LAUSR

Background The offer of injectable MTX in Europe expanded during past few years with different types of enhanced devices such as prefilled syringes and autoinjector pens. Objectives SELFi trial intended to compare historical MTX prefilled syringes vs a new MTX autoinjector in terms of treatment adherence, functional capacity and patients’ preference at 6 months in RA patients. Methods SELFi was a phase III, randomised open-label trial, conducted in France between Sept. 2015 and March 2017. It included RA patients, treated by oral or injectable MTX for ≥3 months (monotherapy or association). Patients were randomised in two arms: MTX in prefilled syringes (PS) or MTX in autoinjectors (AI) at the dosage decided by the investigator. Primary objectives of the trial were to prove the 4% non-inferiority of AI vs PS in terms of patients’ adherence and functional capacity (HAQ-DI) at 6 months. Secondary objectives included the evaluation of satisfaction and patients’ preference. Results Between Sept. 2015 and ,Sept. 2016 50 rheumatologists, mostly in private practice, included 271 patients, 197 of which composed the per protocol population. Patients baseline characteristics were [mean (±SD)]: age: 59.2 (±12.3) yrs; BMI: 26.0 (±4.9) kg/m²; RA duration: 5.35 (±6.70) yrs; DAS28: 3.1 (±1.2); HAQ-DI: 0.6 (±0.6). All patients were treated by MTX (1/3 oral; 2/3 parenteral) at a mean dose of 15.4 (±4.1) mg/wk. There were no significant differences at baseline between PS and AI arms. At 6 months, the treatment adherence was over 95% for both arms, and HAQ-DI was improved by a mean of 0.05 in both arms. The AI 4% non-inferiority as compared to PS was shown for both primary criteria. Patients’ reported satisfaction was very significantly higher (p≤0.001) in AI arm vs PS for the following criteria: easy to use, pleasant, satisfying, willingness for further utilisation and significantly higher (p<0,05) for reassuring and not constraining. Of the 132 patients who experienced both devices (during the study or before it), 127 (96%; p<0.001) preferred the auto injector over the historical prefilled syringe. No unexpected safety issues were observed during this trial and injection point safety tolerance satisfaction was higher for AI vs PS. Conclusions SELFi trial showed that although the new MTX autoinjector is comparable to historical prefilled syringe in terms of treatment adherence and functional capacity improvement, it is significantly superior in terms of patients’ satisfaction. Over 95% of patients who have tried both devices report preferring the pen. Disclosure of Interest A. Saraux Consultant for: Nordic Pharma, C. Hudry Consultant for: Nordic Pharma, E. Zinovieva Employee of: Nordic Pharma, H. Herman-Demars Employee of: Nordic Pharma