Efficacy and safety of infliximab and adalimumab in inflammatory bowel disease patients.

IF 4.6 2区医学 Q2 IMMUNOLOGY

Inflammopharmacology Pub Date : 2024-10-01 Epub Date: 2024-07-10 DOI:10.1007/s10787-024-01508-w

Mahmoud E Kamal, Rehab H Werida, Mahasen A Radwan, Safaa R Askar, Gamal A Omran, Marwa A El-Mohamdy, Radwa S Hagag

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引用次数: 0

Abstract

Introduction: Inflammatory bowel disease (IBD), consists of two primary types: Ulcerative Colitis (UC) and Crohn's Disease (CD). Infliximab (IFX) and Adalimumab (ADA) are frequently utilized in the management of moderate to severe cases of IBD.

Aim: This study aimed to assess the efficacy and safety of IFX and ADA in individuals diagnosed with moderate to severe IBD.

Method: This study is a prospective open-labeled randomized parallel study that included moderate to severe IBD patients treated with either IFX or ADA. A total of 56 patients participated, with 34 patients received IFX and 22 patients received ADA. Various measures, including Crohn's Disease Activity Index (CDAI), Mayo Score/ Disease Activity Index (DAI), and C-reactive protein (CRP) levels, were taken at baseline and week 14 to assess the efficacy of the treatments. In addition, the levels of drugs and sTREM-1 were measured at 14 weeks. Patient safety was monitored throughout the study period.

Results: In the group received IFX, there was a notable decrease in CDAI (P = 0.045), DAI (P = 0.026), and CRP (P = 0.023 for CD, and P = 0.021 for UC) levels. In addition, the group received ADA experienced a significant reduction in CDAI (P = 0.001), DAI (P = 0.032), and CRP (P < 0.018 for CD and P = 0.003 for UC) levels. Responders had higher drug concentrations than non-responders, notably IFX concentration was higher in responders with CD (P = 0.001) and UC (P < 0.001). ADA concentration was higher in UC (P <= 0.001) and all CD patients responded to the treatment. The same trend was observed for sTREM-1 levels in CD and UC patients (P = 0.042, and P = 0.015, respectively) in the IFX group. In UC patients treated with ADA, the level of sTREM-1 was significantly low (P = 0.002).

Conclusion: Both IFX and ADA have a good safety profile and deliver a beneficial clinical and laboratory response in moderate-severe IBD patients.

Clinical trial registration: This study is registered on ClinicalTrials.gov under the identifier NCT05291039. (You can access the study at https://clinicaltrials.gov/study/NCT05291039 (First Posted: March 22, 2022).

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英夫利昔单抗和阿达木单抗对炎症性肠病患者的疗效和安全性。

简介炎症性肠病（IBD）主要包括两种类型：溃疡性结肠炎（UC）和克罗恩病（CD）。英夫利昔单抗（IFX）和阿达木单抗（ADA）常用于治疗中重度 IBD 病例。目的：本研究旨在评估 IFX 和 ADA 对确诊为中重度 IBD 患者的疗效和安全性：本研究是一项前瞻性开放标签随机平行研究，研究对象包括接受IFX或ADA治疗的中重度IBD患者。共有56名患者参与了这项研究，其中34名患者接受了IFX治疗，22名患者接受了ADA治疗。研究人员在基线和第14周进行了各种测量，包括克罗恩病活动指数（CDAI）、梅奥评分/疾病活动指数（DAI）和C反应蛋白（CRP）水平，以评估两种疗法的疗效。此外，还在第 14 周测量了药物和 sTREM-1 的水平。在整个研究期间，对患者的安全性进行了监测：接受 IFX 治疗组的 CDAI（P = 0.045）、DAI（P = 0.026）和 CRP（CD 组 P = 0.023，UC 组 P = 0.021）水平显著下降。此外，接受 ADA 治疗组的 CDAI（P = 0.001）、DAI（P = 0.032）和 CRP（P 结论：IFX 和 ADA 均具有良好的治疗效果：IFX和ADA都具有良好的安全性，并能为中度重症IBD患者带来有益的临床和实验室反应：本研究已在ClinicalTrials.gov上注册，标识符为NCT05291039。(您可以访问 https://clinicaltrials.gov/study/NCT05291039 （首次发布时间：2022 年 3 月 22 日）。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Inflammopharmacology IMMUNOLOGYTOXICOLOGY-TOXICOLOGY

CiteScore

8.00

自引率

3.40%

发文量

200

期刊介绍： Inflammopharmacology is the official publication of the Gastrointestinal Section of the International Union of Basic and Clinical Pharmacology (IUPHAR) and the Hungarian Experimental and Clinical Pharmacology Society (HECPS). Inflammopharmacology publishes papers on all aspects of inflammation and its pharmacological control emphasizing comparisons of (a) different inflammatory states, and (b) the actions, therapeutic efficacy and safety of drugs employed in the treatment of inflammatory conditions. The comparative aspects of the types of inflammatory conditions include gastrointestinal disease (e.g. ulcerative colitis, Crohn''s disease), parasitic diseases, toxicological manifestations of the effects of drugs and environmental agents, arthritic conditions, and inflammatory effects of injury or aging on skeletal muscle. The journal has seven main interest areas: -Drug-Disease Interactions - Conditional Pharmacology - i.e. where the condition (disease or stress state) influences the therapeutic response and side (adverse) effects from anti-inflammatory drugs. Mechanisms of drug-disease and drug disease interactions and the role of different stress states -Rheumatology - particular emphasis on methods of measurement of clinical response effects of new agents, adverse effects from anti-rheumatic drugs -Gastroenterology - with particular emphasis on animal and human models, mechanisms of mucosal inflammation and ulceration and effects of novel and established anti-ulcer, anti-inflammatory agents, or antiparasitic agents -Neuro-Inflammation and Pain - model systems, pharmacology of new analgesic agents and mechanisms of neuro-inflammation and pain -Novel drugs, natural products and nutraceuticals - and their effects on inflammatory processes, especially where there are indications of novel modes action compared with conventional drugs e.g. NSAIDs -Muscle-immune interactions during inflammation [...]