Protocol for a Systematic Review and Meta-Analysis on Randomized Clinical Trials on the Efficacy and Safety of Sphingosine-1-Phosphotase Receptor Modulators

Abstract

Asim Ahmed Elnour, Adel Sadeq, Farah Hamad Farah, Noor Alhouda Kassem, Haia Abdulsamad, N Al Mazrouei, Israa Yousif Khidir, Doaa Nassar, Abubakar B. Abubakar, Abdelgadir Elamin, Abdulla Al Amoodi, Sasha Mohammed Elamin Suliman, Mohamed Elamin Hassan, Noora Alhajri, Ekrima Elmoeiz Gaffar Osman, Salma Mohamed Magboul, Judit Don; Jamila Alaryani, Islam Moahmmed Abd Alla, Warda Salah Mohammed Elkhalifa, Nadeen T Ali, Hanan Siddig Ali Alamin, Hagar Awad Abdelrahim, Sahar Asim Ahmed Elnour, Asil Adel, Wadah Mohamed Ali Khogali, Haya Hamed Ahmed Lulu

Background: Sphingosine-1-phosphate (S1P) receptor modulators is a new group that possesses some advantages over the other conventional therapy for multiple sclerosis. Aim of the review: The aim is to assess the efficacy and safety of sphingosine1-phosphate receptor modulators. 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 Sphingosine-1-phosphate (S1P) receptor modulators (amiselimod; ozanimod; ponesimod; siponimod) in randomized clinical trials. The subjects with multiple sclerosis (population) receiving sphingosine-1-phosphate receptor modulator (intervention) will be compared to placebo or other modalities of multiple sclerosis (comparators), for the non-inferiority or superiority in terms of effects on walk, disability, relapse and/or other disease clinical markers (outcome). The secondary safety outcomes such as treatment-emergent adverse events and Quality of Life-54 will be assessed as well. 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 trials’ effect sizes. Conclusion: This protocol will report the differences in the efficacy and safety of sphingosine-1-phosphate receptor modulators (intervention) as compared to the placebo or other modalities (comparators).