Tuesday, October 28, 2008

Campath for multiple sclerosis

Alemtuzumab vs. interferon Beta-1a in early multiple sclerosis. The CAMMS223Trial Investigators. NEJM 2008;359: 1786-1801. (phase 2 trial)

In patients with early RRMS alemtuzumab (Campath 1H) was more effective than interferon-1a but was associated with autoimmunity most seriusly manifesting as immune thrombocytopenic purpura. The study was not powered to detect uncommon adverse effects.

Blogger notes. The investigators deserve credit for going up against Rebif (high bar to hurdle) and then hurdling it. Autoimmune events included in addition to ITP, Graves' disease and Goodpasture's syndrome. The patients studied all had MILD MS (EDSS was less than or equal to 3) in naive patients and no conclusions can be drawn about its use in advancing patients or as switch therapy in patients who have had the disease more than three years. The conundrum in a brand new patient is whether to use the most effective drug when it works (Campath) before they fail Rebif, even though it exposes the patient to the risk of autoimmune disease on Campath, because Campath might not work if given later (see 1999 paper on Campath in 2pms). In addition, it is not clear how many times to dose Campath. In this study, subjects were dosed one, two or three times, with eight protocol changes during the study. One or two times should be enough, but Genzyme wants to try to test using the drug every year. A final issue is the use of concomitant drugs-- once campath is finished. Should none be used (the allure), or copaxone ? Does the risk of adverse effects increase with each dosing? We need more answers before Campath can be widely utilized.

Saturday, October 11, 2008

BECOME trial

Betaseron v. Copaxone with triple dose gado and 3T MRI. Head to head trial with combined active lesions as primary endpoint. No difference between 2 groups in 75 randomized patients. In a secondary endpoint, IFN but not GA has a drop in active lesions from pre treatment. Not clear what this means