4CPS-310 Tofacitinib effectiveness and safety results: real world data

Abstract

became available as a unique option for oral MS treatment in our hospital in 2017. Aim and objectives To describe our experience with the use of TRF and assess its safety profile, as disease modifying therapies (DMTs) work differently and have different adverse reactions (AR). Material and methods An observational retrospective study was conducted from January 2017 to January 2020. Collected variables from medical records were: age, sex, expanded disability status scale score (EDSS), previous DMTs, safety profile (AR, suspension of TRF treatment) and results of blood tests. Sustained disability progression was defined as at least a 1 point increase from the baseline EDSS score £5.5 (or at least a 0.5 point increase for those with a baseline EDSS score >5.5) sustained for at least 12 weeks. 1 Results 45 patients were analysed, 10 men and 35 women (mean age 35.7 years). TRF was the firstline drug for 10 patients, the rest had switched to TRF from parenteral therapies: 7 subcutaneous glatiramer acetate, 20 intramuscular or subcutaneous interferon beta and 2 intravenous natalizumab. The main reasons for change were: convenience of oral administration, poor tolerance and AR at the site of injection. The average duration for TRF was 2.5 years with no suspension recorded. In this period, for 30 patients EDSS score remained stable. The mean change in EDSS from baseline was 0.7; no increase in disability progression. 30 patients showed no AR and 15 patients presented gastrointestinal disorders (9), temporary alopecia (4) or headache (2). 9 patients experienced moderate elevation of liver enzymes. Conclusion and relevance TRF seemed to have a manageable safety profile, was well tolerated, and no new or unexpected AR were reported and there were no suspensions of treatment. Because our experience reflects only 3 years, increased monitoring is necessary to assess the long term safety. REFERENCES AND/OR ACKNOWLEDGEMENTS 1. AUBAGIO (package insert). Cambridge, MA: Genzyme Corporation