Τίτλος:
Long-term efficacy and safety of alemtuzumab in patients with RRMS: 12-year follow-up of CAMMS223
Γλώσσες Τεκμηρίου:
Αγγλικά
Περίληψη:
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. © 2020, The Author(s).
Συγγραφείς:
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.
the CAMMS223, CAMMS03409,
TOPAZ Investigators
Περιοδικό:
Egyptian Journal of Neurology, Psychiatry and Neurosurgery
Εκδότης:
Springer Science and Business Media Deutschland GmbH
Λέξεις-κλειδιά:
alemtuzumab; peginterferon beta1a; alemtuzumab; beta1a interferon; monoclonal antibody, adult; Article; autoimmune disease; controlled study; disease activity; drug efficacy; drug fatality; drug safety; drug withdrawal; Expanded Disability Status Scale; female; follow up; human; idiopathic thrombocytopenic purpura; incidence; infection; major clinical study; male; malignant neoplasm; multiple sclerosis; nuclear magnetic resonance imaging; open study; phase 2 clinical trial; priority journal; randomized controlled trial; recurrence risk; thyroid disease; unspecified side effect; diagnostic imaging, Alemtuzumab; Antibodies, Monoclonal, Humanized; Follow-Up Studies; Humans; Interferon beta-1a; Multiple Sclerosis, Relapsing-Remitting
DOI:
10.1007/s00415-020-09983-1
