Tanaka Y, Bae S, Bass D, et al. Long-term open-label continuation study of the safety and efficacy of belimumab for up to 7 years in patients with systemic lupus erythematosus from Japan and South Korea. RMD Open 2021;7:e001629. doi: 10.1136/rmdopen-2021-001629.

Following a re-review of belimumab data by the GSK Japan Local Operating Company, it was discovered that 21 study drug–related events from one of the parent studies (BEL112341) were incorrectly omitted from study drug–related data reported in this publication of the open-label, long-term BEL114333 extension study. A total of 7 patients who were already included in the number of patients with≥1 drug-related adverse event accounted for 13 of the 21 omitted study drug–related events, and 5 additional patients accounted for 8 of the 21 omitted study drug–related events. This omission was due to study drug–relatedness for the two parent studies, BEL113750 and BEL112341, being collected differently; the programming rules for the BEL114333 did not account for how data on adverse events’ relationship to study drug were collected in the parent study BEL112341. In the parent BEL112341 study, the options of relatedness to the study drug included ‘Not Related’, ‘Probably Not Related’, ‘Possibly Related’, Probably Related’ and ‘Definitely Related’. For the parent BEL113750 study, these options were ‘Yes’ and ‘No’. When the drug-related events were evaluated for the current publication of the open-label, long-term BEL114333 extension study, the same programming rules of ‘Yes’/‘No’ options for identifying these events were applied for both BEL112341 and BEL113750 parent studies, resulting in ‘Possibly Related’, Probably Related’ and ‘Definitely Related’ events from the parent study BEL112341 being reported as not related. This inadvertently resulted in the incorrect derivation of study drug–related events in the integrated BEL114333 study for 12 patients from the parent BEL112341 study. This issue has only impacted study drug–related adverse events data reported in the current publication. The following corrections have been made in the attached PDF of the published article:

1. In paragraph 4 under the safety section, the overall proportion of patients experiencing treatment-emergent adverse events that the investigator considered to be at least possibly related to belimumab treatment was corrected from 57.0% (81/142) to 60.6% (86/142).

2. In the same paragraph, for the treatment-related adverse events with>5% incidence at any time post first dose of belimumab, the proportion of patients experiencing nasopharyngitis was changed from 15.5% to 16.9% and herpes zoster from 8.5% to 9.9%.

3. Some safety data for treatment-related adverse events in tables 2 and 3 have been updated.