Long-term effectiveness in patients previously treated with cladribine tablets: a real-world analysis of the Italian multiple sclerosis registry (CLARINET-MS)
Autor: | Patti, F., Visconti, A., Capacchione, A., Roy, S., Trojano, M., Amato, M. P., Cocco, E., Danni, M. C., Filippi, M., Gasperini, C., Inglese, M., Luca, G. D., Lus, G., Mallucci, G., Marfia, G. A., Pesci, I., Petruzzo, M., Pozzilli, C., Tedeschi, G., Zaffaroni, M. |
---|---|
Jazyk: | angličtina |
Rok vydání: | 2020 |
Předmět: |
Pediatrics
medicine.medical_specialty effectiveness cladribine tablets registry multiple sclerosis lcsh:RC346-429 long-term data 03 medical and health sciences 0302 clinical medicine secondary progressive MS medicine In patient 030212 general & internal medicine Cladribine clinically isolated syndrome real-world data real-world evidence relapsing-remitting MS lcsh:Neurology. Diseases of the nervous system Original Research Pharmacology Clinically isolated syndrome business.industry Multiple sclerosis medicine.disease Term (time) Neurology Long term data Neurology (clinical) Previously treated business Real world data 030217 neurology & neurosurgery medicine.drug |
Zdroj: | Therapeutic Advances in Neurological Disorders, Vol 13 (2020) Therapeutic Advances in Neurological Disorders |
Popis: | Background: The CLARINET-MS study assessed the long-term effectiveness of cladribine tablets by following patients with multiple sclerosis (MS) in Italy, using data from the Italian MS Registry. Methods: Real-world data (RWD) from Italian MS patients who participated in cladribine tablets randomised clinical trials (RCTs; CLARITY, CLARITY Extension, ONWARD or ORACLE-MS) across 17 MS centres were obtained from the Italian MS Registry. RWD were collected during a set observation period, spanning from the last dose of cladribine tablets during the RCT (defined as baseline) to the last visit date in the registry, treatment switch to other disease-modifying drugs, date of last Expanded Disability Status Scale recording or date of the last relapse (whichever occurred last). Time-to-event analysis was completed using the Kaplan–Meier (KM) method. Median duration and associated 95% confidence intervals (CI) were estimated from the model. Results: Time span under observation in the Italian MS Registry was 1–137 (median 80.3) months. In the total Italian patient population ( n = 80), the KM estimates for the probability of being relapse-free at 12, 36 and 60 months after the last dose of cladribine tablets were 84.8%, 66.2% and 57.2%, respectively. The corresponding probability of being progression-free at 60 months after the last dose was 63.7%. The KM estimate for the probability of not initiating another disease-modifying treatment at 60 months after the last dose of cladribine tablets was 28.1%, and the median time-to-treatment change was 32.1 (95% CI 15.5–39.5) months. Conclusion: CLARINET-MS provides an indirect measure of the long-term effectiveness of cladribine tablets. Over half of MS patients analysed did not relapse or experience disability progression during 60 months of follow-up from the last dose, suggesting that cladribine tablets remain effective in years 3 and 4 after short courses at the beginning of years 1 and 2. |
Databáze: | OpenAIRE |
Externí odkaz: |