|SRP. 2020; 11(11): 1050-1061
Protocol for Systematic Review and Meta-Analysis on the Efficacy and Safety of TocilizumabAsim Ahmed Elnour, Adel Sadeq, Farah Hamad Farah, IsraaYousif Khidir, Doaa Nassar, Islam Mohammed Abd Allah, Jamila Alaryani, Judit Don, Mohamed Elamin Hassan, Nadeen Ali, Salma Mohamed Magboul, Noor Alhuda Kassem, Haia Abdulsamad, Warda Salah Mohammed Elkhalifa, Ekrima Elmoeiz Gaffar Osman, Hanan Siddig Ali Alamin, Hagar Awad Abdelrahim, Sahar Asim Ahmed Elnour, Asil Adel, Abubakar B. Abubakar, Abdelgadir Elamin, Abdulla Al Amoodi, Sasha Mohammed Elamin Suliman, Noora Alhajri.
Background: Tocilizumab is a novel interleukin-6 inhibitor that possesses some advantages over the other members of the class and over conventional therapy for rheumatoid arthritis.
Aim of the review: The aim of the current protocol for the systematic review and meta-analysis is to assess the efficacy and safety of tocilizumab.
Methods: The protocol has been developed based on the PRISMA-P checklist by using (PICO [population, intervention, comparators, and outcome]) items, for adult subjects who have received tocilizumab in randomized clinical trials. We will search Google Scholar, PubMed, and the Cochrane Central Register for randomized controlled clinical trials using specific MESH terms. The subjects with rheumatoid arthritis (population) receiving tocilizumab (intervention) will be compared to placebo or other interleukin-6 inhibitors (comparators), for the non-inferiority or superiority in terms of effects on disability and/or other disease clinical markers (outcome). The RevMan will be used to quantify the synthesis of data. Whereas I2 index, tau squared, and the Q-test P value will be used to examine heterogeneity among individual study effect sizes.
Anticipated results: We will present the systematic review results and the meta-analysis results in complete tables based on PICO comparison between the included trials. The results will contain a systematic critical evaluation of the included RCT-s in terms of the number of the population (characteristics), the dosing of intervention (tocilizumab) and the comparators, the main outcome measures. The necessary elements of PRISMA will be strictly followed to report the systematic review. The meta-analysis will be reported with the Cochrane guidelines in synthesis of RCT-s and all forms will be based on the quality measures as per the validated Cochrane templates.
Conclusion: This protocol will report the differences in the efficacy and safety of tocilizumab (intervention) as compared to the placebo or other interleukin-6 inhibitors (comparators).
Key words: Efficacy, interleukin-6 inhibitors (IL-6), meta-analysis; randomized clinical trials; safety; systematic review; tocilizumab