The aim of the SIMPACT study was to evaluate the efficacy and safety of MTX-free s.c.
tocilizumab (TCZ) therapy in RA patients.SIMPACT was an open-label, non-controlled,
non-randomized, non-interventional study, in which RA patients for whom the treating
physicians ordered s.c. TCZ were observed during a 24-week treatment period in Hungarian
centres. Although the use of MTX was avoided during the study period, other conventional
synthetic DMARDs, oral CSs and NSAIDs were allowed. Study endpoints included the change
in DAS28 and clinical activity index (CDAI) scores, the proportion of patients achieving
remission in the whole population and in subgroups defined based on prior RA treatment
history, and age, weight or biological sex post hoc. The extent of supplementary medication
use was monitored.Three hundred and thirty-seven RA patients were enrolled in 18 study
centres. TCZ therapy significantly decreased the disease activity measured by both
DAS28 (P = 0.0001) and CDAI (P = 0.0001). Clinical response was more pronounced in
biologic-naïve patients and was lower in patients >75 years of age. In the whole population,
DAS28 ESR or CRP and CDAI remission rates were 70.10%, 78.95% and 33.59%, respectively.
In patients <45 years of age, the CDAI remission rate doubled (67.86%). A significant
decrease in the frequency of co-administered medication was reported, including oral
CSs and DMARDs.Real-world clinical evidence on s.c. TCZ reported here is in line with
the efficacy outcomes of randomized clinical trials. Subgroup analysis revealed that
TCZ was more effective in biologic-naïve patients and in those <75 years old.ClinicalTrials.gov,
http://www.clinicaltrials.gov, NCT02402686.
