ABSTRACT
BACKGROUND: Adalimumab biosimilar MSB11022 (Idacio ®) has been approved for the same indications as its originator (Humira ®), based on findings from clinical trials in plaque psoriasis. Data on its efficacy and safety in inflammatory bowel disease, however, are scarce. METHODS: Retrospective, observational study of 44 patients with inflammatory bowel disease: 30 were treated with originator adalimumab, 5 were directly started on MSB11022, and 9 switched from originator to biosimilar adalimumab. To evaluate the effectiveness of the use of adalimumab in inflammatory bowel disease, both laboratory markers (fecal calprotectin and C-reactive protein) and scales that measure the activity of inflammatory bowel disease using specific scales (Harvey-Bradshaw Index (HBI) have been usEd.) for Crohn's disease and Mayo Score for Ulcerative Colitis. Efficacy was evaluated by recording the adverse effects that could occur with the administration of adalimumab (original or biosimilar). The success of the switch was determined by analyzing meaningful differences in effectiveness and safety criteria. Concomitant therapy and the need for dose intensification were also analyzed. Objective of this study was to assess the effectiveness and safety of biosimilar adalimumab in adalimumab-naïve patients and patients switched from originator adalimumab. RESULTS: No significant differences were observed in clinical disease activity (P=.317) or biochemical parameters [fecal calprotectin (P=.445) and C-reactive protein P=.661)] after the switch from the originator adalimumab to MSB11022. There was not a significant reduction in the concomitant use of corticosteroids and thiopurines (P=.157). No emergency room visits or hospitalizations were observed during the study period and none of the patients experienced serious adverse effects. CONCLUSIONS: Between originator adalimumab and biosimilar-start cohorts, no differences were observed, between originator adalimumab and switch cohorts, no significant differences were found either, and with the pre- and post-switch to biosimilar comparison, 2 of the 9 patients experienced AEs after the switch. The biosimilar showed a favorable safety profile (one patient with a serious adverse effect (rash) with biosimilar discontinued treatment) and no significant changes to clinical or biochemical parameters were observed after the switch.
ABSTRACT
Objetivo. Evaluar las notificaciones de sospechas de reacciones adversas a las vacunas administradas frente a la gripe, por sexo, grupos de riesgo y por grupos de edad en la Comunidad Valenciana desde el año 2005 a 2011. Métodos. Se ha realizado un estudio farmacoepidemiológico de diseño observacional descriptivo y transversal, basado en las notificaciones de sospechas de reacciones adversas a las vacunas (NRAV) frente a la gripe, registradas a través del Sistema de Información Vacunal (SIV) de la Comunidad Valenciana, de 1 de enero de 2005 hasta 31 de diciembre de 2011. Resultados. Durante el periodo de estudio se registraron 5.107.790 dosis de vacuna frente a la gripe, con una tasa de notificación de NRAV de 1,94 por 100.000 (IC95% 1,59-2,36) y 228.094 dosis de vacuna de gripe A(H1N1)pdm09 (tasa 96,45 por 100.000; IC95% 84,52-110,06). El 70,71% (70) y el 64,55% (142), respectivamente, de las NRAV correspondieron a mujeres. El grupo de riesgo de trabajadores sociosanitarios presentó una mayor tasa de notificación para la gripe estacional (25,35 por 100.000; IC95%: 17,65-36,40) así como para gripe A(H1N1)pdm09 (864,13 por 100.000; IC95% 714,38-1044,93) durante el periodo de estudio. Conclusiones. Las vacunas frente a la gripe administradas durante el periodo de estudio muestran un elevado perfil de seguridad tanto en población con patología de riesgo como en otros grupos diana susceptibles de la vacunación. Las reacciones registradas durante el estudio coinciden en su mayoría con las descritas en las fichas técnicas de las vacunas (AU)
Objective. To evaluate reports of adverse events following influenza immunization by sex, risk and age groups in Valencian Community from 2005 to 2011. Methods. A pharmacoepidemiological descriptive cross-sectional observational study based on the reports of adverse events following immunization (AEFI) against influenza, registered through the Vaccination Information System (SIV) of Valencian Community from 1 January 2005 until 31 December 2011 was done. Results. During the study period 5,107,790 doses of vaccine against influenza were reported, with an AEFI incidence of 1.94 per 100,000 (95% CI 1.59 to 2.36), and 228,094 doses of vaccine for influenza A (H1N1) pdm09 (96.45 per 100,000, 95%CI 84.52-110.06). The 70.71% (70) and 64.55% (142), respectively, of AEFI were in women. The healthcare workers group had a higher reporting rate for seasonal influenza (25.35 per 100,000; 95%CI: 17.65-36.40) and for influenza A(H1N1) pdm09 (864.13 per 100,000; 95%CI 714.38-1044.93) during the study period. Conclusions. Vaccines against influenza administered during the study had a high safety profile in both populations with disease risk and other susceptible target groups of vaccination. Adverse reactions reported during the study mostly coincide with those described in the summary of product characteristics of vaccines (AU)
Subject(s)
Adolescent , Adult , Aged , Child , Female , Humans , Male , Influenza Vaccines/administration & dosage , Influenza Vaccines/adverse effects , Influenza Vaccines/toxicity , Guillain-Barre Syndrome/complications , Influenza, Human/complications , Influenza, Human/therapy , Risk GroupsABSTRACT
OBJECTIVE: To evaluate reports of adverse events following influenza immunization by sex, risk and age groups in Valencian Community from 2005 to 2011. METHODS: A pharmacoepidemiological descriptive cross-sectional observational study based on the reports of adverse events following immunization (AEFI) against influenza, registered through the Vaccination Information System (SIV) of Valencian Community from 1 January 2005 until 31 December 2011 was done. RESULTS: During the study period 5,107,790 doses of vaccine against influenza were reported, with an AEFI incidence of 1.94 per 100,000 (95% CI 1.59 to 2.36), and 228,094 doses of vaccine for influenza A (H1N1) pdm09 (96.45 per 100,000, 95%CI 84.52-110.06). The 70.71% (70) and 64.55% (142), respectively, of AEFI were in women. The healthcare workers group had a higher reporting rate for seasonal influenza (25.35 per 100,000; 95%CI: 17.65-36.40) and for influenza A(H1N1) pdm09 (864.13 per 100,000; 95%CI 714.38-1044.93) during the study period. CONCLUSIONS: Vaccines against influenza administered during the study had a high safety profile in both populations with disease risk and other susceptible target groups of vaccination. Adverse reactions reported during the study mostly coincide with those described in the summary of product characteristics of vaccines.
Subject(s)
Influenza Vaccines/adverse effects , Adolescent , Adult , Age Distribution , Aged , Child , Chronic Disease/epidemiology , Cross-Sectional Studies , Erythema/etiology , Fatigue/etiology , Female , Health Personnel/statistics & numerical data , Humans , Immunocompromised Host , Male , Middle Aged , Obesity, Morbid/epidemiology , Occupational Exposure , Pain/etiology , Pregnancy , Risk , Sex Distribution , Spain/epidemiology , Vulnerable Populations/statistics & numerical data , Young AdultABSTRACT
Guanine-rich sequences found at telomeres and oncogenes have the capacity to form G-quadruplex (G4) structures. It has been found a relationship between the ability to stabilizing G4 structures and anticancer activity. Guanine quadruplexes stabilization and its implication in cancer phenomena is a therapeutic target relatively recent. Computer-aided drug design has been a very useful tool for the search of new candidates. In last years, methodologies have improved with the development of the computational sciences. The hardware is also enhanced, new techniques are explored. NMR and X-ray information about different targets are discovered continually. The continuous augmentation of new powerful and comprehensive software's with this purpose is other significant factor that contributes to the discovering of new compounds. Nevertheless computer-aided drug design has not been vastly employed in the design of new compound with G4 stabilization activity. All things considered, this review will be focused on the influence of computational techniques on speeding up the discovery of new G4 ligands.
