TY - JOUR
T1 - Long-term disability trajectories in relapsing multiple sclerosis patients treated with early intensive or escalation treatment strategies
AU - on behalf of the Italian MS Register
AU - Iaffaldano, Pietro
AU - Lucisano, Giuseppe
AU - Caputo, Francesca
AU - Paolicelli, Damiano
AU - Patti, Francesco
AU - Zaffaroni, Mauro
AU - Brescia Morra, Vincenzo
AU - Pozzilli, Carlo
AU - De Luca, Giovanna
AU - Inglese, Matilde
AU - Salemi, Giuseppe
AU - Maniscalco, Giorgia Teresa
AU - Cocco, Eleonora
AU - Sola, Patrizia
AU - Lus, Giacomo
AU - Conte, Antonella
AU - Amato, Maria Pia
AU - Granella, Franco
AU - Gasperini, Claudio
AU - Bellantonio, Paolo
AU - Totaro, Rocco
AU - Rovaris, Marco
AU - Salvetti, Marco
AU - Torri Clerici, Valentina Liliana Adriana
AU - Bergamaschi, Roberto
AU - Maimone, Davide
AU - Scarpini, Elio
AU - Capobianco, Marco
AU - Comi, Giancarlo
AU - Filippi, Massimo
AU - Trojano, Maria
N1 - Publisher Copyright:
© The Author(s), 2021.
PY - 2021
Y1 - 2021
N2 - Background and aims: No consensus exists on how aggressively to treat relapsing–remitting multiple sclerosis (RRMS) nor on the timing of the treatment. The objective of this study was to evaluate disability trajectories in RRMS patients treated with an early intensive treatment (EIT) or with a moderate-efficacy treatment followed by escalation to higher-efficacy disease modifying therapy (ESC). Methods: RRMS patients with ⩾5-year follow-up and ⩾3 visits after disease modifying therapy (DMT) start were selected from the Italian MS Registry. EIT group included patients who received as first DMT fingolimod, natalizumab, mitoxantrone, alemtuzumab, ocrelizumab, cladribine. ESC group patients received the high efficacy DMT after ⩾1 year of glatiramer acetate, interferons, azathioprine, teriflunomide or dimethylfumarate treatment. Patients were 1:1 propensity score (PS) matched for characteristics at the first DMT. The disability trajectories were evaluated by applying a longitudinal model for repeated measures. The effect of early versus late start of high-efficacy DMT was assessed by the mean annual Expanded Disability Status Scale (EDSS) changes compared with baseline values (delta-EDSS) in EIT and ESC groups. Results: The study cohort included 2702 RRMS patients. The PS matching procedure produced 363 pairs, followed for a median (interquartile range) of 8.5 (6.5–11.7) years. Mean annual delta-EDSS values were all significantly (p < 0.02) higher in the ESC group compared with the EIT group. In particular, the mean delta-EDSS differences between the two groups tended to increase from 0.1 (0.01–0.19, p = 0.03) at 1 year to 0.30 (0.07–0.53, p = 0.009) at 5 years and to 0.67 (0.31–1.03, p = 0.0003) at 10 years. Conclusion: Our results indicate that EIT strategy is more effective than ESC strategy in controlling disability progression over time.
AB - Background and aims: No consensus exists on how aggressively to treat relapsing–remitting multiple sclerosis (RRMS) nor on the timing of the treatment. The objective of this study was to evaluate disability trajectories in RRMS patients treated with an early intensive treatment (EIT) or with a moderate-efficacy treatment followed by escalation to higher-efficacy disease modifying therapy (ESC). Methods: RRMS patients with ⩾5-year follow-up and ⩾3 visits after disease modifying therapy (DMT) start were selected from the Italian MS Registry. EIT group included patients who received as first DMT fingolimod, natalizumab, mitoxantrone, alemtuzumab, ocrelizumab, cladribine. ESC group patients received the high efficacy DMT after ⩾1 year of glatiramer acetate, interferons, azathioprine, teriflunomide or dimethylfumarate treatment. Patients were 1:1 propensity score (PS) matched for characteristics at the first DMT. The disability trajectories were evaluated by applying a longitudinal model for repeated measures. The effect of early versus late start of high-efficacy DMT was assessed by the mean annual Expanded Disability Status Scale (EDSS) changes compared with baseline values (delta-EDSS) in EIT and ESC groups. Results: The study cohort included 2702 RRMS patients. The PS matching procedure produced 363 pairs, followed for a median (interquartile range) of 8.5 (6.5–11.7) years. Mean annual delta-EDSS values were all significantly (p < 0.02) higher in the ESC group compared with the EIT group. In particular, the mean delta-EDSS differences between the two groups tended to increase from 0.1 (0.01–0.19, p = 0.03) at 1 year to 0.30 (0.07–0.53, p = 0.009) at 5 years and to 0.67 (0.31–1.03, p = 0.0003) at 10 years. Conclusion: Our results indicate that EIT strategy is more effective than ESC strategy in controlling disability progression over time.
KW - big data
KW - disability trajectories
KW - disease registry
KW - multiple sclerosis
UR - https://www.scopus.com/pages/publications/85107288620
U2 - 10.1177/17562864211019574
DO - 10.1177/17562864211019574
M3 - Article
AN - SCOPUS:85107288620
SN - 1756-2856
VL - 14
JO - Therapeutic Advances in Neurological Disorders
JF - Therapeutic Advances in Neurological Disorders
ER -