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Correction: Transitioning subcutaneous immunoglobulin 20% therapies in patients with primary and secondary immunodeficiencies: Canadian real‑world study

Allergy, Asthma & Clinical Immunology volume 19, Article number: 54 (2023) Cite this article

The Original Article was published on 07 August 2022

Correction: Allergy, Asthma & Clinical Immunology (2022) 18:70 https://doi.org/10.1186/s13223-022-00709-8

Following the publication of our article [1], a previously undetected error in the data set has come to our attention. MedDRA-coded preferred terms (PTs) were not coded in the derived adverse event (AE) data set used for the summary of AEs and AEs of interest. While the overall number of AEs was reported correctly in the published article, three AEs that were originally categorized as ‘other’ have now been re-categorized. Consequently, safety data presented in the Results require correction.

Firstly, in the Safety subsection, the first sentence stated: “In total, 20 AEs of interest (in 15 patients) and 29 other AEs (in 20 patients) were reported (Table 3).”

It should instead read: “In total, 23 AEs of interest (in 16 patients) and 26 other AEs (in 19 patients) were reported (Table 3).”

The referenced Table 3 (Summary of AEs) originally presented the following data:

 

AEs of interest

Other AEs

SAEsa

Patients, n (%)

(N = 125)

AEs, n

Patients, n (%)

(N = 125)

AEs, n

Patients, n (%)

(N = 125)

AEs, n

Any AE

15 (12.0)

20

20 (16.0)

29

5 (4.0)

5

Severity of AEb

 Mild

10 (8.0)

13

11 (8.8)

14

0

0

 Moderate

5 (4.0)

6

6 (4.8)

12

1 (0.8)

1

 Severe

1 (0.8)

1

3 (2.4)

3

4 (3.2)

4

AEs considered related to Ig20Gly

 Related

7 (5.6)

8

3 (2.4)

4

0

0

 Possibly related

5 (4.0)

5

4 (3.2)

6

1 (0.8)

1

 Probably related

2 (1.6)

2

2 (1.6)

2

0

0

Table 3 should instead present the following corrected data:

 

AEs of interest

Other AEs

SAEsa

Patients, n (%)

(N = 125)

AEs, n

Patients, n (%)

(N = 125)

AEs, n

Patients, n (%)

(N = 125)

AEs, n

Any AE

16 (12.8)

23

19 (15.2)

26

5 (4.0)

5

Severity of AEb

 Mild

11 (8.8)

14

10 (8.0)

13

0

0

 Moderate

5 (4.0)

8

6 (4.8)

10

1 (0.8)

1

 Severe

1 (0.8)

1

3 (2.4)

3

4 (3.2)

4

AEs considered related to Ig20Gly

 Related

7 (5.6)

8

3 (2.4)

4

0

0

 Possibly related

5 (4.0)

7

4 (3.2)

4

1 (0.8)

1

 Probably related

2 (1.6)

2

2 (1.6)

2

0

0

Safety data in Additional file 2: Table S1 (AEs of interest), referenced in the Safety subsection, were originally presented as follows:

AE of interest

Patients, n (%)

(N = 125)

All causality

Considered related to Ig20Gly

Nausea

2 (1.6)

1 (0.8)

Diarrhea

1 (0.8)

0

Headache

6 (4.8)

3 (2.4)

Cough

2 (1.6)

0

Stroke

1 (0.8)

0

Fatigue

2 (1.6)

0

Infusion-site erythema (redness)

1 (0.8)

1 (0.8)

Infusion-site pain

3 (2.4)

3 (2.4)

Infusion-site pruritus (itchiness)

1 (0.8)

0

Table S1 should instead present the following corrected data for all causality fatigue:

AE of interest

Patients, n (%)

(N = 125)

All causality

Considered related to Ig20Gly

Nausea

2 (1.6)

1 (0.8)

Diarrhea

1 (0.8)

0

Headache

6 (4.8)

3 (2.4)

Cough

2 (1.6)

0

Stroke

1 (0.8)

0

Fatigue

3 (2.4)

0

Infusion-site erythema (redness)

1 (0.8)

1 (0.8)

Infusion-site pain

3 (2.4)

3 (2.4)

Infusion-site pruritus (itchiness)

1 (0.8)

0

Safety data in Additional file 2: Table S4 (AEs by mode of Ig20Gly administration), referenced in the Subgroup analysis by mode of administration at 12 months subsection, were originally presented as follows:

 

AEs of interest

Other AEs

SAEs

Infusion pump

Manual

Infusion pump

Manual

Infusion pump

Manual

Patients, n (%)

(N = 71)

AEs, n

Patients, n (%)

(N = 54)

AEs, n

Patients, n (%)

(N = 71)

AEs, n

Patients, n (%)

(N = 54)

AEs, n

Patients, n (%)

(N = 71)

AEs, n

Patients, n (%)

(N = 54)

AEs, n

Any AE

6 (8.5)

9

9 (16.7)

11

12 (16.9)

13

8 (14.8)

16

5 (7.0)

5

0

0

Severity of AE

 Mild

4 (5.6)

7

6 (11.1)

6

6 (8.5)

7

5 (9.3)

7

0

0

0

0

 Moderate

1 (1.4)

1

4 (7.4)

5

3 (4.2)

3

3 (5.6)

9

1 (1.4)

1

0

0

 Severe

1 (1.4)

1

0

0

3 (4.2)

3

0

0

4 (5.6)

4

0

0

AEs considered related to Ig20Gly

 Related

3 (4.2)

3

4 (7.4)

5

2 (2.8)

3

1 (1.9)

1

0

0

0

0

 Possibly related

2 (2.8)

2

3 (5.6)

3

2 (2.8)

2

2 (3.7)

4

1 (1.4)

1

0

0

 Probably related

1 (1.4)

1

1 (1.9)

1

0

0

2 (3.7)

2

0

0

0

0

Table S4 should instead present the following corrected data for the manual administration subgroup:

 

AEs of interest

Other AEs

SAEs

Infusion pump

Manual

Infusion pump

Manual

Infusion pump

Manual

Patients, n (%)

(N = 71)

AEs, n

Patients, n (%)

(N = 54)

AEs, n

Patients, n (%)

(N = 71)

AEs, n

Patients, n (%)

(N = 54)

AEs, n

Patients, n (%)

(N = 71)

AEs, n

Patients, n (%)

(N = 54)

AEs, n

Any AE

6 (8.5)

9

10 (18.5)

14

12 (16.9)

13

7 (13.0)

13

5 (7.0)

5

0

0

Severity of AE

 Mild

4 (5.6)

7

7 (13.0)

7

6 (8.5)

7

4 (7.4)

6

0

0

0

0

 Moderate

1 (1.4)

1

4 (7.4)

7

3 (4.2)

3

3 (5.6)

7

1 (1.4)

1

0

0

 Severe

1 (1.4)

1

0

0

3 (4.2)

3

0

0

4 (5.6)

4

0

0

AEs considered related to Ig20Gly

 Related

3 (4.2)

3

4 (7.4)

5

2 (2.8)

3

1 (1.9)

1

0

0

0

0

 Possibly related

2 (2.8)

2

3 (5.6)

5

2 (2.8)

2

2 (3.7)

2

1 (1.4)

1

0

0

 Probably related

1 (1.4)

1

1 (1.9)

1

0

0

2 (3.7)

2

0

0

0

0

Finally, safety data in Additional file 2: Table S6 (AEs by indication), referenced in the Subgroup analysis by indication at 12 months subsection, were originally presented as follows:

Parameter, n (%)

AEs of interest

Other AEs

SAEs

PID

SID

PID

SID

PID

SID

Patients, n (%)

(N = 61)

AEs, n

Patients, n (%)

(N = 64)

AEs, n

Patients, n (%)

(N = 61)

AEs, n

Patients, n (%)

(N = 64)

AEs, n

Patients, n (%)

(N = 61)

AEs, n

Patients, n (%)

(N = 64)

AEs, n

Any AE

10 (16.4)

15

5 (7.8)

5

8 (13.1)

14

12 (18.8)

15

1 (1.6)

1

4 (6.3)

4

Severity of AE

 Mild

7 (11.5)

10

3 (4.7)

3

6 (9.8)

8

5 (7.8)

6

0

0

0

0

 Moderate

3 (4.9)

4

2 (3.1)

2

2 (3.3)

6

4 (6.3)

6

0

0

1 (1.6)

1

 Severe

1 (1.6)

1

0

0

0

0

3 (4.7)

3

1 (1.6)

1

3 (4.7)

3

AEs considered related to Ig20Gly

 Related

5 (8.2)

6

2 (3.1)

2

2 (3.3)

2

1 (1.6)

2

0

0

0

0

 Possibly related

3 (4.9)

3

2 (3.1)

2

2 (3.3)

2

2 (3.1)

4

1 (1.6)

1

0

0

 Probably related

1 (1.6)

1

1 (1.6)

1

1 (1.6)

1

1 (1.6)

1

0

0

0

0

Table S6 should instead present the following corrected data:

Parameter, n (%)

AEs of interest

Other AEs

SAEs

PID

SID

PID

SID

PID

SID

Patients, n (%)

(N = 61)

AEs, n

Patients, n (%)

(N = 64)

AEs, n

Patients, n (%)

(N = 61)

AEs, n

Patients, n (%)

(N = 64)

AEs, n

Patients, n (%)

(N = 61)

AEs, n

Patients, n (%)

(N = 64)

AEs, n

Any AE

11 (18.0)

16

5 (7.8)

7

7 (11.5)

13

12 (18.8)

13

1 (1.6)

1

4 (6.3)

4

Severity of AE

 Mild

8 (13.1)

11

3 (4.7)

3

5 (8.2)

7

5 (7.8)

6

0

0

0

0

 Moderate

3 (4.9)

4

2 (3.1)

4

2 (3.3)

6

4 (6.3)

4

0

0

1 (1.6)

1

 Severe

1 (1.6)

1

0

0

0

0

3 (4.7)

3

1 (1.6)

1

3 (4.7)

3

AEs considered related to Ig20Gly

 Related

5 (8.2)

6

2 (3.1)

2

2 (3.3)

2

1 (1.6)

2

0

0

0

0

 Possibly related

3 (4.9)

3

2 (3.1)

4

2 (3.3)

2

2 (3.1)

2

1 (1.6)

1

0

0

 Probably related

1 (1.6)

1

1 (1.6)

1

1 (1.6)

1

1 (1.6)

1

0

0

0

0

Please note that the conclusions made in the original publication are unaffected by the errors identified.

Reference

  1. Keith PK, Cowan J, Kanani A, Kim H, Lacuesta G, Lee JK, Chen J, Park M, Gladiator A. Transitioning subcutaneous immunoglobulin 20% therapies in patients with primary and secondary immunodeficiencies: Canadian real-world study. Allergy Asthma Clin Immunol. 2022;18:70. https://doi.org/10.1186/s13223-022-00709-8.

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Authors and Affiliations

  1. Division of Clinical Immunology and Allergy, Department of Medicine, McMaster University, Hamilton, ON, L8N 3Z5, Canada

    Paul K. Keith & Harold Kim

  2. Division of Infectious Diseases, Department of Medicine, Department of Biochemistry, Microbiology, and Immunology; Centre for Infection, Immunity and Inflammation, University of Ottawa, The Ottawa Hospital Research Institute, Ottawa, ON, K1H 8M5, Canada

    Juthaporn Cowan

  3. Division of Allergy and Clinical Immunology, Department of Medicine, St. Paul’s Hospital, University of British Columbia, Vancouver, BC, V6Z 1Y6, Canada

    Amin Kanani

  4. Division of Clinical Immunology and Allergy, Department of Medicine, Western University, London, ON, N6A 5A5, Canada

    Harold Kim

  5. Department of Medicine, Dalhousie University, Halifax, NS, B3H 2Y9, Canada

    Gina Lacuesta

  6. Chair of Toronto Allergists and Evidence Based Medical Educator, Toronto, ON, M5G 1E2, Canada

    Jason K. Lee

  7. Takeda Development Center Americas, Inc., Cambridge, MA, 02139, USA

    Jie Chen & Michelle Park

  8. Glattpark‑Opfikon, Takeda Pharmaceuticals International AG, Thurgauerstrasse 130, 8152, Zurich, Switzerland

    André Gladiator

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Keith, P.K., Cowan, J., Kanani, A. et al. Correction: Transitioning subcutaneous immunoglobulin 20% therapies in patients with primary and secondary immunodeficiencies: Canadian real‑world study. Allergy Asthma Clin Immunol 19, 54 (2023). https://doi.org/10.1186/s13223-023-00805-3

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Allergy, Asthma & Clinical Immunology

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