Cancer rears its ugly head in MS ... again

Remember how we said that the older MS (multiple sclerosis) injectable drugs do not cause cancer, well the newer ones look like they may be doing so ... with a vengeance.

An report accepted to the Annals of Neurology with lead authors: Andreas Schweikert, MD, Marcus Kremer, MD, Florian Ringel, MD, Thomas Liebig, MD, Justus Duyster, MD, Olaf Stüve,MD , PhD, Bernhard Hemmer, MD, Achim Berthele, MD, presents a 40-year-old MS patient treated with 21 courses of Tysabri (natalizumab) who developed primary CNS lymphoma (PCNSL). This horrible disease occurs in the population at a rate of 0.46 per 100,000. There have only been 4 reported cases in MS patients in the last 10 years.

So, are these two things related?

Well, Tysabri does suppress the immune system and PCNSL occurs in immunosuppressed individuals, so ... maybe. The real question is whether the rumors of another case in the EU (is the case true and is it German as well? I doubt it is from Munich, Germany since the lead and senior author are both from the Department of Neurology, Klinikum rechts der Isar, Technische Universität München, Munich, Germany; if they had another case, they probably would have reported it as well).

Other questions include:

- Why is this patient also a man? Is it because being a man is a worse prognostic indicator of MS than being a woman? In Germany (and for that matter globally and in the United States) are men preferentially treated with Tysabri?

- Did this patient receive 21 month of Tysabri in a row or were they in the original clinical trials (AFFIRM or SENTINEL, or Phase II studies). Did this patient have a drug holiday?

- How sure were the pathologists after the biopsy?

- Is a report from Iran in Infection 2003 about a non-Tysabri patient with meningitis/encephalitis "...who was positive for JCV PCR died with a diagnosis of cerebral lymphoma..." important to think about?


The final question is, what does all this mean for MS treatment?


Cladribine [Mylinax - EMD Serono, Ivax, Teva; see CLARITY and ongoing ONWARD] (perhaps, despite the bold statement concerning them not being related by Dr. Viglietta at EMD Serono: "malignancies..unrelated to the MOA of cladribine" -- see our earlier tweat on twitter: http://twitter.com/Neurologique), Fingolimod [FTY720 - Novartis; see FREEDOMS and TRANSFORMS] with breast and skin cancer, who knows about Laquinimod [Teva Neurosciences and Active Biotech (NASDAQ OMX NORDIC: ACTI; see ALLEGRO); also spelled alternatively by some as Laquinomod, including analysts, investors and in the Financial Times by Pharmawire on FT.com], Teriflunomide [Sanofi-Aventis; see TEMSO and TOPICS], BG00012 [fumaric acid - Biogen Idec; see CONFIRM] and Campath [alemtuzumab - Genzyme (GENZ), Bayer Healthcare Pharmaceuticals; see CARE-MS].



- Daniel Kantor, MD BSE
Medical Director
Neurologique

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