The European Medicines
Agency (EMA) has initiated the assessment of tocilizumab (an anti-inflammatory drug) for
the treatment of critically-ill and hospitalised COVID-19 patients who are
already receiving corticosteroids therapy and need extra oxygen or machine
assisted breathing or mechanical ventilation, as mentioned in a recent news
published on 16 August 2021.
Tocilizumab was first
approved in the European Union in the year 2009. Tocilizumab can be a promising
therapeutic option for COVID as it works by preventing the action of
interleukin-6 (a substance produced by immune system as a result to
inflammation), which plays a crucial part in COVID-19.
EMA’s human medicines committee (CHMP) will
perform a fast-track assessment of the data presented in the application,
comprising of the outcomes from 4 large randomized studies in hospitalised
COVID-19 infected individuals, to resolve if the addition of indication should
be permitted.
Evidence for the real impact of severe acute
respiratory syndrome coronavirus 2 (SARS-CoV-2) infection on preterm birth is
unclear, as available series report composite pregnancy outcomes and/or do not
stratify patients according to disease severity. The purpose of the research
was to determine the real impact of asymptomatic/mild SARS-CoV-2 infection on
preterm birth not due to maternal respiratory failure. This case-control study
involved women admitted to Sant Anna Hospital, Turin, for delivery between 20
September 2020 and 9 January 2021. The cumulative incidence of Coronavirus
disease-19 was compared between preterm birth (case group, n = 102) and
full-term delivery (control group, n = 127). Only women with spontaneous or
medically-indicated preterm birth because of placental vascular malperfusion
(pregnancy-related hypertension and its complications) were included. Current
or past SARS-CoV-2 infection was determined by nasopharyngeal swab testing and
detection of IgM/IgG antibodies in blood samples. A significant difference in
the cumulative incidence of Coronavirus disease-19 between the case (21/102,
20.5%) and the control group (32/127, 25.1%) (P= 0.50) was not observed,
although the case group was burdened by a higher prevalence of three known risk
factors (body mass index > 24.9, asthma, chronic hypertension) for severe
Coronavirus disease-19. Logistic regression analysis showed that
asymptomatic/mild SARS-CoV-2 infection was not an independent predictor of
spontaneous and medically-indicated preterm birth due to pregnancy-related
hypertension and its complications (0.77; 95% confidence interval, 0.41-1.43).
Pregnant patients without comorbidities need to be reassured that
asymptomatic/mild SARS-CoV-2 infection does not increase the risk of preterm
delivery. Preterm birth and severe Coronavirus disease-19 share common risk
factors (i.e., body mass index > 24.9, asthma, chronic hypertension), which
may explain the high rate of indicated preterm birth due to maternal conditions
reported in the literature.
Evidence for the real impact of severe acute
respiratory syndrome coronavirus 2 (SARS-CoV-2) infection on preterm birth is
unclear, as available series report composite pregnancy outcomes and/or do not
stratify patients according to disease severity. The purpose of the research
was to determine the real impact of asymptomatic/mild SARS-CoV-2 infection on
preterm birth not due to maternal respiratory failure. This case-control study
involved women admitted to Sant Anna Hospital, Turin, for delivery between 20
September 2020 and 9 January 2021. The cumulative incidence of Coronavirus
disease-19 was compared between preterm birth (case group, n = 102) and
full-term delivery (control group, n = 127). Only women with spontaneous or
medically-indicated preterm birth because of placental vascular malperfusion
(pregnancy-related hypertension and its complications) were included. Current
or past SARS-CoV-2 infection was determined by nasopharyngeal swab testing and
detection of IgM/IgG antibodies in blood samples. A significant difference in
the cumulative incidence of Coronavirus disease-19 between the case (21/102,
20.5%) and the control group (32/127, 25.1%) (P= 0.50) was not observed,
although the case group was burdened by a higher prevalence of three known risk
factors (body mass index > 24.9, asthma, chronic hypertension) for severe
Coronavirus disease-19. Logistic regression analysis showed that
asymptomatic/mild SARS-CoV-2 infection was not an independent predictor of
spontaneous and medically-indicated preterm birth due to pregnancy-related
hypertension and its complications (0.77; 95% confidence interval, 0.41-1.43).
Pregnant patients without comorbidities need to be reassured that
asymptomatic/mild SARS-CoV-2 infection does not increase the risk of preterm
delivery. Preterm birth and severe Coronavirus disease-19 share common risk
factors (i.e., body mass index > 24.9, asthma, chronic hypertension), which
may explain the high rate of indicated preterm birth due to maternal conditions
reported in the literature.
Evidence for the real impact of severe acute
respiratory syndrome coronavirus 2 (SARS-CoV-2) infection on preterm birth is
unclear, as available series report composite pregnancy outcomes and/or do not
stratify patients according to disease severity. The purpose of the research
was to determine the real impact of asymptomatic/mild SARS-CoV-2 infection on
preterm birth not due to maternal respiratory failure. This case-control study
involved women admitted to Sant Anna Hospital, Turin, for delivery between 20
September 2020 and 9 January 2021. The cumulative incidence of Coronavirus
disease-19 was compared between preterm birth (case group, n = 102) and
full-term delivery (control group, n = 127). Only women with spontaneous or
medically-indicated preterm birth because of placental vascular malperfusion
(pregnancy-related hypertension and its complications) were included. Current
or past SARS-CoV-2 infection was determined by nasopharyngeal swab testing and
detection of IgM/IgG antibodies in blood samples. A significant difference in
the cumulative incidence of Coronavirus disease-19 between the case (21/102,
20.5%) and the control group (32/127, 25.1%) (P= 0.50) was not observed,
although the case group was burdened by a higher prevalence of three known risk
factors (body mass index > 24.9, asthma, chronic hypertension) for severe
Coronavirus disease-19. Logistic regression analysis showed that
asymptomatic/mild SARS-CoV-2 infection was not an independent predictor of
spontaneous and medically-indicated preterm birth due to pregnancy-related
hypertension and its complications (0.77; 95% confidence interval, 0.41-1.43).
Pregnant patients without comorbidities need to be reassured that
asymptomatic/mild SARS-CoV-2 infection does not increase the risk of preterm
delivery. Preterm birth and severe Coronavirus disease-19 share common risk
factors (i.e., body mass index > 24.9, asthma, chronic hypertension), which
may explain the high rate of indicated preterm birth due to maternal conditions
reported in the literature.
Evidence for the real impact of severe acute
respiratory syndrome coronavirus 2 (SARS-CoV-2) infection on preterm birth is
unclear, as available series report composite pregnancy outcomes and/or do not
stratify patients according to disease severity. The purpose of the research
was to determine the real impact of asymptomatic/mild SARS-CoV-2 infection on
preterm birth not due to maternal respiratory failure. This case-control study
involved women admitted to Sant Anna Hospital, Turin, for delivery between 20
September 2020 and 9 January 2021. The cumulative incidence of Coronavirus
disease-19 was compared between preterm birth (case group, n = 102) and
full-term delivery (control group, n = 127). Only women with spontaneous or
medically-indicated preterm birth because of placental vascular malperfusion
(pregnancy-related hypertension and its complications) were included. Current
or past SARS-CoV-2 infection was determined by nasopharyngeal swab testing and
detection of IgM/IgG antibodies in blood samples. A significant difference in
the cumulative incidence of Coronavirus disease-19 between the case (21/102,
20.5%) and the control group (32/127, 25.1%) (P= 0.50) was not observed,
although the case group was burdened by a higher prevalence of three known risk
factors (body mass index > 24.9, asthma, chronic hypertension) for severe
Coronavirus disease-19. Logistic regression analysis showed that
asymptomatic/mild SARS-CoV-2 infection was not an independent predictor of
spontaneous and medically-indicated preterm birth due to pregnancy-related
hypertension and its complications (0.77; 95% confidence interval, 0.41-1.43).
Pregnant patients without comorbidities need to be reassured that
asymptomatic/mild SARS-CoV-2 infection does not increase the risk of preterm
delivery. Preterm birth and severe Coronavirus disease-19 share common risk
factors (i.e., body mass index > 24.9, asthma, chronic hypertension), which
may explain the high rate of indicated preterm birth due to maternal conditions
reported in the literature.
Evidence for the real impact of severe acute
respiratory syndrome coronavirus 2 (SARS-CoV-2) infection on preterm birth is
unclear, as available series report composite pregnancy outcomes and/or do not
stratify patients according to disease severity. The purpose of the research
was to determine the real impact of asymptomatic/mild SARS-CoV-2 infection on
preterm birth not due to maternal respiratory failure. This case-control study
involved women admitted to Sant Anna Hospital, Turin, for delivery between 20
September 2020 and 9 January 2021. The cumulative incidence of Coronavirus
disease-19 was compared between preterm birth (case group, n = 102) and
full-term delivery (control group, n = 127). Only women with spontaneous or
medically-indicated preterm birth because of placental vascular malperfusion
(pregnancy-related hypertension and its complications) were included. Current
or past SARS-CoV-2 infection was determined by nasopharyngeal swab testing and
detection of IgM/IgG antibodies in blood samples. A significant difference in
the cumulative incidence of Coronavirus disease-19 between the case (21/102,
20.5%) and the control group (32/127, 25.1%) (P= 0.50) was not observed,
although the case group was burdened by a higher prevalence of three known risk
factors (body mass index > 24.9, asthma, chronic hypertension) for severe
Coronavirus disease-19. Logistic regression analysis showed that
asymptomatic/mild SARS-CoV-2 infection was not an independent predictor of
spontaneous and medically-indicated preterm birth due to pregnancy-related
hypertension and its complications (0.77; 95% confidence interval, 0.41-1.43).
Pregnant patients without comorbidities need to be reassured that
asymptomatic/mild SARS-CoV-2 infection does not increase the risk of preterm
delivery. Preterm birth and severe Coronavirus disease-19 share common risk
factors (i.e., body mass index > 24.9, asthma, chronic hypertension), which
may explain the high rate of indicated preterm birth due to maternal conditions
reported in the literature.
Evidence for the real impact of severe acute
respiratory syndrome coronavirus 2 (SARS-CoV-2) infection on preterm birth is
unclear, as available series report composite pregnancy outcomes and/or do not
stratify patients according to disease severity. The purpose of the research
was to determine the real impact of asymptomatic/mild SARS-CoV-2 infection on
preterm birth not due to maternal respiratory failure. This case-control study
involved women admitted to Sant Anna Hospital, Turin, for delivery between 20
September 2020 and 9 January 2021. The cumulative incidence of Coronavirus
disease-19 was compared between preterm birth (case group, n = 102) and
full-term delivery (control group, n = 127). Only women with spontaneous or
medically-indicated preterm birth because of placental vascular malperfusion
(pregnancy-related hypertension and its complications) were included. Current
or past SARS-CoV-2 infection was determined by nasopharyngeal swab testing and
detection of IgM/IgG antibodies in blood samples. A significant difference in
the cumulative incidence of Coronavirus disease-19 between the case (21/102,
20.5%) and the control group (32/127, 25.1%) (P= 0.50) was not observed,
although the case group was burdened by a higher prevalence of three known risk
factors (body mass index > 24.9, asthma, chronic hypertension) for severe
Coronavirus disease-19. Logistic regression analysis showed that
asymptomatic/mild SARS-CoV-2 infection was not an independent predictor of
spontaneous and medically-indicated preterm birth due to pregnancy-related
hypertension and its complications (0.77; 95% confidence interval, 0.41-1.43).
Pregnant patients without comorbidities need to be reassured that
asymptomatic/mild SARS-CoV-2 infection does not increase the risk of preterm
delivery. Preterm birth and severe Coronavirus disease-19 share common risk
factors (i.e., body mass index > 24.9, asthma, chronic hypertension), which
may explain the high rate of indicated preterm birth due to maternal conditions
reported in the literature.
Thereafter, the CHMP’s opinion, plus any
requirements for additional studies and safety monitoring, will be redirected
to the European Commission. A final legally binding verdict valid in all the
European Union Member States will then be released. As expected, the EMA will converse on the outcome of its
assessment on tocilizumab therapy
by the mid of October unless some extra information is required.
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