Literature DB >> 22290025

36 months observational clinical study of 38 adult Pompe disease patients under alglucosidase alfa enzyme replacement therapy.

Caroline Regnery1, Cornelia Kornblum, Frank Hanisch, Stefan Vielhaber, Nicola Strigl-Pill, Birgit Grunert, Wolfgang Müller-Felber, Franz Xaver Glocker, Matthias Spranger, Marcus Deschauer, Eugen Mengel, Benedikt Schoser.   

Abstract

OBJECTIVES: Glycogen storage disease type 2(GSD2)/Pompe disease is characterized by respiratory and skeletal muscle weakness and atrophy, resulting in functional disability and reduced life span.
METHODS: We present an open-label, investigator-initiated observational study of alglucosidase alfa enzyme replacement therapy (ERT) in 38 adult-onset GSD2 patients (20 female, 18 male) with a mean age at disease onset of 36.2 ± 10.5 years. Mean delay between symptom onset and start of ERT was 14.5 ± 7.2 years. Assessments included serial Walton Gardner Medwin scale, arm function tests, timed 10-meter walk tests, 4- stair climb tests, modified Gowers' maneuvers, 6-minute walk test (6MWT), MRC sum score, forced vital capacities (FVC), creatine kinase (CK) levels, and SF-36 selfreporting questionnaires. All tests were performed at baseline and every 12 months for 36 months of ERT.
RESULTS: In the 6MWT we found 21 patients able to walk at baseline a mean distance of 312 ± 165.5 m, improving to 344 ± 165.8 m after 12 months (p=0.006), remaining at 356.4 ± 155.9 m at 24 months (p=0.033), and declining to 325.6 ± 174.8 m after 36 months of ERT (p=0.49, n.s.). The mean FVC in 28 patients was 80.27 ± 14.08% of predicted normal at baseline, after 12 months 79.19 ± 13.09%, at 24 months 78.62 ± 16.55%, and 77.19 ± 18.05%after 36 months. Only mean CK levels were significantly decreased by 8.8% (p=0.041). All other tests were statistically nonsignificant changed.
CONCLUSION: Our data denote a rather variable course of neuromuscular deficits in chronic adult-onset Pompe patients during 36 months of alglucosidase alfa ERT.

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Year:  2012        PMID: 22290025     DOI: 10.1007/s10545-012-9451-8

Source DB:  PubMed          Journal:  J Inherit Metab Dis        ISSN: 0141-8955            Impact factor:   4.982


  35 in total

1.  Juvenile and adult-onset acid maltase deficiency in France: genotype-phenotype correlation.

Authors:  M G Ausems; J H Wokke; A J Reuser; O P van Diggelen
Journal:  Neurology       Date:  2001-11-27       Impact factor: 9.910

2.  Effects of enzyme replacement therapy on five patients with advanced late-onset glycogen storage disease type II: a 2-year follow-up study.

Authors:  Yoshihiko Furusawa; Madoka Mori-Yoshimura; Toshiyuki Yamamoto; Chikako Sakamoto; Mizuki Wakita; Yoko Kobayashi; Yutaka Fukumoto; Yasushi Oya; Tokiko Fukuda; Hideo Sugie; Yukiko K Hayashi; Ichizo Nishino; Ikuya Nonaka; Miho Murata
Journal:  J Inherit Metab Dis       Date:  2011-10-07       Impact factor: 4.982

3.  Broad spectrum of Pompe disease in patients with the same c.-32-13T->G haplotype.

Authors:  M A Kroos; R J Pomponio; M L Hagemans; J L M Keulemans; M Phipps; M DeRiso; R E Palmer; M G E M Ausems; N A M E Van der Beek; O P Van Diggelen; D J J Halley; A T Van der Ploeg; A J J Reuser
Journal:  Neurology       Date:  2007-01-09       Impact factor: 9.910

4.  Effect of enzyme therapy in juvenile patients with Pompe disease: a three-year open-label study.

Authors:  C I van Capelle; N A M E van der Beek; M L C Hagemans; W F M Arts; W C J Hop; P Lee; J Jaeken; I M E Frohn-Mulder; P J F M Merkus; D Corzo; A C Puga; A J Reuser; A T van der Ploeg
Journal:  Neuromuscul Disord       Date:  2010-12       Impact factor: 4.296

Review 5.  The natural course of non-classic Pompe's disease; a review of 225 published cases.

Authors:  Léon P F Winkel; Marloes L C Hagemans; Pieter A van Doorn; M Christa B Loonen; Wim J C Hop; Arnold J J Reuser; Ans T van der Ploeg
Journal:  J Neurol       Date:  2005-08       Impact factor: 4.849

6.  Long-term observational, non-randomized study of enzyme replacement therapy in late-onset glycogenosis type II.

Authors:  Bruno Bembi; Federica Edith Pisa; Marco Confalonieri; Giovanni Ciana; Agata Fiumara; Rossella Parini; Miriam Rigoldi; Arrigo Moglia; Alfredo Costa; Annalisa Carlucci; Cesare Danesino; Maria Gabriela Pittis; Andrea Dardis; Sabrina Ravaglia
Journal:  J Inherit Metab Dis       Date:  2010-09-14       Impact factor: 4.982

7.  High antibody titer in an adult with Pompe disease affects treatment with alglucosidase alfa.

Authors:  Juna M de Vries; Nadine A M E van der Beek; Marian A Kroos; Lale Ozkan; Pieter A van Doorn; Susan M Richards; Crystal C C Sung; Jan-Dietert C Brugma; Adrienne A M Zandbergen; Ans T van der Ploeg; Arnold J J Reuser
Journal:  Mol Genet Metab       Date:  2010-08-14       Impact factor: 4.797

Review 8.  Pompe's disease.

Authors:  Ans T van der Ploeg; Arnold J J Reuser
Journal:  Lancet       Date:  2008-10-11       Impact factor: 79.321

9.  Adult onset acid maltase deficiency. Distribution and progression of clinical and pathological abnormality in a family.

Authors:  M Swash; M S Schwartz; M C Apps
Journal:  J Neurol Sci       Date:  1985-04       Impact factor: 3.181

10.  The impact of antibodies on clinical outcomes in diseases treated with therapeutic protein: lessons learned from infantile Pompe disease.

Authors:  Suhrad G Banugaria; Sean N Prater; Yiu-Ki Ng; Joyce A Kobori; Richard S Finkel; Roger L Ladda; Yuan-Tsong Chen; Amy S Rosenberg; Priya S Kishnani
Journal:  Genet Med       Date:  2011-08       Impact factor: 8.822

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  45 in total

1.  Therapeutic advances in the management of Pompe disease and other metabolic myopathies.

Authors:  Corrado Angelini; Anna Chiara Nascimbeni; Claudio Semplicini
Journal:  Ther Adv Neurol Disord       Date:  2013-09       Impact factor: 6.570

2.  Urge incontinence and gastrointestinal symptoms in adult patients with pompe disease: a cross-sectional survey.

Authors:  Nesrin Karabul; Anika Skudlarek; Janine Berndt; Cornelia Kornblum; Rudolf A Kley; Stephan Wenninger; Nikolaus Tiling; Eugen Mengel; Ursula Plöckinger; Matthias Vorgerd; Marcus Deschauer; Benedikt Schoser; Frank Hanisch
Journal:  JIMD Rep       Date:  2014-08-26

Review 3.  [Diagnosis and therapy of late onset Pompe disease].

Authors:  A Schüller; C Kornblum; M Deschauer; M Vorgerd; B Schrank; E Mengel; Z Lukacs; D Gläser; P Young; U Plöckinger; B Schoser
Journal:  Nervenarzt       Date:  2013-12       Impact factor: 1.214

4.  European muscle MRI study in limb girdle muscular dystrophy type R1/2A (LGMDR1/LGMD2A).

Authors:  Andrea Barp; Pascal Laforet; Luca Bello; Giorgio Tasca; John Vissing; Mauro Monforte; Enzo Ricci; Ariane Choumert; Tanya Stojkovic; Edoardo Malfatti; Elena Pegoraro; Claudio Semplicini; Roberto Stramare; Olivier Scheidegger; Jana Haberlova; Volker Straub; Chiara Marini-Bettolo; Nicoline Løkken; Jordi Diaz-Manera; Jon A Urtizberea; Eugenio Mercuri; Martin Kynčl; Maggie C Walter; Robert Y Carlier
Journal:  J Neurol       Date:  2019-09-25       Impact factor: 4.849

5.  Autophagy in Natural History and After ERT in Glycogenosis Type II.

Authors:  Corrado Angelini; Anna C Nascimbeni; Marina Fanin
Journal:  JIMD Rep       Date:  2015-02-25

6.  36-Months follow-up assessment after cessation and resuming of enzyme replacement therapy in late onset Pompe disease: data from the Swiss Pompe Registry.

Authors:  Olivier Scheidegger; Daniela Leupold; Rafael Sauter; Oliver Findling; Kai Michael Rösler; Thomas Hundsberger
Journal:  J Neurol       Date:  2018-09-19       Impact factor: 4.849

7.  Safety and efficacy of short- and long-term inspiratory muscle training in late-onset Pompe disease (LOPD): a pilot study.

Authors:  Stephan Wenninger; Eva Greckl; Haris Babačić; Kristina Stahl; Benedikt Schoser
Journal:  J Neurol       Date:  2018-11-14       Impact factor: 4.849

8.  Ten years of the international Pompe survey: patient reported outcomes as a reliable tool for studying treated and untreated children and adults with non-classic Pompe disease.

Authors:  J C van der Meijden; D Güngör; M E Kruijshaar; A D J Muir; H A Broekgaarden; A T van der Ploeg
Journal:  J Inherit Metab Dis       Date:  2014-08-12       Impact factor: 4.982

9.  Cessation and resuming of alglucosidase alfa in Pompe disease: a retrospective analysis.

Authors:  Thomas Hundsberger; Kai M Rösler; Oliver Findling
Journal:  J Neurol       Date:  2014-06-13       Impact factor: 4.849

10.  Sleep-Disordered Breathing and Effects of Noninvasive Ventilation in Patients with Late-Onset Pompe Disease.

Authors:  Matthias Boentert; Bianca Dräger; Christian Glatz; Peter Young
Journal:  J Clin Sleep Med       Date:  2016-12-15       Impact factor: 4.062

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