Evaluation of the efficacy and safety of the combined use of 5-aminosalicylic acid and genetically engineered biological drugs in patients with moderate ulcerative colitis
Abstract. Currently, there is no sufficient data to determine the indications for continuing 5-aminosalicylic acid (5-ASA) therapy in patients who have been prescribed genetically engineered biological drugs (GEBDs) due to their inefficiency. Currently, 60–80% of patients continue to receive 5-ASA concomitantly with GEBDs, despite previously documented inefficiency of 5-ASA monotherapy. Since the treatment of inflammatory bowel diseases is associated with high costs, there is a significant need to reduce unnecessary costs in the treatment of patients with ulcerative colitis (UC) and Crohn’s disease. The aim: to study the efficacy and safety of the combined use of 5-ASA and GEBDs in patients with moderate UC. Material and methods. For the study, four groups of patients were formed depending on the therapy administered: Group 1 – 68 (26.6%) biologic-naive patients with UC who received combination therapy with infliximab (INFL) and 5-ASA; Group 2 – 60 (23.4%) biologic-naive patients with UC who received monotherapy with INFL without 5-ASA; Group 3 included 73 (28.5%) patients with UC who had previously received GEBDs before receiving IFNL therapy and were continuing to use 5-ASA; Group 4 included 55 (21.5%) patients with UC who had used GEBDs before receiving IFNL therapy and were not receiving 5-ASA. The secondary endpoint was colonic mucosal (CM) healing with a Mayo score of 0. Results. When comparing groups 1 and 4 of UC patients, we found that in bionaive and non-bionaive patients, the probability of CM healing with a combination of GEBDs (INFL) and 5-ASA drugs was higher than with therapy without 5-ASA (OR 9.402; 95% CI: 4.111–21.499; χ2 = 31.389; p <0.001), as well as when comparing groups 2 and 4 (OR 5.281; 95% CI: 2.358–11.831; χ2 = 17.325; p <0.001). Conclusion. To achieve colonic mucosal healing (Mayo index = 0 points) in patients with UC previously treated with TNF-α inhibitors, a combination of biologic agents and 5-ASA preparations is advisable.O.V. Knyazev, M.A. Priymak, A.V. Kagramanova, A.A. Lishchinskaya, N.A. Fadeeva, A.N. Demchenko
Keywords
ulcerative colitis
colonic mucosal healing
5-aminosalicylic acid preparations
genetically engineered biological drugs
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About the Authors
Oleg V. Knyazev, MD, Dr. Sci. (Medicine), head of the Department of intestinal pathology, A.S. Loginov Moscow Clinical Scientific Center, head of the Moscow State Center of Gastroenterology, Moscow, Russian Federation.E-mail: oleg7@bk.ru
ORCID: https://orcid.org/0000-0001-7250-0977. Scopus ID: 36164337800. eLibrary SPIN: 3268-0360
Maxim A. Priymak, MD, deputy chief physician for medical affairs, A.S. Loginov Moscow Clinical Scientific Center, Moscow, Russian Federation.
E-mail: m.priymak@mknc.ru
ORCID: https://orcid.org/0000-0003-4984-9526. eLibrary SPIN: 3090-7083
Anna V. Kagramanova, MD, PhD (Medicine), head of the Department of intestinal pathology, A.S. Loginov Moscow Clinical Scientific Center, Moscow, Russian Federation.
E-mail: a.kagramanova@mknc.ru
ORCID: https://orcid.org/0000-0002-3818-6205. eLibrary SPIN: 4086-6745
Albina A. Lishchinskaya, MD, PhD (Medicine), senior researcher at the Department of intestinal pathology, A.S. Loginov Moscow Clinical Scientific Center, Moscow, Russian Federation.
E-mail: lalbina@inbox.ru
ORCID: https://orcid.org/0000-0001-7891-2702. eLibrary SPIN: 9369-9674
Nina A. Fadeeva, MD, PhD (Medicine), head of the Department of gastroenterology, A.S. Loginov Moscow Clinical Scientific Center; associate professor of the Department of gastroenterology, Russian Medical Academy of Continuous Professional Education; chief freelance gastroenterologist of the North-Western Administrative District (Department of Healthcare of Moscow), Moscow, Russian Federation.
E-mail: n.fadeeva@mknc.ru
ORCID: https://orcid.org/0000-0002-0524-2514. eLibrary SPIN:6047-7590
Alexandra N. Demchenko, gastroenterologist at the Department of intestinal pathology, A.S. Loginov Moscow Clinical Scientific Center, Moscow, Russian Federation.
ORCID: https://orcid.org/0009-0007-5952-6233. eLibrary SPIN: 7199-3201
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