Long-term efficacy and safety of alemtuzumab in patients with RRMS: 12-year follow-up of CAMMS223
- PDF / 636,315 Bytes
- 11 Pages / 595.276 x 790.866 pts Page_size
- 51 Downloads / 174 Views
ORIGINAL COMMUNICATION
Long‑term efficacy and safety of alemtuzumab in patients with RRMS: 12‑year follow‑up of CAMMS223 Brian Steingo1 · Yaser Al Malik2 · Ann D. Bass3 · Regina Berkovich4,5 · Matthew Carraro6 · Óscar Fernández7 · Carolina Ionete8 · Luca Massacesi9 · Sven G. Meuth10 · Dimos D. Mitsikostas11 · Gabriel Pardo12 · Renata Faria Simm13 · Anthony Traboulsee14 · Zia Choudhry15 · Nadia Daizadeh15 · D. Alastair S. Compston16 on behalf of the CAMMS223, CAMMS03409, and TOPAZ Investigators Received: 6 March 2020 / Revised: 4 June 2020 / Accepted: 6 June 2020 © The Author(s) 2020
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. Keywords Alemtuzumab · Multiple sclerosis · Disease-modifying therapy · Efficacy · Safety · Long-term
Introduction Multiple sclerosis (MS) is a lifelong potentially debilitating disorder of the central nervous system that usually evolves over several decades and requires long-term treatment to slow the accumulation of disability and disease progression [1–3]. Alemtuzumab ( LEMTRADA®; Sanofi, Cambridge, MA, USA) is an anti-CD52 humanized monoclonal Electronic supplementary material The online version of this article (https://doi.org/10.1007/s00415-020-09983-1) contains supplementary material, which is available to authorized users. * Brian Steingo [email protected] Extended a
Data Loading...
