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Efficacy and safety of alemtuzumab in a real-life cohort of patients with multiple sclerosis.
J Neurol. 2019 Jun; 266(6):1405-1411.JN

Abstract

BACKGROUND

No postmarketing randomised clinical trials are available about alemtuzumab, and real-world data are limited. We aimed to analyse the efficacy and safety of alemtuzumab in a single-centre cohort of patients with relapsing-remitting MS.

METHODS

Patients who took alemtuzumab were enrolled. We collected the following data: age, sex, MS history, expanded disability status scale (EDSS), relapses, magnetic resonance imaging (MRI) parameters after alemtuzumab, and adverse events. EDSS scores before alemtuzumab and at the last follow-up were compared by Wilcoxon test. Time to first relapse was analysed after dividing the cohort on the basis of previous treatment.

RESULTS

Ninety patients were enrolled [women 74.4%; naïve 7; mean follow-up 27 months (SD 23)]. The EDSS was reduced from a median of 2.5 (IQR 1.5-4) before alemtuzumab to 2.0 (IQR 1.5-3.5) after (p = 0.025). The time to first relapse was shorter in patients shifting from a second-line therapy (p = 0.011). Over 2 years, 43.7% had no evidence of disease activity. We observed infusion-related reactions in 95.5% patients, including 11.1% with pneumonitis, thyroiditis in 11%, and thrombocytopenia in 3.3%.

CONCLUSIONS

We confirmed the clinical and MRI efficacy of alemtuzumab in the clinical setting and the frequency of infusion-related reactions. Compared with that in clinical trials, higher number of patients developed pneumonitis during infusion.

Authors+Show Affiliations

Multiple Sclerosis Center, University of Cagliari/ATS Sardegna, Via Is Guadazzonis, 2, 09126, Cagliari, Italy. jessicafrau@hotmail.it.Multiple Sclerosis Center, University of Cagliari/ATS Sardegna, Via Is Guadazzonis, 2, 09126, Cagliari, Italy.Multiple Sclerosis Center, University of Cagliari/ATS Sardegna, Via Is Guadazzonis, 2, 09126, Cagliari, Italy.Multiple Sclerosis Center, University of Cagliari/ATS Sardegna, Via Is Guadazzonis, 2, 09126, Cagliari, Italy.Multiple Sclerosis Center, University of Cagliari/ATS Sardegna, Via Is Guadazzonis, 2, 09126, Cagliari, Italy.Multiple Sclerosis Center, University of Cagliari/ATS Sardegna, Via Is Guadazzonis, 2, 09126, Cagliari, Italy.

Pub Type(s)

Journal Article
Observational Study

Language

eng

PubMed ID

30863891

Citation

Frau, Jessica, et al. "Efficacy and Safety of Alemtuzumab in a Real-life Cohort of Patients With Multiple Sclerosis." Journal of Neurology, vol. 266, no. 6, 2019, pp. 1405-1411.
Frau J, Coghe G, Lorefice L, et al. Efficacy and safety of alemtuzumab in a real-life cohort of patients with multiple sclerosis. J Neurol. 2019;266(6):1405-1411.
Frau, J., Coghe, G., Lorefice, L., Fenu, G., Musu, L., & Cocco, E. (2019). Efficacy and safety of alemtuzumab in a real-life cohort of patients with multiple sclerosis. Journal of Neurology, 266(6), 1405-1411. https://doi.org/10.1007/s00415-019-09272-6
Frau J, et al. Efficacy and Safety of Alemtuzumab in a Real-life Cohort of Patients With Multiple Sclerosis. J Neurol. 2019;266(6):1405-1411. PubMed PMID: 30863891.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and safety of alemtuzumab in a real-life cohort of patients with multiple sclerosis. AU - Frau,Jessica, AU - Coghe,Giancarlo, AU - Lorefice,Lorena, AU - Fenu,Giuseppe, AU - Musu,Luigina, AU - Cocco,Eleonora, Y1 - 2019/03/12/ PY - 2019/02/04/received PY - 2019/03/05/accepted PY - 2019/03/04/revised PY - 2019/3/14/pubmed PY - 2019/12/18/medline PY - 2019/3/14/entrez KW - Alemtuzumab KW - Efficacy KW - Real-life KW - Safety SP - 1405 EP - 1411 JF - Journal of neurology JO - J Neurol VL - 266 IS - 6 N2 - BACKGROUND: No postmarketing randomised clinical trials are available about alemtuzumab, and real-world data are limited. We aimed to analyse the efficacy and safety of alemtuzumab in a single-centre cohort of patients with relapsing-remitting MS. METHODS: Patients who took alemtuzumab were enrolled. We collected the following data: age, sex, MS history, expanded disability status scale (EDSS), relapses, magnetic resonance imaging (MRI) parameters after alemtuzumab, and adverse events. EDSS scores before alemtuzumab and at the last follow-up were compared by Wilcoxon test. Time to first relapse was analysed after dividing the cohort on the basis of previous treatment. RESULTS: Ninety patients were enrolled [women 74.4%; naïve 7; mean follow-up 27 months (SD 23)]. The EDSS was reduced from a median of 2.5 (IQR 1.5-4) before alemtuzumab to 2.0 (IQR 1.5-3.5) after (p = 0.025). The time to first relapse was shorter in patients shifting from a second-line therapy (p = 0.011). Over 2 years, 43.7% had no evidence of disease activity. We observed infusion-related reactions in 95.5% patients, including 11.1% with pneumonitis, thyroiditis in 11%, and thrombocytopenia in 3.3%. CONCLUSIONS: We confirmed the clinical and MRI efficacy of alemtuzumab in the clinical setting and the frequency of infusion-related reactions. Compared with that in clinical trials, higher number of patients developed pneumonitis during infusion. SN - 1432-1459 UR - https://www.unboundmedicine.com/medline/citation/30863891/Efficacy_and_safety_of_alemtuzumab_in_a_real_life_cohort_of_patients_with_multiple_sclerosis_ L2 - https://dx.doi.org/10.1007/s00415-019-09272-6 DB - PRIME DP - Unbound Medicine ER -