Profiling the long-term risk of severe adverse events in a cohort of multiple sclerosis patients treated with different treatment sequences: Results from the Italian Multiple Sclerosis and Related Disorders Registry (I-MS&RD) (ProSA study).
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Paolicelli Damiano, Lucisano Giuseppe, Manni Alessia, Iaffaldano Pietro, Simone Marta, Iaffaldano Antonio, Guerra Tommaso, Mangialardi Vincenzo, Patti Francesco, Cocco Eleonora, De Luca Giovanna, Annovazzi Pietro, Ragonese Paolo, Pozzilli Carlo, Inglese Matilde, Perini Paola, Gasperini Claudio, Tortorella Carla, Marfia Girolama Alessandra, Ferraro Diana, Lus Giacomo, Vianello Marika, Rocca Maria Assunta, Conte Antonella, Romano Silvia, Brescia Morra Vincenzo, Lugaresi Alessandra, Di Sapio Alessia, Chisari Clara Grazia, Cerqua Raffaella, Aguglia Umberto, Pesci Ilaria, Avolio Carlo, D'Amico Emanuele, Bergamaschi Roberto, Totaro Rocco, Rovaris Marco, Crisafulli Sebastiano, Mirabella Massimiliano, Cavalla Paola, Fantozzi Roberta, Gallo Antonio, Amato Maria Pia, Filippi Massimo, Trojano Maria, Italian Multiple Sclerosis and Related Disorders Registry (I-MS&RD)
Аннотация
OBJECTIVE: To compare the incidence of infections and neoplasms in patients treated with different treatment sequences.
METHODS: Data were extracted from the Italian MS and Related Disorders Register. DMTs were classified as moderate-efficacy treatment (MET), continuous HET (C-HET) or pulsed HET (P-HET). Six therapeutic sequences were reconstructed: MET-only, C-HET-only, P-HET-only, MET→C-HET, MET→P-HET and P-HET→MET. Incidence rates (IRs; per 1000 person-years) and incidence rate ratios (IRRs) were estimated using multivariable Poisson regression, adjusting for age, sex, Expanded Disability Status Scale (EDSS), disease duration, MS phenotype and prior relapse activity.
RESULTS: A total of 37,375 patients were included in the analysis, with a median duration of treatment exposure of 8.8 years. Infection risk was significantly higher with C-HET-only (IR, 24.82; IRR, 3.12), P-HET-only (IR, 13.43; IRR, 1.69), MET→C-HET (IR, 10.46; IRR, 1.32) and MET→P-HET (IR, 12.30; IRR, 1.55) versus MET-only (IR, 7.94), while P-HET→MET showed no significant difference from MET-only (IR, 7.67; IRR, 0.97). Regarding neoplasm incidence, P-HET-only showed the lowest rates (IR, 0.18; IRR, 0.24), whereas it was significantly higher in C-HET-only (IR, 1.33; IRR, 1.79) and MET→C-HET (IR, 1.01; IRR, 1.36) versus MET-only (IR, 0.74).
CONCLUSIONS: This is the first real-world study to compare the safety of different sequences in a national registry. ESC strategies did not confer a long-term safety advantage over EIT. Among HET regimens, C-HET was associated with the greatest risk of both serious infections and neoplasms, whereas P-HET showed the lowest neoplasm incidence.