J Rheumatol 2019; doi:10.3899/jrheum.180718
Recently, the sponsor became aware of data errors related to Bath Ankylosing Spondylitis Metrology Index (BASMI) and the University of California San Francisco (UCSF) Enthesitis Index. The ensuing tabular and in-text corrections are provided hereinafter.
The corrected BASMI results are reflected in excerpts from Table 1. Mean ± SD values for “BASMI, change from baseline” are updated for both the “Placebo → GOL, 2 mg/kg” and “GOL, 2 mg/kg” groups, respectively, from −0.4 ± 0.7 to −0.8 ± 1.0 and −0.4 ± 0.6 to −0.8 ± 1.0.
Efficacy at Week 52a.
The corrected UCSF Enthesitis Index (referred to simply as “enthesitis”) results are reflected in excerpts from Table 1 and within the updated text of the “Clinical efficacy” subsection of the Results section. In Table 1, the “Enthesitis” value for “n” (ie, the number of subjects evaluable for change from baseline in UCSF enthesitis index at Week 52) is updated for both the “Placebo → GOL, 2 mg/kg” and “GOL, 2 mg/kg” groups, respectively, from 85 to 90 and 87 to 89. The mean ± SD values for enthesitis “Change from baseline” are updated for both the “Placebo → GOL, 2 mg/kg” and “GOL, 2 mg/kg” groups, respectively, from −3.6 ± 4.0 to −3.6 ± 3.9 and from −3.8 ± 5.0 to −3.8 ± 4.6.
The corrected proportions of patients with enthesitis at baseline and a UCSF Enthesitis Index score of 0 (referred to as resolution of enthesitis) are in the second paragraph of the “Clinical efficacy” subsection of the Results section. At Week 16, the proportion of patients in the golimumab group who had an enthesitis score of 0 has been updated from 43.7% to 41.6% and the proportion of patients who had an enthesitis score of 0 in the placebo group has been updated from 14.1% to 12.2%. The P value comparing the difference between the 2 groups remained unchanged (P < 0.001). The proportion of patients who had resolution of enthesitis at Week 28 after placebo crossover to golimumab has been updated from 47.1% to 42.7% in the golimumab group and from 42.4% to 35.6% in the placebo crossover group, and the proportion of patients who had resolution of enthesitis at Week 52 has been updated from 59.8% to 57.3% in the golimumab group and from 42.4% to 41.1% in the placebo crossover group.
These changes are minor and do not affect our interpretation of the data or conclusions regarding the efficacy of golimumab in ankylosing spondylitis. The authors apologize for these error
This correction applies to the April 15 2019 First Release and October 2019 print issue. The online version has been corrected.
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