J Rheumatol 2018; doi:10.3899/jrheum.170487
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 that occurred during the study. The ensuing tabular and in-text corrections are provided hereinafter.
Updates related to BASMI are made in the third paragraph of the “Clinical efficacy and HRQOL” subsection within the Results section, Table 1, Table 2, and Appendix 1.
The corrected BASMI results are reflected in excerpts from:
Table 1: Mean ± SD values for “BASMI” are updated for both the “Placebo” and “Golimumab, 2 mg/kg” groups, respectively, from 5.0 ± 0.8 to 4.7 ± 1.6 and from 5.0 ± 0.9 to 4.7 ± 1.8.
Table 2: Mean ± SD values for “Change from baseline in BASMI (linear), n (mean ± SD)” are updated for both the “Placebo” and “Golimumab, 2 mg/kg” groups, respectively, from −0.1 ± 0.5 to −0.2 ± 0.7 and from −0.4 ± 0.6 to −0.7 ± 0.9.
Appendix 1: Values for “Change from baseline in BASMI (linear), mean ± SD” are updated for both the “Placebo” and “Golimumab, 2 mg/kg” groups, respectively, from −0.02 ± 0.55 to 0.21 ± 1.07 and from −0.34 ± 0.36 to −0.30 ± 0.48.
In the “Clinical efficacy and HRQOL” subsection, the third paragraph changes from “The mean improvement from baseline in BASMI score was also greater in the GOL group compared with PBO at Week 16 (−0.4 vs −0.1; p = 0.001). At Week 28, the mean change from baseline in BASMI score for patients in the PBO group (−0.3), who began receiving GOL at Week 16, improved nearly to that for patients in the GOL group (−0.4). Among patients with enthesitis at baseline, those in the GOL group had greater mean changes from baseline in enthesitis score when compared with the PBO group at weeks 2 (−2.3 vs −0.7) and 16 (−3.5 vs −1.2; p < 0.001 for both).” to “The mean improvement from baseline in BASMI score was also greater in the GOL group compared with PBO at Week 16 (−0.7 vs −0.2; p < 0.001). At Week 28, the mean change from baseline in BASMI score for patients in the PBO group (−0.6), who began receiving GOL at Week 16, improved nearly to that for patients in the GOL group (−0.8). Among patients with enthesitis at baseline, those in the GOL group had greater mean changes from baseline in enthesitis score when compared with the PBO group at weeks 2 (−2.1 vs −0.6) and 16 (−3.4 vs −1.2; p < 0.001 for both).”
Updated excerpts from Table 1, Table 2, and Appendix 1 are provided.
These changes are minor and do not affect our interpretation of the data or conclusions regarding the efficacy of intravenous golimumab in ankylosing spondylitis. The authors apologize for these errors.
This correction applies to the December 15 2017 First Release and March 2018 print issue. The online version has been corrected.
Baseline demographic and disease characteristics. Data are presented as mean ± SD.
Clinical efficacy at Week 16.
APPENDIX 1. Efficacy at Week 16 for patients with complete ankylosis at baseline.
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