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2. Onset and Progression of Persistent Choroidal Hypertransmission Defects in Intermediate AMD: A Novel Clinical Trial Endpoint

Author

Liu, Jeremy, primary, Shen, Mengxi, additional, Laiginhas, Rita, additional, Herrera, Gissel, additional, Li, Jianqing, additional, Shi, Yingying, additional, Hiya, Farhan, additional, Trivizki, Omer, additional, Waheed, Nadia K., additional, Chung, Carol Y., additional, Moult, Eric M., additional, Fujimoto, James G., additional, Gregori, Giovanni, additional, and Rosenfeld, Philip J., additional

Published
2023
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4. 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

5. Complement C3 Inhibitor Pegcetacoplan for Geographic Atrophy Secondary to Age-Related Macular Degeneration

Author

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

Published
2020
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8. 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

11. 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

12. Bevacizumab vs Ranibizumab Treatment for Age-Related Macular Degeneration.

Author

Rosenfeld, Philip J., Brown, David M., Heier, Jeffrey S., Boyer, David S., Kaiser, Peter K., Chung, Carol Y., Kim, Robert Y., and Jampol, Lee M.

Abstract

Background: Ranibizumab--a recombinant, humanized, monoclonal antibody Fab that neutralizes all active forms of vascular endothelial growth factor A--has been evaluated for the treatment of neovascular age-related macular degeneration. Methods: In this multicenter, 2-year, double-blind, sham-controlled study, we randomly assigned patients with age-related macular degeneration with either minimally classic or occult (with no classic lesions) choroidal neovascularization to receive 24 monthly intravitreal injections of ranibizumab (either 0.3 mg or 0.5 mg) or sham injections. The primary end point was the proportion of patients losing fewer than 15 letters from baseline visual acuity at 12 months. Results: We enrolled 716 patients in the study. At 12 months, 94.5% of the group given 0.3 mg of ranibizumab and 94.6% of those given 0.5 mg lost fewer than 15 letters, as compared with 62.2% of patients receiving sham injections (P < .001 for both comparisons). Visual acuity improved by 15 or more letters in 24.8% of the 0.3-mg group and 33.8% of the 0.5-mg group, as compared with 5.0% of the sham-injection group (P<.001 for both doses). Mean increases in visual acuity were 6.5 letters in the 0.3-mg group and 7.2 letters in the 0.5-mg group, as compared with a decrease of 10.4 letters in the shaminjection group (P<.001 for both comparisons). The benefit in visual acuity was maintained at 24 months. During 24 months, presumed endophthalmitis was identified in five patients (1.0%) and serious uveitis in six patients (1.3%) given ranibizumab. Conclusions: Intravitreal administration of ranibizumab for 2 years prevented vision loss and improved mean visual acuity, with low rates of serious adverse events, in patients with minimally classic or occult (with no classic lesions) choroidal neovascularization secondary to age-related macular degeneration. [ABSTRACT FROM AUTHOR]

Published
2007

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