Tocilizumab Case Study
To know the risk of adverse effects (AEs) in patients with Rheumatoid arthritis treated with tocilizumab, an IL-6 receptor antibody which is made by randomized controlled trials (RCTs).
Method:
A systematic literature search was conducted using the Cochrane library, PUBMED and EMBASE for all Randomized Control Trials (of the use of tocilizumab for Rhumatoid Arthritis treatment). Fixed effect meta-analyses were conducted to give the incidence of Adverse effects after treatment with and 8 mg/kg tocilizumab monotherapy, with controls. Pooled summary odds ratios (ORs) were calculated using the Mantel–Haenszel method.
Results :
Eight trials were following an electronic searches from the Cochrane database in which 93 were reported in manuscripts …show more content…
Similarly . The comparison of SAEs between the 8 mg/kg dose group and the control group for the tocilizumab combination therapy gave a P-value of 0.065 for the χ2-test of heterogeneity Serious Adverse Effects between the 8 mg/kg dose group and the control group for tocilizumab combination therapy (I2 = 0.59; 95% CI 0, 0.86); AEs between the 4 mg/kg dose group and the control group for tocilizumab combination therapy (I2 = 0.30; 95% CI 0, 0.93); AEs (I2 = 0.35; 95% CI 0, 0.79) and SAEs (I2 = 0.46; 95% CI 0, 0.84) between the 8 and the 4 mg/kg dose group for tocilizumab combination therapy; and AEs (I2 = 0.64; 95% CI 0, 0.90) and infections (I2 = 0.03) between the 8 mg/kg dose group and the control group for tocilizumab monotherapy.
Adverse Effects: the estimated odds for one or more AEs was significantly greater for the 8 mg/kg dose group compared with control group .The estimated odds were not significantly greater for the 4 mg/kg dose group compared with control group and the estimated odds for the 8 mg/kg dose group were not significantly different to the 4 mg/kg dose group .
Serious Adverse …show more content…
The other estimated odds for infection were not significantly different for the 4 mg/kg dose group compared with controls and for the 8 mg/kg dose group compared with the 4 mg/kg dose group .Patients taking monotherapy were estimated to have odds approximately 0.94 times those of the control for developing at least one infection.
Serious infections
The odds of serious infection were not significantly different between the 4 mg/kg dose groups and control .
Other laboratory markers
Other AEs mentioned included changes in lipids, LFTs and neutrophil counts. Overall the LFT elevations were not associated with clinical signs or symptoms of liver disease and an increased risk of infection was not seen in individuals who developed neutropenia.
Sensitivity analysis
The comparison of AEs between the 4 mg/kg tocilizumab and control groups (combination therapy) also gave a significant results .
Discussion
RCTs are difficult to identify rare effects, including AEs such as severe infections , undertaking meta-analyses provide a means to identify
Method:
A systematic literature search was conducted using the Cochrane library, PUBMED and EMBASE for all Randomized Control Trials (of the use of tocilizumab for Rhumatoid Arthritis treatment). Fixed effect meta-analyses were conducted to give the incidence of Adverse effects after treatment with and 8 mg/kg tocilizumab monotherapy, with controls. Pooled summary odds ratios (ORs) were calculated using the Mantel–Haenszel method.
Results :
Eight trials were following an electronic searches from the Cochrane database in which 93 were reported in manuscripts …show more content…
Similarly . The comparison of SAEs between the 8 mg/kg dose group and the control group for the tocilizumab combination therapy gave a P-value of 0.065 for the χ2-test of heterogeneity Serious Adverse Effects between the 8 mg/kg dose group and the control group for tocilizumab combination therapy (I2 = 0.59; 95% CI 0, 0.86); AEs between the 4 mg/kg dose group and the control group for tocilizumab combination therapy (I2 = 0.30; 95% CI 0, 0.93); AEs (I2 = 0.35; 95% CI 0, 0.79) and SAEs (I2 = 0.46; 95% CI 0, 0.84) between the 8 and the 4 mg/kg dose group for tocilizumab combination therapy; and AEs (I2 = 0.64; 95% CI 0, 0.90) and infections (I2 = 0.03) between the 8 mg/kg dose group and the control group for tocilizumab monotherapy.
Adverse Effects: the estimated odds for one or more AEs was significantly greater for the 8 mg/kg dose group compared with control group .The estimated odds were not significantly greater for the 4 mg/kg dose group compared with control group and the estimated odds for the 8 mg/kg dose group were not significantly different to the 4 mg/kg dose group .
Serious Adverse …show more content…
The other estimated odds for infection were not significantly different for the 4 mg/kg dose group compared with controls and for the 8 mg/kg dose group compared with the 4 mg/kg dose group .Patients taking monotherapy were estimated to have odds approximately 0.94 times those of the control for developing at least one infection.
Serious infections
The odds of serious infection were not significantly different between the 4 mg/kg dose groups and control .
Other laboratory markers
Other AEs mentioned included changes in lipids, LFTs and neutrophil counts. Overall the LFT elevations were not associated with clinical signs or symptoms of liver disease and an increased risk of infection was not seen in individuals who developed neutropenia.
Sensitivity analysis
The comparison of AEs between the 4 mg/kg tocilizumab and control groups (combination therapy) also gave a significant results .
Discussion
RCTs are difficult to identify rare effects, including AEs such as severe infections , undertaking meta-analyses provide a means to identify