1. Long-term efficacy and safety of alemtuzumab in patients with RRMS: 12-year follow-up of CAMMS223
- Author
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Steingo, Brian, Al Malik, Yaser, Bass, Ann D, Berkovich, Regina, Carraro, Matthew, Fernández, Óscar, Ionete, Carolina, Massacesi, Luca, Meuth, Sven G, Mitsikostas, Dimos D, Pardo, Gabriel, Simm, Renata Faria, Traboulsee, Anthony, Choudhry, Zia, Daizadeh, Nadia, Compston, D Alastair S, CAMMS223, CAMMS03409, and TOPAZ Investigators, and Apollo - University of Cambridge Repository
- Subjects
medicine.medical_specialty ,Efficacy ,Antibodies, Monoclonal, Humanized ,Nephropathy ,Multiple sclerosis ,03 medical and health sciences ,0302 clinical medicine ,Multiple Sclerosis, Relapsing-Remitting ,Long-term ,Internal medicine ,Medicine ,Disease-modifying therapy ,Humans ,030212 general & internal medicine ,Adverse effect ,Alemtuzumab ,Expanded Disability Status Scale ,Original Communication ,business.industry ,Incidence (epidemiology) ,medicine.disease ,Clinical trial ,Neurology ,Cohort ,Neurology (clinical) ,Safety ,business ,030217 neurology & neurosurgery ,Interferon beta-1a ,medicine.drug ,Follow-Up Studies - Abstract
Funder: Sanofi; doi: http://dx.doi.org/10.13039/100004339, Funder: Bayer Healthcare Pharmaceuticals, 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.
- Published
- 2020