulka G, Dymek A, Bumbacea D, McIver T, Schwab B, and Mansikka H

Subjects
Administration, Inhalation, Adolescent, Adult, Aged, Aged, 80 and over, Asthma physiopathology, Double-Blind Method, Drug Combinations, Drug Therapy, Combination, Epidemiologic Methods, Female, Fluticasone, Forced Expiratory Volume physiology, Formoterol Fumarate, Humans, Male, Metered Dose Inhalers, Middle Aged, Nebulizers and Vaporizers, Treatment Outcome, Young Adult, Androstadienes administration & dosage, Anti-Asthmatic Agents administration & dosage, Asthma drug therapy, Ethanolamines administration & dosage, Forced Expiratory Volume drug effects
Abstract

Background: Fluticasone and formoterol are well established medications for the treatment of asthma. This study (Clinicaltrials.gov identifier: NCT00734318) compares the efficacy and safety of a combination of these drugs in a single inhaler (fluticasone/formoterol) versus the individual components (fluticasone + formoterol)., Methods: Patients aged ≥ 18 years (n=620) with a history of severe, persistent reversible asthma for ≥ 6 months prior to screening were included in this randomized, double-blind study, which consisted of a screening phase of up to 5 days, a 2-week run-in phase and an 8-week treatment period., Results: Fluticasone/formoterol (500/20 μg, b.i.d.) was at least as effective as fluticasone + formoterol (500 μg + 24 μg, b.i.d.) with respect to the primary outcome measure: there were similar increases in mean pre-morning dose forced expiratory volume in the first second (FEV(1)) in these two groups. Fluticasone/formoterol (500/20 μg, b.i.d.) also demonstrated similar efficacy to fluticasone + formoterol in terms of change in mean FEV(1) from baseline pre-morning dose to 2 h post-morning dose at week 8, as well as for several secondary parameters. Fluticasone/formoterol (500/20 μg, b.i.d.) demonstrated superiority to fluticasone monotherapy (500 μg, b.i.d.) and fluticasone/formoterol (100/10 μg, b.i.d.) for several secondary efficacy parameters. Fluticasone/formoterol had a similar safety and tolerability profile to fluticasone + formoterol., Conclusion: This study demonstrated that the fluticasone/formoterol combination is at least as effective as its components administered concurrently from separate inhalers. Fluticasone/formoterol (500/20 μg, b.i.d.) showed superior efficacy to its inhaled corticosteroid component alone and the efficacy of fluticasone/formoterol was dose-dependent for several clinically important parameters., (Copyright © 2010 Elsevier Ltd. All rights reserved.)

Published
2011
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