ABSTRACT
BACKGROUND: The objectives of the treatment of patients with ulcerative colitis (UC) in accordance with the STRIDE-I provision, involves endoscopic healing of the colon mucosa. Histological remission is associated with endoscopic healing, which can be a predictor of long-term results. Biological and cellular therapy is most effective in the early stages of the disease. OBJECTIVE: To assess the depth of histological remission with the duration of UC. METHODS: The biopsy material of 75 patients with total or left-sided UC of moderate severity and severe severity aged from 22 to 56 years (average age 31 ± 2.5 years), who were divided into groups depending on the therapy, was studied. The first group of patients with UC aged 22 to 51 years (Me-32) (n = 29) received anti-inflammatory therapy using mesenchymal stromal cell culture (MSCs) 2 million/kg; the second group of patients with UC (n = 27) aged 24 to 56 years (Me-38) received vedolizumab (VDB) according to the recommended scheme, the third group of patients with UC (n = 19) aged 27 to 52 years (Me-31) received MSCs+VDB. The achievement of histological remission was assessed by the score of Geboes (SG). RESULTS: In 1st group, patients who achieved histological remission (SG1) with a disease duration of more than 5 years - 14 (48.3%) patients, less than 5 years - 5 (17.2%) (95% CI 1.256 - 19.293; x2-7.635; p = 0.006). In the 2nd group of patients who achieved histological remission (SG1) with a disease duration of more than 5 years - 15 (55.5%) patients, less than 5 years - 4 (14.9%) (95% CI 1.262 - 20.615; x2-7.026; p = 0.009). In the 3rd group of patients who achieved histological remission (SG1) with a disease duration of more than 5 years - 4 (21.1%) patients, less than 5 years - 7 (36.8%) (95% CI 1.080 - 138.995; x2-4.968; p = 0.026). CONCLUSION: A statistically significant majority of patients who achieved histological remission, regardless of the therapy, had a disease duration of less than 5 years.
ABSTRACT
BACKGROUND: Goal: To identify the relationship between the level of immunoglobulins G and E and the development of adverse reaction (AR) in patients with ulcerative colitis (UC) receiving original infliximab (IFÐ¥) and infliximab biosimilar (BS). METHODS: 35 UC patients with moderate to severe course of the disease (according to Truelove-Witts) who received maintenance therapy with IFÐ¥ at a standard dose of 5 mg/kg of body weight for a year were retrospectively analyzed. There were 16 men (45.7%), 19 women (54.3%). The average age is 34±4.2 years. The duration of the anamnesis was from 3 to 7 years. Patients were divided into 3 groups depending on the development of AR and the received biological drug, without taking into account concomitant anti-inflammatory therapy. The 1st group (n=14) alternated the introduction of the original IFÐ¥ and its BS; The 2nd group (n=7) consisted of patients alternating between the original IFÐ¥ and BS, in whom AR was registered; the 3rd group (n=14) received BS by one trade name. Using enzyme immunoassay, the level of immunoglobulins in the groups of patients was assessed. RESULTS: In the 1st and 3rd groups, AR was not observed. AR in 2nd group was characterized by: bronchospasm 3 (42.8%), Quincke's edema 1 (14.3%), urticaria 1 (14.3%), rhinitis 1 (14.3%), anaphylactic shock 1 (14.3%). In patients of 1st group, the level of IgE is 44.8 ± 5.1 IU/ml, IgG is 16.5 ± 1.7 g/l. In 2nd group -IgE-44.5 ± 11.7 IU / ml, IgG-26.1 ± 2.1 g/l, while in patients in group 3-IgE - 31.5 ± 3.04 IU/ml, IgG - 9.46 ± 1.01 g/l. It was reliably established that the highest level of IgG was observed in the 2nd group, while in the 3rd group it was minimal (p < 0.05). The IgG level in 1st group is higher than in 3rd group, although in both groups the IgG level was within the reference values. In all groups, the IgE value remained normal. CONCLUSION: AR on the background of therapy with IFL and biosimilars are not associated with an increase in the level of IgE, but are caused by an increase in the level of IgG. The alternation of the original drug and the biosimilar increases the risk of developing AR due to increased IgG levels. Treatment with a biosimilar by one trade name does not increase the risk of developing AR.
