MS Patients Treated in Clinical Practice with Fingolimod Show Benefits

MS Patients Treated in Clinical Practice with Fingolimod Show Benefits

New research evaluating fingolimod’s clinical efficacy, safety, and tolerability in patients with relapsing-remitting multiple sclerosis (RRMS) largely supported its use, finding that the oral drug’s efficacy in a real-world setting was comparable to results observed in Phase 3 clinical studies. The research article, “Efficacy and Safety of Fingolimod in an Unselected Patient Population,” was published in the journal PLOS ONE.

Fingolimod (Gilenya, by Novartis), a first-in-class oral compound approved for the treatment of RRMS, is a sphingosine 1-phosphate receptor modulator that leads to the downregulation of these receptors on the surface of cells. This event, in turn, leads to the sequestration of lymphocytes in the lymph nodes, ultimately preventing these immune cells’ ability to contribute to autoimmunity. The drug has been shown to reduce significantly MS relapse rates in an effective and safe manner; however, due to exclusion factors in clinical trials, the safety and tolerability of fingolimod in patients with cardiac risk factors remains poorly studied.

The researchers assessed the effects, safety, and tolerability of fingolimod in an unselected population in a clinical practice setting, as opposed to a controlled and carefully selected clinical trial patient population. The researchers conducted an observational study, following 105 RRMS patients at the University Hospital of Basel, Switzerland, recording clinical and magnetic resonance imaging (MRI) responses. In addition, scientists analyzed a group of pro-inflammatory cytokines as potential, and much-needed, biomarkers for MS disease evolution and response to treatment.

The results indicated that, compared to the year before commencing fingolimod therapy, the patients’ annual relapse rate was reduced by 44% and the percentage of patients with a worsening of the expanded disability status scale (EDSS, a method of quantifying MS-related disability) also decreased. Moreover, the proportion of patients with null disease activity, evaluated through the absence of relapses and new active lesions in MRI, as well as stable EDSS, increased from 11% to 38%. The efficacy and safety results of this study were found to be comparable to those observed in Phase 3 clinical trials, suggesting that the drug has a similar therapeutic profile in both highly active patients and patients with comorbidities.

The research team concluded its article with a positive note about fingolimod, but also highlighted some necessary precautions: “In summary, this study in a real-world setting adds data primarily on safety of fingolimod in an unselected patient population that differs significantly from the population that has been investigated in clinical trials. Data on efficacy are to be seen with caution because of the lack of a control group, the lack of blinding, and the limited follow-up. Despite these limitations, it is conceivable that many patients profit from a switch to fingolimod.”


  1. Shasha says:

    MS people need to change their diet, not just rely on a drug to help block immune attacks. Vit D/sunlight may also help autoimmune issues and taking vitamins/good oils/minerals. Probiotics may help and detoxing. LDN may help block hidden gluten. Not eating gluten/dairy/soy/sugar/GMO/corn/heated oils/dehydrated food/flax/saturated/monounsaturated fat help me. I eat basically the Celiac/Asian diet. People may heal their MS fast by diet/lifestyle changes and being aware of how food/helps hurts them. Any food with a label or nuts not sold in the shell/meat basting/some spice/certified gluten free food and more may have hidden gluten. Gluten is wheat/barley/rye…oats may act like gluten with avenin. Gluten may make antibodies to the thyroid which lowers oxygen. Gluten maylower nutrients absorbed in intestines, then cells are not made right to work right to burn oxygen. Low oxygen in my brain makes my MS kick in. Best wishes.

    • Hannah Rose says:

      So do you take an MS medication. I was diagnosed, finally, in February 2000. I have been afraid to take any of the medications. My sister who was 5 years younger than I, died of “MS complications” which I believe was an anaphylactic reaction to an injected medication. Just wondering how many people are like me in being afraid of the meds. I am being bullied. I’ve been told they will not treat the horrible symptoms in my legs and back unless I take one of the poisonous MS medications. Up til now, I’ve just done symptom treatment.

      • Shasha says:

        Hi, I don’t take MS drugs. I take LDN and do the Celiac diet/vitamins/good oils/minerals/probiotic…detox. The MS drugs don’t fix the root cause of MS which for me is Celiac and are expensive…all about $5000 a month. Celiac can cause allergies due to leaky gut. Gluten can hurt thyroid and many MS people are not given thyroid medicine maybe due to a strange TSH…very low maybe due to the pituitary being hurt also due to gluten which makes TSH. Gluten can burn out adrenals which then anaphylactic shot may happen since the adrenals can’t deal with the allergy..too burned out. The legs back may heal fast. Corn also hurts me. Fish oil lowers inflammation and Vit C. Celiac may cause Osteoporosis due to low minerals absorbed in intestines.Covering symptoms doesn’t fix the root cause. Pain medicine may lower the immune system. My protocol: Best wishes.

        What I do (short version):
        No gluten/dairy/soy/sugar/GMO and vitamins/good oils, LDN and detoxing help me. Vit D3 5000IU, zinc 50mg if detoxing, 2000mg fish oil , 20000mg evening primrose oil. 2000 mg lecithin, Phosphatidylserine/DMAE, krill oil, CLA, Coenzyme Q10, Rhodiola, Mg citrate 400mg, Vit C, 5000mcg of biotin, Nature’s Plus- Source of life multiple, HCl and enzymes with meals, dairy free probiotic, Vit B12 methylcobalamin shot/spray/under the tongue kind/intrinsic factor kind, MTHF folate, coenyzme Q10, rhodiola, may help brain/body/thyroid/depression/immune system and more. Gluten is wheat/barley/rye..oats may act like gluten with avenin. GMO corn/soy/canola oil may hurt. Amour thyroid maybe needed since gluten may made antibodies to the thyroid. Coenzymated B vitamins far from synthetic kind make make me calm.

        Sunlight (helps the immune system and helps to heal the gut lining),exercise, organic food, good water..not tap water, cooking by scratch pure food….. no food in a box/bag/premade/label/restaurant which may help avoid hidden gluten. Certified gluten free food may have 20ppm of gluten…too much. Nuts not sold in the shell/meat basting/some spices may have hidden gluten and lotion/make up etc. One restaurant cooks special for me…rice/veg/tea/extra mushrooms (no meat since the woks may have MSG/gluten in them).

        EDTA/DMPS IV chelations from an Alternative doctor, 600mg of cilantro, organic sulfur, Now brand- Detox support, Far Infrared Sauna and more may help detox. Hair tests show good minerals and heavy metals. Heavy metals can block thyroid and other chemical reactions in the body/brain.

        LDN may help block hidden gluten/heal the gut lining and help the immune system, but the Celiac diet is still needed. 100% no hidden or microscopic gluten may help. Cutting back on gluten or cheating by eating gluten hurts the immune system. It may take 1 1/2 months to heal the gut lining after getting hidden gluten.

        Amour thyroid has some T3 and Calcitonin. Synthroid is only T4..may not convert to T3. Zn/Se/enough iron/strong probiotic may help convert T4 to T3 for thyroid.

        Alternative doctor/chiropractors/acupuncturist and more may help with health/vitamins etc.

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