Efficacy of a modern treat-to-target strategy in patients with Crohn’s disease: Results of a 52-week clinical observation
Abstract. Key goals in the treatment of inflammatory bowel diseases today include not only control of symptoms but also achieving endoscopic healing of the intestinal mucosa and normalizing laboratory markers of inflammation. The aim: to prospectively evaluate the dynamics of clinical symptoms, laboratory markers, and endoscopic activity in patients with Crohn’s disease (CD) over 52 weeks of observation, also to find the correlation between the nature of performing therapy and achievement of remission in accordance with the treat-to-target strategy. Material and methods. The study included 66 patients with CD. Clinical activity was assessed using the PRO2 scale (stool frequency, abdominal pain). Laboratory examinations included complete blood counts and biochemical blood tests with calculation of hematological phlogosis index. Endoscopic activity was assessed using SES-CD scale. Clinical observation was performed at checkpoints of 0, 3, 6, and 12 months. Results. By the 12th month of observation, the participants showed a statistically significant decrease in the mean stool frequency score (from 1.74 ± 0.91 to 1.05 ± 0.83; p = 0.008) and abdominal pain (from 1.86 ± 0.87 to 1.05 ± 0.87; p = 0.001). The proportion of patients with normal stool frequency reached 74.1%, with a complete absence of pain – 31.0% (a 4-fold increase comparatively to the baseline level). There was a decrease in the level of C-reactive protein (CRP) (from a peak of 24.8 ± 6.6 to 10.9 ± 3.8 mg/L), leukocytes, neutrophils, platelets and fibrinogen (p <0.05), as well as an increase inhemoglobin content (p = 0.02). The proportion of patients with endoscopic remission increased from 1.5 to 10.3% (p = 0.02). A strong correlation was found between CRP (ρ = 0.892; p < 0.001) and platelet (ρ = 0.721; p = 0.008) levels and the degree of endoscopic CD activity. Patients also experienced a sharp reduction in glucocorticoid use (from 45.5% to 5.2%; p <0.001) and an increase in the proportion of genetically engineered biological drugs in therapy (from 40.9 to 70.1%; p <0.001), with a change in their structure toward agents with alternative mechanisms of action (different from TNF-α inhibition). Conclusion. Treat-to-target strategy in patients with Crohn’s disease demonstrates high efficacy, resulting in regression of clinical symptoms, normalization of laboratory markers of inflammation, and improvement of the endoscopic picture of the disease. The identified correlations support the use of CRP and hemoglobin levels as surrogate markers of endoscopic healing in real-world clinical practice.M.V. Zlobin, D.I. Abdulganieva, N.A. Dubova
Keywords
inflammatory bowel disease
Crohn’s disease
treat-to-target strategy
STRIDE-II
genetically engineered biological drugs
glucocorticoids
endoscopic remission
C-reactive protein
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About the Authors
Maksim V. Zlobin, MD, head of the Department of rheumatology, N.A. Semashko Nizhny Novgorod Regional Clinical Hospital, Nizhny Novgorod, Russian Federation.E-mail: zlomax@list.ru
ORCID: https://orcid.org/0000-0002-8200-3293
Diana I. Abdulganieva, MD, Dr. Sci. (Medicine), professor, head of the Department of hospital therapy, Kazan State Medical University, Kazan, Russian Federation.
E-mail: diana-s@mail.ru
ORCID: https://orcid.org/0000-0001-7069-2725. Scopus ID: 39161040600 eLibrary SPIN: 6676-4270
Natalya A. Dubova, MD, deputy chief physician, N.A. Semashko Nizhny Novgorod Regional Clinical Hospital, Nizhny Novgorod, Russian Federation.
E-mail: n.a.dubova@mail.ru
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