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1. Long-Term Efficacy and Safety of the Long-Acting Complement C5 Inhibitor Ravulizumab for the Treatment of Atypical Hemolytic Uremic Syndrome in Adults

Author

Thomas Barbour, Marie Scully, Gema Ariceta, Spero Cataland, Katherine Garlo, Nils Heyne, Yosu Luque, Jan Menne, Yoshitaka Miyakawa, Sung-Soo Yoon, David Kavanagh, Sunil Babu, Nilufer Broeders, Nicole Lietar, Fiona Brown, Philip Campbell, Josep M. Campistol, Paramit Chowdhury, Theo Kasimatis, Lino Cirami, Leonardo Caroti, Guilia Antognoli, Yahsou Delmas, Vladimir Dobronravov, Anja Gaeckler, Cyril Garrouste, Gregory Greenwood, Siân Griffin, Chiu-Ching Huang, I-Ru Chen, Susan Huang, Jin Seok Kim, Gaetano La Manna, Moglie Le Quintrec, Guillaume Jeantet, Iino Fumie, Eric Rondeau, Hermann Haller, Johan Morelle, Eric Goffin, Anja Muhlfeld, Shashi Nagaraj, Gowthami Arepally, Doyeun Oh, Masayoshi Okumi, Manuel Praga Terente, Francois Provot, Ulf Schönermarck, Michael Fischereder, Natalia Ramos Terrada, Barbara Seitz-Polski, Guillaume Favre, Sonia Boyer-Suavet, Maria Vinogradova, Tatiana Kirsanova, and Edwin K.S. Wong

Subjects
atypical hemolytic uremic syndrome, complement, hemolytic uremic syndrome, kidney failure, ravulizumab, thrombotic microangiopathy, Diseases of the genitourinary system. Urology, RC870-923
Abstract

Introduction: Atypical hemolytic uremic syndrome (aHUS) is a rare, complex, multisystem disease of dysregulated complement activity, characterized by progressive thrombotic microangiopathy (TMA), acute kidney injury, and multiorgan dysfunction, which often progresses to chronic kidney disease. Results from the prospective clinical trial of ravulizumab (NCT02949128) reveal rapid resolution of TMA in patients with aHUS, with sustained efficacy and safety in a 26-week initial evaluation period. Methods: The aim of this analysis was to characterize the long-term efficacy and the safety profile of ravulizumab in adults with aHUS who had completed the initial evaluation period of the trial. Complete TMA response, hematologic and kidney functions, and safety were evaluated for all patients available for follow-up in the extension period (median follow-up: 76.7 weeks; range: 0.6–118.3). This trial included a total of 58 patients, 49 of whom entered the extension period. Results: A total of 4 additional patients achieved complete TMA response during the follow-up period. Normalization of platelet count, serum lactate dehydrogenase (LDH), and hemoglobin observed in the 26-week initial evaluation period was sustained until the last available follow-up, as were the improvements in the estimated glomerular filtration rate (eGFR) and patient quality of life. All efficacy endpoints were correlated with the sustained inhibition of complement C5. Most adverse events (AEs) occurred early during the initial evaluation period and decreased substantially during the extension period. No patient developed a meningococcal infection or died during the extension period. Conclusion: This analysis reveals that ravulizumab administered every 8 weeks is efficacious with an acceptable safety profile for the long-term treatment of adults with aHUS and provides additional clinical benefit beyond 6 months of treatment.

Published
2021
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2. The long-acting C5 inhibitor, Ravulizumab, is effective and safe in adult patients with atypical hemolytic uremic syndrome naïve to complement inhibitor treatment

Author

Sunil Babu, Guilia Antognoli, Elena Gutierréz, Yoshitaka Miyakawa, Moglie Le Quintrec, Jan Menne, David J. Kavanagh, Tatiana Kirsanova, Edwin K.S. Wong, Maria Vinogradova, Philip Campbell, Guillaume Favre, Michael Fischereder, Spero R. Cataland, Iino Fumie, Hermann Haller, Vladimir A. Dobronravov, Paramit Chowdhury, Guillaume Jeantet, Marie Scully, Sonia Boyer-Suavet, Thomas D. Barbour, Yosu Luque, Leonardo Caroti, Stephan Ortiz, Shashi K. Nagaraj, Cyril Garrouste, Masayoshi Okumi, Anja Gaeckler, Maria Cappuccilli, Chiu-Ching Huang, Anja Muhlfeld, Gema Ariceta, Gaetano La Manna, Eric Rondeau, Nils Heyne, Giorgia Comai, Natalia Ramos Terrada, Eric Goffin, Paola Rodriguez, Gregory Greenwood, Eugene Swenson, Barbara Seitz-Polski, Nilufer Broeders, Gowthami M. Arepally, Manuel Praga Terente, Marc Vallee, Johan Morelle, Siân V. Griffin, Nicole Lietar, Doyeun Oh, Theo Kasimatis, I-Ru Chen, Ulf Schönermarck, Susan Huang, Jin Seok Kim, Fiona G. Brown, François Provôt, Lino Cirami, Sung-Soo Yoon, Yahsou Delmas, UCL - SSS/IREC/NEFR - Pôle de Néphrologie, UCL - (SLuc) Service de néphrologie, Sorbonne Université (SU), The Ohio State University Press, and Hannover Medical School [Hannover] (MHH)

Subjects
0301 basic medicine, Adult, medicine.medical_specialty, Thrombotic microangiopathy, [SDV]Life Sciences [q-bio], 030232 urology & nephrology, Renal function, Antibodies, Monoclonal, Humanized, Gastroenterology, 03 medical and health sciences, Complement inhibitor, chemistry.chemical_compound, 0302 clinical medicine, Internal medicine, Atypical hemolytic uremic syndrome, medicine, Clinical endpoint, Humans, complement, Adverse effect, Atypical Hemolytic Uremic Syndrome, Creatinine, business.industry, Thrombotic Microangiopathies, atypical hemolytic uremic syndrome, Complement System Proteins, Eculizumab, medicine.disease, ravulizumab, 3. Good health, thrombotic microangiopathy, 030104 developmental biology, Complement Inactivating Agents, chemistry, Nephrology, hemolytic uremic syndrome, eculizumab, business, medicine.drug
Abstract

Ravulizumab is a long-acting C5 inhibitor engineered from eculizumab with increased elimination half-life, allowing an extended dosing interval from two to eight weeks. Here we evaluate the efficacy and safety of ravulizumab in adults with atypical hemolytic uremic syndrome presenting with thrombotic microangiopathy. In this global, phase 3, single arm study in complement inhibitor-naive adults (18 years and older) who fulfilled diagnostic criteria for atypical hemolytic uremic syndrome, enrolled patients received ravulizumab through a 26-week initial evaluation period. The primary endpoint was complete thrombotic microangiopathy response defined as normalization of platelet count and lactate dehydrogenase and 25% or more improvement in serum creatinine. Secondary endpoints included changes in hematologic variables and renal function. Safety was also evaluated. Ravulizumab treatment resulted in an immediate, complete, and sustained C5 inhibition in all patients. Complete thrombotic microangiopathy response was achieved in 53.6% of patients. Normalization of platelet count, lactate dehydrogenase and 25% or more improvement in serum creatinine was achieved in 83.9%, 76.8% and 58.9% of patients, respectively. Improvement in estimated glomerular filtration rate by one or more stage was achieved in 68.1% of patients by day 183. No unexpected adverse events were reported across a safety analysis set of 58 patients. Four deaths occurred (three within one month of study initiation, including one in a patient excluded based on eligibility criteria after the first dose) with none considered treatment-related by the study investigator. Thus, treatment with ravulizumab once every eight weeks resulted in rapidly improved hematologic and renal endpoints with no unexpected adverse events in adults with atypical hemolytic uremic syndrome.

Published
2020

3. Corrigendum to 'Rondeau E, Scully M, Ariceta G, Barbour T, Cataland S, Heyne N, Miyakawa Y, Ortiz S, Swenson E, Vallee M, Yoon S-S, Kavanagh D and Haller H; on behalf of the 311 Study Group. The long-acting C5 inhibitor, Ravulizumab, is effective and safe in adult patients with atypical hemolytic uremic syndrome naïve to complement inhibitor treatment.' Kidney Int. 2020;97:1287–1296

Author

Eric Rondeau, Marie Scully, Gema Ariceta, Tom Barbour, Spero Cataland, Nils Heyne, Yoshitaka Miyakawa, Stephan Ortiz, Eugene Swenson, Marc Vallee, Sung-Soo Yoon, David Kavanagh, Hermann Haller, Sunil Babu, Nilufer Broeders, Nicole Lietar, Fiona Brown, Philip Campbell, Josep M. Campistol, Miquel Blasco, Paramit Chowdhury, Theo Kasimatis, Lino Cirami, Leonardo Caroti, Guilia Antognoli, Yahsou Delmas, Vladimir Dobronravov, Anja Gaeckler, Cyril Garrouste, Gregory Greenwood, Siân Griffin, Chiu-Ching Huang, I-Ru Chen, Susan Huang, Jin Seok Kim, Gaetano La Manna, Giorgia Comai, Maria Cappuccilli, Moglie Le Quintrec, Guillaume Jeantet, Iino Fumie, Yosu Luque, Jan Menne, Johan Morelle, Eric Goffin, Anja Muhlfeld, Shashi Nagaraj, Gowthami Arepally, Doyeun Oh, Masayoshi Okumi, Manuel Praga Terente, Elena Gutierréz, Paola Rodriguez, Francois Provot, Ulf Schönermarck, Michael Fischereder, Natalia Ramos Terrada, Barbara Seitz-Polski, Guillaume Favre, Sonia Boyer-Suavet, Maria Vinogradova, Tatiana Kirsanova, Edwin K.S. Wong, Rondeau E., Scully M., Ariceta G., Barbour T., Cataland S., Heyne N., Miyakawa Y., Ortiz S., Swenson E., Vallee M., Yoon S.-S., Kavanagh D., Haller H., Babu S., Broeders N., Lietar N., Brown F., Campbell P., Campistol J.M., Blasco M., Chowdhury P., Kasimatis T., Cirami L., Caroti L., Antognoli G., Delmas Y., Dobronravov V., Gaeckler A., Garrouste C., Greenwood G., Griffin S., Huang C.-C., Chen I.-R., Huang S., Kim J.S., La Manna G., Comai G., Cappuccilli M., Le Quintrec M., Jeantet G., Fumie I., Luque Y., Menne J., Morelle J., Goffin E., Muhlfeld A., Nagaraj S., Arepally G., Oh D., Okumi M., Terente M.P., Gutierrez E., Rodriguez P., Provot F., Schonermarck U., Fischereder M., Terrada N.R., Seitz-Polski B., Favre G., Boyer-Suavet S., Vinogradova M., Kirsanova T., and Wong E.K.S.

Subjects
Kidney, medicine.medical_specialty, Adult patients, business.industry, INT, medicine.disease, Gastroenterology, Complement inhibitor, medicine.anatomical_structure, Long acting, Nephrology, Internal medicine, Atypical hemolytic uremic syndrome, Medicine, Ravulizumab, Thrombotic microangiopathy, Pregnancy microangiopathies, Atypical hemolytic uremic syndrome, business
Abstract

The authors regret that 2 investigators were not included in the 311 Study Group. Members of the 311 Study Group are listed in the Appendix. The authors would like to apologize for any inconvenience caused.

Published
2021

4. Erratum to 'Rondeau E, Scully M, Ariceta G, Barbour T, Cataland S, Heyne N, Miyakawa Y, Ortiz S, Swenson E, Vallee M, Yoon S-S, Kavanagh D, Haller H; on behalf of the 311 Study Group. The long-acting C5 inhibitor, Ravulizumab, is effective and safe in adult patients with atypical hemolytic uremic syndrome naïve to complement inhibitor treatment' Kidney Int. 2020;97:1287–1296

Author

Eric Rondeau, Marie Scully, Gema Ariceta, Tom Barbour, Spero Cataland, Nils Heyne, Yoshitaka Miyakawa, Stephan Ortiz, Eugene Swenson, Marc Vallee, Sung-Soo Yoon, David Kavanagh, Hermann Haller, Sunil Babu, Nilufer Broeders, Nicole Lietar, Fiona Brown, Philip Campbell, Paramit Chowdhury, Theo Kasimatis, Lino Cirami, Leonardo Caroti, Guilia Antognoli, Yahsou Delmas, Vladimir Dobronravov, Anja Gaeckler, Cyril Garrouste, Gregory Greenwood, Siân Griffin, Chiu-Ching Huang, I-Ru Chen, Susan Huang, Jin Seok Kim, Gaetano La Manna, Giorgia Comai, Maria Cappuccilli, Moglie Le Quintrec, Guillaume Jeantet, Iino Fumie, Yosu Luque, Jan Menne, Johan Morelle, Eric Goffin, Anja Muhlfeld, Shashi Nagaraj, Gowthami Arepally, Doyeun Oh, Masayoshi Okumi, Manuel Praga Terente, Elena Gutierréz, Paola Rodriguez, Francois Provot, Ulf Schönermarck, Michael Fischereder, Natalia Ramos Terrada, Barbara Seitz-Polski, Guillaume Favre, Sonia Boyer-Suavet, Maria Vinogradova, Tatiana Kirsanova, Edwin K.S. Wong, Rondeau E., Scully M., Ariceta G., Barbour T., Cataland S., Heyne N., Miyakawa Y., Ortiz S., Swenson E., Vallee M., Yoon S.-S., Kavanagh D., Haller H., Babu S., Broeders N., Lietar N., Brown F., Campbell P., Chowdhury P., Kasimatis T., Cirami L., Caroti L., Antognoli G., Delmas Y., Dobronravov V., Gaeckler A., Garrouste C., Greenwood G., Griffin S., Huang C.-C., Chen I.-R., Huang S., Kim J.S., La Manna G., Comai G., Cappuccilli M., Le Quintrec M., Jeantet G., Fumie I., Luque Y., Menne J., Morelle J., Goffin E., Muhlfeld A., Nagaraj S., Arepally G., Oh D., Okumi M., Terente M.P., Gutierrez E., Rodriguez P., Provot F., Schonermarck U., Fischereder M., Terrada N.R., Seitz-Polski B., Favre G., Boyer-Suavet S., Vinogradova M., Kirsanova T., and Wong E.K.S.

Subjects
N.A, Nephrology
Abstract

The publisher regrets that the members of the 311 Study Group were not included as collaborative authors. Members of the 311 Study Group are listed in the Appendix. The publisher would like to apologize for any inconvenience caused.

Published
2020

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