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4 results on '"Chung, Carol Y."'

1. Complement C3 Inhibitor Pegcetacoplan for Geographic Atrophy Secondary to Age-Related Macular Degeneration A Randomized Phase 2 Trial

Author

Liao, David S., Grossi, Federico, V, El Mehdi, Delphine, Gerber, Monica R., Brown, David M., Heier, Jeffrey S., Wykoff, Charles C., Singerman, Lawrence J., Abraham, Prema, Grassmann, Felix, Nuernberg, Peter, Weber, Bernhard H. F., Deschatelets, Pascal, Kim, Robert Y., Chung, Carol Y., Ribeiro, Ramiro M., Hamdani, Mohamed, Rosenfeld, Philip J., Boyer, David S., Slakter, Jason S., Francois, Cedric G., Liao, David S., Grossi, Federico, V, El Mehdi, Delphine, Gerber, Monica R., Brown, David M., Heier, Jeffrey S., Wykoff, Charles C., Singerman, Lawrence J., Abraham, Prema, Grassmann, Felix, Nuernberg, Peter, Weber, Bernhard H. F., Deschatelets, Pascal, Kim, Robert Y., Chung, Carol Y., Ribeiro, Ramiro M., Hamdani, Mohamed, Rosenfeld, Philip J., Boyer, David S., Slakter, Jason S., and Francois, Cedric G.

Abstract

Purpose: Geographic atrophy (GA), a late stage of age-related macular degeneration (AMD), is a major cause of blindness. Even while central visual acuity remains relatively well preserved, GA often causes considerable compromise of visual function and quality of life. No treatment currently exists. We evaluated the safety and efficacy of pegcetacoplan, a complement C3 inhibitor, for treatment of GA. Design: Prospective, multicenter, randomized, sham-controlled phase 2 study. Participants: Two hundred forty-six patients with GA. Methods: Patients with GA were assigned randomly in a 2:2:1:1 ratio to receive intravitreal injections of 15 mg pegcetacoplan monthly or every other month (EOM) or sham intravitreal injections monthly or EOM for 12 months with follow-up at months 15 and 18. Area and growth of GA were measured using fundus autofluorescence imaging. Main Outcome Measures: The primary efficacy end point was mean change in square root GA lesion area from baseline to month 12. Secondary outcome measures included mean change from baseline in GA lesion area without the square root transformation, distance of GA lesion from the fovea, best-corrected visual acuity (BCVA), low-luminance BCVA, and low-luminance visual acuity deficit. The primary safety end point was the number and severity of treatment-emergent adverse events. Results: In patients receiving pegcetacoplan monthly or EOM, the GA growth rate was reduced by 29% (95% confidence interval [CI], 9-49; P = 0.008) and 20% (95% CI, 0-40; P = 0.067) compared with the sham treatment group. Post hoc analysis showed that the effect was greater in the second 6 months of treatment, with observed reductions of 45% (P = 0.0004) and 33% (P = 0.009) for pegcetacoplan monthly and EOM, respectively. Two cases of culture-positive endophthalmitis and 1 case of culture-negative endophthalmitis occurred in the pegcetacoplan monthly group. New-onset investigator-determined exudative AMD was reported more frequently in pegcetacopla

Published
2020

2. Rheumatoid arthritis - treatment: 180. Utility of Body Weight Classified Low-Dose Leflunomide in Japanese Rheumatoid Arthritis

Author

Nishikawa, Masataka, Owaki, Hajime, Fuji, Takeshi, Soliman, Moetaza M., Ashcroft, Darren M., Watson, Kath D., Lunt, Mark, Symmons, Deborah, Hyrich, Kimme L., Atkinson, Francesca, Malik, Saadia, Heycock, Carol, Saravanan, Vadivelu, Rynne, Martin, Hamilton, Jennifer, Kelly, Clive, Burmester, Gerd, Kary, Sonja, Unnebrink, Kristina, Guérette, Benoit, Oezer, Uemit, Kupper, Hartmut, Dennison, Elaine, Jameson, Karen, Hyrich, Kimme, Watson, Kath, Landewe, Robert, Keystone, Edward, Smolen, Josef, Goldring, Mary, Patra, Kaushik, Cifaldi, Mary, van der Heijde, Désirée, Lloyd, Lois A., Owen, Catherine, Breslin, Anne, Ahmad, Yasmeen, Emery, Paul, Matteson, E. L., Genovese, M., Sague, S., Hsia, E. C., Doyle, M. K., Fan, H., Elashoff, M., Kirkham, Bruce, Wasco, M. C., Bathon, J., Fleischmann, R., Genovese, M. C., Liu, H., Goldman, J., Leirisalo-Repo, M., Zanetakis, E., El-Kadi, H., Kellner, H., Bolce, R., Wang, J., Dehoratius, R., Decktor, D., Kremer, J., Taylor, Peter, Mendelsohn, A., Baker, D., Kim, L., Ritchlin, C., Mariette, Xavier, Matucci Cerenic, Marco, Pavelka, Karel, van Vollenhoven, Ronald, Heatley, Rebecca, Walsh, Claire, Lawson, Richard, Reynolds, Alan, Iaremenko, Oleg, Mikitenko, Ganna, Kavanaugh, Arthur, Luijtens, Kristel, Curtis, Jeffrey, Schiff, Michael, Kvien, Tore, Khanna, Dinesh, Furst, Dan, Behrens, Frank, Koehm, Michaela, Scharbatke, Eva C., Kleinert, Stefan, Weyer, Gerd, Tony, Hans-Peter, Burkhardt, Harald, Blunn, Karina J., Williams, Richard B., Young, Adam, McDowell, Jackie, Weinblatt, Michael, Haraoui, Boulos, Mozaffarian, Neelufar, Khraishi, Majed, Alten, Rieke, Gomez-Reino, Juan, Rizzo, Warren, Schechtman, Joy, Kahan, Andre, Vernon, Emma, Taylor, Monet, Hogan, Vanessa, Holweg, Cecile, Kummerfeld, Sarah, Teng, Onno, Townsend, Michael, van Laar, Jacob M., Gullick, Nicola J., De Silva, Chulanie, Kirkham, Bruce W., Roy, Sanjoy, Emery, P., van der Heijde, D., Keystone, E., Conaghan, P. G., Xu, W., Baratelle, A., Beutler, A., Rahman, M. U., Nikiphorou, Elena, Kiely, Patrick, Walsh, David A., Williams, Richard, Shah, Devron, Knight, Gregory D., Hutchinson, David G., Dass, Shouvik, Atzeni, Fabiola, Vital, Edward M., Bingham, Sarah J., Buch, Maya, Beirne, Paul, Fleischmann, Roy, Dougados, Maxime, Williams, Sarah, Reynard, Mark, Blackler, Laura, Zain, Amir, Oakley, Stephen, Rees, Jonathon, Jones, Tim, Mistlin, Alan, Panayi, Gabriel, Westhovens, Rene, Durez, Patrick, Genant, Harry, Robles, Manuel, Becker, Jean-Claude, Covucci, Allison, Bathon, Joan, Genovese, Mark C., Luggen, Michael, Le Bars, Manuela, Aranda, Richard, Li, Tracy, Elegbe, Ayanbola, Fichtner, Andreas, Strand, Vibeke, Vencovsky, Jiri, Davies, Rebecca, Galloway, James, Hochberg, Marc, Kelly, Sheila, Khan, Nadar, Qi, Keqin, Pappu, Ramesh, Delaet, Ingrid, Luo, Allison, Torbeyns, Anne, Moreland, Larry, Cohen, Roger, Gujrathi, Sheila, Bykerk, Vivian P., Álvaro-Gracia, Jose, Andres Roman Ivorra, Jose, Nurmohamed, Michael T., Bernasconi, Corrado, Stancati, Andrea, Sibilia, Jean, Östör, Andrew, Strangfeld, Anja, Eveslage, Maria, Listing, Joachim, Herzer, Peter, Liebhaber, Anke, Krummel-Lorenz, Brigitte, Zink, Angela, Breedveld, Ferdinand C., Cohen, Stanley B., Matteson, Eric L., Burke, Laura, Chai, Akiko, Reiss, William, Sweetser, Marianne, Shaw, Tim, Ellis, Shawn D., Ehrenstein, Michael R., Notley, Clare A., Yazici, Yusuf, Ince, Akgun, Baraf, Herbert, Malamet, Raymond, Chung, Carol Y., Hughes, Chris, Faurholm, Bjarne, Dell'Accio, Francesco, Manzo, Antonio, Seed, Michael, Eltawil, Noha, Marrelli, Alessandra, Gould, David, Subang, Christina, Al-Kashi, Adam, De Bari, Cosimo, Winyard, Paul, Chernajovsky, Yuti, Nissim, Ahuva, Bingham, Clifton, Fleischmann, Roy M., Furst, Daniel E., Macey, Katherine M., Sweetser, Marianne T., Lehane, Patricia, Farmer, Pamela, Long, Simon G., Kremer, Joel M., Burgos-Vargas, Ruben, Dudler, Jean, Mela, Christopher M., Wegner, Natalia, Lugli, Helena, Quirke, Anne-Marie, Guo, Yonghua, Potempa, Jan, Venables, Patrick, Nishikawa, Masataka, Owaki, Hajime, Fuji, Takeshi, Soliman, Moetaza M., Ashcroft, Darren M., Watson, Kath D., Lunt, Mark, Symmons, Deborah, Hyrich, Kimme L., Atkinson, Francesca, Malik, Saadia, Heycock, Carol, Saravanan, Vadivelu, Rynne, Martin, Hamilton, Jennifer, Kelly, Clive, Burmester, Gerd, Kary, Sonja, Unnebrink, Kristina, Guérette, Benoit, Oezer, Uemit, Kupper, Hartmut, Dennison, Elaine, Jameson, Karen, Hyrich, Kimme, Watson, Kath, Landewe, Robert, Keystone, Edward, Smolen, Josef, Goldring, Mary, Patra, Kaushik, Cifaldi, Mary, van der Heijde, Désirée, Lloyd, Lois A., Owen, Catherine, Breslin, Anne, Ahmad, Yasmeen, Emery, Paul, Matteson, E. L., Genovese, M., Sague, S., Hsia, E. C., Doyle, M. K., Fan, H., Elashoff, M., Kirkham, Bruce, Wasco, M. C., Bathon, J., Fleischmann, R., Genovese, M. C., Liu, H., Goldman, J., Leirisalo-Repo, M., Zanetakis, E., El-Kadi, H., Kellner, H., Bolce, R., Wang, J., Dehoratius, R., Decktor, D., Kremer, J., Taylor, Peter, Mendelsohn, A., Baker, D., Kim, L., Ritchlin, C., Mariette, Xavier, Matucci Cerenic, Marco, Pavelka, Karel, van Vollenhoven, Ronald, Heatley, Rebecca, Walsh, Claire, Lawson, Richard, Reynolds, Alan, Iaremenko, Oleg, Mikitenko, Ganna, Kavanaugh, Arthur, Luijtens, Kristel, Curtis, Jeffrey, Schiff, Michael, Kvien, Tore, Khanna, Dinesh, Furst, Dan, Behrens, Frank, Koehm, Michaela, Scharbatke, Eva C., Kleinert, Stefan, Weyer, Gerd, Tony, Hans-Peter, Burkhardt, Harald, Blunn, Karina J., Williams, Richard B., Young, Adam, McDowell, Jackie, Weinblatt, Michael, Haraoui, Boulos, Mozaffarian, Neelufar, Khraishi, Majed, Alten, Rieke, Gomez-Reino, Juan, Rizzo, Warren, Schechtman, Joy, Kahan, Andre, Vernon, Emma, Taylor, Monet, Hogan, Vanessa, Holweg, Cecile, Kummerfeld, Sarah, Teng, Onno, Townsend, Michael, van Laar, Jacob M., Gullick, Nicola J., De Silva, Chulanie, Kirkham, Bruce W., Roy, Sanjoy, Emery, P., van der Heijde, D., Keystone, E., Conaghan, P. G., Xu, W., Baratelle, A., Beutler, A., Rahman, M. U., Nikiphorou, Elena, Kiely, Patrick, Walsh, David A., Williams, Richard, Shah, Devron, Knight, Gregory D., Hutchinson, David G., Dass, Shouvik, Atzeni, Fabiola, Vital, Edward M., Bingham, Sarah J., Buch, Maya, Beirne, Paul, Fleischmann, Roy, Dougados, Maxime, Williams, Sarah, Reynard, Mark, Blackler, Laura, Zain, Amir, Oakley, Stephen, Rees, Jonathon, Jones, Tim, Mistlin, Alan, Panayi, Gabriel, Westhovens, Rene, Durez, Patrick, Genant, Harry, Robles, Manuel, Becker, Jean-Claude, Covucci, Allison, Bathon, Joan, Genovese, Mark C., Luggen, Michael, Le Bars, Manuela, Aranda, Richard, Li, Tracy, Elegbe, Ayanbola, Fichtner, Andreas, Strand, Vibeke, Vencovsky, Jiri, Davies, Rebecca, Galloway, James, Hochberg, Marc, Kelly, Sheila, Khan, Nadar, Qi, Keqin, Pappu, Ramesh, Delaet, Ingrid, Luo, Allison, Torbeyns, Anne, Moreland, Larry, Cohen, Roger, Gujrathi, Sheila, Bykerk, Vivian P., Álvaro-Gracia, Jose, Andres Roman Ivorra, Jose, Nurmohamed, Michael T., Bernasconi, Corrado, Stancati, Andrea, Sibilia, Jean, Östör, Andrew, Strangfeld, Anja, Eveslage, Maria, Listing, Joachim, Herzer, Peter, Liebhaber, Anke, Krummel-Lorenz, Brigitte, Zink, Angela, Breedveld, Ferdinand C., Cohen, Stanley B., Matteson, Eric L., Burke, Laura, Chai, Akiko, Reiss, William, Sweetser, Marianne, Shaw, Tim, Ellis, Shawn D., Ehrenstein, Michael R., Notley, Clare A., Yazici, Yusuf, Ince, Akgun, Baraf, Herbert, Malamet, Raymond, Chung, Carol Y., Hughes, Chris, Faurholm, Bjarne, Dell'Accio, Francesco, Manzo, Antonio, Seed, Michael, Eltawil, Noha, Marrelli, Alessandra, Gould, David, Subang, Christina, Al-Kashi, Adam, De Bari, Cosimo, Winyard, Paul, Chernajovsky, Yuti, Nissim, Ahuva, Bingham, Clifton, Fleischmann, Roy M., Furst, Daniel E., Macey, Katherine M., Sweetser, Marianne T., Lehane, Patricia, Farmer, Pamela, Long, Simon G., Kremer, Joel M., Burgos-Vargas, Ruben, Dudler, Jean, Mela, Christopher M., Wegner, Natalia, Lugli, Helena, Quirke, Anne-Marie, Guo, Yonghua, Potempa, Jan, and Venables, Patrick

Abstract

Background: In Japan, more than 20 rheumatoid arthritis (RA) patients died of interstitial pneumonia (IP) caused by leflunomide (LEF) were reported, but many of them were considered as the victims of opportunistic infection currently. In this paper, efficacy and safety of low-dose LEF classified by body weight (BW) were studied. Methods: Fifty-nine RA patients were started to administrate LEF from July 2007 to July 2009. Among them, 25 patients were excluded because of the combination with tacrolimus, and medication modification within 3 months before LEF. Remaining 34 RA patients administered 20 to 50 mg/week of LEF were followed up for 1 year and enrolled in this study. Dose of LEF was classified by BW (50 mg/week for over 50 kg, 40 mg/week for 40 to 50 kg and 20 to 30 mg/week for under 40 kg). The average age and RA duration of enrolled patients were 55.5 years old and 10.2 years. Prednisolone (PSL), methotrexate (MTX) and etanercept were used in 23, 28 and 2 patients, respectively. In case of insufficient response or adverse effect, dosage change or discontinuance of LEF were considered. Failure was defined as dosages up of PSL and MTX, or dosages down or discontinuance of LEF. Last observation carried forward method was used for the evaluation of failed patients at 1 year. Results: At 1 year after LEF start, good/ moderate/ no response assessed by the European League Against Rheumatism (EULAR) response criteria using Disease Activity Score, including a 28-joint count (DAS28)-C reactive protein (CRP) were showed in 14/ 10/ 10 patients, respectively. The dosage changes of LEF at 1 year were dosage up: 10, same dosage: 5, dosage down: 8 and discontinuance: 11 patients. The survival rate of patients in this study was 23.5% (24 patients failed) but actual LEF continuous rate was 67.6% (11 patients discontinued) at 1 year. The major reason of failure was liver dysfunction, and pneumocystis pneumonia was occurred in 1 patient resulted in full recovery. One patient die

Published
2017

3. Rheumatoid arthritis - treatment: 180. Utility of Body Weight Classified Low-Dose Leflunomide in Japanese Rheumatoid Arthritis

Author

Nishikawa, Masataka, Owaki, Hajime, Fuji, Takeshi, Soliman, Moetaza M., Ashcroft, Darren M., Watson, Kath D., Lunt, Mark, Symmons, Deborah, Hyrich, Kimme L., Atkinson, Francesca, Malik, Saadia, Heycock, Carol, Saravanan, Vadivelu, Rynne, Martin, Hamilton, Jennifer, Kelly, Clive, Burmester, Gerd, Kary, Sonja, Unnebrink, Kristina, Guérette, Benoit, Oezer, Uemit, Kupper, Hartmut, Dennison, Elaine, Jameson, Karen, Hyrich, Kimme, Watson, Kath, Landewe, Robert, Keystone, Edward, Smolen, Josef, Goldring, Mary, Patra, Kaushik, Cifaldi, Mary, van der Heijde, Désirée, Lloyd, Lois A., Owen, Catherine, Breslin, Anne, Ahmad, Yasmeen, Emery, Paul, Matteson, E. L., Genovese, M., Sague, S., Hsia, E. C., Doyle, M. K., Fan, H., Elashoff, M., Kirkham, Bruce, Wasco, M. C., Bathon, J., Fleischmann, R., Genovese, M. C., Liu, H., Goldman, J., Leirisalo-Repo, M., Zanetakis, E., El-Kadi, H., Kellner, H., Bolce, R., Wang, J., Dehoratius, R., Decktor, D., Kremer, J., Taylor, Peter, Mendelsohn, A., Baker, D., Kim, L., Ritchlin, C., Mariette, Xavier, Matucci Cerenic, Marco, Pavelka, Karel, van Vollenhoven, Ronald, Heatley, Rebecca, Walsh, Claire, Lawson, Richard, Reynolds, Alan, Iaremenko, Oleg, Mikitenko, Ganna, Kavanaugh, Arthur, Luijtens, Kristel, Curtis, Jeffrey, Schiff, Michael, Kvien, Tore, Khanna, Dinesh, Furst, Dan, Behrens, Frank, Koehm, Michaela, Scharbatke, Eva C., Kleinert, Stefan, Weyer, Gerd, Tony, Hans-Peter, Burkhardt, Harald, Blunn, Karina J., Williams, Richard B., Young, Adam, McDowell, Jackie, Weinblatt, Michael, Haraoui, Boulos, Mozaffarian, Neelufar, Khraishi, Majed, Alten, Rieke, Gomez-Reino, Juan, Rizzo, Warren, Schechtman, Joy, Kahan, Andre, Vernon, Emma, Taylor, Monet, Hogan, Vanessa, Holweg, Cecile, Kummerfeld, Sarah, Teng, Onno, Townsend, Michael, van Laar, Jacob M., Gullick, Nicola J., De Silva, Chulanie, Kirkham, Bruce W., Roy, Sanjoy, Emery, P., van der Heijde, D., Keystone, E., Conaghan, P. G., Xu, W., Baratelle, A., Beutler, A., Rahman, M. U., Nikiphorou, Elena, Kiely, Patrick, Walsh, David A., Williams, Richard, Shah, Devron, Knight, Gregory D., Hutchinson, David G., Dass, Shouvik, Atzeni, Fabiola, Vital, Edward M., Bingham, Sarah J., Buch, Maya, Beirne, Paul, Fleischmann, Roy, Dougados, Maxime, Williams, Sarah, Reynard, Mark, Blackler, Laura, Zain, Amir, Oakley, Stephen, Rees, Jonathon, Jones, Tim, Mistlin, Alan, Panayi, Gabriel, Westhovens, Rene, Durez, Patrick, Genant, Harry, Robles, Manuel, Becker, Jean-Claude, Covucci, Allison, Bathon, Joan, Genovese, Mark C., Luggen, Michael, Le Bars, Manuela, Aranda, Richard, Li, Tracy, Elegbe, Ayanbola, Fichtner, Andreas, Strand, Vibeke, Vencovsky, Jiri, Davies, Rebecca, Galloway, James, Hochberg, Marc, Kelly, Sheila, Khan, Nadar, Qi, Keqin, Pappu, Ramesh, Delaet, Ingrid, Luo, Allison, Torbeyns, Anne, Moreland, Larry, Cohen, Roger, Gujrathi, Sheila, Bykerk, Vivian P., Álvaro-Gracia, Jose, Andres Roman Ivorra, Jose, Nurmohamed, Michael T., Bernasconi, Corrado, Stancati, Andrea, Sibilia, Jean, Östör, Andrew, Strangfeld, Anja, Eveslage, Maria, Listing, Joachim, Herzer, Peter, Liebhaber, Anke, Krummel-Lorenz, Brigitte, Zink, Angela, Breedveld, Ferdinand C., Cohen, Stanley B., Matteson, Eric L., Burke, Laura, Chai, Akiko, Reiss, William, Sweetser, Marianne, Shaw, Tim, Ellis, Shawn D., Ehrenstein, Michael R., Notley, Clare A., Yazici, Yusuf, Ince, Akgun, Baraf, Herbert, Malamet, Raymond, Chung, Carol Y., Hughes, Chris, Faurholm, Bjarne, Dell'Accio, Francesco, Manzo, Antonio, Seed, Michael, Eltawil, Noha, Marrelli, Alessandra, Gould, David, Subang, Christina, Al-Kashi, Adam, De Bari, Cosimo, Winyard, Paul, Chernajovsky, Yuti, Nissim, Ahuva, Bingham, Clifton, Fleischmann, Roy M., Furst, Daniel E., Macey, Katherine M., Sweetser, Marianne T., Lehane, Patricia, Farmer, Pamela, Long, Simon G., Kremer, Joel M., Burgos-Vargas, Ruben, Dudler, Jean, Mela, Christopher M., Wegner, Natalia, Lugli, Helena, Quirke, Anne-Marie, Guo, Yonghua, Potempa, Jan, Venables, Patrick, Nishikawa, Masataka, Owaki, Hajime, Fuji, Takeshi, Soliman, Moetaza M., Ashcroft, Darren M., Watson, Kath D., Lunt, Mark, Symmons, Deborah, Hyrich, Kimme L., Atkinson, Francesca, Malik, Saadia, Heycock, Carol, Saravanan, Vadivelu, Rynne, Martin, Hamilton, Jennifer, Kelly, Clive, Burmester, Gerd, Kary, Sonja, Unnebrink, Kristina, Guérette, Benoit, Oezer, Uemit, Kupper, Hartmut, Dennison, Elaine, Jameson, Karen, Hyrich, Kimme, Watson, Kath, Landewe, Robert, Keystone, Edward, Smolen, Josef, Goldring, Mary, Patra, Kaushik, Cifaldi, Mary, van der Heijde, Désirée, Lloyd, Lois A., Owen, Catherine, Breslin, Anne, Ahmad, Yasmeen, Emery, Paul, Matteson, E. L., Genovese, M., Sague, S., Hsia, E. C., Doyle, M. K., Fan, H., Elashoff, M., Kirkham, Bruce, Wasco, M. C., Bathon, J., Fleischmann, R., Genovese, M. C., Liu, H., Goldman, J., Leirisalo-Repo, M., Zanetakis, E., El-Kadi, H., Kellner, H., Bolce, R., Wang, J., Dehoratius, R., Decktor, D., Kremer, J., Taylor, Peter, Mendelsohn, A., Baker, D., Kim, L., Ritchlin, C., Mariette, Xavier, Matucci Cerenic, Marco, Pavelka, Karel, van Vollenhoven, Ronald, Heatley, Rebecca, Walsh, Claire, Lawson, Richard, Reynolds, Alan, Iaremenko, Oleg, Mikitenko, Ganna, Kavanaugh, Arthur, Luijtens, Kristel, Curtis, Jeffrey, Schiff, Michael, Kvien, Tore, Khanna, Dinesh, Furst, Dan, Behrens, Frank, Koehm, Michaela, Scharbatke, Eva C., Kleinert, Stefan, Weyer, Gerd, Tony, Hans-Peter, Burkhardt, Harald, Blunn, Karina J., Williams, Richard B., Young, Adam, McDowell, Jackie, Weinblatt, Michael, Haraoui, Boulos, Mozaffarian, Neelufar, Khraishi, Majed, Alten, Rieke, Gomez-Reino, Juan, Rizzo, Warren, Schechtman, Joy, Kahan, Andre, Vernon, Emma, Taylor, Monet, Hogan, Vanessa, Holweg, Cecile, Kummerfeld, Sarah, Teng, Onno, Townsend, Michael, van Laar, Jacob M., Gullick, Nicola J., De Silva, Chulanie, Kirkham, Bruce W., Roy, Sanjoy, Emery, P., van der Heijde, D., Keystone, E., Conaghan, P. G., Xu, W., Baratelle, A., Beutler, A., Rahman, M. U., Nikiphorou, Elena, Kiely, Patrick, Walsh, David A., Williams, Richard, Shah, Devron, Knight, Gregory D., Hutchinson, David G., Dass, Shouvik, Atzeni, Fabiola, Vital, Edward M., Bingham, Sarah J., Buch, Maya, Beirne, Paul, Fleischmann, Roy, Dougados, Maxime, Williams, Sarah, Reynard, Mark, Blackler, Laura, Zain, Amir, Oakley, Stephen, Rees, Jonathon, Jones, Tim, Mistlin, Alan, Panayi, Gabriel, Westhovens, Rene, Durez, Patrick, Genant, Harry, Robles, Manuel, Becker, Jean-Claude, Covucci, Allison, Bathon, Joan, Genovese, Mark C., Luggen, Michael, Le Bars, Manuela, Aranda, Richard, Li, Tracy, Elegbe, Ayanbola, Fichtner, Andreas, Strand, Vibeke, Vencovsky, Jiri, Davies, Rebecca, Galloway, James, Hochberg, Marc, Kelly, Sheila, Khan, Nadar, Qi, Keqin, Pappu, Ramesh, Delaet, Ingrid, Luo, Allison, Torbeyns, Anne, Moreland, Larry, Cohen, Roger, Gujrathi, Sheila, Bykerk, Vivian P., Álvaro-Gracia, Jose, Andres Roman Ivorra, Jose, Nurmohamed, Michael T., Bernasconi, Corrado, Stancati, Andrea, Sibilia, Jean, Östör, Andrew, Strangfeld, Anja, Eveslage, Maria, Listing, Joachim, Herzer, Peter, Liebhaber, Anke, Krummel-Lorenz, Brigitte, Zink, Angela, Breedveld, Ferdinand C., Cohen, Stanley B., Matteson, Eric L., Burke, Laura, Chai, Akiko, Reiss, William, Sweetser, Marianne, Shaw, Tim, Ellis, Shawn D., Ehrenstein, Michael R., Notley, Clare A., Yazici, Yusuf, Ince, Akgun, Baraf, Herbert, Malamet, Raymond, Chung, Carol Y., Hughes, Chris, Faurholm, Bjarne, Dell'Accio, Francesco, Manzo, Antonio, Seed, Michael, Eltawil, Noha, Marrelli, Alessandra, Gould, David, Subang, Christina, Al-Kashi, Adam, De Bari, Cosimo, Winyard, Paul, Chernajovsky, Yuti, Nissim, Ahuva, Bingham, Clifton, Fleischmann, Roy M., Furst, Daniel E., Macey, Katherine M., Sweetser, Marianne T., Lehane, Patricia, Farmer, Pamela, Long, Simon G., Kremer, Joel M., Burgos-Vargas, Ruben, Dudler, Jean, Mela, Christopher M., Wegner, Natalia, Lugli, Helena, Quirke, Anne-Marie, Guo, Yonghua, Potempa, Jan, and Venables, Patrick

Abstract

Background: In Japan, more than 20 rheumatoid arthritis (RA) patients died of interstitial pneumonia (IP) caused by leflunomide (LEF) were reported, but many of them were considered as the victims of opportunistic infection currently. In this paper, efficacy and safety of low-dose LEF classified by body weight (BW) were studied. Methods: Fifty-nine RA patients were started to administrate LEF from July 2007 to July 2009. Among them, 25 patients were excluded because of the combination with tacrolimus, and medication modification within 3 months before LEF. Remaining 34 RA patients administered 20 to 50 mg/week of LEF were followed up for 1 year and enrolled in this study. Dose of LEF was classified by BW (50 mg/week for over 50 kg, 40 mg/week for 40 to 50 kg and 20 to 30 mg/week for under 40 kg). The average age and RA duration of enrolled patients were 55.5 years old and 10.2 years. Prednisolone (PSL), methotrexate (MTX) and etanercept were used in 23, 28 and 2 patients, respectively. In case of insufficient response or adverse effect, dosage change or discontinuance of LEF were considered. Failure was defined as dosages up of PSL and MTX, or dosages down or discontinuance of LEF. Last observation carried forward method was used for the evaluation of failed patients at 1 year. Results: At 1 year after LEF start, good/ moderate/ no response assessed by the European League Against Rheumatism (EULAR) response criteria using Disease Activity Score, including a 28-joint count (DAS28)-C reactive protein (CRP) were showed in 14/ 10/ 10 patients, respectively. The dosage changes of LEF at 1 year were dosage up: 10, same dosage: 5, dosage down: 8 and discontinuance: 11 patients. The survival rate of patients in this study was 23.5% (24 patients failed) but actual LEF continuous rate was 67.6% (11 patients discontinued) at 1 year. The major reason of failure was liver dysfunction, and pneumocystis pneumonia was occurred in 1 patient resulted in full recovery. One patient die

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