[Vedolizumab in patients with inflammatory bowel diseases of in real clinical practice].

Vedolizumab is currently the only selective biological drug for the treatment of inflammatory bowel diseases (IBD). Its effectiveness and safety has been shown in clinical trials. This article presents the experience of using vedolizumab in real clinical practice in patients with various forms of ulcerative colitis (UC) and Crohns disease (CD). MATERIALS AND METHODS: 96 patients with IBD (62 with CD and 34 with UC) were prescribed therapy with vedolizumab at a dose of 300 mg intravenously at 0, 2, and 6 weeks, and further maintenance therapy was continued every 8 weeks. Most patients had prolonged inflammation (27 (79.4%) with total UC, 35 patients with CD (56.5%) had ileocolitis), resistance to therapy, including biological drugs (19 (55.9%) in patients with UC and 49 (79.0%) in patients with CD). The effectiveness of therapy was evaluated after 3 months (based on clinical response and clinical remission), 6 and 12 months (endoscopic response and endoscopic remission were additionally evaluated). RESULTS: After 3 months, clinical remission was observed in 62.5% and 36.6%, respectively. After 6 months, these indicators were 66.7% and 61.0%, and after 12 months, 70.8% and 61.0%, respectively. After 6 months, endoscopic remission was observed in 50.0% of UC patients and 26.8% of CD patients. After 12 months, it reached 58.3% and 31.7%, respectively. The analysis showed greater efficacy in bio-naive patients with CD (steroid-free remission after 12 months 62.5%, endoscopic remission 37.5%), as well as patients with non-stricturizing non-penetrating CD (58%). In patients with UC, vedolizumab showed the same effectiveness both in bio-naive patients (70.0%) and as a second-line therapy (71.2%). It turned out to be more effective in patients with moderate UC (76.2%) and steroid-dependent UC (77.8%). CONCLUSIONS: Vedolizumab is effective in achieving clinical response and clinical remission, as well as endoscopic response and endoscopic remission in patients with UC and CD. Given the selective mechanism of action of the drug, it can be recommended as a first-line therapy.

Certolizumab pegol in treatment of Crohn's disease with perianal lesions.

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.

[Efficiency of tacrolimus therapy for perianal Crohn's disease].

AIM: To determine the efficacy of 0.1% tacrolimus ointment in patients with perianal Crohn's disease (CD). SUBJECTS AND METHODS: This prospective randomized trial enrolled 20 patients with perianal CD as anal fissures and rectal fistulas. The inclusion criteria were rectovaginal or extrasphincteric fistulas and purulent leakages. A study group comprised 11 patients, including 9 with anal fissures and 2 with fistulas. A control group included 9 patients, including 8 with fissures and 1 with fistulas. The study group received systemic therapy with azathioprine 2 mg/kg/day and tacrolimus ointment 2 mg/day; the control group had systemic therapy with azathioprine 2 mg/kg/day, hormone ointment 1 mg/day, and metronidazole suppositories 250 mg/day. Control examination and perianal CD activity index (PCDAI) determination were done 6 and 12 weeks after therapy initiation. RESULTS: At 6 weeks after beginning the study, local examination revealed the signs of anal fissure epithelialization in 5 (45.5%) of the 11 patients in the study group and in 3 (33.3%) of the 9 patients in the control one. At 12 weeks, fissure epithelialization and fistula obliteration were stated in 6 (54%) patients in the study group and in 3 (33%) of the 9 patients in the control group. At 12 weeks, PCDAI in the study and control groups was 2.00 and 4.44 scores (p = 0.01). CONCLUSION: The findings suggest that topical 0.1% tacrolimus ointment versus antibacterial suppositories and hormone ointments is effective in treating patients with perianal CD. Topical 0.1% tacrolimus ointment therapy caused a reduction in PCDAI.

[Long-term results of medical treatment in patients with a severe attack of ulcerative colitis].

AIM: To assess the long-term result of medical treatment in patients with a severe attack (SA) of ulcerative colitis (UC). SUBJECTS AND METHODS: The course of UC was analyzed in 56 patients who were accessible by telephone contact and consecutively recruited for a year after therapy for a SA of UC. All the patients were stated to have a SA of UC according to the Truelove-Witts' criteria; they received therapy with intravenous glucocorticosteroids (GCS) (prednisolone 2 mg/kg) along with anti-recurrence therapy with mesalasine (5-ASA) or azathioprine (AZA). Ten (17.9%) GCS-resistant patients were given infliximab (INF) (5 mg/ kg), followed by its maintenance infusions. Anti-recurrence therapy using 5-ASA, AZA, and INF was performed in 33 (58.9%), 13 (23.2%), and 10 (17.9%) patients, respectively. RESULTS: During one year, 14 (25%) patients continued to be in clinical remission on maintenance therapy or to have attacks stopped without using GCS, immunosuppressive agents, or INF (a satisfactory response group). Colectomy was carried out in 23 (41.1%) patients; due to recurrent UC when decreasing the dose of GCS, 5 (8.9%) patients continued to take the latter during a year. A GCS cycle was repeated in 3 patients who had received AZA (the basic therapy was not corrected) and 11 patients who had taken 5-ASA. The prognostic factors for a long-term result of medical therapy included the choice of AZA as an anti-recurrent drug (57.1 and 11.9% in the satisfactory and poor treatment outcome groups, respectively; p = 0.004) and patient age (34.4 and 42.8 years, respectively; p = 0.0357). CONCLUSION: During 1 year after a SA of UC, indications for colectomy and repeated GCS use occurred in 41 and 34% of the patients, respectively. The long-term efficiency of medical therapy for a SA of UC declines with advancing age. The use of AZA as an anti-recurrence agent after termination of GCS intake increases the probability of long-term clinical response.