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Allergy, Asthma, and Clinical Immunology : Official Journal of the Canadian Society of Allergy and Clinical Immunology logoLink to Allergy, Asthma, and Clinical Immunology : Official Journal of the Canadian Society of Allergy and Clinical Immunology
. 2023 Jun 23;19:54. doi: 10.1186/s13223-023-00805-3

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

Paul K Keith 1, Juthaporn Cowan 2, Amin Kanani 3, Harold Kim 1,4, Gina Lacuesta 5, Jason K Lee 6, Jie Chen 7, Michelle Park 7, André Gladiator 8,
PMCID: PMC10290310  PMID: 37353830

Correction: Allergy, Asthma & Clinical Immunology (2022) 18:70 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.

Footnotes

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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. doi: 10.1186/s13223-022-00709-8. [DOI] [PMC free article] [PubMed] [Google Scholar]

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