The facts about the MS Treatment options available to you
interferons make half of the drugs approved today for MS treatment. They appear to reduce inflammation by modulating a good balance between cells that increase inflammation and cells that decrease it. This property to “reduce inflammation” by obtaining a balance between good and not-so-good cells, made it possible to have the first MS treatment - indicated for Relapsing and Remitting MS - almost 20 years ago. Before the appearance of the interferons, there were no disease management alternatives for the growing number of MS patients around the world. Here you will find a simple and to the point description of each of the MS treatment options that are now available. AVONEX (Interferon Beta-1a) Approved for Relapsing forms of MS and persons with Clinical Isolated Syndrome (CIS) which is defined as a single attack (or the appearance of one or more symptoms usually present in MS) with a very high risk of developing MS, when no other diseases are apparent. Avonex is taken via weekly intramuscular injections. The indicated dosage is 30 mcg. Avonex has been shown to reduce the number of relapses and lesions on MRI, as well as slowing the progression of physical disability. BETASERON (Interferon Beta-1b) Betaseron was the first MS treatment approved by the FDA for Relapsing forms of MS. It was also approved for those individuals with Clinical Isolated Syndrome (CIS). It was demonstrated that it reduces the number and the severity of MS attacks. It is taken by subcutaneous injection every other day and the dosage is 250 mcg. REBIF(Interferon Beta-1a) Was approved for Relapsing forms of MS. Nowadays there is a Rebif new formulation (RNF) which is designed to minimize the development of neutralizing antibodies that may decrease the response to treatment. This RNF is better tolerated than the original formulation. This new formulation is not yet available in the USA but it may be approved in the near future. It is taken by subcutaneous injection three times a week and the dosage is 22 and 44 mcg. The 44 mcg, dosage, based on the latest study’s result, is more effective than the 22 mcg. This new formulation (RNF) also results in fewer injection-site reactions and pain
MY PERSONAL EXPERIENCE WITH AVONEX AND REBIF The first MS treatment I used was Avonex in August 1998. Since the MS treatment involved the application of an intramuscular injection every week, the first thing I did was learn to inject myself in the legs. That was not very traumatic and gave me a sense of independence and control. I quickly got used to my weekly Friday night injection. In preparation, I would take 2 mild pain killers, usually Tylenol 200 mg (acetaminophen) pills, before injection time and then 400 mg every 4 hours.
Later my doctor recommended that I switch to ibuprofen pills instead of acetaminophen pills to deal with the flu-like symptoms and avoid any future liver problems. With Avonex as with all the interferons used for MS treatment, blood work was ordered by my doctor every 6 months to prevent and avoid liver problems and a switch to an ibuprofen based pain killer, as I mentioned before, was recommended. At the beginning I did have some flue like symptoms (mostly chills) and some joint pain but with time the side effects became less and less and the frequency of ibuprofen pills also decreased. Late in 2004 I suffered a new MS relapse and my neurologist told me that my body had created anti-bodies to the MS treatment. The medicine Avonex was no longer doing what it was supposed to do so a change to Rebif was recommended and I have been on Rebif since.
THE SWITCH TO REBIF Subcutaneous injections, even if it meant 3 times per week, were better than 1 intramuscular injection. That’s my opinion. With this new medication came the REBIJET. This auto-injector made it a whole lot easier to get used to taking the medicine. COPAXONE (Glatiramer Acetate) Copaxone is a synthetic protein that mimics myelin basic protein, a key component of the myelin sheath that is damaged in MS. This MS treatment appears to block immune system T cells that damage myelin and may lower inflammation. It was approved for Relapsing forms of MS. It is taken by daily subcutaneous injections and the recommended dosage is 20 mg.
TYSABRI (Natalizumab) This laboratory-produced monoclonal antibody acts against a molecule involved in the activation and function of lymphocytes and their journey into the Central Nervous System (CNS) . Recent data suggest that this MS treatment may also enhance myelination and stabilize damage to the myelin sheath
After a suspension of the drug after two patients developed Progressive Multifocal Leukoencephalopathy (PML) – an often fatal viral infection of the brain – Tysabri was re-release. All patients now receive MS treatment through safety monitoring programs like the Tysabri Outreach and others. As of early March 2011, 102 cases of the infection were confirmed, including 21 deaths. The label of the drug Tysabri has been changed to include the updated incidence of this rare brain infection (PML).
NOVANTRONE (Mitoxantrone) This drug is an immunosuppressant that has been used for years to treat cancer. Novantrone has been approved for use in Secondary Progressive MS (SPMS), Progressive-relapsing MS (PRMS), worsening Relapsing Remitting MS (RRMS) and for those folks who are not responding favorably to standard therapies. This drug is given via intravenous infusion once every three months for a maximum of two or three years. Dosage depends on an individual’s weight and the total dose that can be administered is limited to avoid the risk of damage to the heart. EXPERIMENTAL & NEW ORAL MEDICATIONS
This drug is currently being used in its injection form to treat leukemia. As an MS treatment alternative, it’s taken orally once or twice a year depending on the study’s defined guidelines. Based on studies of the Cladribine being administered by injection, it was demonstrated an average 90% reduction in gadolinium-enhancing lesions and a well defined reduction in relapse rate, the orally administered MS treatment drug was designated by the Food and Drug Administration (FDA) as a Fast Track product for relapsing forms of multiple sclerosis (MS). It may soon receive FDA’s approval. As far as MS treatment options, there are several studies currently being performed on Cladribine and the future looks very promising. This MS treatment blocks potentially damaging T cells from leaving lymph nodes, lowering their numbers in the blood and tissues. It may reduce damage to nerves and enhance nerve repair. Data in the animal model of MS (EAE) suggest that fingolimod may have neuroprotective effects. This drug is for daily oral use. Adverse effects may include slowed heart rate, increased blood pressure, obstruction of airways and infections. Studies are being performed to evaluate long term safety, tolerability and efficacy. There have been 2 deaths from Herpes infection in one of the trials. A 36 month Phase II study showed that 60% of Relapsing Remitting MS (RRMS) patients did not have any relapses during that time and a low rate of disease activity was observed on MRI tests. There is an ongoing study for Primary Progressive MS (PPMS) to evaluate the effect of the drug against placebo on delaying the time to sustained disability progression. It will also evaluate safety and tolerability in patients. Laquinimod, has met its primary endpoint in a two-year phase III study named ALLEGRO. Initial results from the study showed Laquinimod, a once-daily oral drug, met primary endpoint of reducing annualized relapse rate. In addition it significantly slowed progression of disability and showed a favorable safety and tolerability profile. Initial results from the study demonstrated that relapsing-remitting multiple sclerosis (MS) folks treated with 0.6 mg daily oral Laquinimod experienced a statistically significant reduction in annualized relapse rate compared to placebo. Additional clinical endpoints, including significant reduction in disability progression, as measured by Expanded Disability Severity Scale (EDSS), were also achieved. The ALLEGRO study compared oral Laquinimod with placebo in patients with relapsing-remitting MS. The study was conducted at 139 sites in 24 countries and enrolled 1106 MS patients. Laquinimod was safe and well tolerated in the ALLEGRO study. The overall frequencies of adverse events and overall incidence of infections were comparable to those seen with placebo. No deaths were reported among those taking Laquinimod. The reduction in the progression of disability may be explained by Laquinimod’s unique mechanism of action that seems to include neuroprotective properties. Additional analyses of the ALLEGRO study data are ongoing, and detailed results will be submitted for presentation at a leading scientific conference during the first half of 2011. This drug is an immunomodulator with anti-inflammatory properties. As a possible MS treatment alternative, it is going to be taken orally every day. Trials to date show that the drug is safe and its tolerability improves with continued use. Several studies are currently being performed. A Phase 3 trial of BG- 12 met the primary endpoint of reducing the number of patients who relapsed at two years when compared with a placebo. The investigational oral compound, dimethyl fumarate, also met secondary targets, including lower annual relapse rates and disability progression rates at two years, as well as a favorable safety and tolerability profile. The study included more than 1,200 patients and evaluated two dosing levels. The compound, which is aimed at relapsing-remitting multiple sclerosis, received fast-track designation in 2008 from the U.S. Food and Drug Administration. The fast-track designation is intended to expedite the review of drugs to treat serious diseases and meet an unmet medical need This drug is an immunomodulator that affects the division of T cells. It is given orally every day. Several studies are being conducted. Results from the two year phase III TEMSO study showed that both doses of teriflunomide (7 and 14mg) significantly reduced annualized relapse rate
EXPERIMENTAL MONOCLONAL ANTIBODY MEDICATIONS
This drug was developed several years ago for the treatment of B-cell chronic lymphocytic leukemia. It is currently undergoing Phase III trials around the world to find out whether it can help those folks with an early form of MS. The drug is a monoclonal antibody designed to target that part of the immune system which is assumed to be harming MSers. The drug is administered once a year by intravenous infusion over 3 to 5 consecutive days. Side effects include a reduction in blood clotting, thyroid disorders, infusion reaction and infection. All patients need to be monitored closely due to risk of serious toxicity. This drug is already approved for the treatment of both non-Hodgkin’s lymphoma (NHL) and rheumatoid arthritis (RA). Rituxan ® an MS treatment option, is administered via intravenous infusion and it works by binding to a molecule on the surface of B cells and reducing them from circulation. Results of an early-stage clinical trial, recently published in the New England Journal of Medicine, show that it may have great potential in treating MS. The most common side effect was mild to moderate infusion-related adverse events. These were less frequent with the second infusion than the first. The symptoms include fever, chills, rigors, nausea, itching, weakness and high blood pressure. Administered via intravenous infusion every four weeks (also studied in subcutaneous injections). This drug is a genetically engineered antibody against a substance necessary for the growth of T cells. A study in Relapsing Remitting MS (RRMS) and Secondary Progressive MS (SPMS) patients (who continued to experience worsening disease activity with interferon-beta therapy) showed the drug was well tolerated. This study also showed that 60% of the patients treated had either improved or stabilized showing a considerable reduction in active lesions. An ongoing study of Relapsing Remitting MS (RRMS) is going to determine the effect of 3 different doses of Zenapax on brain-lesion activity as measured by MRI. An extension study is also underway measuring safety and tolerability.
OTHER THERAPIES BEING STUDIED
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