Study objectives: To define the rate, timing, and clinical risk factors for the development of autoimmune disease after alemtuzumab treatment in MS'ers.
"What is alemtuzumab? You may know the drug as Campath-1h. This is a powerful immuno-modulator that is given as a course of intravenous infusions. It depletes the immune system and allows it to recover. I refer to it as an immune system rebooter. Short of bone marrow transplantation it is probably the most effective MS disease-modifying therapy in late stage development."
"What is an autoimmune disease? Autoimmunity refers to a family of related diseases in which the body's immune system goes awry and attacks itself. For every organ system in the body there is an autoimmune disease. Please see Wikipedia's article on the subject for more information; autoimmunity"
Methods: The data on 248 MS'ers treated with alemtuzumab, with a median follow-up of 34.3 months (range 6.7-107.3), was analysed.
Novel autoimmune disease developed in 22.2%.
Thyroid autoimmune disease was the most frequent (15.7%).
A range of blood, kidney, and skin autoimmune disease were also observed as was the development of asymptomatic autoantibodies.
Autoimmune disease was seen from 2 weeks after initial treatment and was most frequent 12-18 months after first treatment.
No new cases of autoimmune disease were identified after 60 months after initial treatment.
The risk of autoimmune disease was not linked to the dose or interval of alemtuzumab treatments.
Established risk factors for autoimmune diseases including sex and age had no impact on autoimmune disease frequency.
In this study MS'ers with a family history of an autoimmune disease were 7.3x more likely to develop an autoimmune disease, compared to MS'ers without a family history.
MS'ers with a personal smoking history were 3x more likely to develop autoimmune disease, compared to non-smokers.
Conclusions: Individual risk of autoimmune disease post-alemtuzumab is modified by smoking and family history, which should be incorporated into the counseling process prior to treatment.
"This is a very useful study and allows us to assess the risk of developing autoimmunity after alemtuzumab therapy. Some MS'ers may find this risk too high and others may find the risk acceptable. The good news is that the risk falls off after 5 years. This will help us as it means we may not need to monitor for these complications beyond this time."
"More data on how bad smoking is for MS'ers; time to give up?"
"This was not a negative study; Alemtuzumab is still a very promising disease-modifying therapy! The patients in this trial were less active than previously therefore the trial lacked power to detect a difference in ...
More on the Alemtuzumab trial. The previous post is simply the headline results; we need to wait for the full results that will be presented at the ECTRIMS/ACTRIMS meeting from the 19 – 22 October 2011, in Amsterdam, ...
A press release on the headline results of the Alemtuzumab vs. Interferon-beta-1a trial: "Sanofi said Lemtrada worked better than an older drug, Rebif, in preventing relapses, as patients treated with Lemtrada were 55 ...