Netakimab (NTK) is a humanized anti-interleukin-17A monoclonal antibody. To date, the drug has been approved to treat ankylosing spondylitis (AS), psoriatic arthritis, and plaque psoriasis. The paper gives the data obtained during 52-week follow-up of AS patients in the phase III ASTERA study.Objective: to study the efficacy and safety of NTK when used long in patients with active AS.Patients and methods. The investigation enrolled 228 patients with active AS, in whom nonsteroidal anti-inflammatory drugs or biological agents were ineffective. The patients were randomized in a 1:1 ratio to receive NTK 120 mg or placebo. The drug was administered subcutaneously at weeks 0, 1, 2, and then once every 2 weeks. Patients who received placebo and achieved a 20% improvement according to the ASAS criteria (ASAS20) were excluded from the study at week 16. At this week, patients who took placebo and did not achieve an ASAS20 response were switched to subcutaneous NTK at 120 mg dose once every two weeks. The follow-up period was 52 weeks.Results and discussion. Patients with active AS who received NTK were more likely to respond to treatment than those who took placebo. The proportion of people who achieved 40% improvement (ASAS40) during treatment with NTK increased throughout the follow-up period and amounted to 80.7% at week 52. Positive changes were achieved in all used clinical and laboratory parameters of AS activity. There was also a decrease in inflammatory changes, as shown by magnetic resonance imaging (MRI). The adverse events (AEs) were mainly laboratory abnormalities and upper respiratory tract infections. Treatment-related AEs were recorded in no more than one third of patients and they were mild to moderate. Severe AEs were singular.Conclusion. Response to NTK therapy generates in the first weeks of drug use and increases throughout a year. The safety profile of NTK when used long is generally favorable.

The Russian biotechnological company «BIOCAD» has designed a chimeric monoclonal antibody against CD20 (BCD-020, Acellbia®) that is a biosimilar of rituximab (RTM; MabThera®, F. Hoffmann-La Roche Ltd., Switzerland). In recent years, there has been evidence that RTM can be used at lower doses than those given in the standard recommendations and instructions for the use of this drug. This serves as the basis for the BCD-020-4/ALTERRA (ALTErnative Rituximab regimen in Rheumatoid Arthritis) trial, the objective of which was to investigate the efficiency and safety of using Acellbia® (at a dose of 600 mg twice at a 2-week interval) as the first biological agent (BA) for methotrexate (MTX)-resistant active rheumatoid arthritis (RA). The investigation enrolled 159 patients aged 18 to 80 years with active RA. After 24 weeks 65.7 and 29.4% of patients achieved 20% improvement by the American College of Rheumatology (ACR) criteria in the Acellbia® + MTX and placebo (PL) + MTX groups, respectively (p<0.0001). The differences in the ACR20 response rate in the two groups were 36.3% (95% CI, 19.27–53.28%). There were significant differences between the groups in the ACR50 response rates: 28.4% and 5.9% (p=0.001) and in the ACR70 ones: 12.8% and only 2.0%, respectively (p=0.036). Analysis of all recorded adverse events (AE) frequency showed no significant differences between the patients in the study and control groups and demonstrates its equivalence with that of RTM (MabThera®); all the AE were expectable. It is noted that antibodies to RTM with binding and neutralizing activities had no impact on the efficiency and safety of therapy.

Предложена и проверена гипотеза о том, что патологический дуоденогастральный рефлюкс и медикаментозная кислотосупрессия могут снижать устойчивость препаратов омепразола с кишечнорастворимой оболочкой. С помощью модифицированного теста сравнительной кинетики растворения изучали кинетику растворения оригинального (РП) и 4 воспроизведенных (ВЛС1, ВЛС2, ВЛС3, ВЛС4) препаратов омепразола разных производителей в умеренно кислой среде, имитирующей среду желудка, при медикаментозной кислотосупрессии и на модели патологического дуоденогастрального рефлюкса. Методом ВЭЖХ определяли концентрации омепразола в аликвотах, отбираемых через 0, 4, 10, 15, 20, 30, 45, 60 мин из раствора с pH = (7,0 ± 0,05) после 2-часовой экспозиции при pH = (1,2 ± 0,05) или pH = (4,0 ± 0,05). 4 мин — время воздействия патологического дуоденогастрального рефлюктата на лекарственную форму омепразола. Фармацевтически эквивалентным оригинальному препарату в экспериментальных условиях оказался только ВЛС2; ВЛС1, ВЛС3, ВЛС4 в этих условиях не являются фармацевтически эквивалентными оригинальному препарату. ВЛС3 и ВЛС4 могут разрушаться в желудке при патологическом дуоденогастральном рефлюксе, ВЛС3, кроме того, может разрушаться в желудке при курсовом приеме антисекреторных препаратов.

No abstract

В статье представлены результаты изучения параметров фармакокинетики оригинального противотуберкулезного препарата тиозонид, капсулы 100 мг (ЗАО «Фарм-Синтез», Москва) при однократном приеме возрастающих доз различными группами здоровых добровольцев в рамках клинического исследования I фазы.