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2. A phase 3, randomized, double-blind, active-controlled clinical trial to compare BAT1806/BIIB800, a tocilizumab biosimilar, with tocilizumab reference product in participants with moderate-to-severe rheumatoid arthritis with inadequate response to methotrexate: treatment period 2 analysis (week 24 to week 48)

Author

Leng, Xiaomei, Leszczyński, Piotr, Jeka, Slawomir, Liu, Shengyun, Liu, Huaxiang, Miakisz, Malgorzata, Gu, Jieruo, Kilasonia, Lali, Stanislavchuk, Mykola, Yang, Xiaolei, Zhou, Yinbo, Dong, Qingfeng, Mitroiu, Marian, Addison, Janet, Rezk, Mourad F., and Zeng, Xiaofeng

Published
2024
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3. Comparing tocilizumab biosimilar BAT1806/BIIB800 with reference tocilizumab in patients with moderate-to-severe rheumatoid arthritis with an inadequate response to methotrexate: a phase 3, randomised, multicentre, double-blind, active-controlled clinical trial

Author

Leng, Xiaomei, Leszczyński, Piotr, Jeka, Sławomir, Liu, Sheng-Yun, Liu, Huaxiang, Miakisz, Małgorzata, Gu, Jieruo, Kilasonia, Lali, Stanislavchuk, Mykola, Yang, Xiaolei, Zhou, Yinbo, Dong, Qingfeng, Rezk, Mourad, Mitroiu, Marian, Addison, Janet, and Zeng, Xiaofeng

Published
2024
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4. Tocilizumab in systemic sclerosis: a randomised, double-blind, placebo-controlled, phase 3 trial

Author

Lucero, Eleonora, Pons-Estel, Bernardo, Rivero, Mariano, Tate, Guillermo, Smith, Vanessa, De Langhe, Ellen, Rashkov, Rasho, Batalov, Anastas, Goranov, Ivan, Stoilov, Rumen, Dunne, James, Johnson, Sindhu R., Pope, Janet E., Martinović Kaliterna, Dušanka, Mogensen, Mette, Olesen, Anne Braae, Allanore, Yannick, Henes, Joerg Christoph, Müller-Ladner, Ulf, Riemekasten, Gabriela, Skapenko, Alla, Vlachoyiannopoulos, Panayiotis, Kiss, Emese, Minier, Tünde, Beretta, Lorenzo, Gremese, Elisa, Matucci-Cerinic, Marco, Valentini, Gabriele, Asano, Yoshihide, Atsumi, Tatsuya, Ihn, Hironobu, Ishii, Tomonori, Ishikawa, Osamu, Kuwana, Masataka, Shima, Yoshihito, Takahashi, Hiroki, Takehara, Kazuhiko, Tanaka, Yoshiya, Yamasaki, Yoshioki, Bukauskiene, Loreta, Butrimiene, Irena, Medrano Ramirez, Gabriel, Ramos-Remus, Cesar, Sofia Rodriguez Reyna, Tatiana, de Vries-Bouwstra, Jeska, van Laar, Jacob M., Batko, Bogdan, Jeka, Slawomir, Kucharz, Eugeniusz, Majdan, Maria, Olesinska, Marzena, Smolenska, Zaneta, Alves, Jose, Santos, Maria, Mihai, Carmen Marina, Rednic, Simona, Castellvi Barranco, Ivan, Lopez Longo, Francisco Javier, Simeon Aznar, Carmen, Carreira, Patricia, Distler, Oliver, Walker, Ulrich A., Derrett-Smith, Emma, Griffiths, Bridget, McKay, Neil, Denton, Christopher P., Aelion, Jacob, Borofsky, Michael, Fleischmann, Roy, Forstot, Joseph Z., Furst, Daniel E., Kafaja, Suzanne, Khan, M. Faisal, Khanna, Dinesh, Kohen, Michael D., Martin, Richard W., Mendoza-Ballesteros, Fabian, Nami, Alireza, Pang, Shirley, Rios, Grissel, Simms, Robert, Sullivan, Keith Michael, Steen, Virginia D., Lin, Celia J F, Furst, Daniel E, Goldin, Jonathan, Kim, Grace, van Laar, Jacob M, Spotswood, Helen, Wagner, Bridget, Siegel, Jeffrey, Jahreis, Angelika, and Denton, Christopher P

Published
2020
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5. Factors associated with quality of life in systemic sclerosis : a cross-sectional study

Author

Sierakowska, Matylda, Doroszkiewicz, Halina, Sierakowska, Justyna, Olesińska, Marzena, Grabowska-Jodkowska, Agnieszka, Brzosko, Marek, Leszczyński, Piotr, Pawlak-Bus, Katarzyna, Batko, Bogdan, Wiland, Piotr, Majdan, Maria, Bykowska-Sochacka, Małgorzata, Romanowski, Wojciech, Zon-Giebel, Aleksandra, Jeka, Sławomir, and Ndosi, Mwidimi

Published
2019

6. Efficacy and safety of biosimilar CT-P17 versus reference adalimumab in subjects with rheumatoid arthritis: 24-week results from a randomized study

Author

Kay, Jonathan, Jaworski, Janusz, Wojciechowski, Rafal, Wiland, Piotr, Dudek, Anna, Krogulec, Marek, Jeka, Slawomir, Zielinska, Agnieszka, Trefler, Jakub, Bartnicka-Maslowska, Katarzyna, Krajewska-Wlodarczyk, Magdalena, Klimiuk, Piotr A., Lee, Sang Joon, Bae, Yun Ju, Yang, Go Eun, Yoo, Jae Kyoung, Furst, Daniel E., and Keystone, Edward

Published
2021
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7. Efficacy and safety of tofacitinib monotherapy, tofacitinib with methotrexate, and adalimumab with methotrexate in patients with rheumatoid arthritis (ORAL Strategy): a phase 3b/4, double-blind, head-to-head, randomised controlled trial

Author

Adams, Luthando, Ally, Mahmood M, du Plooy, Maria C, Louw, Ingrid C, Nayiager, Savithree, Nel, Christoffel B, Nel, Debra, Reuter, Helmuth, Soloman, Ahmed S, Spargo, Catherine E, Hall, Stephen, Rischmueller, Maureen, Sharma, Shunil D, Will, Robert K, Youssef, Peter P, Arroyo, Caroline, Baes, Rosario P, Dulos, Roger B, Hao, Llewellyn T, Lanzon, Allan E, Lichauco, Juan Javier T, Mangubat, Jill H, Ramiterre, Edgar B, Reyes, Bernadette Heizel M, Tan, Perry P, Choe, Jung-Yoon, Kang, Young Mo, Kwon, Seong Ryul, Lee, Sang-Heon, Lee, Shin-Seok, Yoo, Dae-Hyun, Lin, Hsiao-Yi, Luo, Shue-Fen, Tsai, Shih-Tzu, Tsai, Wen-Chan, Tseng, Jui-Cheng, Wei, Cheng-Chung C, Asavatanabodee, Paijit, Nantiruj, Kanokrat, Nilganuwong, Surasak, Uea-Areewongsa, Parichat, Majstorovic, Ljubinka Bozic, Bacic, Suada Mulic, Batalov, Anastas Z, Georgieva-Slavcheva, Gabriela, Mihailova, Mariyana, Nikolov, Nikolay G, Penev, Dimitar P, Spasov, Yuliy A, Stanimirova, Krasimira, Todorov, Stoyan, Toncheva, Antoaneta R, Yordanova, Nadezhda, Mosterova, Zdenka, Novosad, Libor, Prochazkova, Leona, Stehlikova, Helena, Stejfova, Zuzana, Kiseleva, Natalia, Pank, Lea, Savi, Triin, Alexandra, Balbir-Gurman, Amital, Howard, Mevorach, Dror, Rosner, Itzhak A, Mihailova, Anna, Stumbra-Stumberga, Evija, Basijokiene, Vida, Lietuvininkiene, Virginija, Unikiene, Dalia, Brzezicki, Jan, Dudek, Anna M, Glowacka-Kulesz, Maria B, Grabowicz-Wasko, Barbara, Hajduk-Kubacka, Sabina, Hilt, Joanna, Hrycaj, Pawel, Jeka, Slawomir, Kolasa, Renata, Krogulec, Marek, Mastalerz, Hanna, Olak-Popko, Anna, Owczarek, Elzbieta, Ruzga, Zofia, Walczak, Alina, Ancuta, Codrina I, Ancuta, Ioan, Balanescu, Andra R, Berghea, Florian, Bojin, Silvia, Arvunescu, Mihaela A Ianuli, Ionescu, Ruxandra M, Mociran, Eugenia, Pavel, Mariana, Rednic, Simona, Voie, Adriana, Zainea, Carmen M, Bugrova, Olga V, Demin, Alexander, Ershova, Olga B, Gavrisheva, Inna A, Krechikova, Diana G, Kuropatkin, Gennady V, Marusenko, Irina M, Menshikova, Irina V, Noskov, Sergey M, Rebrov, Andrey P, Smakotina, Svetlana A, Yakushin, Sergey S, Zhilyaev, Evgeny, Ramos, Juan Jose Amarelo, Garcia, Francisco Javier Blanco, Nebro, Antonio Fernandez, Esteban, Silvia Perez, Burson, Juan Miguel Sanchez, Sala, Raimon Sanmarti, Ataman, Sebnem, Hizmetli, Sami, Kuru, Omer, Douglas, Karen M, Emery, Paul, Moots, Robert J, Ong, Voon H, Sheeran, Thomas P, Faraawi, Rafat Y, Lessard, Clode, Mendoza, Carlos Abud, Avila-Armengol, Hilario Ernesto, Zapata, Francisco I Avila, Irazoque-Palazuelos, Fedra Consuelo, Cecena, Marco Antonio Maradiaga, Pacheco-Tena, Cesar F, Rizo-Rodriguez, Juan C, Rodriguez-Torres, Isaura M, Aelion, Jacob A, Caciolo, Barbara A, Calmes, James M, Chatpar, Prem, Dayal, Nimesh, De Jesus, Alex, Dikranian, Ara H, Diri, Erdal, Fairfax, Michael J, Fenton, Ira F, Fleischmann, Roy M, Gaylis, Norman B, George, Ronald L, Halter, Dale G, Hernandez, Paul, Hole, Susan A, Hou, Antony C, Huff, John P, Kafaja, Suzanne, Kennedy, Alastair C, Kenney, Howard, Kimmel, Steven C, Kirby, Brian S, Kivitz, Alan J, Legerton, Clarence W, Lindsey, Stephen M, Mallepalli, Jyothi R, Mathews, Steven D, Metyas, Samy K, Mizutani, Wesley T, Najam, Sabeen, Nascimento, Joao M, Pang, Shirley W, Patel, Rakesh C, Poiley, Jeffrey E, Ramirez, Carlos E, Reddy, Riteesha, Rehman, Qaiser, Schnitz, William M, Scoville, Craig D, Shergy, William J, Silverfield, Joel C, Singhal, Atul K, Smallwood-Sherrer, Yvonne R, Songcharoen, Suthin N, Stack, Michael T, Stohl, William, Su, Tien-I K, Udell, James, Waraich, Saleem, Weidmann, Charles E, Wei, Nathan, Wiesenhutter, Craig W, Winkler, Anne E, Zagar, Karen E, Berman, Alberto, Mysler, Eduardo F, Hidalgo, Rodolfo A Pardo, Venarotti, Horacio O, Sariego, Irmgadt Annelise Goecke, Calabresse, Renato E Jimenez, Ruiz-Tagle, Juan Ignacio Vargas, Vargas, Luis Fernando M Bellatin, Berrocal, Alfredo E, Portocarrero, Manuel Gustavo Leon, Jesus, Felix, Pena, Romero, Fleischmann, Roy, Mysler, Eduardo, Luo, Zhen, DeMasi, Ryan, Soma, Koshika, Zhang, Richard, Takiya, Liza, Tatulych, Svitlana, Mojcik, Christopher, Krishnaswami, Sriram, Menon, Sujatha, and Smolen, Josef S

Published
2017
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8. Long-Term Efficacy and Safety of Biosimilar CT-P10 Versus Innovator Rituximab in Rheumatoid Arthritis: 48-Week Results from a Randomized Phase III Trial

Author

Suh, Chang-Hee, Yoo, Dae Hyun, Berrocal Kasay, Alfredo, Chalouhi El-Khouri, Elia, Cons Molina, Francisco Fidenci, Shesternya, Pavel, Miranda, Pedro, Medina-Rodriguez, Francisco G., Wiland, Piotr, Jeka, Slawomir, Chavez-Corrales, Jose, Linde, Thomas, Hrycaj, Pawel, Abello-Banfi, Mauricio, Hospodarskyy, Ihor, Jaworski, Janusz, Piotrowski, Mariusz, Brzosko, Marek, Krogulec, Marek, Shevchuk, Sergii, Calvo, Armando, Andersone, Daina, Park, Won, Shim, Seung Cheol, Lee, Sang Joon, and Lee, Sung Young

Published
2019
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10. Real-world effectiveness and safety of SDZ ETN, an etanercept biosimilar, in patients with rheumatic diseases: final results from multi-country COMPACT study

Author

Schmalzing, Marc, Kellner, Herbert, Askari, Ayman, De-Toro, Javier, Vázquez Pérez-Coleman, Julio César, Foti, Rosario, Jeka, Slawomir, Haraoui, Boulos, Allanore, Yannick, Peichl, Peter, Oehri, Martin, Rahman, Masiur, Furlan, Fabricio, Romero, Elisa, Hachaichi, Sohaib, Both, Charlotte, Brueckmann, Ines, Sheeran, Tom, Schmalzing, Marc, Kellner, Herbert, Askari, Ayman, De-Toro, Javier, Vázquez Pérez-Coleman, Julio César, Foti, Rosario, Jeka, Slawomir, Haraoui, Boulos, Allanore, Yannick, Peichl, Peter, Oehri, Martin, Rahman, Masiur, Furlan, Fabricio, Romero, Elisa, Hachaichi, Sohaib, Both, Charlotte, Brueckmann, Ines, and Sheeran, Tom

Abstract

[Abstract] Introduction: COMPACT, a non-interventional study, evaluated the persistence, effectiveness, safety and patient-reported outcomes (PROs) in patients with rheumatoid arthritis (RA), axial-spondyloarthritis (axSpA) or psoriatic arthritis (PsA) treated with SDZ ETN (etanercept [ETN] biosimilar) in Europe and Canada. Methods: Patients (aged ≥ 18 years) who have been treated with SDZ ETN were categorised on the basis of prior treatment status (groups A-D): patients in clinical remission or with low disease activity under treatment with reference ETN or biosimilar ETN and switched to SDZ ETN; patients who received non-ETN targeted therapies and switched to SDZ ETN; biologic-naïve patients who started SDZ ETN after conventional therapy failure; or disease-modifying anti-rheumatic drug (DMARD)-naïve patients with RA considered suitable for treatment initiation with a biologic and started on treatment with SDZ ETN. The primary endpoint was drug persistence, defined as time from study enrolment until discontinuation of SDZ ETN treatment. Results: Of the 1466 patients recruited, 844 (57.6%) had RA, 334 (22.8%) had axSpA and 288 (19.6%) had PsA. Patients had an ongoing SDZ ETN treatment at the time of enrolment for an observed average of 138 days (range 1-841); 22.7% of patients discontinued SDZ ETN through 12 months of study observation. Overall, all the patients receiving SDZ ETN showed good treatment persistence at 12 months with discontinuation rates of 15.2%, 25.7% and 27.8% in groups A, B and C, respectively. Across all patient groups, no major differences were observed in the disease activity and PRO scores between baseline and month 12. Injection-site reactions were low across the treatment groups. Conclusion: These results support the effectiveness and safety of SDZ ETN treatment in patients with RA, axSpA or PsA in real-life conditions. The treatment persistence rates observed were consistent with previously published reports of patients treated with refere

Published
2023

12. Efficacy, Safety and Pharmacokinetics of Up to Two Courses of the Rituximab Biosimilar CT-P10 Versus Innovator Rituximab in Patients with Rheumatoid Arthritis: Results up to Week 72 of a Phase I Randomized Controlled Trial

Author

Yoo, Dae Hyun, Suh, Chang-Hee, Shim, Seung Cheol, Jeka, Slawomir, Molina, Francisco Fidencio Cons, Hrycaj, Pawel, Wiland, Piotr, Lee, Eun Young, Medina-Rodriguez, Francisco G., Shesternya, Pavel, Radominski, Sebastiao, Stanislav, Marina, Kovalenko, Volodymyr, Sheen, Dong Hyuk, Myasoutova, Leysan, Lim, Mie Jin, Choe, Jung-Yoon, Lee, Sang Joon, Lee, Sung Young, Kim, Sung Hwan, and Park, Won

Published
2017
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13. Efficacy and Safety of Switching from Innovator Rituximab to Biosimilar CT-P10 Compared with Continued Treatment with CT-P10: Results of a 56-Week Open-Label Study in Patients with Rheumatoid Arthritis

Author

Park, Won, Suh, Chang-Hee, Shim, Seung Cheol, Molina, Francisco Fidencio Cons, Jeka, Slawomir, Medina-Rodriguez, Francisco G., Hrycaj, Pawel, Wiland, Piotr, Lee, Eun Young, Shesternya, Pavel, Kovalenko, Volodymyr, Myasoutova, Leysan, Stanislav, Marina, Radominski, Sebastiao, Lim, Mie Jin, Choe, Jung-Yoon, Lee, Sang Joon, Lee, Sung Young, Kim, Sung Hwan, and Yoo, Dae Hyun

Published
2017
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15. A multicentre randomised controlled trial to compare the pharmacokinetics, efficacy and safety of CT-P10 and innovator rituximab in patients with rheumatoid arthritis

Author

Yoo, Dae Hyun, Suh, Chang-Hee, Shim, Seung Cheol, Jeka, Slawomir, Cons-Molina, Francisco Fidencio, Hrycaj, Pawel, Wiland, Piotr, Lee, Eun Young, Medina-Rodriguez, Francisco G, Shesternya, Pavel, Radominski, Sebastiao, Stanislav, Marina, Kovalenko, Volodymyr, Sheen, Dong Hyuk, Myasoutova, Leysan, Lim, Mie Jin, Choe, Jung-Yoon, Lee, Sang Joon, Lee, Sung Young, Kwon, Taek Sang, and Park, Won

Published
2017
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17. Efficacy and safety of switching from reference adalimumab to CT-P17 (100 mg/ml): 52-week randomized, double-blind study in rheumatoid arthritis

Author

Furst, Daniel E, primary, Jaworski, Janusz, additional, Wojciechowski, Rafal, additional, Wiland, Piotr, additional, Dudek, Anna, additional, Krogulec, Marek, additional, Jeka, Slawomir, additional, Zielinska, Agnieszka, additional, Trefler, Jakub, additional, Bartnicka-Maslowska, Katarzyna, additional, Krajewska-Wlodarczyk, Magdalena, additional, Klimiuk, Piotr A, additional, Lee, Sang Joon, additional, Kim, Sung Hyun, additional, Bae, Yun Ju, additional, Yang, Go Eun, additional, Yoo, Jae Kyoung, additional, Kay, Jonathan, additional, and Keystone, Edward, additional

Published
2021
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18. P184 Secukinumab provides sustained improvements in clinical and imaging outcomes in patients with psoriatic arthritis and axial manifestations: results from the MAXIMISE trial

Author

Baraliakos, Xenofon, primary, Gossec, Laure, additional, Pournara, Effie, additional, Jeka, Slawomir, additional, Blanco, Ricardo, additional, D'Angelo, Salvatore, additional, Schett, Georg, additional, Schulz, Barbara, additional, Rissler, Michael, additional, Whyms, Dermot, additional, Perella, Chiara, additional, and Coates, Laura C, additional

Published
2021
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19. Trial of Upadacitinib and Adalimumab for Psoriatic Arthritis

Author

McInnes, Iain B., primary, Anderson, Jaclyn K., additional, Magrey, Marina, additional, Merola, Joseph F., additional, Liu, Yi, additional, Kishimoto, Mitsumasa, additional, Jeka, Slawomir, additional, Pacheco-Tena, Cesar, additional, Wang, Xin, additional, Chen, Liang, additional, Zueger, Patrick, additional, Liu, John, additional, Pangan, Aileen L., additional, and Behrens, Frank, additional

Published
2021
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20. A randomised, double-blind, multicentre, parallel-group, prospective study comparing the pharmacokinetics, safety, and efficacy of CT-P13 and innovator infliximab in patients with ankylosing spondylitis: the PLANETAS study

Author

Park, Won, Hrycaj, Pawel, Jeka, Slawomir, Kovalenko, Volodymyr, Lysenko, Grygorii, Miranda, Pedro, Mikazane, Helena, Gutierrez-Ureña, Sergio, Lim, MieJin, Lee, Yeon-Ah, Lee, Sang Joon, Kim, HoUng, Yoo, Dae Hyun, and Braun, Jürgen

Published
2013
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21. Secukinumab in patients with psoriatic arthritis and axial manifestations: results from the double-blind, randomised, phase 3 MAXIMISE trial

Author

Baraliakos, Xenofon, primary, Gossec, Laure, additional, Pournara, Effie, additional, Jeka, Slawomir, additional, Mera-Varela, Antonio, additional, D'Angelo, Salvatore, additional, Schulz, Barbara, additional, Rissler, Michael, additional, Nagar, Kriti, additional, Perella, Chiara, additional, and Coates, Laura C, additional

Published
2020
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22. Tocilizumab in systemic sclerosis: a randomised, double-blind, placebo-controlled, phase 3 trial

Author

Khanna, Dinesh, primary, Lin, Celia J F, additional, Furst, Daniel E, additional, Goldin, Jonathan, additional, Kim, Grace, additional, Kuwana, Masataka, additional, Allanore, Yannick, additional, Matucci-Cerinic, Marco, additional, Distler, Oliver, additional, Shima, Yoshihito, additional, van Laar, Jacob M, additional, Spotswood, Helen, additional, Wagner, Bridget, additional, Siegel, Jeffrey, additional, Jahreis, Angelika, additional, Denton, Christopher P, additional, Lucero, Eleonora, additional, Pons-Estel, Bernardo, additional, Rivero, Mariano, additional, Tate, Guillermo, additional, Smith, Vanessa, additional, De Langhe, Ellen, additional, Rashkov, Rasho, additional, Batalov, Anastas, additional, Goranov, Ivan, additional, Stoilov, Rumen, additional, Dunne, James, additional, Johnson, Sindhu R., additional, Pope, Janet E., additional, Martinović Kaliterna, Dušanka, additional, Mogensen, Mette, additional, Olesen, Anne Braae, additional, Henes, Joerg Christoph, additional, Müller-Ladner, Ulf, additional, Riemekasten, Gabriela, additional, Skapenko, Alla, additional, Vlachoyiannopoulos, Panayiotis, additional, Kiss, Emese, additional, Minier, Tünde, additional, Beretta, Lorenzo, additional, Gremese, Elisa, additional, Valentini, Gabriele, additional, Asano, Yoshihide, additional, Atsumi, Tatsuya, additional, Ihn, Hironobu, additional, Ishii, Tomonori, additional, Ishikawa, Osamu, additional, Takahashi, Hiroki, additional, Takehara, Kazuhiko, additional, Tanaka, Yoshiya, additional, Yamasaki, Yoshioki, additional, Bukauskiene, Loreta, additional, Butrimiene, Irena, additional, Medrano Ramirez, Gabriel, additional, Ramos-Remus, Cesar, additional, Sofia Rodriguez Reyna, Tatiana, additional, de Vries-Bouwstra, Jeska, additional, van Laar, Jacob M., additional, Batko, Bogdan, additional, Jeka, Slawomir, additional, Kucharz, Eugeniusz, additional, Majdan, Maria, additional, Olesinska, Marzena, additional, Smolenska, Zaneta, additional, Alves, Jose, additional, Santos, Maria, additional, Mihai, Carmen Marina, additional, Rednic, Simona, additional, Castellvi Barranco, Ivan, additional, Lopez Longo, Francisco Javier, additional, Simeon Aznar, Carmen, additional, Carreira, Patricia, additional, Walker, Ulrich A., additional, Derrett-Smith, Emma, additional, Griffiths, Bridget, additional, McKay, Neil, additional, Denton, Christopher P., additional, Aelion, Jacob, additional, Borofsky, Michael, additional, Fleischmann, Roy, additional, Forstot, Joseph Z., additional, Furst, Daniel E., additional, Kafaja, Suzanne, additional, Khan, M. Faisal, additional, Khanna, Dinesh, additional, Kohen, Michael D., additional, Martin, Richard W., additional, Mendoza-Ballesteros, Fabian, additional, Nami, Alireza, additional, Pang, Shirley, additional, Rios, Grissel, additional, Simms, Robert, additional, Sullivan, Keith Michael, additional, and Steen, Virginia D., additional

Published
2020
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23. Fenebrutinib Versus Placebo or Adalimumab in Rheumatoid Arthritis: A Randomized, Double‐Blind, Phase II Trial

Author

Cohen, Stanley, primary, Tuckwell, Katie, additional, Katsumoto, Tamiko R., additional, Zhao, Rui, additional, Galanter, Joshua, additional, Lee, Chin, additional, Rae, Julie, additional, Toth, Balazs, additional, Ramamoorthi, Nandhini, additional, Hackney, Jason A., additional, Berman, Alberto, additional, Damjanov, Nemanja, additional, Fedkov, Dmytro, additional, Jeka, Slawomir, additional, Chinn, Leslie W., additional, Townsend, Michael J., additional, Morimoto, Alyssa M., additional, Genovese, Mark C., additional, Porto, Alejandro, additional, Granel, Amelia, additional, Asnal, Cecilia, additional, Mysler, Eduardo Fabian, additional, Testa, Gladys Alicia, additional, Zamora, Jose Luis Velasco, additional, Moreno, Jose Luis Cristian, additional, Gulin, Juan Pablo, additional, Hofman, Julio, additional, Ulla, Maria Rosa, additional, Sabelli, Mirtha, additional, Mannucci, Pablo Alejandro, additional, Maid, Pablo Jorge, additional, Melazzi, Ana Cláudia Cauceglia, additional, Scotton, Antônio Scafuto, additional, Ximenes, Antônio Carlos, additional, Funes, Elisete, additional, Gimenez, Emerson Alves, additional, Marcolino, Flora Maria D’Andrea, additional, Neto, João Francisco Marques, additional, Keiserman, Mauro Waldemar, additional, Radominski, Sebastião Cézar, additional, Lima, Sônia Maria Alvarenga Anti Loduca, additional, Pavan, Thaís Rohde, additional, Azevedo, Valderílio Feijó, additional, Koleva, Aneliya, additional, Toncheva, Antoaneta, additional, Bichovska, Daniela, additional, Ivanova, Delina, additional, Penev, Dimitar, additional, Dimitrov, Emil, additional, Mihaylova, Mariyana, additional, Kapandjieva, Nadezhda, additional, Marinova, Natalia, additional, Aleksieva, Tanya, additional, Tsvetanova, Tanya, additional, Petranova, Tsvetanka, additional, Popova, Valentina, additional, Spasov, Yuliy, additional, Toro, Carlos Enrique, additional, Arteaga Unigarro, Carlos Ernesto, additional, Jauregui, Edwin, additional, Hernandez, Javier Dario Marquez, additional, Raad, Juan Jose Jaller, additional, Sanchez, Patricia Julieta Velez, additional, Lee, Chang Keun, additional, Suh, Chang‐Hee, additional, Lee, Eun Young, additional, Lee, Sang‐Heon, additional, Kang, Seong Wook, additional, Lee, Shin‐Seok, additional, Lee, Yun Jong, additional, Montiel, Beatriz Elena Zazueta, additional, Pinzon de la O, Blanca Irma, additional, Friedmann, Daniel Xibille, additional, Lopez, Francisco Rosas, additional, Torres, Isaura Rodriguez, additional, Quezada, Luis Jara, additional, Ceceña, Marco Maradiaga, additional, Hernandez, Miguel Cortes, additional, Salinas, Miguel Saavedra, additional, Rapa, Agnieszka, additional, Pawtel, Agnieszka, additional, Zielinska, Agnieszka, additional, Dudek, Anna, additional, Rychlewska‐Hanczewska, Anna, additional, Strzelecka, Anna, additional, Racewicz, Artur, additional, Stasiuk, Barbara, additional, Gruszecka, Katarzyna, additional, Dworak, Krystyna, additional, Lowenhoff, Tomasz, additional, Maslyanskiy, Alexey, additional, Rebrov, Andrey, additional, Krechikova, Diana, additional, Zhugrova, Elena, additional, Shmidt, Evgeniya, additional, Matsievskaya, Galina, additional, Vinogradova, Irina, additional, Ler, Irina, additional, Eliseeva, Larisa, additional, Savina, Ludmila, additional, Stanislav, Marina, additional, Sandin, Mikhail, additional, Zyablova, Natalia, additional, Korshunov, Nikolay, additional, Mosesova, Nino, additional, Polovnikova, Oksana, additional, Nesmeyanova, Olga, additional, Samigullina, Ruzana, additional, Moiseev, Sergey, additional, Noskov, Sergey, additional, Raskina, Tatiana, additional, Popova, Tatiana, additional, Marchenko, Valeriy, additional, Jovanovski, Aleksandar, additional, Stamenkovic, Bojana, additional, Ristic, Gorica, additional, Lazarevic, Milijanka, additional, Veselinovic, Mirjana, additional, Vujasinovic‐Stupar, Nada, additional, Ostojic, Predrag, additional, Yagensky, Andriy, additional, Gnylorybov, Andriy, additional, Rekalov, Dmytro, additional, Reshotko, Dmytroo, additional, Dzyak, Georgiy, additional, Gasanov, Iurii, additional, Khimion, Ludmila, additional, Stanislavchuk, Mykola, additional, Prykhodko, Natalya, additional, Nadashkevych, Oleg, additional, Bortkevych, Oleg, additional, Abrahamovych, Orest, additional, Yatsyshyn, Roman, additional, Turyanytsya, Samvel, additional, Smiyan, Svitlana, additional, Vizir, Vadym, additional, Kachur, Victoria, additional, Tseluyko, Vira, additional, Povoroznyuk, Vladyslav, additional, Koshlia, Volodymyr, additional, Zhdan, Vyacheslav, additional, Lymar, Yurii, additional, Mostovoy, Yuriy, additional, Hawkes, Angela, additional, Mabaquiao, Arthur, additional, Chu, Cong‐Qiu, additional, Scoville, Craig, additional, Wyatt, David, additional, Weinstein, Debra, additional, McIlwain, Harris, additional, Vo, Jacqueline, additional, Poiley, Jeffrey, additional, Forstot, Joseph, additional, Dao, Kathryn, additional, Turner, Mark, additional, Genovese, Mark, additional, Borofsky, Michael, additional, Caldron, Paul, additional, Waller, Philip, additional, Levin, Robert, additional, Metyas, Samy, additional, Stein, Scott, additional, Shroff, Sharukh, additional, Pang, Shirley, additional, Cohen, Stanley, additional, Syed, Tauseef, additional, and Chindalore, Vishala, additional

Published
2020
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26. Efficacy and safety of switching from reference adalimumab to CT-P17 (100 mg/ml): 52-week randomized, double-blind study in rheumatoid arthritis.

Author

Furst, Daniel E, Jaworski, Janusz, Wojciechowski, Rafal, Wiland, Piotr, Dudek, Anna, Krogulec, Marek, Jeka, Slawomir, Zielinska, Agnieszka, Trefler, Jakub, Bartnicka-Maslowska, Katarzyna, Krajewska-Wlodarczyk, Magdalena, Klimiuk, Piotr A, Lee, Sang Joon, Kim, Sung Hyun, Bae, Yun Ju, Yang, Go Eun, Yoo, Jae Kyoung, Kay, Jonathan, and Keystone, Edward

Subjects
THERAPEUTICS, DISEASE progression, TIME, BIOSIMILARS, TREATMENT effectiveness, RANDOMIZED controlled trials, RHEUMATOID arthritis, BLIND experiment, DESCRIPTIVE statistics, IMMUNITY, ADALIMUMAB, STATISTICAL sampling, PATIENT safety, SUBCUTANEOUS injections, JOINTS (Anatomy)
Abstract

Objective To compare the safety and efficacy of switching from reference adalimumab to adalimumab biosimilar CT-P17 with continuing reference adalimumab/CT-P17 in active RA. Methods This double-blind, phase III study randomized (1:1) subjects with active RA to receive 40 mg (100 mg/ml) CT-P17 or European Union-sourced reference adalimumab subcutaneously every 2 weeks (Q2W) until week (W) 24 [treatment period (TP) 1]. Thereafter, subjects receiving reference adalimumab were randomized (1:1) to continue reference adalimumab or switch to CT-P17 from W26 (both Q2W until W48; TP2). Subjects receiving CT-P17 in TP1 continued CT-P17. W0–W24 results were previously reported; we present W26–W52 findings. End points were efficacy (including joint damage progression), pharmacokinetics, safety and immunogenicity. Results Of 607 subjects who initiated TP2 treatment, 303 continued CT-P17, 153 continued reference adalimumab and 151 switched to CT-P17. Efficacy improvements up to W24 were maintained during TP2; efficacy was comparable among groups. At W52, 20% improvement in ACR response rates were 80.5% (continued CT-P17), 77.8% (continued reference adalimumab) and 82.2% (switched to CT-P17). Joint damage progression was minimal. Mean trough serum adalimumab concentrations were similar among groups. CT-P17 and reference adalimumab safety profiles were numerically similar and switching did not affect immunogenicity. At W52, 28.4% (continued CT-P17), 27.0% (continued reference adalimumab) and 28.3% (switched to CT-P17) of subjects were anti-drug antibody-positive. Conclusion Efficacy, pharmacokinetics, safety and immunogenicity of CT-P17 and reference adalimumab were comparable after 1 year of treatment, including after switching from reference adalimumab to CT-P17. Trial registration ClinicalTrials.gov, http://clinicaltrials.gov , NCT03789292. [ABSTRACT FROM AUTHOR]

Published
2022
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27. Tocilizumab in systemic sclerosis:a randomised, double-blind, placebo-controlled, phase 3 trial

Author

Khanna, Dinesh, Lin, Celia J.F., Furst, Daniel E., Goldin, Jonathan, Kim, Grace, Kuwana, Masataka, Allanore, Yannick, Matucci-Cerinic, Marco, Distler, Oliver, Shima, Yoshihito, van Laar, Jacob M., Spotswood, Helen, Wagner, Bridget, Siegel, Jeffrey, Jahreis, Angelika, Denton, Christopher P., Lucero, Eleonora, Pons-Estel, Bernardo, Rivero, Mariano, Tate, Guillermo, Smith, Vanessa, De Langhe, Ellen, Rashkov, Rasho, Batalov, Anastas, Goranov, Ivan, Stoilov, Rumen, Dunne, James, Johnson, Sindhu R., Pope, Janet E., Martinović Kaliterna, Dušanka, Mogensen, Mette, Olesen, Anne Braae, Henes, Joerg Christoph, Müller-Ladner, Ulf, Riemekasten, Gabriela, Skapenko, Alla, Vlachoyiannopoulos, Panayiotis, Kiss, Emese, Minier, Tünde, Beretta, Lorenzo, Gremese, Elisa, Valentini, Gabriele, Asano, Yoshihide, Atsumi, Tatsuya, Ihn, Hironobu, Ishii, Tomonori, Ishikawa, Osamu, Takahashi, Hiroki, Takehara, Kazuhiko, Tanaka, Yoshiya, Yamasaki, Yoshioki, Bukauskiene, Loreta, Butrimiene, Irena, Medrano Ramirez, Gabriel, Ramos-Remus, Cesar, Sofia Rodriguez Reyna, Tatiana, de Vries-Bouwstra, Jeska, Batko, Bogdan, Jeka, Slawomir, Kucharz, Eugeniusz, Majdan, Maria, Olesinska, Marzena, Smolenska, Zaneta, Alves, Jose, Santos, Maria, Mihai, Carmen Marina, Rednic, Simona, Castellvi Barranco, Ivan, Lopez Longo, Francisco Javier, Simeon Aznar, Carmen, Carreira, Patricia, Walker, Ulrich A., Derrett-Smith, Emma, Griffiths, Bridget, McKay, Neil, Aelion, Jacob, Borofsky, Michael, Fleischmann, Roy, Forstot, Joseph Z., Kafaja, Suzanne, Khan, M. Faisal, Kohen, Michael D., Martin, Richard W., Mendoza-Ballesteros, Fabian, Nami, Alireza, Pang, Shirley, Rios, Grissel, Simms, Robert, Sullivan, Keith Michael, Steen, Virginia D., Khanna, Dinesh, Lin, Celia J.F., Furst, Daniel E., Goldin, Jonathan, Kim, Grace, Kuwana, Masataka, Allanore, Yannick, Matucci-Cerinic, Marco, Distler, Oliver, Shima, Yoshihito, van Laar, Jacob M., Spotswood, Helen, Wagner, Bridget, Siegel, Jeffrey, Jahreis, Angelika, Denton, Christopher P., Lucero, Eleonora, Pons-Estel, Bernardo, Rivero, Mariano, Tate, Guillermo, Smith, Vanessa, De Langhe, Ellen, Rashkov, Rasho, Batalov, Anastas, Goranov, Ivan, Stoilov, Rumen, Dunne, James, Johnson, Sindhu R., Pope, Janet E., Martinović Kaliterna, Dušanka, Mogensen, Mette, Olesen, Anne Braae, Henes, Joerg Christoph, Müller-Ladner, Ulf, Riemekasten, Gabriela, Skapenko, Alla, Vlachoyiannopoulos, Panayiotis, Kiss, Emese, Minier, Tünde, Beretta, Lorenzo, Gremese, Elisa, Valentini, Gabriele, Asano, Yoshihide, Atsumi, Tatsuya, Ihn, Hironobu, Ishii, Tomonori, Ishikawa, Osamu, Takahashi, Hiroki, Takehara, Kazuhiko, Tanaka, Yoshiya, Yamasaki, Yoshioki, Bukauskiene, Loreta, Butrimiene, Irena, Medrano Ramirez, Gabriel, Ramos-Remus, Cesar, Sofia Rodriguez Reyna, Tatiana, de Vries-Bouwstra, Jeska, Batko, Bogdan, Jeka, Slawomir, Kucharz, Eugeniusz, Majdan, Maria, Olesinska, Marzena, Smolenska, Zaneta, Alves, Jose, Santos, Maria, Mihai, Carmen Marina, Rednic, Simona, Castellvi Barranco, Ivan, Lopez Longo, Francisco Javier, Simeon Aznar, Carmen, Carreira, Patricia, Walker, Ulrich A., Derrett-Smith, Emma, Griffiths, Bridget, McKay, Neil, Aelion, Jacob, Borofsky, Michael, Fleischmann, Roy, Forstot, Joseph Z., Kafaja, Suzanne, Khan, M. Faisal, Kohen, Michael D., Martin, Richard W., Mendoza-Ballesteros, Fabian, Nami, Alireza, Pang, Shirley, Rios, Grissel, Simms, Robert, Sullivan, Keith Michael, and Steen, Virginia D.

Abstract

Background: A phase 2 trial of tocilizumab showed preliminary evidence of efficacy in systemic sclerosis. We assessed skin fibrosis and systemic sclerosis-associated interstitial lung disease (SSc-ILD) in a phase 3 trial to investigate the safety and efficacy of tocilizumab, an anti-interleukin-6 receptor antibody, in the treatment of systemic sclerosis. Methods: In this multicentre, randomised, double-blind, placebo-controlled, phase 3 trial, participants were recruited from 75 sites in 20 countries across Europe, North America, Latin America, and Japan. Adults with diffuse cutaneous systemic sclerosis for 60 months or less and a modified Rodnan skin score (mRSS) of 10–35 at screening were randomly assigned (1:1) with a voice-web-response system to receive subcutaneous tocilizumab 162 mg or placebo weekly for 48 weeks, stratified by IL-6 levels; participants and investigators were masked to treatment group. The primary endpoint was the difference in change from baseline to week 48 in mRSS. Percentage of predicted forced vital capacity (FVC% predicted) at week 48, time to treatment failure, and patient-reported and physician-reported outcomes were secondary endpoints. This trial is registered with ClinicalTrials.gov (number NCT02453256) and is closed to accrual. Findings: Between Nov 20, 2015, and Feb 14, 2017, 210 individuals were randomly assigned to receive tocilizumab (n=104) or placebo (n=106). In the intention-to-treat population, least squares mean [LSM] change from baseline to week 48 in mRSS was −6·14 for tocilizumab and −4·41 for placebo (adjusted difference −1·73 [95% CI −3·78 to 0·32]; p=0·10). The shift in distribution of change from baseline in FVC% predicted at week 48 favoured tocilizumab (van Elteren nominal p=0·002 vs placebo), with a difference in LSM of 4·2 (95% CI 2·0–6·4; nominal p=0·0002), as did time to treatment failure (hazard ratio 0·63 [95% CI 0·37–1·06]; nominal p=0·08). Change in LSM from baseline to week 48 in Health Assessment Ques

Published
2020

28. Efficacy and safety of switching from rituximab to biosimilar CT-P10 in rheumatoid arthritis: 72-week data from a randomized Phase 3 trial

Author

Shim, Seung Cheol, primary, Božić-Majstorović, Ljubinka, additional, Berrocal Kasay, Alfredo, additional, El-Khouri, Elias Chalouhi, additional, Irazoque-Palazuelos, Fedra, additional, Cons Molina, Francisco Fidencio, additional, Medina-Rodriguez, Francisco G, additional, Miranda, Pedro, additional, Shesternya, Pavel, additional, Chavez-Corrales, Jose, additional, Wiland, Piotr, additional, Jeka, Slawomir, additional, Garmish, Olena, additional, Hrycaj, Pawel, additional, Fomina, Natalia, additional, Park, Won, additional, Suh, Chang-Hee, additional, Lee, Sang Joon, additional, Lee, Sung Young, additional, Bae, Yun Ju, additional, and Yoo, Dae Hyun, additional

Published
2019
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29. Secukinumab in patients with psoriatic arthritis and axial manifestations: results from the double-blind, randomised, phase 3 MAXIMISE trial.

Author

Baraliakos, Xenofon, Gossec, Laure, Pournara, Effie, Jeka, Slawomir, Mera-Varela, Antonio, D'Angelo, Salvatore, Schulz, Barbara, Rissler, Michael, Nagar, Kriti, Perella, Chiara, and Coates, Laura C.

Subjects
PSORIATIC arthritis, RESEARCH, RESEARCH methodology, MONOCLONAL antibodies, MEDICAL cooperation, EVALUATION research, ANTIRHEUMATIC agents, SEVERITY of illness index, TREATMENT effectiveness, COMPARATIVE studies, BLIND experiment, QUESTIONNAIRES
Abstract

Objectives: MAXIMISE (Managing AXIal Manifestations in psorIatic arthritis with SEcukinumab) trial was designed to evaluate the efficacy of secukinumab in the management of axial manifestations of psoriatic arthritis (PsA).Methods: This phase 3b, double-blind, placebo-controlled, multi-centre 52-week trial included patients (≥18 years) diagnosed with PsA and classified by ClASsification criteria for Psoriatic Arthritis (CASPAR) criteria, with spinal pain Visual Analogue Score ≥40/100 and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score ≥4 despite use of at least two non-steroidal anti-inflammatory drugs (NSAIDs). Patients were randomised (1:1:1) to secukinumab 300 mg, secukinumab 150 mg or placebo weekly for 4 weeks and every 4 weeks thereafter. At week 12, placebo patients were re-randomised to secukinumab 300/150 mg. Primary endpoint was ASAS20 (Assessment of SpondyloArthritis international Society) response with secukinumab 300 mg at week 12.Results: Patients were randomly assigned; 167 to secukinumab 300 mg, 165 to secukinumab 150 mg and 166 to placebo. Secukinumab 300 mg and 150 mg significantly improved ASAS20 response versus placebo at week 12 (63% and 66% vs 31% placebo). The OR (95% CI) comparing secukinumab 300 mg and 150 mg versus placebo, using a logistic regression model after multiple imputation, was 3.8 (2.4 and 6.1) and 4.4 (2.7 and 7.0; p<0.0001).Conclusions: Secukinumab 300 mg and 150 mg provided significant improvement in signs and symptoms of axial disease compared with placebo in patients with PsA and axial manifestations with inadequate response to NSAIDs.Trial Registration Number: NCT02721966. [ABSTRACT FROM AUTHOR]

Published
2021
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30. Three Multicenter, Randomized, Double‐Blind, Placebo‐Controlled Studies Evaluating the Efficacy and Safety of Ustekinumab in Axial Spondyloarthritis

Author

Deodhar, Atul, primary, Gensler, Lianne S., additional, Sieper, Joachim, additional, Clark, Michael, additional, Calderon, Cesar, additional, Wang, Yuhua, additional, Zhou, Yiying, additional, Leu, Jocelyn H., additional, Campbell, Kim, additional, Sweet, Kristen, additional, Harrison, Diane D., additional, Hsia, Elizabeth C., additional, Heijde, Désirée, additional, Ariel, Frederico, additional, Asnal, Cecilia Adma, additional, Berman, Alberto, additional, Citera, Gustavo, additional, Rodriguez, Graciela, additional, Savio, Veronica Gabriela, additional, Bird, Paul, additional, Griffiths, Hedley, additional, Nicholls, David, additional, Rischmueller, Maureen, additional, Zochling, Jane, additional, De Vlam, Kurt, additional, Malaise, Michel, additional, Toukap, Adrien Nzeusseu, additional, Van den Bosch, Filip, additional, Vanhoof, Johan, additional, Bonfiglioli, Rubens, additional, Keiserman, Mauro, additional, Scotton, Antonio Scafuto, additional, Xavier, Ricardo, additional, Ximenes, Antonio Carlos, additional, Atanasov, Assen, additional, Goranov, Ivan, additional, Kazmin, Ivan, additional, Licheva, Rodina Nestorova, additional, Nikolov, Nikolay, additional, Oparanov, Boycho, additional, Stoilov, Rumen, additional, Bessette, Louis, additional, Rodrigues, Jude, additional, Bortilik, Ladislav, additional, Dokoupilova, Eva, additional, Dvoarak, Zdenek, additional, Galatikova, Dagmar, additional, Nemec, Petr, additional, Podrazilova, Lucie, additional, Simkova, Gabriela, additional, Stejfova, Zuzana, additional, Moravcova, Radka, additional, Vitek, Petr, additional, Cantagrel, Alain, additional, Baillet, Athan, additional, Banneville, Beatrice, additional, Combe, Bernard, additional, Breban, Maxime, additional, Nguyen, Minh, additional, Goupille, Philippe, additional, Braun, Juergen, additional, Everding, Andrea, additional, Kekow, Joern, additional, Koenig, Ramona, additional, Rubbert‐Roth, Andrea, additional, Witte, Torsten, additional, Bartha, Attila, additional, Drescher, Edit, additional, Kerekes, Kata, additional, Kovacs, Attila, additional, Pulai, Judit, additional, Rojkovich, Bernadette, additional, Szanto, Sandor, additional, Toth, Edit, additional, Avila, Hilario, additional, Torre, Igancio Garcia, additional, Irazoque, Fedra, additional, Maradiaga, Marco, additional, Pacheco, Cesar, additional, Brzosko, Marek, additional, Dudek, Anna, additional, Jeka, Slawomir, additional, Krogulec, Marek, additional, Kwiatkowska, Brygida, additional, Wiland, Piotr, additional, Wojciechowski, Rafal, additional, Zielinska, Agnieszka, additional, Santos, Helena, additional, Bugrova, Olga, additional, Christyakov, Valery, additional, Gorbunov, Vladimir, additional, Ilivanova, Elena, additional, Zemerova, Elena, additional, Kamalova, Rima, additional, Kameneva, Tatyana, additional, Macievskaya, Galina, additional, Marusenko, Irina, additional, Maslyansky, Alexey, additional, Myasoedova, Svetlana, additional, Myasoutova, Leisan, additional, Nemtsov, Boris, additional, Nesmeyanova, Olga, additional, Plaksina, Tatyana, additional, Pokrovskaya, Tatyana, additional, Polyakova, Svetlana, additional, Rebrov, Andrey, additional, Savina, Liudmila, additional, Smakotina, Svetlana, additional, Stanislav, Marina, additional, Ukhanova, Olga, additional, Vinogradova, Irina, additional, Zonova, Elena, additional, Baek, Han Joo, additional, Kim, Tae‐Hwan, additional, Lee, ChangKeun, additional, Lee, SangHeon, additional, Lee, Sang‐Hoon, additional, Lee, Shin‐Seok, additional, Park, Sung‐Hwan, additional, Song, YeongWook, additional, Suh, Chang‐Hee, additional, Ramos, Juan Amarelo, additional, Blanco, Franciso Javier, additional, Collantes, Eduardo, additional, Diaz, Miguel Consuelo, additional, Vivar, Maria Luz Garcia, additional, Gratacos, Jordi, additional, Juanola, Xavier, additional, Chen, Der‐Yuan, additional, Chen, Hsiang‐Cheng, additional, Chen, Kun‐Hung, additional, Chen, Ying‐Chou, additional, Chiu, Ying‐Ming, additional, Luo, Shue‐Fen, additional, Tsai, Shih‐Tzu, additional, Tseng, Jui‐Cheng, additional, Wei, Cheng‐Chung, additional, Weng, Meng‐Yu, additional, Abrahamovych, Orest, additional, Reshotko, Dmytro, additional, Golovchenko, Oleksandr, additional, Hospodarsky, Ihor, additional, Iaremenko, Oleg, additional, Levchenko, Olena, additional, Dudnyk, Oleksandr, additional, Garmish, Olena, additional, Grishyna, Olena, additional, Protsenko, Galyna, additional, Rekalov, Dmytro, additional, Smiyan, Svitlana, additional, Stanislavchuk, Mykola, additional, Trypilka, Svitlana, additional, Tseluyko, Vira, additional, Turianytsia, Samvel, additional, Vasylets, Viktoriya, additional, Virstyuk, Nataliya, additional, Kleban, Yaroslav, additional, Ciurtin, Coziana, additional, Gaffney, Karl, additional, Gunasekera, Wiranthi, additional, Mackay, Kirsten, additional, Packham, Jon, additional, Sengupta, Raj, additional, Tahir, Hasan, additional, Aelion, Jacob, additional, Bennett, Ralph, additional, Deodhar, Atul, additional, Gonzalez‐Paoli, Julio, additional, Griffin, Robert M., additional, Grisanti, Michael, additional, Mallepalli, Jyothi, additional, Peters, Eric, additional, Schechtman, Joy, additional, and Singhal, Atul, additional

Published
2018
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31. Comparison of biosimilar CT-P10 and innovator rituximab in patients with rheumatoid arthritis: a randomized controlled Phase 3 trial

Author

Park, Won, primary, Božić-Majstorović, Ljubinka, additional, Milakovic, Dragana, additional, Berrocal Kasay, Alfredo, additional, El-Khouri, Elias Chalouhi, additional, Irazoque-Palazuelos, Fedra, additional, Molina, Francisco Fidencio Cons, additional, Shesternya, Pavel, additional, Miranda, Pedro, additional, Medina-Rodriguez, Francisco G., additional, Wiland, Piotr, additional, Jeka, Slawomir, additional, Chavez-Corrales, Jose, additional, Garmish, Olena, additional, Linde, Thomas, additional, Rekalov, Dmytro, additional, Hrycaj, Pawel, additional, Krause, Andreas, additional, Fomina, Natalia, additional, Piura, Olena, additional, Abello-Banfi, Mauricio, additional, Suh, Chang-Hee, additional, Shim, Seung Cheol, additional, Lee, Sang Joon, additional, Lee, Sung Young, additional, Kim, Sung Hwan, additional, and Yoo, Dae Hyun, additional

Published
2018
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33. CNTO6785, a Fully Human Antiinterleukin 17 Monoclonal Antibody, in Patients with Rheumatoid Arthritis with Inadequate Response to Methotrexate: A Randomized, Placebo-controlled, Phase II, Dose-ranging Study

Author

Mease, Philip J., primary, Jeka, Slawomir, additional, Jaller, Juan Jose, additional, Kitumnuaypong, Tasanee, additional, Louthrenoo, Worawit, additional, Mann, Herman, additional, Matsievskaia, Galina, additional, Soriano, Enrique R., additional, Jia, Bin, additional, Wang, Caihong, additional, Nie, Jing, additional, and Hsia, Elizabeth, additional

Published
2017
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34. Efficacy and safety of tofacitinib monotherapy, tofacitinib with methotrexate, and adalimumab with methotrexate in patients with rheumatoid arthritis (ORAL Strategy): a phase 3b/4, double-blind, head-to-head, randomised controlled trial

Author

Fleischmann, Roy, primary, Mysler, Eduardo, additional, Hall, Stephen, additional, Kivitz, Alan J, additional, Moots, Robert J, additional, Luo, Zhen, additional, DeMasi, Ryan, additional, Soma, Koshika, additional, Zhang, Richard, additional, Takiya, Liza, additional, Tatulych, Svitlana, additional, Mojcik, Christopher, additional, Krishnaswami, Sriram, additional, Menon, Sujatha, additional, Smolen, Josef S, additional, Adams, Luthando, additional, Ally, Mahmood M, additional, du Plooy, Maria C, additional, Louw, Ingrid C, additional, Nayiager, Savithree, additional, Nel, Christoffel B, additional, Nel, Debra, additional, Reuter, Helmuth, additional, Soloman, Ahmed S, additional, Spargo, Catherine E, additional, Rischmueller, Maureen, additional, Sharma, Shunil D, additional, Will, Robert K, additional, Youssef, Peter P, additional, Arroyo, Caroline, additional, Baes, Rosario P, additional, Dulos, Roger B, additional, Hao, Llewellyn T, additional, Lanzon, Allan E, additional, Lichauco, Juan Javier T, additional, Mangubat, Jill H, additional, Ramiterre, Edgar B, additional, Reyes, Bernadette Heizel M, additional, Tan, Perry P, additional, Choe, Jung-Yoon, additional, Kang, Young Mo, additional, Kwon, Seong Ryul, additional, Lee, Sang-Heon, additional, Lee, Shin-Seok, additional, Yoo, Dae-Hyun, additional, Lin, Hsiao-Yi, additional, Luo, Shue-Fen, additional, Tsai, Shih-Tzu, additional, Tsai, Wen-Chan, additional, Tseng, Jui-Cheng, additional, Wei, Cheng-Chung C, additional, Asavatanabodee, Paijit, additional, Nantiruj, Kanokrat, additional, Nilganuwong, Surasak, additional, Uea-Areewongsa, Parichat, additional, Majstorovic, Ljubinka Bozic, additional, Bacic, Suada Mulic, additional, Batalov, Anastas Z, additional, Georgieva-Slavcheva, Gabriela, additional, Mihailova, Mariyana, additional, Nikolov, Nikolay G, additional, Penev, Dimitar P, additional, Spasov, Yuliy A, additional, Stanimirova, Krasimira, additional, Todorov, Stoyan, additional, Toncheva, Antoaneta R, additional, Yordanova, Nadezhda, additional, Mosterova, Zdenka, additional, Novosad, Libor, additional, Prochazkova, Leona, additional, Stehlikova, Helena, additional, Stejfova, Zuzana, additional, Kiseleva, Natalia, additional, Pank, Lea, additional, Savi, Triin, additional, Alexandra, Balbir-Gurman, additional, Amital, Howard, additional, Mevorach, Dror, additional, Rosner, Itzhak A, additional, Mihailova, Anna, additional, Stumbra-Stumberga, Evija, additional, Basijokiene, Vida, additional, Lietuvininkiene, Virginija, additional, Unikiene, Dalia, additional, Brzezicki, Jan, additional, Dudek, Anna M, additional, Glowacka-Kulesz, Maria B, additional, Grabowicz-Wasko, Barbara, additional, Hajduk-Kubacka, Sabina, additional, Hilt, Joanna, additional, Hrycaj, Pawel, additional, Jeka, Slawomir, additional, Kolasa, Renata, additional, Krogulec, Marek, additional, Mastalerz, Hanna, additional, Olak-Popko, Anna, additional, Owczarek, Elzbieta, additional, Ruzga, Zofia, additional, Walczak, Alina, additional, Ancuta, Codrina I, additional, Ancuta, Ioan, additional, Balanescu, Andra R, additional, Berghea, Florian, additional, Bojin, Silvia, additional, Arvunescu, Mihaela A Ianuli, additional, Ionescu, Ruxandra M, additional, Mociran, Eugenia, additional, Pavel, Mariana, additional, Rednic, Simona, additional, Voie, Adriana, additional, Zainea, Carmen M, additional, Bugrova, Olga V, additional, Demin, Alexander, additional, Ershova, Olga B, additional, Gavrisheva, Inna A, additional, Krechikova, Diana G, additional, Kuropatkin, Gennady V, additional, Marusenko, Irina M, additional, Menshikova, Irina V, additional, Noskov, Sergey M, additional, Rebrov, Andrey P, additional, Smakotina, Svetlana A, additional, Yakushin, Sergey S, additional, Zhilyaev, Evgeny, additional, Ramos, Juan Jose Amarelo, additional, Garcia, Francisco Javier Blanco, additional, Nebro, Antonio Fernandez, additional, Esteban, Silvia Perez, additional, Burson, Juan Miguel Sanchez, additional, Sala, Raimon Sanmarti, additional, Ataman, Sebnem, additional, Hizmetli, Sami, additional, Kuru, Omer, additional, Douglas, Karen M, additional, Emery, Paul, additional, Ong, Voon H, additional, Sheeran, Thomas P, additional, Faraawi, Rafat Y, additional, Lessard, Clode, additional, Mendoza, Carlos Abud, additional, Avila-Armengol, Hilario Ernesto, additional, Zapata, Francisco I Avila, additional, Irazoque-Palazuelos, Fedra Consuelo, additional, Cecena, Marco Antonio Maradiaga, additional, Pacheco-Tena, Cesar F, additional, Rizo-Rodriguez, Juan C, additional, Rodriguez-Torres, Isaura M, additional, Aelion, Jacob A, additional, Caciolo, Barbara A, additional, Calmes, James M, additional, Chatpar, Prem, additional, Dayal, Nimesh, additional, De Jesus, Alex, additional, Dikranian, Ara H, additional, Diri, Erdal, additional, Fairfax, Michael J, additional, Fenton, Ira F, additional, Fleischmann, Roy M, additional, Gaylis, Norman B, additional, George, Ronald L, additional, Halter, Dale G, additional, Hernandez, Paul, additional, Hole, Susan A, additional, Hou, Antony C, additional, Huff, John P, additional, Kafaja, Suzanne, additional, Kennedy, Alastair C, additional, Kenney, Howard, additional, Kimmel, Steven C, additional, Kirby, Brian S, additional, Legerton, Clarence W, additional, Lindsey, Stephen M, additional, Mallepalli, Jyothi R, additional, Mathews, Steven D, additional, Metyas, Samy K, additional, Mizutani, Wesley T, additional, Najam, Sabeen, additional, Nascimento, Joao M, additional, Pang, Shirley W, additional, Patel, Rakesh C, additional, Poiley, Jeffrey E, additional, Ramirez, Carlos E, additional, Reddy, Riteesha, additional, Rehman, Qaiser, additional, Schnitz, William M, additional, Scoville, Craig D, additional, Shergy, William J, additional, Silverfield, Joel C, additional, Singhal, Atul K, additional, Smallwood-Sherrer, Yvonne R, additional, Songcharoen, Suthin N, additional, Stack, Michael T, additional, Stohl, William, additional, Su, Tien-I K, additional, Udell, James, additional, Waraich, Saleem, additional, Weidmann, Charles E, additional, Wei, Nathan, additional, Wiesenhutter, Craig W, additional, Winkler, Anne E, additional, Zagar, Karen E, additional, Berman, Alberto, additional, Mysler, Eduardo F, additional, Hidalgo, Rodolfo A Pardo, additional, Venarotti, Horacio O, additional, Sariego, Irmgadt Annelise Goecke, additional, Calabresse, Renato E Jimenez, additional, Ruiz-Tagle, Juan Ignacio Vargas, additional, Vargas, Luis Fernando M Bellatin, additional, Berrocal, Alfredo E, additional, Portocarrero, Manuel Gustavo Leon, additional, Jesus, Felix, additional, and Pena, Romero, additional

Published
2017
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35. Association of MICA-129Met/Val polymorphism with clinical outcome of anti-TNF therapy and MICA serum levels in patients with rheumatoid arthritis

Author

Iwaszko, Milena, Swierkot, Jerzy, Dratwa, Marta, Wysoczanska, Barbara, Korman, Lucyna, Bugaj, Bartosz, Kolossa, Katarzyna, Jeka, Slawomir, Wiland, Piotr, and Bogunia-Kubik, Katarzyna

Abstract

MHC class I polypeptide-related sequence A (MICA) is a stress-induced protein involved in activation of NK and T cells through interaction with NKG2D receptor. These molecules are atypically expressed in synovium of patients diagnosed with rheumatoid arthritis (RA). A total of 279 patients with RA, qualified to TNF-blockade therapy, were genotyped for MICArs1051792 SNP. The effectiveness of anti-TNF agents was assessed with European League Against Rheumatism criteria. Significant relationship between MICArs1051792 and outcome of TNF-blockade therapy has been found. The MICArs1051792 GGgenotype was overrepresented in patients non-responsive to anti-TNF drugs in comparison with other genotypes (p?=?0.010). On the other hand, beneficial therapeutic response was more frequently detected among RA subjects possessing heterozygous genotype than those with homozygous genotypes (p?=?0.003). Furthermore, increased MICA concentrations in serum were observed in patients possessing MICArs1051792 GGgenotype as compared with those with GAor AAgenotypes (p?=?1.8?×?10-5). The results from this study indicate the potential influence of MICArs1051792 polymorphism on modulation of therapeutic response to TNF-blockade treatment in RA.

Published
2020
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36. A multicentre randomised controlled trial to compare the pharmacokinetics, efficacy and safety of CT-P10 and innovator rituximab in patients with rheumatoid arthritis

Author

Yoo, Dae Hyun, primary, Suh, Chang-Hee, additional, Shim, Seung Cheol, additional, Jeka, Slawomir, additional, Cons-Molina, Francisco Fidencio, additional, Hrycaj, Pawel, additional, Wiland, Piotr, additional, Lee, Eun Young, additional, Medina-Rodriguez, Francisco G, additional, Shesternya, Pavel, additional, Radominski, Sebastiao, additional, Stanislav, Marina, additional, Kovalenko, Volodymyr, additional, Sheen, Dong Hyuk, additional, Myasoutova, Leysan, additional, Lim, Mie Jin, additional, Choe, Jung-Yoon, additional, Lee, Sang Joon, additional, Lee, Sung Young, additional, Kwon, Taek Sang, additional, and Park, Won, additional

Published
2016
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38. Dynamics of Stomach Growth in the Human Fetal Period: a Postmortem Study

Author

Gworys, Bohdan, Jeka, Slawomir, Brukiewa, Radoslaw, and Rymko, Marcin

Subjects
Stomach, Estómago, Desarrollo fetal, Fetal development
Abstract

The aim of this work was to analyze the stomach growth rate, variability of proportion and shape during prenatal period, as well as evaluation of final features differentiation process distinctive for perinatal period. It seems interesting to compare stomach growth analyzed in situ on post-mortem fetuses with results obtained by other authors evaluating this process in sonographic examinations. Research was conducted on 225 post-mortem fetuses 12th to 40 th week of fetal age. There were measurements of stomach total length, lengths of greater and lesser curvature and cardia and pylorus widths performed. We evaluated the thickness of stomach front wall and bottom and its total mass. Statistical analysis was performed using statistical program package Statistica 8. Rate of post mortem examined stomach dimensions growth - estimated on the base of mean conditional values is characterized by diverse rhythm. Proportions variability during prenatal period results from disharmonic growth of its dimensions. There were no dysmorphic differences in process of fetal stomach growth and in dynamics of its proportions and shapes changes found. In fetal period marks clearly tendency to organ shape changes consistent with fetal age. Based on analysis performed - four stages of stomach growth in fetal period were distinguished: 1. Intensive growth phase last till 22th fetal week. 2. Formation of final stomach shape between 20th and 26th gestational age. 3. Phase of stomach topography changes between 26th and 30th gestational age. 4. Phase of harmonic growth lasts from 30th week until childbirth. El objetivo fue analizar la tasa de crecimiento del estómago, variabilidad de la proporción y forma durante el período prenatal, así como evaluar las características distintivas del proceso final de diferenciación para el período perinatal. Es interesante comparar el crecimiento del estómago de los fetos analizado in situ en el post-mortem con resultados obtenidos por otros autores tras la evaluación de este proceso en exámenes ecográficos. La investigación fue realizada en 225 fetos post-mortem desde la 12 a la 40 semana de edad fetal. Se determinaron la longitud total del estómago, la longitud de las curvaturas mayor y menor, y los anchos del cardias y píloro. Se evaluó el grosor de la paredes frontal e inferior del estómago y su masa total. El análisis estadístico se realizó mediante el programa Statistica 8. La tasa de crecimiento en las dimensiones de los estómagos post-mortem examinados se estimaron sobre la base de valores medios condicionales caracterizados por el ritmo diverso. Las proporciones de variabilidad en el periodo prenatal resultaron en un crecimiento inarmónico de sus dimensiones. No hubo diferencias dismórficas en proceso de crecimiento fetal del estómago, mientras que en la dinámica de sus proporciones y formas se encuentraron cambios. El período fetal, marca claramente la tendencia a cambios en la forma de órganos acorde con la edad del feto. Basado en el análisis realizado, se distinguen cuatro etapas de crecimiento de estómago en el período fetal: 1. Fase de crecimiento intensivo hasta finales de la semana 22 del feto. 2. Formación de la forma del estómago definitiva entre la 20 y 26 semana de gestación. 3. Fase de cambios en la topografía del estómago entre la 26 y 30 semana de gestació. 4. Fase de crecimiento armónico desde la semana 30 hasta el parto.

Published
2012

39. CNTO6785, a Fully Human Antiinterleukin 17 Monoclonal Antibody, in Patients with Rheumatoid Arthritis with Inadequate Response to Methotrexate: A Randomized, Placebo-controlled, Phase II, Dose-ranging Study.

Author

Mease, Philip J., Jeka, Slawomir, Jaller, Juan Jose, Kitumnuaypong, Tasanee, Louthrenoo, Worawit, Mann, Herman, Matsievskaia, Galina, Soriano, Enrique R., Bin Jia, Caihong Wang, Jing Nie, Hsia, Elizabeth, Jia, Bin, Wang, Caihong, and Nie, Jing

Published
2018
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40. A multicentre randomised controlled trial to compare the pharmacokinetics, efficacy and safety of CT-P10 and innovator rituximab in patients with rheumatoid arthritis.

Author

Dae Hyun Yoo, Chang-Hee Suh, Seung Cheol Shim, Jeka, Slawomir, Cons-Molina, Francisco Fidencio, Hrycaj, Pawel, Wiland, Piotr, Eun Young Lee, Medina-Rodriguez, Francisco G., Shesternya, Pavel, Radominski, Sebastiao, Stanislav, Marina, Kovalenko, Volodymyr, Dong Hyuk Sheen, Myasoutova, Leysan, Mie Jin Lim, Jung-Yoon Choe, Sang Joon Lee, Sung Young Lee, and Taek Sang Kwon

Subjects
METHOTREXATE, ANTIRHEUMATIC agents, COMBINATION drug therapy, CLINICAL trials, COMPARATIVE studies, IMMUNOGLOBULINS, RESEARCH methodology, MEDICAL cooperation, PHARMACOKINETICS, RESEARCH, RHEUMATOID arthritis, EVALUATION research, RANDOMIZED controlled trials, SEVERITY of illness index
Abstract

Objective: To demonstrate pharmacokinetic equivalence of CT-P10 and innovator rituximab (RTX) in patients with rheumatoid arthritis (RA) with inadequate responses or intolerances to antitumour necrosis factor agents.Methods: In this randomised phase I trial, patients with active RA were randomly assigned (2:1) to receive 1000 mg CT-P10 or RTX at weeks 0 and 2 (alongside continued methotrexate therapy). Primary endpoints were area under the serum concentration-time curve from time zero to last quantifiable concentration (AUC0-last) and maximum serum concentration after second infusion (Cmax). Additional pharmacokinetic parameters, efficacy, pharmacodynamics, immunogenicity and safety were also assessed. Data are reported up to week 24.Results: 103 patients were assigned to CT-P10 and 51 to RTX. The 90% CIs for the ratio of geometric means (CT-P10/RTX) for both primary endpoints were within the bioequivalence range of 80%-125% (AUC0-last: 97.7% (90% CI 89.2% to 107.0%); Cmax: 97.6% (90% CI 92.0% to 103.5%)). Pharmacodynamics and efficacy were comparable between groups. Antidrug antibodies were detected in 17.6% of patients in each group at week 24. CT-P10 and RTX displayed similar safety profiles.Conclusions: CT-P10 and RTX demonstrated equivalent pharmacokinetics and comparable efficacy, pharmacodynamics, immunogenicity and safety.Trial Registration Number: NCT01534884. [ABSTRACT FROM AUTHOR]

Published
2017
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43. A randomised, double-blind, multicentre, parallel-group, prospective study comparing the pharmacokinetics, safety, and efficacy of CT-P13 and innovator infliximab in patients with ankylosing spondylitis: the PLANETAS study.

Author

Won Park, Hrycaj, Pawel, Jeka, Slawomir, Kovalenko, Volodymyr, Lysenko, Grygorii, Miranda, Pedro, Mikazane, Helena, Gutierrez-Ureña, Sergio, MieJin Lim, Yeon-Ah Lee, Sang Joon Lee, HoUng Kim, Dae Hyun Yoo, and Jürgen Braun

Abstract

Objectives To compare the pharmacokinetics (PK), safety and efficacy of innovator infliximab (INX) and CT-P13, a biosimilar to INX, in patients with active ankylosing spondylitis (AS). Methods Phase 1 randomised, double-blind, multicentre, multinational, parallel-group study. Patients were randomised to receive 5 mg/kg of CT-P13 (n=125) or INX (n=125). Primary endpoints were area under the concentration-time curve (AUC) at steady state and observed maximum steady state serum concentration (Cmax,ss) between weeks 22 and 30. Additional PK, efficacy endpoints, including 20% and 40% improvement response according to Assessment in Ankylosing Spondylitis International Working Group criteria (ASAS20 and ASAS40), and safety outcomes were also assessed. Results Geometric mean AUC was 32 765.8 μgh/ml for CT-P13 and 31 359.3 μgh/ml for INX. Geometric mean Cmax,ss was 147.0 μg/ml for CT-P13 and 144.8 μg/ml for INX. The ratio of geometric means was 104.5% (90% CI 94% to 116%) for AUC and 101.5% (90% CI 95% to 109%) for Cmax,ss. ASAS20 and ASAS40 responses at week 30 were 70.5% and 51.8% for CT-P13 and 72.4% and 47.4% for INX, respectively. In the CT-P13 and INX groups more than one adverse event occurred in 64.8% and 63.9% of patients, infusion reactions occurred in 3.9% and 4.9%, active tuberculosis occurred in 1.6% and 0.8%, and 27.4% and 22.5% of patients tested positive for anti-drug antibodies, respectively. Conclusions The PK profiles of CT-P13 and INX were equivalent in patients with active AS. CT-P13 was well tolerated, with an efficacy and safety profile comparable to that of INX up to week 30. [ABSTRACT FROM AUTHOR]

Published
2013
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44. Disparate effects of anti-TNF-a therapies on measures of disease activity and mediators of endothelial damage in ankylosing spondylitis

Author

Korkosz, Mariusz, Gasowski, Jerzy, Surdacki, Andrzej, Leszczynski, Piotr, Pawlak-Buœ, Katarzyna, Jeka, Slawomir, Siedlar, Maciej, and Grodzicki, Tomasz

Abstract

Background: Asymmetric dimethylarginine (ADMA) is associated with endothelial injury. Increased ADMA levels are found in rheumatoid arthritis (RA) and ankylosing spondylitis (AS). We set out to assess the ADMA and symmetric dimethylarginine (SDMA) levels in AS, RA, and healthy controls, and in the anti-TNF treated patients with active AS. Methods: In 78 AS patients and 29 RA patients who were anti-TNF treatment naive at baseline, along with 23 healthy control subjects, we assessed erythrocyte sedimentation rate (ESR), high-sensitivity C-reactive protein (hsCRP), ADMA, and SDMA. For AS patients, the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), back pain VAS and patient’s global activity of disease were calculated. After 6 months, we repeated the assessment in 30 out of the 78 AS patients in whom the anti-TNF treatment was initiated. Results: The baseline mean (SD) plasma ADMA concentration of AS patients was 0.64 (0.19) µmol/l and did not differ from controls (0.65 [0.19] µmol/l, p > 0.05). In the RA group, ADMA concentration was higher than in controls (0.77 vs.0.65 µmol/l, p &lt; 0.05). Both at baseline and at follow-up, ADMA levels correlated positively with BASDAI (R = 0.52, p = 0.02, and R = 0.47, p = 0.04, baseline and follow-up, respectively). Six months of anti-TNF treatment did not influence ADMA concentration (0.51 [0.12] vs.0.51 [0.11] µmol/l, p = 0.70). Conclusion: An absence of changes in plasma ADMA levels in the anti-TNF treated AS group despite the improvement in disease activity (BASDAI) and inflammation (ESR, CRP) may suggest either a lack of effect, or, even if such an effect were to take place, it needs not imply measurable changes in blood ADMA.

Published
2013
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46. High disease activity in ankylosing spondylitis is associated with increased serum sclerostin level and decreased wingless protein-3a signaling but is not linked with greater structural damage.

Author

Korkosz, Mariusz, Gsowski, Jerzy, Leszczynski, Piotr, Pawlak-Bus, Katarzyna, Jeka, Slawomir, Kucharska, Ewa, Grodzicki, Tomasz, Gąsowski, Jerzy, Leszczyński, Piotr, Pawlak-Buś, Katarzyna, and Jeka, Sławomir

Abstract

Background: Clinical activity of ankylosing spondylitis (AS) predicts the natural course of the disease and the response to treatment. Several molecules are involved in new bone formation resulting in structural damage in patients with AS. However, the link between the clinical and molecular phenomena has not yet been fully established. The aim of the study was to investigate the relation between markers of bone remodeling and inflammation with clinical activity and structural damage in AS.Methods: We assessed the serum levels of sclerostin, Dickkopf-1 protein, Wingless protein-3a, bone morphogenic protein-7, matrix metalloproteinase-3, osteoprotegerin, bone alkaline phosphatase and inflammatory markers in 50 AS patients with high disease activity (BASDAI ≥ 4), 28 with low disease activity (BASDAI <4), and 23 healthy controls. Cervical and lumbar spine x-rays were performed in 46 patients to measure structural damage (mSASSS).Results: Sclerostin level was significantly greater in high disease activity patients than in controls. Wingless protein-3a and Dikkopf-1 protein levels were significantly lower in high activity group compared to low activity group and controls. Negative correlation was found between sclerostin and Dikkopf-1 protein in high activity group (R = -0.28, P = 0.048). The median mSASSS values were not different between patient groups.Conclusions: Higher disease activity in AS may not be per se associated with greater new bone formation. [ABSTRACT FROM AUTHOR]

Published
2013
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47. Baseline new bone formation does not predict bone loss in ankylosing spondylitis as assessed by quantitative computed tomography (QCT): 10-year follow-up.

Author

Korkosz, Mariusz, Gsowski, Jerzy, Grzanka, Piotr, Gorczowski, Janusz, Pluskiewicz, Wojciech, Jeka, Slawomir, Grodzicki, Tomasz, Gąsowski, Jerzy, and Jeka, Sławomir

Subjects
HIP joint radiography, SPINE radiography, ANALYSIS of variance, ANKYLOSING spondylitis, BONE regeneration, BONE growth, COMPUTED tomography, HIP joint, LONGITUDINAL method, OSTEOPOROSIS, REGRESSION analysis, SPINE, TIME, BONE density, SEVERITY of illness index, PHOTON absorptiometry, DISEASE complications
Abstract

Background: To evaluate the relationship between bone loss and new bone formation in ankylosing spondylitis (AS) using 10-year X-ray, dual-energy x-ray absorptiometry (DXA) and quantitative computed tomography (QCT) follow-up.Methods: Fifteen AS patients free from medical conditions and drugs affecting bone metabolism underwent X-ray, DXA and QCT in 1999 and 2009.Results: In spine QCT a statistically significant (p = 0,001) decrease of trabecular bone mineral content (BMC) was observed (change ± SD: 18.0 ± 7.3 mg/cm3). In contrast, spine DXA revealed a significant increase of bone mineral density (change ± SD: -0.15 ± 0.14 g/cm2). The mean BMC, both at baseline and follow-up was significantly lower (p = 0.02 and p = 0.005, respectively) in advanced radiological group as compared to early radiological group. However, in multiple regression model after adjustment for baseline BMC, the baseline radiological scoring did not influence the progression of bone loss as assessed with QCT (p = 0.22, p for BMC*X-ray syndesmophyte scoring interaction = 0.65, p for ANOVA-based X-ray syndesmophyte scoring*time interaction = 0.39). Baseline BMC was the only significant determinant of 10-year BMC change, to date the longest QCT follow-up data in AS.Conclusions: In AS patients who were not using antiosteoporotic therapy spine trabecular bone density evaluated by QCT decreased over 10-year follow-up and was not related to baseline radiological severity of spine involvement. [ABSTRACT FROM AUTHOR]

Published
2011
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