The establishment of determinants of therapeutic lag in different forms of multiple sclerosis  - Tomáš Kalinčík, 2018


With an expanding number of available disease modifying therapies available in MS, personalisation of care is paramount. Therapeutic lag represents time from treatment start to its fully clinically manifest effect. Knowledge of this lag period has been dependent on pharmacodynamic drug properties, without taking individual patient and disease characteristics into account.

To develop robust, externally validated methodology to identify the clinical onset of treatment effect after commencement of disease modifying therapy. Further develop the concept of therapeutic lag by exploring the patient, disease and therapy related determinants thereof and the impact this has on treatment efficacy in those with progressive and relapsing disease forms.

International longitudinal cohort study using a merged MSBase-OFSEP cohort. Key inclusion criteria include adults with the diagnosis of CIS or MS, minimum of 1-year treatment exposure, 3-year pre-treatment follow-up and yearly EDSS measurements. The Primary endpoint is time to, and determinants of, the first observable effect of therapy on relapse frequency after treatment initiation and last observable effect after treatment cessation. All available and sufficiently represented disease modifying therapies will be included.

Expected findings are that time to treatment effect is shorter in patients with lower levels of disability and those treated with higher efficacy therapy. Once this time is accounted for, benefit of high efficacy therapy in patients with active progressive forms of disease will be observed. Time to recurrence of disease activity after treatment cessation is dependent on pre- cessation relapse rate and preceding therapy. This will be of interest to determine decisions around treatment discontinuation.


Below, you will find informations on this project that were made as part of ECTRIMS 2019: