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Randomized Controlled Trial
. 2024 Oct;32(5):3259-3269.
doi: 10.1007/s10787-024-01508-w. Epub 2024 Jul 10.

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

Mahmoud E Kamal  1 , Rehab H Werida  2 , Mahasen A Radwan  3 , Safaa R Askar  4 , Gamal A Omran  5 , Marwa A El-Mohamdy  6 , Radwa S Hagag  3
Affiliations
Randomized Controlled Trial

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

Mahmoud E Kamal et al. Inflammopharmacology. 2024 Oct.

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).

Keywords: Adalimumab; CDAI; DAI; Efficacy; Inflammatory bowel disease; Infliximab; Safety; sTREM-1.

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Conflict of interest statement

No conflicts of interest were declared by the authors.

Figures

Fig. 1
Fig. 1
Flow diagram for the IBD patients included in the study. UC ulcerative colitis, CD Crohn’s disease, TB Tuberculosis
Fig. 2
Fig. 2
Number of CD and UC patients who showed a clinical response for IFX and ADA according to CR-70, CR-100, and DAI. CR clinical response, DAI Mayo Score/Disease Activity Index, IFX Infliximab, ADA Adalimumab
Fig. 3
Fig. 3
Levels of IFX in responsive and non-responsive CD patients
Fig. 4
Fig. 4
Levels of IFX in responsive and non-responsive UC patients
Fig. 5
Fig. 5
Levels of ADA in responsive and non-responsive UC patients
See this image and copyright information in PMC

References

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