Early beginning of alemtuzumab: Changing the multiple sclerosis treatment paradigm. Interim analysis of the LEMVIDA study

LEMVIDA is a real-world prospective study of 3-year follow-up on quality of life of patients with multiple sclerosis (MS) receiving alemtuzumab in Spain. This is an interim analysis evaluating the baseline characteristics of patients who started alemtuzumab between October 2016-September 2018. For 3 additional subanalysis patients were categorised by baseline EDSS score; time of alemtuzumab initiation during the recruitment period (cohort 1: October 2016-March 2017, cohort 2: April-September 2017, cohort 3: October 2017-March 2018 and cohort 4: April-September 2018); and the presence of highly active MS criteria. 161 patients were analysed: 67.1% female, age 38.7 ± 9.4 years, MS duration 8.5 ± 6.0 years, EDSS 3.3 ± 1.7 and number of relapses in the previous 2 years 1.8 ± 1.3. 48.3% of patients presented gadolinium-enhanced (Gd+) lesions (mean: 5.2 ± 6.9) and 63.1% had received prior treatment with fingolimod or natalizumab. Baseline EDSS scores and number of Gd+ lesions were higher in cohort 1 than in cohort 4 (4.1 ± 1.8 vs 3.2 ± 1.7; P = .040 and 10.9 ± 11.9 vs 4.5 ± 5.7; P = .020). The frequency of prior treatment with fingolimod and natalizumab was lower in cohort 4 (60.6%) than in cohort 1 (70.6%) (comparison between groups not analysed). Unlike phase 3 studies of alemtuzumab, the patients included in LEMVIDA are older, have a longer duration of MS, higher disability and have received previous immunosuppressants. However, throughout the recruitment period, there is a tendency towards an early beginning of treatment with alemtuzumab, probably due to the evidence of higher effectiveness in the early stages of MS. LEMVIDA es un estudio de práctica clínica, prospectivo de 3 años de seguimiento sobre calidad de vida en pacientes con esclerosis múltiple (EM) tratados con alemtuzumab en España. Análisis intermedio de las características basales de los pacientes que iniciaron alemtuzumab entre octubre de 2016 y septiembre de 2018. Se realizaron tres subanálisis en función de: puntuación EDSS basal; periodo de inicio de alemtuzumab durante el reclutamiento (cohorte1: octubre de 2016 a marzo de 2017, cohorte 2: abril a septiembre de 2017; cohorte 3: octubre de 2017 a marzo de 2018, y cohorte 4: abril a septiembre de 2018); y criterios de EM muy activa. Se analizaron 161 pacientes: 67,1% mujeres, edad 38,7 ± 9,4 años, duración de la EM 8,5 ± 6,0 años, EDSS 3,3 ± 1,7 y número de brotes en los 2 años previos 1,8 ± 1,3. El 48,3% presentaba lesiones realzadas con gad