Tags

Type your tag names separated by a space and hit enter

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.

Links

Publisher Full Text

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.

MeSH

AdultAlemtuzumabDrug-Related Side Effects and Adverse ReactionsFemaleFollow-Up StudiesHumansImmunologic FactorsMagnetic Resonance ImagingMaleMultiple Sclerosis, Relapsing-RemittingPneumoniaSeverity of Illness IndexThrombocytopeniaThyroiditis

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 -