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Long-term efficacy and safety of alemtuzumab in patients with RRMS: 12-year follow-up of CAMMS223.
J Neurol. 2020 Jun 24 [Online ahead of print]JN

Abstract

BACKGROUND

In the phase 2 CAMMS223 trial (NCT00050778), alemtuzumab significantly improved clinical and MRI outcomes versus subcutaneous interferon beta-1a over 3 years in treatment-naive patients with relapsing-remitting MS. Here, we assess efficacy and safety of alemtuzumab over 12 years in CAMMS223 patients who enrolled in the CAMMS03409 extension (NCT00930553), with available follow-up through the subsequent TOPAZ extension (NCT02255656).

METHODS

In CAMMS223, patients received 2 alemtuzumab courses (12 mg/day; baseline: 5 days; 12 months later: 3 days); 22% received a third course. In the open-label, nonrandomized extensions, patients could receive as-needed additional alemtuzumab or other disease-modifying therapies.

RESULTS

Of 108 alemtuzumab-treated patients in CAMMS223, 60 entered the CAMMS03409 extension; 33% received a total of 2 alemtuzumab courses, and 73% received no more than 3 courses through Year 12. Over 12 years, annualized relapse rate was 0.09, 71% of patients had stable or improved Expanded Disability Status Scale scores, and 69% were free of 6-month confirmed disability worsening. In Year 12, 73% of patients were free of MRI disease activity. Cumulatively throughout the extensions (Years 7-12), 34% of patients had no evidence of disease activity. Adverse event (AE) incidence declined through Year 12. Infusion-associated reactions peaked at first course and declined thereafter. Cumulative thyroid AE incidence was 50%; one immune thrombocytopenia event occurred, and there were no autoimmune nephropathy cases.

CONCLUSIONS

Alemtuzumab efficacy was maintained over 12 years in CAMMS223 patients, with 73% receiving no more than three courses. The safety profile in this cohort was consistent with other alemtuzumab clinical trials.

Authors+Show Affiliations

Infinity Clinical Research, Sunrise, FL, USA. ogniets@yahoo.com.King Saud Bin Abdulaziz University for Health Sciences, King Abdulaziz Medical City, Riyadh, Saudi Arabia.Neurology Center of San Antonio, San Antonio, TX, USA.Keck School of Medicine of University of Southern California, Los Angeles, CA, USA. Synergy Healthcare Medical Associates, Los Angeles, CA, USA.Novant Health, Charlotte, NC, USA.Fundación IMABIS, Hospital Universitario Carlos Haya, Málaga, Spain.University of Massachusetts Memorial Medical Center, Worcester, MA, USA.Department of Neurosciences, Drugs and Child Health, University of Florence, Florence, Italy.Clinic of Neurology with Institute of Translational Neurology, University Clinic Münster, Münster, Germany.First Neurology Department, Aeginition Hospital, National and Kapodistrian University of Athens, Athens, Greece.Oklahoma Medical Research Foundation, Oklahoma City, OK, USA.Universidade de São Paulo, São Paulo, Brazil.University of British Columbia, Vancouver, BC, Canada.Sanofi, Cambridge, MA, USA.Sanofi, Cambridge, MA, USA.University of Cambridge, Cambridge, UK.No affiliation info available

Pub Type(s)

Journal Article

Language

eng

PubMed ID

32583052

Citation

Steingo, Brian, et al. "Long-term Efficacy and Safety of Alemtuzumab in Patients With RRMS: 12-year Follow-up of CAMMS223." Journal of Neurology, 2020.
Steingo B, Al Malik Y, Bass AD, et al. Long-term efficacy and safety of alemtuzumab in patients with RRMS: 12-year follow-up of CAMMS223. J Neurol. 2020.
Steingo, B., Al Malik, Y., Bass, A. D., Berkovich, R., Carraro, M., Fernández, Ó., Ionete, C., Massacesi, L., Meuth, S. G., Mitsikostas, D. D., Pardo, G., Simm, R. F., Traboulsee, A., Choudhry, Z., Daizadeh, N., & Compston, D. A. S. (2020). Long-term efficacy and safety of alemtuzumab in patients with RRMS: 12-year follow-up of CAMMS223. Journal of Neurology. https://doi.org/10.1007/s00415-020-09983-1
Steingo B, et al. Long-term Efficacy and Safety of Alemtuzumab in Patients With RRMS: 12-year Follow-up of CAMMS223. J Neurol. 2020 Jun 24; PubMed PMID: 32583052.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Long-term efficacy and safety of alemtuzumab in patients with RRMS: 12-year follow-up of CAMMS223. AU - Steingo,Brian, AU - Al Malik,Yaser, AU - Bass,Ann D, AU - Berkovich,Regina, AU - Carraro,Matthew, AU - Fernández,Óscar, AU - Ionete,Carolina, AU - Massacesi,Luca, AU - Meuth,Sven G, AU - Mitsikostas,Dimos D, AU - Pardo,Gabriel, AU - Simm,Renata Faria, AU - Traboulsee,Anthony, AU - Choudhry,Zia, AU - Daizadeh,Nadia, AU - Compston,D Alastair S, AU - ,, Y1 - 2020/06/24/ PY - 2020/03/06/received PY - 2020/06/06/accepted PY - 2020/06/04/revised PY - 2020/6/26/entrez KW - Alemtuzumab KW - Disease-modifying therapy KW - Efficacy KW - Long-term KW - Multiple sclerosis KW - Safety JF - Journal of neurology JO - J. Neurol. N2 - BACKGROUND: In the phase 2 CAMMS223 trial (NCT00050778), alemtuzumab significantly improved clinical and MRI outcomes versus subcutaneous interferon beta-1a over 3 years in treatment-naive patients with relapsing-remitting MS. Here, we assess efficacy and safety of alemtuzumab over 12 years in CAMMS223 patients who enrolled in the CAMMS03409 extension (NCT00930553), with available follow-up through the subsequent TOPAZ extension (NCT02255656). METHODS: In CAMMS223, patients received 2 alemtuzumab courses (12 mg/day; baseline: 5 days; 12 months later: 3 days); 22% received a third course. In the open-label, nonrandomized extensions, patients could receive as-needed additional alemtuzumab or other disease-modifying therapies. RESULTS: Of 108 alemtuzumab-treated patients in CAMMS223, 60 entered the CAMMS03409 extension; 33% received a total of 2 alemtuzumab courses, and 73% received no more than 3 courses through Year 12. Over 12 years, annualized relapse rate was 0.09, 71% of patients had stable or improved Expanded Disability Status Scale scores, and 69% were free of 6-month confirmed disability worsening. In Year 12, 73% of patients were free of MRI disease activity. Cumulatively throughout the extensions (Years 7-12), 34% of patients had no evidence of disease activity. Adverse event (AE) incidence declined through Year 12. Infusion-associated reactions peaked at first course and declined thereafter. Cumulative thyroid AE incidence was 50%; one immune thrombocytopenia event occurred, and there were no autoimmune nephropathy cases. CONCLUSIONS: Alemtuzumab efficacy was maintained over 12 years in CAMMS223 patients, with 73% receiving no more than three courses. The safety profile in this cohort was consistent with other alemtuzumab clinical trials. SN - 1432-1459 UR - https://www.unboundmedicine.com/medline/citation/32583052/Long-term_efficacy_and_safety_of_alemtuzumab_in_patients_with_RRMS:_12-year_follow-up_of_CAMMS223 L2 - https://dx.doi.org/10.1007/s00415-020-09983-1 DB - PRIME DP - Unbound Medicine ER -
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