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P432. Mesenchymal stromal cells did not increase the risk of infectious complications in patients with inflammatory bowel disease compared to treatment with infliximab

O. Knyazev1, I. Ruchkina1, A. Parfenov1, Z. Mikhailova1, P. Shcherbakov1, L. Lazebnik2, 1Central Research Institute of Gastroenterology, Moscow, Russian Federation, 2Clinical Hospital 33 of Moscow City, Moscow, Russian Federation

Background

In any immunosuppressive therapy, the question always arises whether this therapy increases the risk of infectious complications. The most serious problem in modern medicine have severe infectious complications of anticytokine therapy in patients with inflammatory bowel disease (IBD), having acquired immune deficiency. Accumulated to date show that in spite of the pronounced effect on immunnosupressivny alloreaktivnye and mitogen-provoked reactions, mesenchymal stromal cells (MSC) did not inhibit the activity of immune cells directed against infectious agents.

Objective: To compare the risk of infectious complications in patients treated with anticytokine therapy with infliximab (IFX) and cell therapy using culture MSC.

Methods

60 patients with ulcerative colitis (UC) and Crohn's disease (CD) at the age of 19 to 58 years (Me-29), who received a comprehensive anti-inflammatory therapy with culture MSCs, which were introduced under the scheme 0–1-26. 59 patients with UC and CD in age from 20 to 62 years (Me-38) received induction IFX therapy 0–2-6 and maintenance therapy after 8 weeks for 12 months. The observation time for both groups of patients was 64 weeks.

Results

Frequency of severe infection (SI) among patients treated with MSCs was 1.6% (1 case of pneumonia). Frequency of severe SI among patients receiving IFX was 15.6% (6 cases). For individual forms that look as follows: pneumonia – 3 cases (5.7%), throat abscess – 1 case (1.9%), lung abscess – 1 case (1.9%), pleural effusion – a case of (1.9%). The frequency of exacerbations of chronic inflammatory disease and mild SI was 10.0% and 33.9% respectively (p < 0.05). The risk of developing tuberculosis, and activation of latent tuberculosis infection was higher in patients who received IFX, than in patients receiving cell therapy 0.03 (95% CI 0.17–0.72), (p = 0.0007, x2–13.4). The relative risk of developing opportunistic infections and infectious complications in patients with IBD receiving biological therapy MSCs compared with anticytokine therapy was 0.3 (95% CI 0.13–0.68), OR-0, 22 (95% CI 0.07–0.64), (p = 0.003, x2–8.6).

Conclusion

The frequency of infectious complications, acute exacerbations of chronic inflammatory diseases, the risks of opportunistic infection and activation of latent tuberculosis infection was higher in patients who received IFX, than in patients receiving therapy of MSC.