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Effectiveness and safety of alemtuzumab in the treatment of active relapsing–remitting multiple sclerosis: a multicenter, observational study

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Abstract

Objective

So far, a limited number of real-world evidence studies about the effectiveness and safety of alemtuzumab (ALM) have been published, some of them with a relatively small number of included patients. We aimed to study the efficacy and safety of ALM in real-world clinical practice in two MS centers in Slovenia and Croatia.

Methods

This was a retrospective chart review of 71 consecutive patients with relapsing–remitting MS who were treated with ALM from 2015 till 2018. The following data were collected: gender, age at disease onset, disease duration at ALM initiation, previous disease modifying therapy, number of relapses, active MRI lesions, and EDSS in the year prior to ALM initiation and every year of follow-up.

Results

All patients completed the standard dosing schedule and were followed for a mean time of 3.2±1.1 years after the initiation of treatment. Complete data for the 2 years after treatment (relapses, EDSS, and MRI) were available for 48 patients, of which 14 (29.2%) achieved NEDA. Clinical NEDA was achieved in 38 out of 63 participants (60.3%). In year 1, 24 out of 57 (42.1%) patients achieved NEDA. In year 2, 26 out of 41 (63.4%) patients achieved NEDA. Lower EDSS prior to starting ALM was the only independent predictor of NEDA in a multivariable model. Adverse events occurred in 58 participants (84.1%), with no new safety signals identified.

Conclusion

According to the data from our cohort of early active RRMS patients we conclude ALM efficacy remains high in the real-world clinical practice.

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Authors and Affiliations

  1. Department of Neurology, University Medical Centre Ljubljana, Ljubljana, Slovenia

    Gregor Brecl Jakob, Sarah Gomezelj, Saša Šega Jazbec, Alenka Horvat Ledinek & Uroš Rot

  2. Department of Neurology, University Hospital Center Zagreb, Kišpatićeva 12, HR-10000, Zagreb, Croatia

    Barbara Barun, Tereza Gabelić, Ivan Adamec, Magdalena Krbot Skorić & Mario Habek

  3. School of Medicine, University of Zagreb, Zagreb, Croatia

    Barbara Barun, Tereza Gabelić & Mario Habek

  4. Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia

    Uroš Rot

  5. Faculty of Electrical Engineering and Computing, University of Zagreb, Zagreb, Croatia

    Magdalena Krbot Skorić

Authors
  1. Gregor Brecl Jakob
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  2. Barbara Barun
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  3. Sarah Gomezelj
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  4. Tereza Gabelić
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  5. Saša Šega Jazbec
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  6. Ivan Adamec
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  7. Alenka Horvat Ledinek
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  8. Uroš Rot
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  9. Magdalena Krbot Skorić
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  10. Mario Habek
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Contributions

Study concept and design: Brecl Jakob, Habek. Acquisition of data: Brecl Jakob, Barun, Gomezelj, Gabelić, Šega Jazbec, Adamec, Horvat Ledinek, Rot, Krbot Skorić, Habek.

Analysis and interpretation of data: Brecl Jakob, Barun, Gomezelj, Gabelić, Šega Jazbec, Adamec, Horvat Ledinek, Rot, Krbot Skorić, Habek. Drafting of the manuscript: Brecl Jakob, Gomezelj, Krbot Skorić, Habek. Critical revision of the manuscript for important intellectual content: Brecl Jakob, Barun, Gomezelj, Gabelić, Šega Jazbec, Adamec, Horvat Ledinek, Rot, Krbot Skorić, Habek. Administrative, technical, and material support: Brecl Jakob, Gomezelj, Krbot Skorić, Habek.

Corresponding author

Correspondence to Mario Habek.

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Conflict of interest

GBJ: participated as a clinical investigator and/or received consultation and/or speaker fees from: Biogen, Sanofi Genzyme, Merck, Novartis, Pliva/Teva, Roche.

BB: participated as a clinical investigator and/or received consultation and/or speaker fees from: Biogen, Sanofi Genzyme, Merck, Bayer, Novartis, Pliva/Teva, Roche, Alvogen, Actelion, Alexion Pharmaceuticals.

SG: participated as a clinical investigator and/or received speaker fees from: Roche.

TG: participated as a clinical investigator and/or received consultation and/or speaker fees from: Biogen, Sanofi Genzyme, Merck, Bayer, Novartis, Pliva/Teva, Roche, Alvogen, Actelion, Alexion Pharmaceuticals, TG Pharmaceuticals.

SSJ: participated as a clinical investigator and/or received consultation and/or speaker fees from: Bayer, Biogen, Sanofi Genzyme, Merck, Novartis, Pliva/Teva, Roche.

IA: participated as a clinical investigator and/or received consultation and/or speaker fees from: Biogen, Sanofi Genzyme, Merck, Bayer, Novartis, Pliva/Teva, Roche, Alvogen, Actelion, Alexion Pharmaceuticals, TG Pharmaceuticals.

AHL: participated as a clinical investigator and/or received consultation and/or speaker fees from: Bayer, Biogen, Sanofi Genzyme, Merck, Novartis, Pliva/Teva, Roche.

UR: participated as a clinical investigator and/or received consultation and/or speaker fees from: Bayer, Biogen, Sanofi Genzyme, Merck, Novartis, Pliva/Teva, Roche.

MKS: received consultation and/or speaker fees from: Sanofi Genzyme, Roche.

MH: participated as a clinical investigator and/or received consultation and/or speaker fees from: Biogen, Sanofi Genzyme, Merck, Bayer, Novartis, Pliva/Teva, Roche, Alvogen, Actelion, Alexion Pharmaceuticals, TG Pharmaceuticals.

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Brecl Jakob, G., Barun, B., Gomezelj, S. et al. Effectiveness and safety of alemtuzumab in the treatment of active relapsing–remitting multiple sclerosis: a multicenter, observational study. Neurol Sci 42, 4591–4597 (2021). https://doi.org/10.1007/s10072-021-05145-x

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  • DOI: https://doi.org/10.1007/s10072-021-05145-x

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