RESUMO
Netakimab has shown high efficacy in controlled clinical trials in the treatment of AS patients. This article presents results of an observational study of netakimab using in routine clinical practice. OBJECTIVE: : To evaluate retention rates and safety of netakimab in patients with AS in real-world clinical practice. Additionally, the efficacy of netakimab was evaluated at 1-year follow-up. 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 patients who were prescribed netakimab therapy before enrollment, so clinical and medical history data for the first visit were entered retrospectively, and following visits at 12, 24, and 52 weeks of therapy were collected within the study. Drug survival rate was calculated according to Kaplan-Meier analysis. RESULTS: : The study included 137 (93 men and 44 women) patients with AS. The average age of patients was 42.3 (11.9) years, 34.3% of patients had previously received therapy with bDMARD, mainly TNF inhibitors. At the end of the analyzed period (52 weeks of therapy), 90.4% (95% CI, 85.4-95.7) of patients continued treatment with netakimab. The BASDAI and ASDAS-CRP showed statistically significant decreases in scores from baseline at all time points. Netakimab was well tolerated by patients; AEs, related to therapy according to the investigator's opinion, were reported in 7 (5.1%) patients. Two patients stopped taking netakimab due to AEs (terminal ileitis and chronic colitis). CONCLUSIONS: : In real-world clinical practice, netakimab demonstrated high retention rates, a favorable safety profile, and sustained efficacy throughout the first year of therapy.
Assuntos
Espondilite Anquilosante , Humanos , Masculino , Feminino , Adulto , Espondilite Anquilosante/tratamento farmacológico , Pessoa de Meia-Idade , Resultado do Tratamento , Anticorpos Monoclonais Humanizados/uso terapêutico , Anticorpos Monoclonais Humanizados/efeitos adversos , Estudos RetrospectivosAssuntos
Clavícula/lesões , Corpos Estranhos/cirurgia , Fixação Interna de Fraturas/efeitos adversos , Cavidade Pleural/cirurgia , Adulto , Corpos Estranhos/diagnóstico por imagem , Fraturas Ósseas/cirurgia , Humanos , Masculino , Cavidade Pleural/diagnóstico por imagem , Radiografia , Contenções , Cirurgia Torácica VídeoassistidaRESUMO
A course of the disease was studied in 190 patients with hepatic cirrhosis and portal hypertension without bleeding as well as in 107 patients with bleeding from esophageal and gastric varices. The Wald's consecutive analysis with derivation of a summary diagnostic coefficient on the basis of 13 clinical signs was used. Effectiveness of the method was assessed by means of retrospective analysis of 150 case records and long-term results of treatment of 30 patients. The method permits to predict the development of gastroesophageal bleeding in 95.4% of cases.