Efficacy and safety of tocilizumab in patients with polyarticular-course juvenile idiopathic arthritis

Results from a phase 3, randomised, double-blind withdrawal trial

Hermine I. Brunner, Nicolino Ruperto, Zbigniew Zuber, Caroline Keane, Olivier Harari, Andrew Kenwright, Peng Lu, Ruben Cuttica, Vladimir Keltsev, Ricardo M. Xavier, Inmaculada Calvo, Irina Nikishina, Nadina Rubio-Pérez, Ekaterina Alexeeva, Vyacheslav Chasnyk, Gerd Horneff, Violetta Opoka-Winiarska, Pierre Quartier, Clovis A. Silva, Earl Silverman & 58 others Alberto Spindler, Eileen Baildam, M. Luz Gámir, Alan Martin, Christoph Rietschel, Daniel Siri, Elzbieta Smolewska, Daniel Lovell, Alberto Martini, Fabrizio De Benedetti, T. Sherrard, A. Johnson, A. Merritt, W. Long, Simona Angioloni, Laura Carenini, Chiara Pallotti, Eugenia Mosci, Marco Garrone, Irene Gregorini, Silvia Scala, Luca Villa, Giuseppe Silvestri, Graciela Espada, Roger Allen, Jeffrey Chaitow, Rik Joos, Carine Wouters, Sheila Knupp, Flavio Sztajnbok, David Cabral, Kristin Houghton, Johannes Roth, Heinrike Schmeling, Chantal Job-Deslandre, Christian Jorgensen, Isabelle Konepaut, Kirsten Minden, Frank Weller, Valeria Gerloni, Francesco Zulian, Ruben Burgos-Vargas, Carolina Duarte Salazar, Eunice Solis Vallejo, Armando Calvo, José Chavez, Manuel Ferrandiz Zavaler, Anna Gruenpeter, Katarzyna Kobusinska, Alexey Sarychev, Elena Zholobova, Athimalaipet Ramanan, Patricia Woo, Abraham Gedalia, Steven Goodman, Yukiko Kimura, Karen Onel, Kenneth Schikler

Research output: Contribution to journalArticle

115 Citations (Scopus)

Abstract

Objective To evaluate the interleukin-6 receptor inhibitor tocilizumab for the treatment of patients with polyarticular-course juvenile idiopathic arthritis ( pcJIA). Methods This three-part, randomised, placebocontrolled, double-blind withdrawal study (NCT00988221) included patients who had active pcJIA for ≥6 months and inadequate responses to methotrexate. During part 1, patients received open-label tocilizumab every 4 weeks (8 or 10 mg/kg for body weight (BW)

Original languageEnglish
Pages (from-to)1110-1117
Number of pages8
JournalAnnals of the Rheumatic Diseases
Volume74
Issue number6
DOIs
Publication statusPublished - Jun 1 2015

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Juvenile Arthritis
Safety
Interleukin-6 Receptors
Methotrexate
Labels
Double-Blind Method
Body Weight
tocilizumab
Therapeutics

ASJC Scopus subject areas

  • Rheumatology
  • Immunology
  • Biochemistry, Genetics and Molecular Biology(all)
  • Immunology and Allergy

Cite this

Efficacy and safety of tocilizumab in patients with polyarticular-course juvenile idiopathic arthritis : Results from a phase 3, randomised, double-blind withdrawal trial. / Brunner, Hermine I.; Ruperto, Nicolino; Zuber, Zbigniew; Keane, Caroline; Harari, Olivier; Kenwright, Andrew; Lu, Peng; Cuttica, Ruben; Keltsev, Vladimir; Xavier, Ricardo M.; Calvo, Inmaculada; Nikishina, Irina; Rubio-Pérez, Nadina; Alexeeva, Ekaterina; Chasnyk, Vyacheslav; Horneff, Gerd; Opoka-Winiarska, Violetta; Quartier, Pierre; Silva, Clovis A.; Silverman, Earl; Spindler, Alberto; Baildam, Eileen; Gámir, M. Luz; Martin, Alan; Rietschel, Christoph; Siri, Daniel; Smolewska, Elzbieta; Lovell, Daniel; Martini, Alberto; De Benedetti, Fabrizio; Sherrard, T.; Johnson, A.; Merritt, A.; Long, W.; Angioloni, Simona; Carenini, Laura; Pallotti, Chiara; Mosci, Eugenia; Garrone, Marco; Gregorini, Irene; Scala, Silvia; Villa, Luca; Silvestri, Giuseppe; Espada, Graciela; Allen, Roger; Chaitow, Jeffrey; Joos, Rik; Wouters, Carine; Knupp, Sheila; Sztajnbok, Flavio; Cabral, David; Houghton, Kristin; Roth, Johannes; Schmeling, Heinrike; Job-Deslandre, Chantal; Jorgensen, Christian; Konepaut, Isabelle; Minden, Kirsten; Weller, Frank; Gerloni, Valeria; Zulian, Francesco; Burgos-Vargas, Ruben; Salazar, Carolina Duarte; Vallejo, Eunice Solis; Calvo, Armando; Chavez, José; Zavaler, Manuel Ferrandiz; Gruenpeter, Anna; Kobusinska, Katarzyna; Sarychev, Alexey; Zholobova, Elena; Ramanan, Athimalaipet; Woo, Patricia; Gedalia, Abraham; Goodman, Steven; Kimura, Yukiko; Onel, Karen; Schikler, Kenneth.

In: Annals of the Rheumatic Diseases, Vol. 74, No. 6, 01.06.2015, p. 1110-1117.

Research output: Contribution to journalArticle

Brunner, HI, Ruperto, N, Zuber, Z, Keane, C, Harari, O, Kenwright, A, Lu, P, Cuttica, R, Keltsev, V, Xavier, RM, Calvo, I, Nikishina, I, Rubio-Pérez, N, Alexeeva, E, Chasnyk, V, Horneff, G, Opoka-Winiarska, V, Quartier, P, Silva, CA, Silverman, E, Spindler, A, Baildam, E, Gámir, ML, Martin, A, Rietschel, C, Siri, D, Smolewska, E, Lovell, D, Martini, A, De Benedetti, F, Sherrard, T, Johnson, A, Merritt, A, Long, W, Angioloni, S, Carenini, L, Pallotti, C, Mosci, E, Garrone, M, Gregorini, I, Scala, S, Villa, L, Silvestri, G, Espada, G, Allen, R, Chaitow, J, Joos, R, Wouters, C, Knupp, S, Sztajnbok, F, Cabral, D, Houghton, K, Roth, J, Schmeling, H, Job-Deslandre, C, Jorgensen, C, Konepaut, I, Minden, K, Weller, F, Gerloni, V, Zulian, F, Burgos-Vargas, R, Salazar, CD, Vallejo, ES, Calvo, A, Chavez, J, Zavaler, MF, Gruenpeter, A, Kobusinska, K, Sarychev, A, Zholobova, E, Ramanan, A, Woo, P, Gedalia, A, Goodman, S, Kimura, Y, Onel, K & Schikler, K 2015, 'Efficacy and safety of tocilizumab in patients with polyarticular-course juvenile idiopathic arthritis: Results from a phase 3, randomised, double-blind withdrawal trial', Annals of the Rheumatic Diseases, vol. 74, no. 6, pp. 1110-1117. https://doi.org/10.1136/annrheumdis-2014-205351
Brunner, Hermine I. ; Ruperto, Nicolino ; Zuber, Zbigniew ; Keane, Caroline ; Harari, Olivier ; Kenwright, Andrew ; Lu, Peng ; Cuttica, Ruben ; Keltsev, Vladimir ; Xavier, Ricardo M. ; Calvo, Inmaculada ; Nikishina, Irina ; Rubio-Pérez, Nadina ; Alexeeva, Ekaterina ; Chasnyk, Vyacheslav ; Horneff, Gerd ; Opoka-Winiarska, Violetta ; Quartier, Pierre ; Silva, Clovis A. ; Silverman, Earl ; Spindler, Alberto ; Baildam, Eileen ; Gámir, M. Luz ; Martin, Alan ; Rietschel, Christoph ; Siri, Daniel ; Smolewska, Elzbieta ; Lovell, Daniel ; Martini, Alberto ; De Benedetti, Fabrizio ; Sherrard, T. ; Johnson, A. ; Merritt, A. ; Long, W. ; Angioloni, Simona ; Carenini, Laura ; Pallotti, Chiara ; Mosci, Eugenia ; Garrone, Marco ; Gregorini, Irene ; Scala, Silvia ; Villa, Luca ; Silvestri, Giuseppe ; Espada, Graciela ; Allen, Roger ; Chaitow, Jeffrey ; Joos, Rik ; Wouters, Carine ; Knupp, Sheila ; Sztajnbok, Flavio ; Cabral, David ; Houghton, Kristin ; Roth, Johannes ; Schmeling, Heinrike ; Job-Deslandre, Chantal ; Jorgensen, Christian ; Konepaut, Isabelle ; Minden, Kirsten ; Weller, Frank ; Gerloni, Valeria ; Zulian, Francesco ; Burgos-Vargas, Ruben ; Salazar, Carolina Duarte ; Vallejo, Eunice Solis ; Calvo, Armando ; Chavez, José ; Zavaler, Manuel Ferrandiz ; Gruenpeter, Anna ; Kobusinska, Katarzyna ; Sarychev, Alexey ; Zholobova, Elena ; Ramanan, Athimalaipet ; Woo, Patricia ; Gedalia, Abraham ; Goodman, Steven ; Kimura, Yukiko ; Onel, Karen ; Schikler, Kenneth. / Efficacy and safety of tocilizumab in patients with polyarticular-course juvenile idiopathic arthritis : Results from a phase 3, randomised, double-blind withdrawal trial. In: Annals of the Rheumatic Diseases. 2015 ; Vol. 74, No. 6. pp. 1110-1117.
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T1 - Efficacy and safety of tocilizumab in patients with polyarticular-course juvenile idiopathic arthritis

T2 - Results from a phase 3, randomised, double-blind withdrawal trial

AU - Brunner, Hermine I.

AU - Ruperto, Nicolino

AU - Zuber, Zbigniew

AU - Keane, Caroline

AU - Harari, Olivier

AU - Kenwright, Andrew

AU - Lu, Peng

AU - Cuttica, Ruben

AU - Keltsev, Vladimir

AU - Xavier, Ricardo M.

AU - Calvo, Inmaculada

AU - Nikishina, Irina

AU - Rubio-Pérez, Nadina

AU - Alexeeva, Ekaterina

AU - Chasnyk, Vyacheslav

AU - Horneff, Gerd

AU - Opoka-Winiarska, Violetta

AU - Quartier, Pierre

AU - Silva, Clovis A.

AU - Silverman, Earl

AU - Spindler, Alberto

AU - Baildam, Eileen

AU - Gámir, M. Luz

AU - Martin, Alan

AU - Rietschel, Christoph

AU - Siri, Daniel

AU - Smolewska, Elzbieta

AU - Lovell, Daniel

AU - Martini, Alberto

AU - De Benedetti, Fabrizio

AU - Sherrard, T.

AU - Johnson, A.

AU - Merritt, A.

AU - Long, W.

AU - Angioloni, Simona

AU - Carenini, Laura

AU - Pallotti, Chiara

AU - Mosci, Eugenia

AU - Garrone, Marco

AU - Gregorini, Irene

AU - Scala, Silvia

AU - Villa, Luca

AU - Silvestri, Giuseppe

AU - Espada, Graciela

AU - Allen, Roger

AU - Chaitow, Jeffrey

AU - Joos, Rik

AU - Wouters, Carine

AU - Knupp, Sheila

AU - Sztajnbok, Flavio

AU - Cabral, David

AU - Houghton, Kristin

AU - Roth, Johannes

AU - Schmeling, Heinrike

AU - Job-Deslandre, Chantal

AU - Jorgensen, Christian

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AU - Minden, Kirsten

AU - Weller, Frank

AU - Gerloni, Valeria

AU - Zulian, Francesco

AU - Burgos-Vargas, Ruben

AU - Salazar, Carolina Duarte

AU - Vallejo, Eunice Solis

AU - Calvo, Armando

AU - Chavez, José

AU - Zavaler, Manuel Ferrandiz

AU - Gruenpeter, Anna

AU - Kobusinska, Katarzyna

AU - Sarychev, Alexey

AU - Zholobova, Elena

AU - Ramanan, Athimalaipet

AU - Woo, Patricia

AU - Gedalia, Abraham

AU - Goodman, Steven

AU - Kimura, Yukiko

AU - Onel, Karen

AU - Schikler, Kenneth

PY - 2015/6/1

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