Published in:
Open Access
01-11-2020 | Magnetic Resonance Imaging | Original Communication
Long-term efficacy and safety of alemtuzumab in patients with RRMS: 12-year follow-up of CAMMS223
Authors:
Brian Steingo, Yaser Al Malik, Ann D. Bass, Regina Berkovich, Matthew Carraro, Óscar Fernández, Carolina Ionete, Luca Massacesi, Sven G. Meuth, Dimos D. Mitsikostas, Gabriel Pardo, Renata Faria Simm, Anthony Traboulsee, Zia Choudhry, Nadia Daizadeh, D. Alastair S. Compston, the CAMMS223, CAMMS03409, and TOPAZ Investigators
Published in:
Journal of Neurology
|
Issue 11/2020
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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.