Corrigendum: Ustekinumab is effective and safe for ulcerative colitis through 2 years of maintenance therapy (Aliment Pharmacol Ther., (2020), 52, 11-12, (1658-1675), 10.1111/apt.16119)

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Autores
Categoría Estudio primario
RevistaAlimentary Pharmacology and Therapeutics
Año 2021
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In the article entitled “Ustekinumab is effective and safe for ulcerative colitis through 2 years of maintenance therapy” by Panaccione et al,1 the authors have identified the following three errors as listed below. Although these errors do not change the overall study conclusions, they may impact the interpretation of some of the results presented in the paper. In Table 2, the maintenance baseline values shown for Mayo score are actually the long-term extension baseline values which already appear in Supplemental Table S1. The correct maintenance baseline values are shown below. Also, in Table 2 the second column header should read “Ustekinumab 90 mg q12w” as shown below. (Table presented.) Figure 6 incorrectly summarised the numbers of patients with adverse events (or specific adverse event category) per 100 years of exposure instead of the numbers of adverse events (or specific adverse event category) per 100 years of exposure for the second year results. The corrected figure showing the numbers of events per 100 years of exposure for the second year and footnotes is shown below. 6 FIGURE (Figure presented.) All adverse events (A) and key safety events (B) during ustekinumab exposure†,‡,§,¶,††. †Includes (1) data from Week 44 through Week 96, or up to the dose adjustment if patients had a dose adjustment during the long-term extension, for patients who were in clinical response to ustekinumab IV induction dosing and were randomised to placebo SC on entry into the maintenance study; and (2) data from Week 44 through Week 96 for patients who were in clinical response to placebo IV induction dosing and received placebo SC on entry into the maintenance study. ‡Includes data from Week 44 through Week 96, or up to the dose adjustment if patients had a dose adjustment during the long-term extension for patients who were in clinical response to ustekinumab IV induction dosing and were randomised to ustekinumab 90 mg SC q12w on entry into the maintenance study. §Includes: (1) Patients who were in clinical response to ustekinumab IV induction dosing and were randomised to receive ustekinumab 90 mg SC q8w on entry into the maintenance study, with data from Week 44 through Week 96; (2) Patients who were in clinical response to ustekinumab IV induction dosing, randomised to receive placebo SC or ustekinumab 90 mg SC q12w on entry into the maintenance study, and had a dose adjustment to ustekinumab 90 mg SC q8w, with data from the time of dose adjustment onward; (3) Patients who were not in clinical response to ustekinumab at induction Week 8 but were in clinical response at induction Week 16 after a SC administration of ustekinumab at induction Week 8 and received ustekinumab 90 mg SC q8w on entry into the maintenance study, with data from Week 44 through Week 96. ¶Confidence intervals based on an exact method assuming that the observed number of events follows a Poisson distribution. ††Infection as assessed by the investigator In Supplemental Figure S5, the number of ustekinumab-treated patients with calprotectin data summarised over time should be as shown in the following corrected figure: (Figure presented.) Supplemental Figure S5. Change from maintenance baseline in fecal calprotectin concentrations from Week 44 through Week 92; patients randomized to ustekinumab maintenance therapy and treated in the long-term extension†, ‡, § The authors apologise for these errors.
Epistemonikos ID: 9541b1947f1d3a4bc2cc3132f385da84cecdea2d
First added on: Mar 23, 2022