2,873
Views
2
CrossRef citations to date
0
Altmetric
Original Research

Long-term safety and efficacy of agalsidase beta in Japanese patients with Fabry disease: aggregate data from two post-authorization safety studies

, , & ORCID Icon
Pages 589-601 | Received 28 Jan 2021, Accepted 12 Feb 2021, Published online: 10 Mar 2021

Figures & data

Figure 1. Disposition of patients in the (a) special drug use investigation of agalsidase beta for evaluation of long-term use and (b) drug use investigation of agalsidase beta as all-case surveillance

Abbreviation: GL-3, globotriaosylceramide.
Figure 1. Disposition of patients in the (a) special drug use investigation of agalsidase beta for evaluation of long-term use and (b) drug use investigation of agalsidase beta as all-case surveillance

Table 1. Demographic and baseline clinical characteristics

Table 2. Occurrence of adverse drug reactions (with a PT Incidence ≥n = 3a) overall and by subgroup

Figure 2. Incidence of adverse drug reactions throughout the course of the study period A) Overall and by age and B) Phenotype subgroup

Figure 2. Incidence of adverse drug reactions throughout the course of the study period A) Overall and by age and B) Phenotype subgroup

Figure 3. Timing of infusion-related reactions following initiation of agalsidase beta

Figure 3. Timing of infusion-related reactions following initiation of agalsidase beta

Table 3. Correlation between antibody production and adverse drug reactions and infusion-associated reactions

Table 4. Relationship between adverse events and IgG antibody titer

Figure 4. Change in blood GL-3 Level by (a) age subgroups, (b) disease phenotype, and (c) antibody status

Figure 4. Change in blood GL-3 Level by (a) age subgroups, (b) disease phenotype, and (c) antibody status

Table 5. Change from baseline in blood GL-3 level by patient background factors

Supplemental material

Supplemental Material

Download MS Word (117.2 KB)