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Ravulizumab (ALXN1210) vs eculizumab in C5-inhibitor–experienced adult patients with PNH: the 302 study
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| Zeitschriftentitel: | Blood |
|---|---|
| Personen und Körperschaften: | , , , , , , , , , , , , , , , , , , |
| In: | Blood, 133, 2019, 6, S. 540-549 |
| Format: | E-Article |
| Sprache: | Englisch |
| veröffentlicht: |
American Society of Hematology
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| Schlagwörter: |
| author_facet |
Kulasekararaj, Austin G. Hill, Anita Rottinghaus, Scott T. Langemeijer, Saskia Wells, Richard Gonzalez-Fernandez, F. Ataulfo Gaya, Anna Lee, Jong Wook Gutierrez, Emilio Ojeda Piatek, Caroline I. Szer, Jeff Risitano, Antonio Nakao, Shinji Bachman, Eric Shafner, Lori Damokosh, Andrew I. Ortiz, Stephan Röth, Alexander Peffault de Latour, Regis Kulasekararaj, Austin G. Hill, Anita Rottinghaus, Scott T. Langemeijer, Saskia Wells, Richard Gonzalez-Fernandez, F. Ataulfo Gaya, Anna Lee, Jong Wook Gutierrez, Emilio Ojeda Piatek, Caroline I. Szer, Jeff Risitano, Antonio Nakao, Shinji Bachman, Eric Shafner, Lori Damokosh, Andrew I. Ortiz, Stephan Röth, Alexander Peffault de Latour, Regis |
|---|---|
| author |
Kulasekararaj, Austin G. Hill, Anita Rottinghaus, Scott T. Langemeijer, Saskia Wells, Richard Gonzalez-Fernandez, F. Ataulfo Gaya, Anna Lee, Jong Wook Gutierrez, Emilio Ojeda Piatek, Caroline I. Szer, Jeff Risitano, Antonio Nakao, Shinji Bachman, Eric Shafner, Lori Damokosh, Andrew I. Ortiz, Stephan Röth, Alexander Peffault de Latour, Regis |
| spellingShingle |
Kulasekararaj, Austin G. Hill, Anita Rottinghaus, Scott T. Langemeijer, Saskia Wells, Richard Gonzalez-Fernandez, F. Ataulfo Gaya, Anna Lee, Jong Wook Gutierrez, Emilio Ojeda Piatek, Caroline I. Szer, Jeff Risitano, Antonio Nakao, Shinji Bachman, Eric Shafner, Lori Damokosh, Andrew I. Ortiz, Stephan Röth, Alexander Peffault de Latour, Regis Blood Ravulizumab (ALXN1210) vs eculizumab in C5-inhibitor–experienced adult patients with PNH: the 302 study Cell Biology Hematology Immunology Biochemistry |
| author_sort |
kulasekararaj, austin g. |
| spelling |
Kulasekararaj, Austin G. Hill, Anita Rottinghaus, Scott T. Langemeijer, Saskia Wells, Richard Gonzalez-Fernandez, F. Ataulfo Gaya, Anna Lee, Jong Wook Gutierrez, Emilio Ojeda Piatek, Caroline I. Szer, Jeff Risitano, Antonio Nakao, Shinji Bachman, Eric Shafner, Lori Damokosh, Andrew I. Ortiz, Stephan Röth, Alexander Peffault de Latour, Regis 0006-4971 1528-0020 American Society of Hematology Cell Biology Hematology Immunology Biochemistry http://dx.doi.org/10.1182/blood-2018-09-876805 <jats:title>Abstract</jats:title> <jats:p>Ravulizumab, a new complement component C5 inhibitor administered every 8 weeks, was noninferior to eculizumab administered every 2 weeks in complement-inhibitor–naive patients with paroxysmal nocturnal hemoglobinuria (PNH). This study assessed noninferiority of ravulizumab to eculizumab in clinically stable PNH patients during previous eculizumab therapy. In this phase 3, open-label, multicenter study, 195 PNH patients on labeled-dose (900 mg every 2 weeks) eculizumab for &gt;6 months were randomly assigned 1:1 to switch to ravulizumab (n = 97) or continue eculizumab (n = 98). Primary efficacy end point was percentage change in lactate dehydrogenase (LDH) from baseline to day 183. Key secondary end points included proportion of patients with breakthrough hemolysis, change in Functional Assessment of Chronic Illness Therapy (FACIT)–Fatigue score, transfusion avoidance, and stabilized hemoglobin. In 191 patients completing 183 days of treatment, ravulizumab was noninferior to eculizumab (Pinf &lt; .0006 for all end points), including percentage change in LDH (difference, 9.21% [95% confidence interval (CI), −0.42 to 18.84], P = .058 for superiority), breakthrough hemolysis (difference, 5.1 [95% CI, −8.89 to 18.99]), change in FACIT-Fatigue score (difference, 1.47 [95% CI, −0.21 to 3.15]), transfusion avoidance (difference, 5.5 [95% CI, −4.27 to 15.68]), and stabilized hemoglobin (difference, 1.4 [95% CI, −10.41 to 13.31]). The most frequently reported adverse event was headache (26.8%, ravulizumab; 17.3%, eculizumab). No meningococcal infections or discontinuations due to adverse events occurred. Patients with PNH may be safely and effectively switched from labeled-dose eculizumab administered every 2 weeks to ravulizumab administered every 8 weeks. This trial was funded by Alexion Pharmaceuticals, Inc., and is registered at www.clinicaltrials.gov as #NCT03056040.</jats:p> Ravulizumab (ALXN1210) vs eculizumab in C5-inhibitor–experienced adult patients with PNH: the 302 study Blood |
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| title |
Ravulizumab (ALXN1210) vs eculizumab in C5-inhibitor–experienced adult patients with PNH: the 302 study |
| title_unstemmed |
Ravulizumab (ALXN1210) vs eculizumab in C5-inhibitor–experienced adult patients with PNH: the 302 study |
| title_full |
Ravulizumab (ALXN1210) vs eculizumab in C5-inhibitor–experienced adult patients with PNH: the 302 study |
| title_fullStr |
Ravulizumab (ALXN1210) vs eculizumab in C5-inhibitor–experienced adult patients with PNH: the 302 study |
| title_full_unstemmed |
Ravulizumab (ALXN1210) vs eculizumab in C5-inhibitor–experienced adult patients with PNH: the 302 study |
| title_short |
Ravulizumab (ALXN1210) vs eculizumab in C5-inhibitor–experienced adult patients with PNH: the 302 study |
| title_sort |
ravulizumab (alxn1210) vs eculizumab in c5-inhibitor–experienced adult patients with pnh: the 302 study |
| topic |
Cell Biology Hematology Immunology Biochemistry |
| url |
http://dx.doi.org/10.1182/blood-2018-09-876805 |
| publishDate |
2019 |
| physical |
540-549 |
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<jats:title>Abstract</jats:title>
<jats:p>Ravulizumab, a new complement component C5 inhibitor administered every 8 weeks, was noninferior to eculizumab administered every 2 weeks in complement-inhibitor–naive patients with paroxysmal nocturnal hemoglobinuria (PNH). This study assessed noninferiority of ravulizumab to eculizumab in clinically stable PNH patients during previous eculizumab therapy. In this phase 3, open-label, multicenter study, 195 PNH patients on labeled-dose (900 mg every 2 weeks) eculizumab for &gt;6 months were randomly assigned 1:1 to switch to ravulizumab (n = 97) or continue eculizumab (n = 98). Primary efficacy end point was percentage change in lactate dehydrogenase (LDH) from baseline to day 183. Key secondary end points included proportion of patients with breakthrough hemolysis, change in Functional Assessment of Chronic Illness Therapy (FACIT)–Fatigue score, transfusion avoidance, and stabilized hemoglobin. In 191 patients completing 183 days of treatment, ravulizumab was noninferior to eculizumab (Pinf &lt; .0006 for all end points), including percentage change in LDH (difference, 9.21% [95% confidence interval (CI), −0.42 to 18.84], P = .058 for superiority), breakthrough hemolysis (difference, 5.1 [95% CI, −8.89 to 18.99]), change in FACIT-Fatigue score (difference, 1.47 [95% CI, −0.21 to 3.15]), transfusion avoidance (difference, 5.5 [95% CI, −4.27 to 15.68]), and stabilized hemoglobin (difference, 1.4 [95% CI, −10.41 to 13.31]). The most frequently reported adverse event was headache (26.8%, ravulizumab; 17.3%, eculizumab). No meningococcal infections or discontinuations due to adverse events occurred. Patients with PNH may be safely and effectively switched from labeled-dose eculizumab administered every 2 weeks to ravulizumab administered every 8 weeks. This trial was funded by Alexion Pharmaceuticals, Inc., and is registered at www.clinicaltrials.gov as #NCT03056040.</jats:p> |
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| description | <jats:title>Abstract</jats:title> <jats:p>Ravulizumab, a new complement component C5 inhibitor administered every 8 weeks, was noninferior to eculizumab administered every 2 weeks in complement-inhibitor–naive patients with paroxysmal nocturnal hemoglobinuria (PNH). This study assessed noninferiority of ravulizumab to eculizumab in clinically stable PNH patients during previous eculizumab therapy. In this phase 3, open-label, multicenter study, 195 PNH patients on labeled-dose (900 mg every 2 weeks) eculizumab for &gt;6 months were randomly assigned 1:1 to switch to ravulizumab (n = 97) or continue eculizumab (n = 98). Primary efficacy end point was percentage change in lactate dehydrogenase (LDH) from baseline to day 183. Key secondary end points included proportion of patients with breakthrough hemolysis, change in Functional Assessment of Chronic Illness Therapy (FACIT)–Fatigue score, transfusion avoidance, and stabilized hemoglobin. In 191 patients completing 183 days of treatment, ravulizumab was noninferior to eculizumab (Pinf &lt; .0006 for all end points), including percentage change in LDH (difference, 9.21% [95% confidence interval (CI), −0.42 to 18.84], P = .058 for superiority), breakthrough hemolysis (difference, 5.1 [95% CI, −8.89 to 18.99]), change in FACIT-Fatigue score (difference, 1.47 [95% CI, −0.21 to 3.15]), transfusion avoidance (difference, 5.5 [95% CI, −4.27 to 15.68]), and stabilized hemoglobin (difference, 1.4 [95% CI, −10.41 to 13.31]). The most frequently reported adverse event was headache (26.8%, ravulizumab; 17.3%, eculizumab). No meningococcal infections or discontinuations due to adverse events occurred. Patients with PNH may be safely and effectively switched from labeled-dose eculizumab administered every 2 weeks to ravulizumab administered every 8 weeks. This trial was funded by Alexion Pharmaceuticals, Inc., and is registered at www.clinicaltrials.gov as #NCT03056040.</jats:p> |
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| spelling | Kulasekararaj, Austin G. Hill, Anita Rottinghaus, Scott T. Langemeijer, Saskia Wells, Richard Gonzalez-Fernandez, F. Ataulfo Gaya, Anna Lee, Jong Wook Gutierrez, Emilio Ojeda Piatek, Caroline I. Szer, Jeff Risitano, Antonio Nakao, Shinji Bachman, Eric Shafner, Lori Damokosh, Andrew I. Ortiz, Stephan Röth, Alexander Peffault de Latour, Regis 0006-4971 1528-0020 American Society of Hematology Cell Biology Hematology Immunology Biochemistry http://dx.doi.org/10.1182/blood-2018-09-876805 <jats:title>Abstract</jats:title> <jats:p>Ravulizumab, a new complement component C5 inhibitor administered every 8 weeks, was noninferior to eculizumab administered every 2 weeks in complement-inhibitor–naive patients with paroxysmal nocturnal hemoglobinuria (PNH). This study assessed noninferiority of ravulizumab to eculizumab in clinically stable PNH patients during previous eculizumab therapy. In this phase 3, open-label, multicenter study, 195 PNH patients on labeled-dose (900 mg every 2 weeks) eculizumab for &gt;6 months were randomly assigned 1:1 to switch to ravulizumab (n = 97) or continue eculizumab (n = 98). Primary efficacy end point was percentage change in lactate dehydrogenase (LDH) from baseline to day 183. Key secondary end points included proportion of patients with breakthrough hemolysis, change in Functional Assessment of Chronic Illness Therapy (FACIT)–Fatigue score, transfusion avoidance, and stabilized hemoglobin. In 191 patients completing 183 days of treatment, ravulizumab was noninferior to eculizumab (Pinf &lt; .0006 for all end points), including percentage change in LDH (difference, 9.21% [95% confidence interval (CI), −0.42 to 18.84], P = .058 for superiority), breakthrough hemolysis (difference, 5.1 [95% CI, −8.89 to 18.99]), change in FACIT-Fatigue score (difference, 1.47 [95% CI, −0.21 to 3.15]), transfusion avoidance (difference, 5.5 [95% CI, −4.27 to 15.68]), and stabilized hemoglobin (difference, 1.4 [95% CI, −10.41 to 13.31]). The most frequently reported adverse event was headache (26.8%, ravulizumab; 17.3%, eculizumab). No meningococcal infections or discontinuations due to adverse events occurred. Patients with PNH may be safely and effectively switched from labeled-dose eculizumab administered every 2 weeks to ravulizumab administered every 8 weeks. This trial was funded by Alexion Pharmaceuticals, Inc., and is registered at www.clinicaltrials.gov as #NCT03056040.</jats:p> Ravulizumab (ALXN1210) vs eculizumab in C5-inhibitor–experienced adult patients with PNH: the 302 study Blood |
| spellingShingle | Kulasekararaj, Austin G., Hill, Anita, Rottinghaus, Scott T., Langemeijer, Saskia, Wells, Richard, Gonzalez-Fernandez, F. Ataulfo, Gaya, Anna, Lee, Jong Wook, Gutierrez, Emilio Ojeda, Piatek, Caroline I., Szer, Jeff, Risitano, Antonio, Nakao, Shinji, Bachman, Eric, Shafner, Lori, Damokosh, Andrew I., Ortiz, Stephan, Röth, Alexander, Peffault de Latour, Regis, Blood, Ravulizumab (ALXN1210) vs eculizumab in C5-inhibitor–experienced adult patients with PNH: the 302 study, Cell Biology, Hematology, Immunology, Biochemistry |
| title | Ravulizumab (ALXN1210) vs eculizumab in C5-inhibitor–experienced adult patients with PNH: the 302 study |
| title_full | Ravulizumab (ALXN1210) vs eculizumab in C5-inhibitor–experienced adult patients with PNH: the 302 study |
| title_fullStr | Ravulizumab (ALXN1210) vs eculizumab in C5-inhibitor–experienced adult patients with PNH: the 302 study |
| title_full_unstemmed | Ravulizumab (ALXN1210) vs eculizumab in C5-inhibitor–experienced adult patients with PNH: the 302 study |
| title_short | Ravulizumab (ALXN1210) vs eculizumab in C5-inhibitor–experienced adult patients with PNH: the 302 study |
| title_sort | ravulizumab (alxn1210) vs eculizumab in c5-inhibitor–experienced adult patients with pnh: the 302 study |
| title_unstemmed | Ravulizumab (ALXN1210) vs eculizumab in C5-inhibitor–experienced adult patients with PNH: the 302 study |
| topic | Cell Biology, Hematology, Immunology, Biochemistry |
| url | http://dx.doi.org/10.1182/blood-2018-09-876805 |