Breaking News
April 20, 2018 - Teva and Procter & Gamble Company terminate PGT Healthcare partnership
April 20, 2018 - People diagnosed with traumatic brain injury may have increased risk of Parkinson’s disease, shows study
April 20, 2018 - Researchers use smartphone to diagnose people infected with Loa loa worm
April 20, 2018 - College students with autism have high rate of suicidal thoughts
April 20, 2018 - Study sheds light on how the HSC niche is maintained
April 20, 2018 - Drug test spurs frank talk between hypertension patients and doctors
April 19, 2018 - Low-cost deworming drug improves female farmers’ physical fitness
April 19, 2018 - Genome editing identifies neural circuit behind leptin’s anti-obesity and anti-diabetes effects
April 19, 2018 - Many European countries lack comprehensive policy to eliminate viral hepatitis
April 19, 2018 - Young people with ADHD ‘more likely’ to come from deprived neighbourhoods
April 19, 2018 - SLU professor discovers new biomarkers for chlorine gas exposure
April 19, 2018 - Study proposes new mechanism that may contribute to gender differences in weight control
April 19, 2018 - Sleep restriction therapy does not interfere with insomnia patient’s driving ability, research shows
April 19, 2018 - Deep brain stimulation offers relief to UTHealth patient with treatment-resistant depression
April 19, 2018 - Study shows fatty fish and camelina oil boost HDL and IDL cholesterol
April 19, 2018 - FDA Alert: Euphoric Capsules by Epic Products: Recall
April 19, 2018 - Researchers identify peptide produced during cartilage deterioration as a potential source of osteoarthritis pain
April 19, 2018 - New breakthrough may allow scientists to orchestrate tissue regeneration in humans
April 19, 2018 - SYGNIS AG introduces new TruePrime apoptotic cell free DNA amplification kit
April 19, 2018 - Innovative device shows promise in capturing and releasing circulating tumor cells
April 19, 2018 - Researchers shed light on role of striosomal neurons in reinforcement learning
April 19, 2018 - Genetic make-up impacts long-term effectiveness of phobia treatment
April 19, 2018 - Novel biomarker can distinguish malignant lung nodules
April 19, 2018 - Study reports promising novel approach to treat therapy resistant pediatric brain tumors
April 19, 2018 - One-Hour Plasma Glucose Useful Predictor of Diabetic Retinopathy
April 19, 2018 - Hydroxychloroquine no more effective than placebo for relieving osteoarthritis hand pain
April 19, 2018 - Transplanted livers have a protective effect and reduce potential for organ rejection
April 19, 2018 - Researchers develop new method to study activity of inflammatory cells
April 19, 2018 - Researchers discover highly antibiotic resistant superbugs in Gulf States
April 19, 2018 - Smart-tooth technology shows promise in detecting certain diseases in high-risk patients
April 19, 2018 - Interaction between dioxin and HLA gene variant activates events associated with rheumatoid arthritis
April 19, 2018 - Eyes of adolescents could be associated with increased risk of cardiovascular disease in later life
April 19, 2018 - U.S. Women Less Likely Than Men to Get Statins After Heart Attack
April 19, 2018 - Health Canada grants cannabis cultivation license to High Park Farms
April 19, 2018 - Atypical brain development observed in preschoolers with ADHD symptoms
April 19, 2018 - SC Johnson releases annual Sustainability Report
April 19, 2018 - Positive attitudes about aging reduce risk of dementia in older adults
April 19, 2018 - Environmental pollutants found to worsen rheumatoid arthritis
April 19, 2018 - UT Southwestern scientists discover protein linked to metastatic breast cancer
April 19, 2018 - Study highlights need for further evidence to improve symptom management in end of life care
April 19, 2018 - Detecting diminished dopamine-firing cells inside brain could reveal earliest signs of Alzheimer’s
April 19, 2018 - Uniqsis offers high-power LED light unit for scalable flow photochemistry reactions
April 19, 2018 - Case study shows how intravascular ultrasound imaging helps detect acute aortic syndrome
April 19, 2018 - Research reveals new mechanism by which HIV evades the immune system
April 19, 2018 - Nanodisc-delivered cancer treatment helps eliminate tumors
April 19, 2018 - Functional connectivity MRI could help detect brain disorders and diseases
April 19, 2018 - Finding better way to quantify neuropathy symptoms and treatment efficacy
April 19, 2018 - Study examines effectiveness of caregiver education about sickle cell trait
April 19, 2018 - High-resolution images of tumor vasculature using new technology
April 19, 2018 - Lack of sleep may be linked to risk factor for Alzheimer’s disease
April 19, 2018 - Study finds neurotransmitter may play a role in alcohol relapse, addiction
April 19, 2018 - Researchers build molecular networks of calcific aortic valve disease
April 19, 2018 - Researchers develop highly specific apoptosis assay for pharmacodynamic analyses of tumor specimens
April 19, 2018 - Scientists decipher mechanism of chemotherapy induced female infertility
April 19, 2018 - New insight may allow researchers to design drugs that improve immune responses to vaccines
April 19, 2018 - FDA Approves Crysvita (burosumab-twza) for X-Linked Hypophosphatemia
April 19, 2018 - Researchers uncover origin of virus-fighting plasma B cells
April 19, 2018 - Study finds no evidence of lower intelligence in young children who had anesthesia
April 19, 2018 - Baboons break out of research facility briefly
April 19, 2018 - Study shows how deployment time increases risk of suicide attempt in soldiers
April 19, 2018 - Specific odors from malaria infected individuals attract more mosquitoes
April 19, 2018 - FDA Alert: Rhino 69 Extreme 50000 by AMA Wholesale: Recall
April 19, 2018 - Top HIV cure research team refutes major recent results on how to identify HIV persistence
April 19, 2018 - Experts propose new solutions to increase benefit, affordability of targeted cancer medicines
April 19, 2018 - Deficiency of innate immune adaptor TRIF shortens survival time of ALS mice
April 19, 2018 - New machine learning method offers better way to detect heart disease
April 19, 2018 - CNIO researchers determine structure of protein complex related to cell survival
April 19, 2018 - Faith-based diabetes support program launched by UTSA research team
April 19, 2018 - Volumetric Laser Endomicroscopy Helps ID Barrett’s Regions
April 19, 2018 - Engineered cartilage template to heal broken bones
April 19, 2018 - New computational framework accurately predicts drug-drug and drug-food interactions
April 18, 2018 - Some human cancers may be result of evolutionary accidents, research finds
April 18, 2018 - Higher levels of education linked to lower dementia risk in older African Americans
April 18, 2018 - Smoking Puts Blacks at Higher Risk for Heart Failure
April 18, 2018 - Physiotherapist contributes to guidelines for knee cartilage treatment
April 18, 2018 - Researchers use ‘top-down proteomics’ strategy to get new insights into cancer
April 18, 2018 - Physician assistants less likely to accurately diagnose early stage skin cancers
April 18, 2018 - New faster, streamlined method for bowel cancer detection and treatment
April 18, 2018 - Researchers identify new Listeria species in Costa Rica
April 18, 2018 - Novel interactive diagram shows many facets of mild traumatic brain injury
Extending dosing intervals makes common multiple sclerosis drug safer to use

Extending dosing intervals makes common multiple sclerosis drug safer to use

image_pdfDownload PDFimage_print

A commonly-prescribed multiple sclerosis (MS) infusion medication linked to a rare but serious side effect is safer to use when dosing intervals are extended, according to a new study led by MS specialists NYU Langone Health.

The new research showed that extending dosing of natalizumab from every 4 weeks to every 5 to 12 weeks significantly reduced the risk of developing progressive multifocal leukoencephalopathy (PML), a rare but potentially fatal brain infection. The authors presented their findings February 2 at the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum 2018 in San Diego.

The findings could influence how neurologists prescribe the medication. “Neurologists have been looking for safer ways to administer natalizumab infusions to their patients, but there hasn’t been clear data on whether decreasing dosing frequency improves safety,” says first study author Lana Zhovtis Ryerson, MD, assistant professor of neurology at NYU School of Medicine and an attending neurologist at NYU Langone’s Multiple Sclerosis Comprehensive Care Center. “Our safety findings are clinically and statistically significant, and we believe that extending the dosing schedule of natalizumab is practice changing and may save lives.”

Natalizumab, a monoclonal antibody, is used to prevent MS relapses, improve quality of life, and slow worsening disability. The medication is indicated to be prescribed in 300-milligram infusion doses every 4 weeks.

Taking the medication longer than two years, however, may increase risk PML, which is caused by the John Cunningham virus (JCV). There have been 756 PML cases reported worldwide as of January 2018, with a global incidence rate of 4.19 per 1,000 PML cases in people treated with natalizumab. Patients who test JCV antibody-positive are typically either told to not to start natalizumab, or have had treatment stopped after two years, when risk was deemed to be too high.

The new study, however, reports safety data through up to 72 months, or 6 years, when the extended dosing regimens were applied, with risk reduction for PML as high as 94 percent.

How the Study Was Conducted

Researchers reviewed data on all patients who have been exposed to JCV who are enrolled in TOUCH, the U.S. Food and Drug Administration-mandated Risk Evaluation and Mitigation Strategy (REMS) program for natalizumab that requires manufacturers to document all uses of a medication to ensure that the benefits of a drug outweigh its risks. Since the optimal extended dose schedule is not known, researchers chose to look at the data in multiple ways, with the primary definition looking at extended dose history in the last 18 months, the secondary definition looking at extended dose occurring at any time in the dosing history, and for tertiary definition looking primarily at how extended dose history affects PML risk. The results showed clinically and statistically significant risk reductions with all definitions.

The new study did not look at drug efficacy comparing extended to standard doses. However, previous research led by Dr. Zhovtis-Ryerson’s group found extending the dose up to 8 weeks did not negatively affect the medication’s efficacy in a retrospective sample of 2,000 people. The authors are planning prospective efficacy studies of extended dose natalizumab.

Natalizumab is manufactured by Biogen Idec and Elan, and sold under the name Tysabri®. Biogen provided the researchers access to their data and statistical support.

Other infusion disease-modifying therapies approved to treat MS include the drugs alemtuzumab and ocrelizumab. Oral and injectable medications are also prescribed.

Tagged with:

About author

Related Articles