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Letter: anti‐TNF in steroid‐dependent ulcerative colitis ‐ are the available data enough?

医学 溃疡性结肠炎 英夫利昔单抗 阿达木单抗 不利影响 内科学 肿瘤坏死因子α 结肠炎 胃肠病学 疾病
作者
Manuel Barreiro‐de Acosta,Javier P. Gisbert
出处
期刊:Alimentary Pharmacology & Therapeutics [Wiley]
卷期号:44 (1): 102-102
标识
DOI:10.1111/apt.13646
摘要

We read with interest the article by Singh et al.1 This is a very interesting study, with a well-structured design, which includes a high number of patients with ulcerative colitis (UC). The results confirm that both drugs, infliximab (IFX) and adalimumab (ADA), have similar efficacy and safety, except that IFX-treated patients may have lower glucocorticosteroid use than ADA-treated ones. Nevertheless, we think that we cannot extrapolate from this result a difference in efficacy in glucocorticosteroid-dependent patients. Glucocorticosteroid-dependency is common in UC, being described in more than 20% of all patients.2 It is well known that glucocorticosteroid-dependency is associated with important side effects and complications like diabetes or osteoporosis, and this is the main reason why glucocorticosteroids should be avoided by these patients. According to clinical guidelines, first-line drugs for glucocorticosteroid-dependent UC are thiopurines,3 but despite the use of these drugs, an important number of patients are unable to withdraw from glucocorticosteroids, and more than 15% have adverse events related to these drugs.4 In these patients, the next therapeutic option should be anti-tumour necrosis factor (TNF) drugs. However, anti-TNF data in steroid-dependent UC patients are not consistent. Data from the ACT and ULTRA trials refer only to the need for glucocorticosteroids in milligrams, or the number of patients that need these drugs during follow-up.5, 6 However, the number of patients with defined glucocorticosteroid-dependency criteria is not clearly stated in these important trials. Specific data regarding glucocorticosteroid-dependent UC have only been obtained from open-label studies. In accordance with the Singh et al. study, predominant data obtained from an IFX series has shown a percentage of glucocorticosteroid-free remission in excess of 60%.7 In a prospective open-label study performed by our group we observed, after 2 years of IFX treatment, more than 50% of patients with glucocorticosteroid-free remission and mucosal healing.8 ADA studies in glucocorticosteroid-dependent UC are scarce, with most of them published only as abstracts or retrospective. In summary, we think that glucocorticosteroid-dependency in UC is a real and important problem, and although anti-TNF agents are effective drugs, we believe more specific trials with well-defined inclusion criteria and clear endpoints are necessary in order to choose the most effective drug. Declaration of personal and funding interests: None.

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