A Case of Disseminated Tuberculosis in a Child with Crohn's Disease After Treatment with Azathioprine, Adalimumab and Ustekinumab

Renoux, M; Dutronc, Sarah; Kollen, Laura; Theret, Sarah; Moreau, Johan

doi:10.1016/j.arbr.2020.11.018

Cited by 2 publications

(1 citation statement)

References 8 publications

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“…Ustekinumab was started without a new chest X-ray or a repeat interferon gamma release assays test because the child was switched from another biologic. [40] Also, another case described drug-induced lung disease after starting Ustekinumab; the child complained of shortness of breath, chest pain, and cough. [41] Adult clinical trials are expanding the therapeutic options for IBD patients, but the time lag between adult and pediatric drug approval results in significant off-label use due to a lack of knowledge about optimal pediatric dosing regimens.…”

Section: Discussionmentioning

confidence: 99%

Ustekinumab for steroid-refractory pancolitis in a biologically naive child: A case report and literature review

Alhalabi

2023

Medicine

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Ustekinumab is not recommended for the treatment of children with inflammatory bowel disease, but its off-label use is increasing despite a lack of pediatric pharmacokinetic data. The purpose of this review is to evaluate the therapeutic effects of Ustekinumab on children with inflammatory bowel disease and to recommend the best treatment regimen. Ustekinumab was the first biological treatment for a 10-year-old Syrian boy with steroid-refractory pancolitis who weighed 34 kg. A 260 mg/kg (~6 mg/kg) intravenous dose was followed by 90 mg of subcutaneous Ustekinumab at week 8 (induction). The patient was supposed to receive the first maintenance dose after twelve weeks, but after ten weeks, he developed acute severe ulcerative colitis which was managed according to treatment guidelines, except receiving 90 mg of subcutaneous Ustekinumab when he was discharged. The maintenance dose of 90 mg subcutaneous Ustekinumab was intensified to every 8 weeks. Throughout the treatment period, he achieved and maintained clinical remission. In pediatric inflammatory bowel disease, a dose of intravenous ~6 mg/kg of Ustekinumab is a common induction regimen, while children weighing < 40 kg may require a dose of 9 mg/kg. For maintenance, children may require 90 mg of subcutaneous Ustekinumab every 8 weeks. The outcome of this case report is interesting with improved clinical remission and highlighting the expansion of clinical trials on Ustekinumab for children.Abbreviations: anti-TNF = necrosis factor antagonists, IBD = inflammatory bowel disease, PUCAI = pediatric ulcerative colitis activity index, SC = subcutaneous, UC = ulcerative colitis.

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Section: Discussionmentioning

confidence: 99%

Ustekinumab for steroid-refractory pancolitis in a biologically naive child: A case report and literature review

Alhalabi

2023

Medicine

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Hepatitis B Virus Reactivation and Mycobacterial Infections Associated With Ustekinumab: A Retrospective Study of an International Pharmacovigilance Database

Wang

Geng²,

Zhang³

et al. 2022

Front. Pharmacol.

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Background: Reports were recently published on hepatitis B virus reactivation (HBVr), tuberculosis (TB), and atypical mycobacterial infection (AMI) in patients with ustekinumab treatment. However, the literature is limited to case reports and series. The study was aimed to investigate their relationships by using an extensive population-based database.Methods: Using the United States Food and Drug Administration Adverse Event Reporting System (FAERS) database, we collected all cases of HBVr, TB, and AMI between 1 January 2009 and 30 September 2021, for ustekinumab and other drugs. Disproportionality was analyzed using the reporting odds ratio (ROR), which was considered significant when the lower limit of the 95% confidence interval (95% CI) was >1.Results: Of the 18,760,438 adverse cases reported to FAERS for all drugs, 56,581 cases had been exposed to ustekinumab. Adverse events of HBVr, TB, and AMI were reported in 21, 210, and 20 cases, respectively. The ROR for HBVr with ustekinumab was 2.33 (95% CI, 1.52–3.58), for TB was 5.09 (95% CI, 4.44–5.84), and for AMI was 2.09 (95% CI, 1.35–3.24). In the ustekinumab exposure group, no death occurred in patients with HBVr, but one patient experienced life-threatening liver failure. For those with TB, 24 cases experienced hospitalization and 2 deaths occurred. No death occurred in patients with AMI but eight experienced hospitalization.Conclusion: We identified positive signals between ustekinumab exposure and HBVr, TB, and AMI in FAERS. Although these complications are rare, clinicians using ustekinumab should be aware of the risks.

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A Case of Disseminated Tuberculosis in a Child with Crohn's Disease After Treatment with Azathioprine, Adalimumab and Ustekinumab

Cited by 2 publications

References 8 publications

Ustekinumab for steroid-refractory pancolitis in a biologically naive child: A case report and literature review

Ustekinumab for steroid-refractory pancolitis in a biologically naive child: A case report and literature review

Hepatitis B Virus Reactivation and Mycobacterial Infections Associated With Ustekinumab: A Retrospective Study of an International Pharmacovigilance Database

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