Lemtrada® (alemtuzumab, formerly Campath)

Parent company: Sanofi, Genzyme, and Bayer HealthCare Pharmaceuticals

• Administered in one course yearly by intravenous infusion over three-to-five consecutive days. The drug is a humanized monoclonal antibody that targets a protein present on the surface of mature lymphocytes and is approved for the treatment of B-cell leukemia.
  
  
• This drug was granted Fast Track status by the FDA in June 2010.
  
  
• The CAMMS223 Phase II study of 334 individuals with early, active RRMS compared Lemtrada to high-dose Rebif (44 mcg) in RRMS. In a threeyear safety and efficacy trial, Lemtrada was more effective than Rebif at reducing the relapse rate and the risk for 60-month sustained accumulation of disability in patients with RRMS. In fact, the relapse rate in patients on Lemtrada is about one attack in nine years. This is the lowest relapse rate ever reported for an MS drug. More than 50 percent of the Lemtradatreated patients actually improved. Lemtrada significantly reduced progression of brain atrophy in the second year of treatment, and trended toward reduction of brain atrophy over the entire two- and three-year periods.
  
  
• In a fourth-year extension study of 334 individuals who participated in the original CAMMS223 study, Lemtrada yielded a 73-percent reduction in risk for sustained accumulation of disability, while 77 percent of Lemtrada-treated patients were relapse-free. A five-year assessment showed that 87 percent were free of sustained disability accumulation, 72 percent were relapse-free, and 65 percent were free of clinical disease activity. These data indicate that Lemtrada's treatment effect is durable; it halts clinical disease activity in a significant proportion of RRMS patients through five years, with most patients last treated with Lemtrada at month 12 of the first year of study.
  
  
• The CARE-MS I Phase III study of 581 individuals with RRMS was completed in April 2011. It met one of its two primary endpoints by reducing relapse rates by 55 percent in a two-year study that compared two annual cycles of Lemtrada against standard subcutaneous dosing of Rebif.
  
  
• The Phase III CARE-MS II study of 840 patients with RRMS was completed in September 2011 and data should be released by the end of the year. It has a similar design to CARE-MS I, but focuses on patients who continue to have disease activity while taking currently approved diseasemodifying therapy.
  
  
• A Phase III extension study of approximately 1,500 individuals who participated in the CAMMS223 and the earlier Phase II CARE-MS I and CARE-MS II studies is ongoing. Scheduled from August 2009 to September 2014, it examines long-term safety and efficacy in patients who received Lemtrada, Rebif, or both in one of the prior studies. It will also determine if and when further Lemtrada treatment is needed, as well as the safety and efficacy of this as-needed treatment.
  
  
• Side effects include a reduction in blood clotting, thyroid disorders, infusion reactions, and infection. Patients need to be monitored closely due to risk of significant toxicities.