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P525 The combined cell therapy and anticytokine therapy of adalimumab promotes deep remission (immunobiological and histology) of Crohn’s disease

O. Knyazev1, A. Kagramanova*1, S. Khomeriki2, A. Konoplyannikov3, K. Noskova4, N. Fadeeva5, A. Parfenov1

1Moscow Clinical Research Centre, Department of Inflammatory Bowel Disease, Moscow, Russian Federation, 2Moscow Clinical Research Centre, Department of Pathology, Moscow, Russian Federation, 3Medical Radiological Scientific Centre, Department of Stem Cells Therapy, Obninsk, Russian Federation, 4Moscow Clinical Research Centre, Department of Laboratory, Moscow, Russian Federation, 5Moscow Clinical Research Centre, Department of Inflammatory Bowel Disease, Moscow, Russian Federation

Background

The clinical efficacy of combined use of MSCs and anti-TNF-α drugs in the treatment of patients with CD has yet to be studied. The study objective was to examine the efficacy of combination therapy of mesenchymal stem cells (MSCs), bone marrow, and adalimumab (ADA) to achieve immunobiological and histological remission in patients with Crohn’ disease (CD).

Methods

In total, 48 patients with CD in the form of colitis and ileocolitis were divided into 3 groups. The first group of patients aged 19 to 58 years old (ME-29) (n = 17) received standard anti-inflammatory therapy with 5-aminosalicylic acid (5-ASA), glucocorticosteroids (GCS), and immunosuppressive (IS)+MSCs. The second group of patients with CD (n = 20) aged 20 to 68 years (ME-32) received therapy anticytokine ADA. A third group of patients with CD (n = 11) aged 20 to 62 years old (ME-28) received anticytokine therapy ADA + MSCs. Immunobiological effectiveness of the therapy was evaluated by the level faecal calprotectin (FCP), and pathomorphological assessment was evaluated by index of Geboes. Evaluation of efficacy was performed after 2, 12, and 24 months after initiation of therapy. Baseline FCP in the first group was 804.8 ± 88.8 mcg/g; in the second 848.3 ± 83.9 mcg/g (p = 0.09); and in the third - 937.5 ± 125.6 mcg/g (p = 0.006). The index of Geboes in the first group was 4.4 ± 0.2 points; 4.35 ± 0.2 points (p = 0.11) in the second; and 4.6 ± 0.3 points (p = 0.002) in the third.

Results

After 2 months, the level of the FCP in patients in first group was 88.8 ± 5.3 mcg/g; in the second, 90.6 ± 6.8 mcg/g (p = 0.001); and in the third, 68.8 ± 3.3 mcg/g (p < 0.001). The index of Geboes in the first group was 0.7 ± 0.1 points (p < 0.17); in the second, 0.66 ± 0.1 points; and in the third 0.5 ± 0.06 points (p < 0.001). After 12 months, the level of the FCP in patients in first group was 85 ± 5.0 mcg/g; in the second, 95 ± 3.5 mcg/g (p < 0.001); and in the third group 75 ± 5.0 mcg/g (p < 0.001). The index of Geboes in the first group was 0.9 ± 0.1 points; in the second, 1.1 ± 0.1 points (p < 0.001); and in the third group, 0.8 ± 0.1 points (p < 0.001). After 24 months, the average level of the FCP in patients in first group amounted to 118.0 ± 5.2 mcg/g; in the second, 116.0 ± 4.8 mcg/g (p = 0.17); and in the third group, 80.0 ± 5.0 mcg/g (p < 0.001). The index of Geboes in the first group was 1.1 ± 0.2 points; in the second, 1.1 ± 0.1 points (p = 1.0); and in the third group, 0.8 ± 0.1 points (p < 0.001).

Conclusion

The combined cell and anticytokine anti-inflammatory therapy of CD contributes significantly deeper immunobiological and histological remission CD.