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Chamberlain C, Colman PJ, Ranger AM, et al. Repeated administration of dapirolizumab pegol in a randomised phase I study is well tolerated and accompanied by improvements in several composite measures of systemic lupus erythematosus disease activity and changes in whole blood transcriptomic profiles. Ann of Rheum Dis 2017;77:1837-44.
Since publishing the above article, an error in the programmatic analysis of the renal component of the exploratory BILAG endpoint was identified. Correction of this error results in the following updates to the reported BILAG, BICLA and type I interferon-response genes RNA transcript data. These updates see a small increase in the number of patients treated with dapirolizumab pegol achieving a clinical response, and in no way change our interpretation of these exploratory endpoints.
In Table 1 (Baseline patient demographics and characteristics), baseline BILAG median (range) total scores are corrected from 10.0 (2–21) to 10.0 (2–24) for placebo and from 13.0 (2–21) to 13.0 (2–24) for dapirolizumab pegol. The number of patients in the dapirolizumab pegol group with at least 1 BILAG Grade B is updated from 12 (75.0%) to 13 (81.3%).
The corrected BILAG analysis identified one additional BICLA responder. The BICLA responder rate in the dapirolizumab pegol group is revised from 5/11 (45.5%) to 6/12 (50.0%) (page 5, paragraph 1).
Data for the mean fold change in RNA transcript levels for the additional BICLA responder are added to Figure 4 as shown below. This does not alter the conclusions in the paper.
During this process an additional error was also identified. One patient who received concomitant systemic oral corticosteroids for ‘arthritis’ rather than ‘SLE’ was mistakenly omitted from Table 1. The number of patients receiving concomitant corticosteroids in Table 1 is updated from 14 (87.5%) to 15 (93.8%).
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