Efficacy and safety of abobotulinumtoxinA liquid formulation in
cervical dystonia: A randomized-controlled trial

J 2016

Efficacy and safety of abobotulinumtoxinA liquid formulation in cervical dystonia: A randomized-controlled trial

POEWE, Werner, Pierre BURBAUD, Giovanni CASTELNOVO, Wolfgang H. JOST, Andres O. CEBALLOS-BAUMANN et. al.

Základní údaje

Originální název

Efficacy and safety of abobotulinumtoxinA liquid formulation in cervical dystonia: A randomized-controlled trial

Autoři

POEWE, Werner (40 Rakousko), Pierre BURBAUD (250 Francie), Giovanni CASTELNOVO (250 Francie), Wolfgang H. JOST (276 Německo), Andres O. CEBALLOS-BAUMANN (276 Německo), Marta BANACH (616 Polsko), Anna POTULSKA-CHROMIK (616 Polsko), Joaquim J. FERREIRA (620 Portugalsko), Katalin BIHARI (348 Maďarsko), Edvard EHLER (203 Česká republika), Martin BAREŠ (203 Česká republika, garant, domácí), Lyudmyla A. DZYAK (804 Ukrajina), Anna N. BELOVA (643 Rusko), Emmanuel PHAM (250 Francie), Wenzhong Jerry LIU (840 Spojené státy) a Philippe PICAUT (643 Rusko)

Vydání

Movement Disorders, Hoboken, Wiley-Blackwell, 2016, 0885-3185

Další údaje

Jazyk

angličtina

Typ výsledku

Článek v odborném periodiku

Obor

30000 3. Medical and Health Sciences

Stát vydavatele

Spojené státy

Utajení

není předmětem státního či obchodního tajemství

Impakt faktor

Impact factor: 7.072

Kód RIV

RIV/00216224:14110/16:00092396

Organizační jednotka

Lékařská fakulta

DOI

http://dx.doi.org/10.1002/mds.26760

UT WoS

000387415700012

Klíčová slova anglicky

abobotulinumtoxinA solution for injection; cervical dystonia; Toronto Western Spasmodic Torticollis Rating Scale

Štítky

EL OK

Příznaky

Mezinárodní význam, Recenzováno

Změněno: 18. 12. 2016 15:27, Ing. Mgr. Věra Pospíšilíková

Anotace

V originále

Background Approved botulinum toxin A products require reconstitution. AbobotulinumtoxinA solution for injection is a ready-to-use liquid formulation of abobotulinumtoxinA. Objectives The objective of this study was to demonstrate the superior efficacy of abobotulinumtoxinA solution for injection to placebo and to test the noninferior efficacy of abobotulinumtoxinA solution for injection versus abobotulinumtoxinA (dry formulation) in cervical dystonia. Methods This was a phase-3, multicenter, prospective, double-blind, randomized, active, and placebo-controlled study (N=369). Patients with cervical dystonia were randomized (3:3:1) to abobotulinumtoxinA solution for injection 500 U, abobotulinumtoxinA 500 U, or placebo. Following the double-blind phase, patients received abobotulinumtoxinA solution for injection, open-label, for up to 4 cycles. The primary outcome was change from baseline at week 4 of the Toronto Western Spasmodic Torticollis Rating Scale total score. Secondary measures included change from baseline or cycle baseline in Toronto Western Spasmodic Torticollis Rating Scale scores. Results At week 4, both products were superior to placebo (Toronto Western Spasmodic Torticollis Rating Scale total score least square mean decrease from baseline, abobotulinumtoxinA solution for injection 500 U -12.5, abobotulinumtoxinA 500 U -14.0, placebo -3.9; P<.0001 vs placebo). The noninferiority limit of 3 points in the Toronto Western Spasmodic Torticollis Rating Scale total score at week 4 was not met for abobotulinumtoxinA solution for injection versus abobotulinumtoxinA. Toronto Western Spasmodic Torticollis Rating Scale total score reductions were maintained for up to 4 cycles of abobotulinumtoxinA solution for injection open-label follow-up treatment. Safety profiles of abobotulinumtoxinA solution for injection and abobotulinumtoxinA were similar, with dysphagia and injection-site pain the most frequent drug-related adverse events. Conclusions Although the predefined noninferiority criterion was not met, abobotulinumtoxinA solution for injection was similarly effective to freeze-dried abobotulinumtoxinA in reducing Toronto Western Spasmodic Torticollis Rating Scale total scores with a similar safety profile. AbobotulinumtoxinA solution for injection efficacy was maintained with chronic open-label treatment, and this novel formulation may add convenience as well as dosing accuracy to treatment with abobotulinumtoxinA.

Citovat

POEWE, Werner, Pierre BURBAUD, Giovanni CASTELNOVO, Wolfgang H. JOST, Andres O. CEBALLOS-BAUMANN, Marta BANACH, Anna POTULSKA-CHROMIK, Joaquim J. FERREIRA, Katalin BIHARI, Edvard EHLER, Martin BAREŠ, Lyudmyla A. DZYAK, Anna N. BELOVA, Emmanuel PHAM, Wenzhong Jerry LIU a Philippe PICAUT. Efficacy and safety of abobotulinumtoxinA liquid formulation in cervical dystonia: A randomized-controlled trial. Movement Disorders. Hoboken: Wiley-Blackwell, 2016, roč. 31, č. 11, s. 1649-1657. ISSN 0885-3185. Dostupné z: https://dx.doi.org/10.1002/mds.26760.

@article{1365210,
   author = {Poewe, Werner and Burbaud, Pierre and Castelnovo, Giovanni and Jost, Wolfgang H. and CeballosandBaumann, Andres O. and Banach, Marta and PotulskaandChromik, Anna and Ferreira, Joaquim J. and Bihari, Katalin and Ehler, Edvard and Bareš, Martin and Dzyak, Lyudmyla A. and Belova, Anna N. and Pham, Emmanuel and Liu, Wenzhong Jerry and Picaut, Philippe},
   article_location = {Hoboken},
   article_number = {11},
   doi = {http://dx.doi.org/10.1002/mds.26760},
   keywords = {abobotulinumtoxinA solution for injection; cervical dystonia; Toronto Western Spasmodic Torticollis Rating Scale},
   language = {eng},
   issn = {0885-3185},
   journal = {Movement Disorders},
   title = {Efficacy and safety of abobotulinumtoxinA liquid formulation in cervical dystonia: A randomized-controlled trial},
   volume = {31},
   year = {2016}
}

TY  - JOUR
ID  - 1365210
AU  - Poewe, Werner - Burbaud, Pierre - Castelnovo, Giovanni - Jost, Wolfgang H. - Ceballos-Baumann, Andres O. - Banach, Marta - Potulska-Chromik, Anna - Ferreira, Joaquim J. - Bihari, Katalin - Ehler, Edvard - Bareš, Martin - Dzyak, Lyudmyla A. - Belova, Anna N. - Pham, Emmanuel - Liu, Wenzhong Jerry - Picaut, Philippe
PY  - 2016
TI  - Efficacy and safety of abobotulinumtoxinA liquid formulation in cervical dystonia: A randomized-controlled trial
JF  - Movement Disorders
VL  - 31
IS  - 11
SP  - 1649-1657
EP  - 1649-1657
PB  - Wiley-Blackwell
SN  - 08853185
KW  - abobotulinumtoxinA solution for injection
KW  - cervical dystonia
KW  - Toronto Western Spasmodic Torticollis Rating Scale
N2  - Background Approved botulinum toxin A products require reconstitution. AbobotulinumtoxinA solution for injection is a ready-to-use liquid formulation of abobotulinumtoxinA. Objectives The objective of this study was to demonstrate the superior efficacy of abobotulinumtoxinA solution for injection to placebo and to test the noninferior efficacy of abobotulinumtoxinA solution for injection versus abobotulinumtoxinA (dry formulation) in cervical dystonia. Methods This was a phase-3, multicenter, prospective, double-blind, randomized, active, and placebo-controlled study (N=369). Patients with cervical dystonia were randomized (3:3:1) to abobotulinumtoxinA solution for injection 500 U, abobotulinumtoxinA 500 U, or placebo. Following the double-blind phase, patients received abobotulinumtoxinA solution for injection, open-label, for up to 4 cycles. The primary outcome was change from baseline at week 4 of the Toronto Western Spasmodic Torticollis Rating Scale total score. Secondary measures included change from baseline or cycle baseline in Toronto Western Spasmodic Torticollis Rating Scale scores. Results At week 4, both products were superior to placebo (Toronto Western Spasmodic Torticollis Rating Scale total score least square mean decrease from baseline, abobotulinumtoxinA solution for injection 500 U -12.5, abobotulinumtoxinA 500 U -14.0, placebo -3.9; P<.0001 vs placebo). The noninferiority limit of 3 points in the Toronto Western Spasmodic Torticollis Rating Scale total score at week 4 was not met for abobotulinumtoxinA solution for injection versus abobotulinumtoxinA. Toronto Western Spasmodic Torticollis Rating Scale total score reductions were maintained for up to 4 cycles of abobotulinumtoxinA solution for injection open-label follow-up treatment. Safety profiles of abobotulinumtoxinA solution for injection and abobotulinumtoxinA were similar, with dysphagia and injection-site pain the most frequent drug-related adverse events. Conclusions Although the predefined noninferiority criterion was not met, abobotulinumtoxinA solution for injection was similarly effective to freeze-dried abobotulinumtoxinA in reducing Toronto Western Spasmodic Torticollis Rating Scale total scores with a similar safety profile. AbobotulinumtoxinA solution for injection efficacy was maintained with chronic open-label treatment, and this novel formulation may add convenience as well as dosing accuracy to treatment with abobotulinumtoxinA.
ER  -

POEWE, Werner, Pierre BURBAUD, Giovanni CASTELNOVO, Wolfgang H. JOST, Andres O. CEBALLOS-BAUMANN, Marta BANACH, Anna POTULSKA-CHROMIK, Joaquim J. FERREIRA, Katalin BIHARI, Edvard EHLER, Martin BAREŠ, Lyudmyla A. DZYAK, Anna N. BELOVA, Emmanuel PHAM, Wenzhong Jerry LIU a Philippe PICAUT. Efficacy and safety of abobotulinumtoxinA liquid formulation in cervical dystonia: A randomized-controlled trial. \textit{Movement Disorders}. Hoboken: Wiley-Blackwell, 2016, roč.~31, č.~11, s.~1649-1657. ISSN~0885-3185. Dostupné z: https://dx.doi.org/10.1002/mds.26760.

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