tetano
Editor, Senior Moderator
Medicina (Kaunas)
. 2022 Aug 10;58(8):1076.
doi: 10.3390/medicina58081076.
Assessment of Tocilizumab (Humanized Monoclonal Antibody) for Therapeutic Efficacy and Clinical Safety in Patients with Coronavirus Disease (COVID-19)
Sami Ullah[SUP] 1 [/SUP], Radhya Abid[SUP] 1 [/SUP], Sana Haider[SUP] 2 [/SUP], Fazli Khuda[SUP] 1 [/SUP], Ghadeer M Albadrani[SUP] 3 [/SUP], Jawaher A Abdulhakim[SUP] 4 [/SUP], Ahmed E Altyar[SUP] 5 [/SUP], Mohamed M Abdel-Daim[SUP] 6 7 [/SUP], Syed Muhammad Ashhad Halimi[SUP] 1 [/SUP], Atif Ali Khan Khalil[SUP] 8 [/SUP]
Affiliations
Abstract
Background and objectives: COVID-19 patients exhibit a broad range of manifestations, presenting with a flu-like respiratory tract infection that can advance to a systemic and severe disease characterized by pneumonia, pulmonary edema, severe damage to the airways, and acute respiratory distress syndrome (ARDS, causing fatality in 70% of COVID-19 cases). A 'cytokine storm' profile is found in most severely influenced COVID-19 patients. The treatment protocol of the disease also includes tocilizumab, which is a humanized monoclonal antibody used to treat autoimmune and inflammatory conditions. This study was designed (1) to assess the role of tocilizumab in COVID-19 patients regarding therapeutic efficacy through evaluation of cytokine release syndrome (CRS) resolution and anticoagulant effect, analyzing clinical safety via monitoring of associated adverse effects profile; and (2) to compare the clinical safety and therapeutic efficacy of institutional treatment regimen (alone) versus tocilizumab added to an institutional treatment module in COVID-19 patients. Materials and Methods: In this study, the endpoints parametric assessment of severely diseased patients of COVID-19 was performed (total n = 172, control group (institutional protocol treatment provided), n = 101 and test group (tocilizumab provided), n = 71) at the Khyber Teaching Institution, MTI, Peshawar. The assessments were compared using non-parametric analyses at baseline and after a follow-up of 12-18 days until the patient discharged or expired. Results: Results of the study revealed an insignificant difference among the control vs. test group in resolving inflammatory parameters (C-reactive protein (CRP) 21.30 vs. 50.07; p = 0.470, ferritin 482.9 vs. 211.5; p = 0.612, lactate dehydrogenase (LDH) 29.12 vs.18.8; p = 0.0863, and D-dimer 464 vs.164.4; p = 0.131). However, a statistically significant difference was found between the control group and test group regarding coagulation parameters (international normalized ratio (INR) 0.12 vs. -0.07; p ≤ 0.001; activated partial thromboplastin time (aPTT) 0.42 vs. -1.16; p ≤ 0.001; prothrombin time (PT) 0.31 vs. -0.96; p ≤ 0.001; platelet count -12.34 vs. -1.47; p = 0.012) and clinical survival rate (89.10 vs. 90.14; p < 0.001). Furthermore, there was significantly higher infection rates and raised alanine aminotransferase (ALT) and alkaline phosphatase (ALP) associated with the tocilizumab group as compared to those receiving institutional treatment (bacterial infections: 0.99% vs. 15.49%; p ≤ 0.01, ALT: 3.96% vs. 28.16%; p ≤ 0.01, ALP: 1.98% vs. 22.53%; p ≤ 0.01). Conclusions: From this study, it was concluded that tocilizumab can be a better drug of choice in terms of efficacy, particularly in resolving coagulopathy in severe COVID-19 patients.
Keywords: COVID-19; coagulopathy; inflammatory parameters; tocilizumab.
. 2022 Aug 10;58(8):1076.
doi: 10.3390/medicina58081076.
Assessment of Tocilizumab (Humanized Monoclonal Antibody) for Therapeutic Efficacy and Clinical Safety in Patients with Coronavirus Disease (COVID-19)
Sami Ullah[SUP] 1 [/SUP], Radhya Abid[SUP] 1 [/SUP], Sana Haider[SUP] 2 [/SUP], Fazli Khuda[SUP] 1 [/SUP], Ghadeer M Albadrani[SUP] 3 [/SUP], Jawaher A Abdulhakim[SUP] 4 [/SUP], Ahmed E Altyar[SUP] 5 [/SUP], Mohamed M Abdel-Daim[SUP] 6 7 [/SUP], Syed Muhammad Ashhad Halimi[SUP] 1 [/SUP], Atif Ali Khan Khalil[SUP] 8 [/SUP]
Affiliations
- PMID: 36013543
- DOI: 10.3390/medicina58081076
Abstract
Background and objectives: COVID-19 patients exhibit a broad range of manifestations, presenting with a flu-like respiratory tract infection that can advance to a systemic and severe disease characterized by pneumonia, pulmonary edema, severe damage to the airways, and acute respiratory distress syndrome (ARDS, causing fatality in 70% of COVID-19 cases). A 'cytokine storm' profile is found in most severely influenced COVID-19 patients. The treatment protocol of the disease also includes tocilizumab, which is a humanized monoclonal antibody used to treat autoimmune and inflammatory conditions. This study was designed (1) to assess the role of tocilizumab in COVID-19 patients regarding therapeutic efficacy through evaluation of cytokine release syndrome (CRS) resolution and anticoagulant effect, analyzing clinical safety via monitoring of associated adverse effects profile; and (2) to compare the clinical safety and therapeutic efficacy of institutional treatment regimen (alone) versus tocilizumab added to an institutional treatment module in COVID-19 patients. Materials and Methods: In this study, the endpoints parametric assessment of severely diseased patients of COVID-19 was performed (total n = 172, control group (institutional protocol treatment provided), n = 101 and test group (tocilizumab provided), n = 71) at the Khyber Teaching Institution, MTI, Peshawar. The assessments were compared using non-parametric analyses at baseline and after a follow-up of 12-18 days until the patient discharged or expired. Results: Results of the study revealed an insignificant difference among the control vs. test group in resolving inflammatory parameters (C-reactive protein (CRP) 21.30 vs. 50.07; p = 0.470, ferritin 482.9 vs. 211.5; p = 0.612, lactate dehydrogenase (LDH) 29.12 vs.18.8; p = 0.0863, and D-dimer 464 vs.164.4; p = 0.131). However, a statistically significant difference was found between the control group and test group regarding coagulation parameters (international normalized ratio (INR) 0.12 vs. -0.07; p ≤ 0.001; activated partial thromboplastin time (aPTT) 0.42 vs. -1.16; p ≤ 0.001; prothrombin time (PT) 0.31 vs. -0.96; p ≤ 0.001; platelet count -12.34 vs. -1.47; p = 0.012) and clinical survival rate (89.10 vs. 90.14; p < 0.001). Furthermore, there was significantly higher infection rates and raised alanine aminotransferase (ALT) and alkaline phosphatase (ALP) associated with the tocilizumab group as compared to those receiving institutional treatment (bacterial infections: 0.99% vs. 15.49%; p ≤ 0.01, ALT: 3.96% vs. 28.16%; p ≤ 0.01, ALP: 1.98% vs. 22.53%; p ≤ 0.01). Conclusions: From this study, it was concluded that tocilizumab can be a better drug of choice in terms of efficacy, particularly in resolving coagulopathy in severe COVID-19 patients.
Keywords: COVID-19; coagulopathy; inflammatory parameters; tocilizumab.