Objectives: The aim of this study was to evaluate the efficacy of a therapeutic education program on the knowledge and safety skills of rheumatoid arthritis patients regarding biotherapy, as well as its impact on disease activity and quality of life. Using biosecure questionnaire on Moroccan form.

Patients and Methods: This was an open parallel group randomized controlled trial with two arms, each containing 60 PR-patients. At M6 sixty patients received individual or group ETP sessions. The primary outcome was the assessment of the security and safety skills using biosecure questionnaire on Moroccan form. The secondary outcome was the DAS28-ESR assessment of disease activity, the HAQ and HAD scores. The comparison between the ETP and non-ETP groups was conducted using statistical comparison tests with a significance threshold of p = 0.05.

Results: At M6 (6 months), the mean age of the ETP group was 49±11 y. The mean disease duration was 8±4.52y. The analyses between groups show that the ETP group had a statistically better biosecure score [13.60; 95% CI (24-3.20), p = 0.011], better quality of life [0.35; 95% CI (0.10-0.60), p = 0.006] and psychological score [3; 95% CI (2.40-3.63), p = 0.04] compared to the control group. There were lower DAS28-3 scores in the ETP-group [1.18; 95% CI (0.85-1.51), p<0.001]. The use of corticosteroid and DMARDS drugs was more significant in group control mean change score 53; 95% CI (36.21-65.50) p<0.0001).

Conclusions: We were able to demonstrate, with a validated tool, that therapeutic educational programs seem to improve safety knowledge and skills of RA patients treated by biologics.