Author Of 2 Presentations
P0301 - Beyond pivotal trials inclusion criteria: real world clinical profile of multiple sclerosis patients under disease modifying treatment in Argentina. (ID 851)
- A. Barboza
- J. Rojas
- M. Gaitán
- S. Liwacki
- C. Vrech
- A. Papolla
- J. Miguez
- L. Patrucco
- J. Correale
- M. Marrodan
- M. Fiol
- L. Negrotto
- C. Ysrraelit
- E. Cristiano
- A. Carrá
- A. Chertcoff
- J. Steinberg
- A. Martinez
- C. Curbelo
- L. Cohen
- R. Alonso
- O. Garcea
- C. Pita
- B. Silva
- G. Luetic
- N. Deri
- M. Balbuena
- V. Tkachuk
- E. Carnero Contentti
- P. Lopez
- J. Pettinicchi
- A. Caride
- M. Burgos
- F. Leguizamon
- E. Knorre
- R. Piedrabuena
- P. Nofal
- G. Volman
- A. Alvez Pinheiro
- J. Hryb
- D. Tavolini
- P. Blaya
- L. Recchia
- C. Mainella
- M. Kohler
- E. Kohler
- J. Blanche
- S. Tizio
- M. Saladino
- F. Caceres
- N. Fernandez Liguori
- L. Lazaro
- E. Silva
- G. Zanga
- M. Parada Marcilla
- M. Fracaro
- F. Pagani Cassará
- G. Vazquez
- V. Sinay
- G. Sgrilli
- P. Divi
- M. Jacobo
- E. Reich
- L. Cabrera
- M. Menichini
- M. Coppola
- I. Martos
- J. Viglione
- G. Jose
- S. Bestoso
- R. Manzi
- D. Giunta
- M. Doldan
- M. Alonso Serena
Abstract
Background
Background: In multiple sclerosis (MS), randomized controlled trials (RCT) have provided relevant information about the efficacy and safety in ideal scenarios. While RCT are powerful tools for developing scientific evidence based on their high internal validity, there is always uncertainty about the generalizability, especially since the populations enrolled in such studies may differ in significant ways from those seen in clinical practice.
Objectives
Objective: to describe the frequency and clinical profile of MS patients under disease modifying treatment in Argentina that would have not fulfilled inclusion criteria in RCT.
Methods
Methods: MS patients included in the Argentinean MS and NMOSD registry (RelevarEM, NCT 03375177) were analyzed. RelevarEM is a longitudinal, strictly observational MS and NMOSD registry in Argentina. From May 2018 to March 2020, the centers and principal investigators were contacted and incorporated into the Registry. All patients with definite MS and receiving DMT at 31 December 2019 were screened, those with EDSS >6, phenotypes secondary progressive (SP) and primary progressive (PP)(with other DMT than ocrelizumab) and age <18 and >55 years old were included in the analysis.
Results
Results: A total of 1782 patients with MS receiving DMT were screened, of whom 465 (26%)would not have been included in a pivotal trial. From the 465,218 had and EDSS >6, 67 had phenotype SP and 19 PP; 292 were patients with <18 and >55 years of age (2 under 18 years old). Most prescribed DMT among patients with EDSS >6 was fingolimod (31%), among age >55 was beta interferon (35%), phenotype SP fingolimod (30%) and PP fingolimod and glatiramer acetate (each 26%).
Conclusions
Conclusion: in our registry, we found a significant number of MS patients who would have not been included in pivotal trials, receiving DMT. Real life evidence is highly relevant to assess effectiveness as well as safety of DMT in this subset of patients.
P0493 - Severe infections in patients with multiple sclerosis: a nationwide registry study in Argentina (ID 929)
- E. Silva
- C. Vrech
- A. Pappolla
- J. Miguez
- L. Patrucco
- J. Correale
- M. Marrodan
- M. Gaitán
- M. Fiol
- L. Negrotto
- C. Ysrraelit
- E. Cristiano
- A. Carrá
- A. Chertcoff
- J. Steinberg
- A. Martinez
- C. Curbelo
- L. Cohen
- R. Alonso
- O. Garcea
- C. Pita
- B. Silva
- G. Luetic
- N. Deri
- M. Balbuena
- V. Tkachuk
- E. Carnero Contentti
- P. Lopez
- J. Pettinicchi
- A. Caride
- M. Burgos
- F. Leguizamon
- E. Knorre
- R. Piedrabuena
- A. Barboza
- S. Liwacki
- P. Nofal
- G. Volman
- A. Alvez Pinheiro
- J. Hryb
- D. Tavolini
- P. Blaya
- L. Recchia
- C. Mainella
- M. Kohler
- E. Kohler
- J. Blanche
- S. Tizio
- M. Saladino
- F. Caceres
- N. Fernandez Liguori
- L. Lazaro
- G. Zanga
- M. Parada Marcilla
- M. Fracaro
- F. Pagani Cassará
- G. Vazquez
- V. Sinay
- G. Sgrilli
- P. Divi
- M. Jacobo
- E. Reich
- L. Cabrera
- M. Menichini
- M. Coppola
- I. Martos
- J. Viglione
- G. Jose
- S. Bestoso
- R. Manzi
- D. Giunta
- M. Doldan
- M. Alonso Serena
- J. Rojas
Abstract
Background
Data on the rates of infections among patients with multiple sclerosis (MS) are sparse and even more from Latin American countries.
Objectives
The objective of this study was to quantify the incidence of severe infections (SI) in patients with MS included in the Argentinean MS and NMOSD registry (RelevarEM, NCT 03375177).
Methods
RelevarEM is a longitudinal, strictly observational MS and NMOSD registry in Argentina. From May 2018 to March 2020, the centers and principal investigators were contacted and incorporated into the Registry. SI were defined as those that required intravenous treatment or that led to hospitalization or death. Patients contributed person-years of follow-up for the study period. Incidence rates and 95% CI were calculated.
Results
A total of 2158 patients with MS were included, mean age 42 (IIQ 34-52), 65,5% (1576) were female, 82,3% were RRMS. During the period (May 2018-March 2020), 28 SI were reported (IR 1.16, 95%CI 0.77-1.68). In patients with SI, the mean age was 54 (min 43- max 63, p<0.01) years, 11 (39%) were secondary progressive MS (p<0.01), the mean EDSS was 6.5 (range 5-8)(p<0.01), mean disease duration 12 years (p<0.01). 42% of patients were free of MS treatment while 17% were on injectables, 25% on orals and 10% on monoclonal antibodies (p=0.24). The most common sites of severe infection were the lower respiratory tract (39%)
Conclusions
IR of severe infection during the study period was 1.16 (95%CI 0.77-1.68). Most frequent SI were in SPMS and older patients while no relation was observed regarding MS treatment.