Date of Award
Selective Evidence-Based Medicine Review
Master of Science in Health Sciences - Physician Assistant
Physician Assistant Studies
Objective: The objective of this selective EBM review is to determine whether or not Sarilumab 200mg results in functional improvement in patients who cannot tolerate the traditional line of treatment in rheumatoid arthritis.
Study Design: Review of three randomized control trials (RCTs), published after 2013 all in the English language
Data Sources: 1 double blind, RCT comparing sarilumab 200mg against traditional treatment of TNF-alpha inhibitor adalimumab. 2 RCTs comparing efficacy of sarilumab 200mg to different dosages in patients that had an inadequate response or were unable to tolerate methotrexate (MTX) or TNF-a inhibitor. All studies were found using PubMed.
Outcomes Measured: Each of the articles looked at the effect of sarilumab 200mg on the level of functional improvement of the patient’s symptoms of active RA using the Health Assessment Questionnaire Disability Index (HAQ-DI). The HAQ-DI takes into account 8 different sections; dressing, arising, eating, walking, hygiene, reach, grip, and activities. Patients then rank their score from 0 (having no symptoms) to 3 (unable to perform). From each section, the one highest score is taken, all sections are added and averaged. The number that results is the number that is representative of the disability index.
Results: The study by Burmester et al. patients receiving sarilumab 200mg every 2 weeks (q2w) showed statistically significant functional improvement in the HAQ-DI compared to adalimumab 40mg q2w with p-values of <0.01 and a confidence interval (CI) of 95% (ARD 2017;76(5):840- 847. doi:10.1136/annrheumdis-2016-210310). The Huizinga et al. compared sarilumab 200mg q2w with placebo plus methotrexate, showing a statistically significant improvement in the HAQ-DI for the sarilumab group for functional improvement with a p-value of 0.0019 and a CI of 95% (ARD. 2014;73(9):1626-1634. doi:10.1136/annrheumdis-2013-204405). Fleischmann et al. evaluated sarilumab 200mg q2w against placebo showing a statistically significant functional improvement in the HAQ-DI scores with a p-value of 0.0004 (A&R. 2017;69(2):277-290. doi:10.1002/art.39944).
Conclusions: Based on the current data from the three RCT’s used in this systematic review, sarilumab 200mg does result in a statistically significant functional improvement in patients with RA who are intolerant to traditional treatment.
Andreano, Emily P., "Does Sarilumab 200mg Result In Functional Improvement In Patients With Rheumatoid Arthritis Who Cannot Tolerate The Traditional Line Of Treatment?" (2020). PCOM Physician Assistant Studies Student Scholarship. 571.