Minimal manifestation status and prednisone withdrawal in the MGTX trial
Ikjae Lee, Hui-Chien Kuo, Inmaculada B Aban, Gary R Cutter, Tarrant McPherson, Henry J Kaminski, Jon Sussman, Philipp Ströbel, Joel Oger, Gabriel Cea, Jeannine M Heckmann, Amelia Evoli, Wilfred Nix, Emma Ciafaloni, Giovanni Antonini, Rawiphan Witoonpanich, John O King, Said R Beydoun, Colin H Chalk, Alexandru C Barboi, Anthony A Amato, Aziz I Shaibani, Bashar Katirji, Bryan R F Lecky, Camilla Buckley, Angela Vincent, Elza Dias-Tosta, Hiroaki Yoshikawa, Marcia Waddington-Cruz, Michael T Pulley, Michael H Rivner, Anna Kostera-Pruszczyk, Robert M Pascuzzi, Carlayne E Jackson, Jan J G Verschuuren, Janice M Massey, John T Kissel, Lineu C Werneck, Michael Benatar, Richard J Barohn, Rup Tandan, Tahseen Mozaffar, Robin Conwit, Greg Minisman, Joshua R Sonett, Gil I Wolfe, MGTX study group, Claudio Mazia, Saluto Valeria, Rosenberg Moises, Alvarez Valeria, Rey Lisa, Butzkueven Helmut, Goldblatt John, Carey John, Pollard John, Reddel Stephen, Handel Nicholas, McCaughan Brian, Pallot Linda, Novis Ricardo, Boasquevisque Carlos, Morato-Fernandez Rubens, Ximenes Manoel, Scola Rosana, Soltoski Paulo, Moore Fraser, Mulder David, Wadup Lisa, Mezei Michele, Evans Kenneth, Jiwa Theresa, Schaffar Anne, White Chris, Toth Cory, Gelfand Gary, Wood Susan, Pringle Elizabeth, Zwicker Jocelyn, Maziak Donna, Shamji Farid, Sundaresan Sudhir, Seely Andrew, Verdugo Renato, Aguayo Alberto, Jander Sebastian, Zickler Philipp, Klein Michael, Marx Alexander, Weis Cleo-Aron, Melms Arthur, Bischof Felix, Aebert Hermann, Ziemer Gerhard, Thümler Björn, Wilhem-Schwenkmezger Thomas, Mayer Eckhard, Schalke Berthold, Pöschel Peter, Hieber Gisela, Wiebe Karsten, Clemenzi Alessandro, Ceschin Vanessa, Rendina Erino, Venuta Federico, Morino Stefania, Bucci Elisabetta, Durelli Luca, Tavella Alessia, Clerico Marinella, Contessa Giulia, Borasio Piero, Servidei Serenella, Granone Pierluigi, Mantegazza Renato, Berta Emilia, Novellino Lorenzo, Spinelli Luisa, Motomura Masakatsu, Matsuo Hidenori, Nagayasu Takeshi, Takamori Masaharu, Oda Makoto, Matsumoto Isao, Furukawa Yutaka, Noto Daisuke, Motozaki Yuko, Iwasa Kazuo, Yanase Daisuke, Garcia Ramos Guillermo, Cacho Bernardo, de la Garza Lorenzo, Lipowska Marta, Kwiecinski Hubert, Potulska-Chromik Anna, Orlowski Tadeusz, Silva Ana, Feijo Marta, Freitas António, Frost Andrew, Lee Pan Edward, Tucker Lawrence, Rossouw Johan, Drummond Fiona, Illa Isabel, Diaz Jorge, Leon Carlos, Yeh Jiann-Horng, Chiu Hou-Chang, Hsieh Yei-San, Tunlayadechanont Supoch, Attanavanich Sukasom, Straathof Chiara, Titulaer Maarten, Versteegh Michel, Pels Arda, Krum Yvonne, Leite M. Isabel, Hilton-Jones David, Ratnatunga Chandi, Newsom-Davis John, Farrugia Maria Elena, Petty Richard, Overell James, Kirk Alan, Gibson Andrew, McDermott Chris, Hopkinson David, Dot Marshall David Watling, Deborah Davies Sam Saminaden, Siva Sathasivam Charlotte Dougan, Page Richard, Jon Sussman, Ealing John, Krysiak Peter, Salajegheh Mohammad, Jaklitsch Michael, Roe Kristen, Ashizawa Tetsuo, Smith Robert Glenn, Zwischenberg Joseph, Stanton Penny, Jaradeh Safwan, Tisol William, Gasparri Mario, Haasler George, Yellick Mary, Dennis Cedric, Pasnoor Mamatha, Dimachkie Mazen, McVey April, Gronseth Gary, Dick Arthur, Kramer Jeffrey, Currence Melissa, Herbelin Laura, Belsh Jerry, Li Geoge, Langenfeld John, Mertz Mary Ann, Harrison Taylor, Force Seth, Usher Sharon, Lin Frank, DeMeester Steve, Akhter Salem, Malekniazi Ali, Avenido Gina, Crum Brian, Milone Margherita, Cassivi Stephen, Fisher Janet, Heatwole Chad, Watson Thomas, Hilbert James, Smirnow Alexis, Distad B. Jane, Weiss Michael, Wood Douglas, Haug Joanna, Ernstoff Raina, Cao Jingyang, Chmielewski Gary, Welsh Robert, Duris Robin, Gutmann Laurie, Pawar Gauri, Graeber Geoffrey Marc, Altemus Patricia, Nance Christopher, Gutmann Ludwig, Grogan Patrick, Calhoon John, Kittrell Pamela, Myers Deborah, Hayat Ghazala, Naunheim Keith, Eller Susan, Holzemer Eve, Alshekhlee Amer, Robke Jason, Karlinchak Brenda, Katz Jonathan, Miller Robert, Roan Ralph, Forshew Dallas, Elsheikh Bakri, Ross Patrick, Chelnick Sharon, Lewis Richard, Acsadi Agnes, Baciewicz Frank, Masse Stacey, Juel Vern, Onaitis Mark, Lowe James, Lipscomb Bernadette, Thai Gaby, Milliken Jeffrey, Martin Veronica, Karayan Ronnie, Muley Suraj, Parry Gareth, Shumway Sara, Oh Shin, Claussen Gwen, Lu Liang, Cerfolio Robert, Young Angela, Morgan Marla, Kincaid John, Kesler Kenneth, Guingrich Sandy, Michaels Angi, Phillips Lawrence, Burns Ted, Jones David, Fischer Cindy, Berger Alan, D’Agostino Harry, Smith Lisa, Pruitt Jerry, Landolfo Kevin, Hillman Demetric, Sermas Angelo, Ruel Ross, Ismail Farah, Sivak Mark, Goldstein Martin, Camunas Jorge, Bratton Joan, Panitch Hill, Leavitt Bruce, Jones Marilee, Muppidi Srikanth, Vernino Steven, Nations Sharon, Meyer Dan, Gorham Nina, Ikjae Lee, Hui-Chien Kuo, Inmaculada B Aban, Gary R Cutter, Tarrant McPherson, Henry J Kaminski, Jon Sussman, Philipp Ströbel, Joel Oger, Gabriel Cea, Jeannine M Heckmann, Amelia Evoli, Wilfred Nix, Emma Ciafaloni, Giovanni Antonini, Rawiphan Witoonpanich, John O King, Said R Beydoun, Colin H Chalk, Alexandru C Barboi, Anthony A Amato, Aziz I Shaibani, Bashar Katirji, Bryan R F Lecky, Camilla Buckley, Angela Vincent, Elza Dias-Tosta, Hiroaki Yoshikawa, Marcia Waddington-Cruz, Michael T Pulley, Michael H Rivner, Anna Kostera-Pruszczyk, Robert M Pascuzzi, Carlayne E Jackson, Jan J G Verschuuren, Janice M Massey, John T Kissel, Lineu C Werneck, Michael Benatar, Richard J Barohn, Rup Tandan, Tahseen Mozaffar, Robin Conwit, Greg Minisman, Joshua R Sonett, Gil I Wolfe, MGTX study group, Claudio Mazia, Saluto Valeria, Rosenberg Moises, Alvarez Valeria, Rey Lisa, Butzkueven Helmut, Goldblatt John, Carey John, Pollard John, Reddel Stephen, Handel Nicholas, McCaughan Brian, Pallot Linda, Novis Ricardo, Boasquevisque Carlos, Morato-Fernandez Rubens, Ximenes Manoel, Scola Rosana, Soltoski Paulo, Moore Fraser, Mulder David, Wadup Lisa, Mezei Michele, Evans Kenneth, Jiwa Theresa, Schaffar Anne, White Chris, Toth Cory, Gelfand Gary, Wood Susan, Pringle Elizabeth, Zwicker Jocelyn, Maziak Donna, Shamji Farid, Sundaresan Sudhir, Seely Andrew, Verdugo Renato, Aguayo Alberto, Jander Sebastian, Zickler Philipp, Klein Michael, Marx Alexander, Weis Cleo-Aron, Melms Arthur, Bischof Felix, Aebert Hermann, Ziemer Gerhard, Thümler Björn, Wilhem-Schwenkmezger Thomas, Mayer Eckhard, Schalke Berthold, Pöschel Peter, Hieber Gisela, Wiebe Karsten, Clemenzi Alessandro, Ceschin Vanessa, Rendina Erino, Venuta Federico, Morino Stefania, Bucci Elisabetta, Durelli Luca, Tavella Alessia, Clerico Marinella, Contessa Giulia, Borasio Piero, Servidei Serenella, Granone Pierluigi, Mantegazza Renato, Berta Emilia, Novellino Lorenzo, Spinelli Luisa, Motomura Masakatsu, Matsuo Hidenori, Nagayasu Takeshi, Takamori Masaharu, Oda Makoto, Matsumoto Isao, Furukawa Yutaka, Noto Daisuke, Motozaki Yuko, Iwasa Kazuo, Yanase Daisuke, Garcia Ramos Guillermo, Cacho Bernardo, de la Garza Lorenzo, Lipowska Marta, Kwiecinski Hubert, Potulska-Chromik Anna, Orlowski Tadeusz, Silva Ana, Feijo Marta, Freitas António, Frost Andrew, Lee Pan Edward, Tucker Lawrence, Rossouw Johan, Drummond Fiona, Illa Isabel, Diaz Jorge, Leon Carlos, Yeh Jiann-Horng, Chiu Hou-Chang, Hsieh Yei-San, Tunlayadechanont Supoch, Attanavanich Sukasom, Straathof Chiara, Titulaer Maarten, Versteegh Michel, Pels Arda, Krum Yvonne, Leite M. Isabel, Hilton-Jones David, Ratnatunga Chandi, Newsom-Davis John, Farrugia Maria Elena, Petty Richard, Overell James, Kirk Alan, Gibson Andrew, McDermott Chris, Hopkinson David, Dot Marshall David Watling, Deborah Davies Sam Saminaden, Siva Sathasivam Charlotte Dougan, Page Richard, Jon Sussman, Ealing John, Krysiak Peter, Salajegheh Mohammad, Jaklitsch Michael, Roe Kristen, Ashizawa Tetsuo, Smith Robert Glenn, Zwischenberg Joseph, Stanton Penny, Jaradeh Safwan, Tisol William, Gasparri Mario, Haasler George, Yellick Mary, Dennis Cedric, Pasnoor Mamatha, Dimachkie Mazen, McVey April, Gronseth Gary, Dick Arthur, Kramer Jeffrey, Currence Melissa, Herbelin Laura, Belsh Jerry, Li Geoge, Langenfeld John, Mertz Mary Ann, Harrison Taylor, Force Seth, Usher Sharon, Lin Frank, DeMeester Steve, Akhter Salem, Malekniazi Ali, Avenido Gina, Crum Brian, Milone Margherita, Cassivi Stephen, Fisher Janet, Heatwole Chad, Watson Thomas, Hilbert James, Smirnow Alexis, Distad B. Jane, Weiss Michael, Wood Douglas, Haug Joanna, Ernstoff Raina, Cao Jingyang, Chmielewski Gary, Welsh Robert, Duris Robin, Gutmann Laurie, Pawar Gauri, Graeber Geoffrey Marc, Altemus Patricia, Nance Christopher, Gutmann Ludwig, Grogan Patrick, Calhoon John, Kittrell Pamela, Myers Deborah, Hayat Ghazala, Naunheim Keith, Eller Susan, Holzemer Eve, Alshekhlee Amer, Robke Jason, Karlinchak Brenda, Katz Jonathan, Miller Robert, Roan Ralph, Forshew Dallas, Elsheikh Bakri, Ross Patrick, Chelnick Sharon, Lewis Richard, Acsadi Agnes, Baciewicz Frank, Masse Stacey, Juel Vern, Onaitis Mark, Lowe James, Lipscomb Bernadette, Thai Gaby, Milliken Jeffrey, Martin Veronica, Karayan Ronnie, Muley Suraj, Parry Gareth, Shumway Sara, Oh Shin, Claussen Gwen, Lu Liang, Cerfolio Robert, Young Angela, Morgan Marla, Kincaid John, Kesler Kenneth, Guingrich Sandy, Michaels Angi, Phillips Lawrence, Burns Ted, Jones David, Fischer Cindy, Berger Alan, D’Agostino Harry, Smith Lisa, Pruitt Jerry, Landolfo Kevin, Hillman Demetric, Sermas Angelo, Ruel Ross, Ismail Farah, Sivak Mark, Goldstein Martin, Camunas Jorge, Bratton Joan, Panitch Hill, Leavitt Bruce, Jones Marilee, Muppidi Srikanth, Vernino Steven, Nations Sharon, Meyer Dan, Gorham Nina
Abstract
Objective: To examine whether sustained minimal manifestation status (MMS) with complete withdrawal of prednisone is better achieved in thymectomized patients with myasthenia gravis (MG).
Methods: This study is a post hoc analysis of data from a randomized trial of thymectomy in MG (Thymectomy Trial in Non-Thymomatous Myasthenia Gravis Patients Receiving Prednisone Therapy [MGTX]). MGTX was a multicenter, randomized, rater-blinded 3-year trial that was followed by a voluntary 2-year extension for patients with acetylcholine receptor (AChR) antibody-positive MG without thymoma. Patients were randomized 1:1 to thymectomy plus prednisone vs prednisone alone. Participants were age 18-65 years at enrollment with disease duration less than 5 years. All patients received oral prednisone titrated up to 100 mg on alternate days until they achieved MMS, which prompted a standardized prednisone taper as long as MMS was maintained. The achievement rate of sustained MMS (no symptoms of MG for 6 months) with complete withdrawal of prednisone was compared between the thymectomy plus prednisone and prednisone alone groups.
Results: Patients with MG in the thymectomy plus prednisone group achieved sustained MMS with complete withdrawal of prednisone more frequently (64% vs 38%) and quickly compared to the prednisone alone group (median time 30 months vs no median time achieved, p < 0.001) over the 5-year study period. Prednisone-associated adverse symptoms were more frequent in the prednisone alone group and distress level increased with higher doses of prednisone.
Conclusions: Thymectomy benefits patients with MG by increasing the likelihood of achieving sustained MMS with complete withdrawal of prednisone.
Clinicaltrialsgov identifier: NCT00294658.
Classification of evidence: This study provides Class II evidence that for patients with generalized MG with AChR antibody, those receiving thymectomy plus prednisone are more likely to attain sustained MMS and complete prednisone withdrawal than those on prednisone alone.
© 2020 American Academy of Neurology.
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Source: PubMed