Опыт применения цертолизумаба пэгола в лечении пациентов с болезнью Крона с перианальными поражениями
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Материалы и методы. В исследование включены 20 пациентов с БК с перианальными поражениями в виде свищей. До начала консервативной терапии 7 больным проведены дренирование гнойных затеков и установка латексной лигатуры. В ходе исследования все пациенты получали терапию препаратом цертолизумаба пэгол (ЦП) в течение года. На момент начала лечения и через 12 мес у пациентов проводилась оценка индекса активности БК, качества жизни по опросникам IBDQ, индекса активности перианальной болезни Крона (ИАПБК).
Результаты. Через год от начала терапии ЦП клиническая ремиссия достигнута у 8 (40%) пациентов, клинико-эндоскопическая ремиссия – в 7 (35%) наблюдениях, облитерация свищей прямой кишки – у 6 (30%) пациентов. Также отмечено снижение ИАПБК: средний показатель составил 3,6 балла по сравнению с 9,3 балла (р<0,05). Установлено повышение качества жизни пациентов: средний показатель качества жизни составил 182,2 балла по сравнению со 156 баллами (р<0,05).
Заключение. Настоящее исследование показало, что терапия ЦП эффективна в отношении БК с перианальными поражениями.
Ключевые слова: болезнь Крона, перианальные поражения, цертолизумаба пэгол.
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Aim. To assess the effectiveness of conservative treatment of Crohn's disease (CD) with perianal lesions.
Materials and methods. The study included 20 patients with CD with perianal fistulae. Prior to the start of conservative therapy, 7 patients underwent fistulae drainage with setton placement. During the study, all patients received therapy with certolizumab pegol (CP) for a year. At the time of treatment initiation and after 12 months, the CD activity index, the quality of life according to IBDQ questionnaires and the perianal Crohn's disease activity index (PCDAI) were assessed.
Results. After a year of CP therapy, clinical remission was achieved in 8 (40%) patients, endoscopic remission in 7 (35%) patients, fistula closure in 6 (30%) patients. There was also a decrease in the PCDAI with the average score 3.6 points compared to 9.3 points (p˂0.05) prior to the treatment. An improvement in the quality of life of patients was also established, the average quality of life index was 182,2 points compared to 156,0 points (p˂0.05) prior to the treatment.
Conclusion. This study showed that CP therapy is effective in treatment of CD with perianal lesions.
Keywords: Crohn’s disease, perianal lesions, certolizumab pegol.
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2. Schwartz DA, Loftus EV Jr, Tremaine WJ, et al. The history of fistulizing Crohn’s disease of Olmsted Country, Minnesota. Gastroenterology. 2002;122:875-80. doi: 10.1053/gast.2002.32362
3. Kamm MA, Ng SC. Perianal fistulizing Crohn’s disease: a call to action. Clin Gastroenterol Hepatol. 2008;6:7-10. doi: 10.1016/j.cgh. 2007.10.010
4. [Nikulina IV, Zlatkina AR, Belousova EA, et al. Assessment of clinical and epidemiological indicators of inflammatory bowel diseases in the Moscow Region. Rossiiskii Zhurnal Gastroenterologii, Gepatologii, Koloproktologii. 1997;(2):67-71 (In Russ.)].
5. Sandborn W, Fazio V, Feagan B, et al. AGA technical review on perianal Crohn’s disease. Gastroenterology. 2003;125(5):1508-30.
doi: 10.1016/j.gastro.2003.08.025
6. Neilsen OH, Rogler G, Hahnloser D, Thomsen OO. Diagnosis and management of fistulizing Crohn’s disease. Nat Clin Pract Gastroenterol Hepatol. 2009;6:92-106. doi: 10.1038/ncpgasthep1340
7. [Shelygin YuA, Zharkov EE, Orlova LP, et al. Long-term results of excision of anal fissure in combination with lateral subcutaneous sphincterotomy. In: Aktual'nye problemy koloproktologii [Actual problems of coloproctology]. Moscow; 2005. P. 141-2 (In Russ.)].
8. Judge TA, Lichtenstein GR. Treatment of fistulizing Crohn’s disease. Gastroenterol Clin North Аm. 2004;33:421-54. doi: 10.1016/j.gtc. 2004.03.002
9. Wilkins T, Jarvis К, Patel J. Diagnosis and management of Crohn’s disease. Am Family Phys. 2011;84:1365-75.
10. Thia KT, Mahadevan U, Feagan BG, et al. Ciprofloxacin or metronidazole for the treatment of perianal fistulas in patients with Crohn’s disease: a randomized, double-blind, placebo-controlled pilot study. Inflam Bowel Dis. 2009;15:17-24. doi: 10.1002/ibd.20608
11. Person DC, May GR, Fick GH, Sutherland LR. Azathioprine and 6-mercaptopurine in Crohn’s disease. A meta-analysis. Ann Inter Med. 1995;123:132-42. doi: 10.7326/0003-4819-123-2-199507150-00009
12. Behm BW, Bickston SJ. Tumor necrosis factor-alpha antibody for maintenance of remission in Crohn’s disease. Cochrane Database Syst Rev. 2008 Jan 23;(1):CD006893. doi: 10.1002/14651858.CD006893
13. Peyrin-Biroulet L, Deltenre P, de Suray N, et al. Efficacy and safety of tumor necrosis factor antagonists in Crohn’s disease meta-analysis of placebo-controlled trials. Clin Gastroenterol Hepatol. 2008;6:644-53. doi: 10.1016/j.cgh.2008.03.014
14. Schreiber S, Lawrance I, Thomson O, et al. Randomised clinical trial: certolizumab pegol for fistulas in Crohn’s disease – subgroup results from a placebo-controlled study. Aliment Pharmacol Ther. 2011 Jan;33(2):185-93. doi: 10.1111/j.1365-2036.2010.04509.x
15. Vavricka S, Schoepfer A, Bansky G, et al. Efficacy and safety of Certolizumab pegol in an unselected Crohn’s disease opulation: 26-week data of the FACTS II survey. Inflamm Bowel Dis. 2011;17(7): 1530-9. doi: 10.1002/ibd.21521
16. Lennard-Jons J. Classification of inflammatory bowel disease. Scand J Gastroenerol. 2007;42:576-82.
17. Pikarsky A, Gervaz Р, Wexner S. Perianal Crohn disease: a new scoring system tevaluate and predict outcome of surgical intervention. Arch Surg. 2002;137:774-8. doi: 10.1001/archsurg.137.7.774
ФГБУ «Государственный научный центр колопроктологии им. А.Н. Рыжих» Минздрава России, Москва, Россия
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I.L. Khalif, B.A. Nanaeva, M.V. Shapina, A.V. Vardanyan
A.N. Ryzhikh State Scientific Centre of Coloproctology, Ministry of Health of Russia, Moscow, Russia