INTRODUCTION . Recurrent hiatal hernias are a separate problem of surgery. The scientific community has no generally accepted views on the indications for repeated operations for this pathology, their ideology and technical principles. The results of surgical treatment of recurrent hiatal hernias presented in the literature are also different. The OBJECTIVE was to present his own experience in the treatment of recurrent hiatal hernias. METHODS AND MATHERIALS . The article presents a ten-year experience of revision operations for recurrent hiatal hernias in 96 patients at Pavlov First Saint Petersburg State Medical University. The majority patients (56 – 58.3 %) were initially operated on in other clinics. In 31 (32.3 %) patients, the primary hernia was axial, in 37 (38.5 %) – paraesophageal or mixed type. In 28 (29.2 %) cases, the type of hernia was unknown. Primary plastic surgery using own tissues was performed in 89 patients (92.7 %), in 7 (7.3 %) – using prostheses. Indications for reoperation were not responded to drug therapy gastroesophageal reflux or food transport disorders (“gastric valve”). RESULTS . Laparoscopic access was used in 92 (95.8 %) cases, left-sided thoracotomy – in 4 (4.2 %) cases. Remote treatment results were assessed in 79 patients (82.3 %). A good outcome – absence of anatomical and clinical recurrence of the hernia – was noted in 64 cases (77.7 %). Repeated stomach dislocation into the thoracic cavity with the resumption of clinical symptoms was found in 15 patients (22.3 %). CONCLUSION . The presented data illustrate the complexity of the problem of surgical treatment of recurrent hiatal hernias and the need to search for new approaches to the solution.
Under real-world clinical practice together with indices for assessing disease activity and the effectiveness of therapy, drug retention provides critical information on efficacy, safety, compliance and convenience of use.The aim – to obtain data on the safety of netakimab (NTK) in a population of patients with ankylosing spondylitis (AS), including various somatic diseases, as well as to assess retention on therapy during 2 years of observation in real word clinical practice.Materials and methods. Patients were recruited for the study from August 2020 to December 2021 at 23 centers in the Russian Federation. The study included 137 patients who were prescribed netakimab therapy before enrollment. Clinical and medical history data for the first visit were entered retrospectively, and following visits at 12, 24, 52, 76, 104 weeks of therapy were collected within the study. The average age of the patients 42,3 y. O., 34.3% of them with previous biologics therapy.Results. Median observation period was 104 weeks (range 1–137 weeks). At the end of the analyzed period (104 weeks of therapy), 85,5% [95% confidence interval (95% CI): 79.7–91.8] of patients continued treatment with Netakimab. Retention on NTK therapy was slightly better in “bio-naïve” vs patients who received biologics earlier: 88.7% (95% CI: 82.3–95.5) and 78.9% (95% CI: 67.5–92.2), respectively, without significant differences between groups (p=0.16). 21 (15.3%) patients withdrew from study before visit 6. The main end of study reasons was lost to follow-up – 7 (5.1%) patients, and treatment inefficacy – 6 (4.4%) patients. The BASDAI (Bath Ankylosing Spondylitis Disease Activity Index) and ASDAS-CRP (Ankylosing Spondylitis Disease Activity Score with C-reactive protein) showed statistically significant decreases from baseline: by three times during the first 3 months of therapy and two times decrease during the first year of treatment. This trend continued in the second year of treatment, although with a lower rate of reduction. By week 104 of therapy, 52.9% (95% CI: 47.3–58.4) reached low disease activity (1.3≤ASDAS<2.1), 21.3% (95% CI: 12.8–29.8) had inactive disease (ASDAS<1.3). Netakimab was well tolerated by patients: AEs, related to therapy according to the investigator’s opinion, were reported in 8 (6.0%) patients.Conclusions. In real-world clinical practice, 85.5% of patients continued treatment with Netakimab at the end of 104 weeks. By 104 weeks 74% patients had low disease activity or inactive disease. Netakimab was well tolerated by most of patients.
The aim of the study is to evaluate the efficacy, safety and immunogenicity of divozilimab (DIV), anti-CD20 monoclonal antibody, in patients with systemic sclerosis (SS).Materials and methods. Patients with SS according to ACR/EULAR (American College of Rheumatology/ European Alliance of Associations for Rheumatology) 2013 criteria with modified Rodnan skin score (mRSS) ≥10 and ≲20 and forced vital capacity (FVC) ≥40% from the due took part in the study. Infusions of DIV 250 mg were administered on weeks 0 and 2, and DIV 500 mg – on week 24 with the subsequent use in open mode, starting from week 48. This publication presents data obtained for 48 weeks of trial (before the DIV infusion at week 48). Primary endpoint was the change in the mRSS from baseline to week 48. The dynamic of FVC was estimated as the secondary endpoint. The safety evaluation included the frequency and profile of adverse events and adverse reactions (ARs). Immunogenicity was assessed by detection of binding and neutralizing anti-drug antibodies on weeks 2, 24 and 48.Results. 151 patients were randomized into two groups: DIV (n=76) and Placebo (n=75). The most were female; the median duration of the disease was about 3–4 years. The initial value of the mRSS was 14 and 13 points in DIV and PBO groups, respectively. The change of mRSS from baseline to week 48 was –5.8±1.1 points in DIV group and –2.7±1.0 points in Placebo group (adjusted mean difference (AMD) with 95% confidence interval –3.1 (–4.5; –1.7); p<0.0001). The lung function was stable in patients treated with DIV. A comparable safety profile of DIV and PBO was demonstrated. The most frequent ARs were infusion reactions and a decrease in the number of lymphocytes. There were no severe and serious ARs in DIV group. All infusion reactions were mild and moderate. 5.3% (4/76) patients in DIV group had binding antibodies without neutralizing activity.Conclusion. Divosilimab has demonstrated a significant decrease in severity of skin fibrosis, a positive effect on the respiratory function and a favorable safety profile, which allows to consider it as a promising therapeutic option for SS.
The study aims to evaluate the clinical efficacy, safety, pharmacokinetics, pharmacodynamics and immunogenicity of seniprutug (BCD-180) in patients with active radiographic axial spondyloarthritis (r-axSpA, or ankylosing spondylitis). MATERIALS AND METHODS:Two hundred sixty patients with active r-axSpA and inadequate response to nonsteroidal anti-inflammatory drugs (NSAIDs) were randomized into three groups to receive either seniprutug (BCD-180) 5 or 7 mg/kg, or placebo. BCD-180 was administered in the respective group dose using a 0-12-36 week regimen. The placebo group patients were switched to BCD-180 5 mg/kg at Week 24, with therapy continued at Week 36. The primary endpoint was the proportion of patients achieving 40% improvement in the Assessment in Spondyloarthritis International Society (ASAS40) score at Week 24. The secondary endpoints included the proportion of patients achieving an ASAS20/40 response, improvement in 5 of 6 ASAS criteria (ASAS5/6), partial remission according to ASAS, ASDAS-CRP clinically important improvement in (Ankylosing Spondylitis Disease Activity Score with C-reactive protein level, ASDAS-CII) and ASDAS-CRP major improvement (ASDAS-MI). An analysis of changes over time in the disease activity status according to ASDAS-CRP, BASDAI (Bath Ankylosing Spondylitis Disease Activity Index) and BASFI (Bath Ankylosing Spondylitis Functional Index) scores, as well as changes over time in laboratory markers (CRP and erythrocyte sedimentation rate (ESR)) was also conducted. Safety was assessed based on the frequency and profile of adverse events (AE) and adverse reactions (AR). RESULTS:The proportion of patients who achieved an ASAS40 response at Week 24 on seniprutug (BCD-180) at doses of 7 and 5 mg/kg was 51.4 and 40.8%, respectively, compared with 24% in the Placebo group (p = 0.0012 and p = 0.0417, respectively). Analysis of secondary endpoints showed that the efficacy of BCD-180 at both study doses was statistically significantly superior to placebo in patients with r-axSpA at Week 24 in the following respects: reduction in the proportion of subjects with very high disease activity (ASDAS-CRP > 3.5), achieving ASDAS-CII, ASAS20, ASAS5/6 response. A statistically significant decrease in the ASDAS-CRP, BASDAI, BASFI score, as well as CRP and ESR levels was demonstrated. Tolerability of seniprutug therapy was assessed as acceptable. The most common AEs were infusion-related reactions, most of which were mild to moderate according to CTCAE 5.0 (Common Terminology Criteria for Adverse Events) and developed mainly during the first administration. The proportion of patients with detected binding antibodies was 5.1%. No neutralizing antibodies were detected. CONCLUSIONS:Seniprutug (BCD-180) as a therapy for r-axSpA has demonstrated superiority over placebo in the clinical efficacy, a good safety profile and low immunogenicity.
Objective: To study the efficacy and safety of olokizumab (OKZ) in patients with rheumatoid arthritis (RA) in real-life clinical practice.Material and methods. The observational program was conducted in 73 centers across Russia from Dec 1, 2022 to Jan 31, 2025. It was based on a retrospective analysis of real clinical practice data. Information on patients was collected and analyzed at baseline and after 1, 6, and 12 months of treatment.Results and discussion. A total of 1,576 patients (81.7% women) with RA, aged 55.0 [44.0; 63.0] years and with RA duration of 100.0 [50.0; 156.0] months, were included in the program. After 6 and 12 months of OKZ therapy, the treatment target (remission/low activity) was achieved in 63.3% and 79.8% of patients by DAS28-CRP, and in 55.4% and 75.5% by CDAI respectively. Gender, age, seropositivity, and use of biologic disease-modifying antirheumatic drugs did not significantly affect the achievement of the treatment goal. During the observation period, a significant proportion of patients were able to discontinue glucocorticoids (GCs): 51.1% of patients received GCs initially, after 6 months, 27.6% of patients still received GCs, and after 12 months, 17.0%. During the observation, OKZ treatment was discontinued in 148 (9.5%) patients: in 50 (3.2%) patients due to insufficient efficacy, in 63 (4.0%) patients due to adverse events, and in 35 (2.2%) patients due to other reasons. Conclusion. IL-6 inhibition with OKZ is both effective and safe for achieving RA therapy goals in real-world clinical settings.
