Interferons slow down MS by modulating the body’s T-Cell response.  They have been the main stay of MS therapies for ten years. Their detailed mechanism of action is still not fully understood, even though some progress is being made to that effect [1,2]. Interferons efficacies are decent enough to fund a multi-billion dollars industry [3].

However drugs other than interferons are also available or in later stage clinical trials:

Gilenya (Fingolimod) [4]: The new oral drug from Novartis. Based on myriocin (ISP-1), an antibiotic originating of the fungus Isaria sinclairii (Wiki). More effective than previous  interferons. However the drug seems to have issues of possible serious side effects such as fatal infections, bradycardia, skin cancer, see Novartis’s warnings.

BG-12 [ 5]: Presented by the media and Biogen/IDEC as a potential winner with high efficacy and reasonable safety profile. Oral therapy in Phase III clinical trials and phase II rheumatoid arthritis clinical trials. The 1,237-patient of the DEFINE trial showed that patients who took BG-12 twice a day had a reduced annualized relapse rate of 53% and a reduced risk of disability progression of 38%. (from bioportfolio)

Risks of BG-12: “..The most common adverse events were flushing, gastrointestinal disorders, headache, and nasopharyngitis, as well as liver enzyme elevation….

Note: Drugs undergo three phases before FDA approval to go on the market. “…While not required in all cases, it is typically expected that there be at least two successful Phase III trials, demonstrating a drug’s safety and efficacy, in order to obtain approval from the appropriate regulatory agencies such as FDA (USA), or the EMA (European Union)…” [Wikipedia]

 

Ocrelizumab:  A new guy , if not on the block, at least , on the horizon. A monoclonal antibody and a product of Roche, it has been announced in sciencedaily [6], based on the Roche press release [7].

Quoting :

“..Overall, 67.3% patients in the ocrelizumab 600mg group and 76.4% of patients in the ocrelizumab 1000mg group had no relapses and no confirmed EDSS progression from week 0–96 (‘clinical disease activity free’); 78.2% and 80.0% of patients, respectively, were relapse-free..”

Not bad for almost two years.

As for the risks of “adverse events”

“..At 24 weeks in the double-blinded treatment groups (ocrelizumab 600mg, ocrelizumab 2000mg vs. placebo) SAEs (serious adverse events) included: systemic inflammatory response syndrome [SIRS] (0.0 percent, 1.8 percent vs. 0.0 percent), hypersensitivity (1.8 percent, 0.0 percent vs. 0.0 percent), oral herpes (0.0 percent, 0.0 percent vs. 1.9 percent), squamous cell carcinoma of the skin (pre-existing lesion) (0.0 percent, 1.8 percent vs. 0.0 percent) and anxiety (0.0 percent, 1.8 percent vs. 0.0 percent)..” So the risks are there, but the drug seems to have some success in a 2 years period in reducing relapses .

The difficulty is to find published specific risk probabilities attached to these drugs. We will keep at it and let you know…In the meantime th MSer would be well advised to add a dose of caution to the mix, and vigorously discuss the risk/benefit ratio with their MDs.  Not all “adverse events” are reversible.  1% probability for such  side effects is considered by the medical media as “rare”. 1% of US MSers represent at least 5000 patients.  See our previous posts [8,9] and the post of the wheelchairkamikaze [10]….

Again, discuss this post with your Doctor.

Sources:

[1] Multiple Sclerosis Research, Barts and the London school of medicine and dentistry,

[2] Neurology ; “Interferon-beta: mechanism of action and dosing issues”; Neurology. 2007 Jun 12

[3] Wikiinvest ; “Multiple Sclerosis (MS) Drug Market”

[4] Neuropsychiatry ; “Critical appraisal of the role of fingolimod in the treatment of multiple sclerosis” ; Neuropsychiatry Dis Treat. 2011; 7: 519–527.

[5] foxbusiness ; “Biogen’s Oral MS Drug BG-12 Meets Goals In Key Study

[6] sciencedaily ; “New Drug Shows Promise Against Multiple Sclerosis” ; Nov. 1, 2011

[7] Roche Press Release ; “Phase II study showed Ocrelizumab maintained significant reduction in disease activity for multiple sclerosis patients for almost two years” ;Basel, 20 October 2011

[8] medinewsdigest ; “Autoimmune diseases and B-cell targeted therapies in human: Mixed results as yet” ; December 25, 2010

[9] medinewsdigest ;”Multiple Sclerosis Disease Modifying Drugs: Are they worth the cost or possible side effects?

[10] wheelchairkamikaze ; “Latest MS Drugs News , much of it is bad”

 

 

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