Breaking News
July 17, 2018 - Women Often Unaware of Their Hospital’s Religious Affiliation
July 17, 2018 - CRISPR editing reduces repetitive behavior in mice with a form of autism
July 17, 2018 - Scientists use magnets to detect cancer
July 17, 2018 - Microfluidic chip to detect sepsis proves successful in clinical study
July 17, 2018 - Research provides better understanding of mechanisms underlying memory storage
July 17, 2018 - A Multi-Modal Approach for the Early Detection of Breast Cancer
July 17, 2018 - Mailing colorectal cancer tests to patients increases screening rates, report researchers
July 17, 2018 - Scientists find possible sources of medicinal and antimicrobial drugs
July 17, 2018 - Molecules formed when the body metabolizes omega-3 fatty acids may inhibit cancer
July 17, 2018 - Efficient communication between hospitals improves patient safety and reduces mortality
July 17, 2018 - Study highlights potential of fetal gene therapy to prevent lethal neurodegenerative disease
July 17, 2018 - For Americans, in Science They Trust
July 17, 2018 - Combating HIV/AIDS | NIH MedlinePlus the Magazine
July 17, 2018 - Study shows minorities widely underrepresented in autism diagnoses
July 17, 2018 - Multigene testing replacing BRCA tests for breast cancer risk | News Center
July 17, 2018 - Pre-clinical pilot study shows promising results of ‘concussion pill’
July 17, 2018 - Researchers reduce size of tumors in mice by artificially activating the brain’s reward system
July 17, 2018 - New study documents symptoms of people before they acquire multiple sclerosis
July 17, 2018 - Researchers discover why CRISPR gene editing sometimes fails
July 17, 2018 - New finding may hold key to better understand the complexities of neurological disorders
July 17, 2018 - The Current issue of “The view from here” is concerned with Novel Targets.
July 17, 2018 - Fighting the Flu with a Universal Vaccine
July 17, 2018 - Key social reward circuit in the brain impaired in kids with autism | News Center
July 17, 2018 - Insight into causes, types and treatment of aphasia
July 16, 2018 - Quark Pharmaceuticals, Inc Announces First Patient Dosed in Phase 3 Clinical Trial of QPI-1002 for Prevention of Acute Kidney Injury Following Cardiac Surgery
July 16, 2018 - NSAIDs shown to have causal role in cardiovascular risk of patients with osteoarthritis
July 16, 2018 - PET scan tracer predicts success of cancer ‘vaccine’ | News Center
July 16, 2018 - Parents struggle with what to do when their child has headache, shows study
July 16, 2018 - Outrageous or overblown? HHS announces another round of ACA navigator funding cuts
July 16, 2018 - Weight loss surgery may impact individual’s risk of developing cancer, shows study
July 16, 2018 - Alexion Submits Application for Priority Review and Approval of ALXN1210 as a Treatment for Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) in the U.S.
July 16, 2018 - Restoring epigenetic balance reinstates memory in flies with Alzheimer’s disease symptoms
July 16, 2018 - Magnetized wire could be used to detect cancer in people | News Center
July 16, 2018 - Non-surgical management found to be feasible option for penetrating kidney trauma
July 16, 2018 - California clinic screens asylum seekers for honesty
July 16, 2018 - FDA Approves Xtandi (enzalutamide) for the Treatment of Men with Non-Metastatic Castration-Resistant Prostate Cancer (CRPC)
July 16, 2018 - Can nanotechnology help treat Alzheimer’s?
July 16, 2018 - Researchers identify protein essential for making stem cells | News Center
July 16, 2018 - Severe childhood infections linked with lower school achievement in adolescence
July 16, 2018 - Radiologist discusses causes, treatments of varicose veins
July 16, 2018 - Researchers develop nanostructured surface to accelerate wound healing after dental implants
July 16, 2018 - New non-invasive procedure to reposition kidney stones could benefit astronauts
July 16, 2018 - Attending Surgeon Influences Genetic Testing in Breast Cancer
July 16, 2018 - Medical doctors with addictions fear professional repercussions if they seek treatment
July 16, 2018 - 5 Questions: John Ioannidis calls for more rigorous nutrition research | News Center
July 16, 2018 - University of Illinois buys 3D-Bioplotter for regenerative biology, tissue engineering research
July 16, 2018 - Charité’s researchers integrate open-source platform into the ‘Human Brain Project’
July 16, 2018 - SUSU scientists develop rehabilitation device for people with lower limbs injuries
July 16, 2018 - Researchers find definite increase in scooter-related injuries
July 16, 2018 - Researchers solve mystery of final blood group system
July 16, 2018 - Researchers develop near-infrared fluorophores-based PDT to cure cancer with less side effects
July 16, 2018 - Traumatic brain injury biomarker could help predict patient prognosis
July 16, 2018 - Researchers to investigate role of hormones in mosquito’s ability to use human blood for egg production
July 16, 2018 - AHA: Doctor Makes Lifesaving House Call in His Own Home
July 16, 2018 - Nearsightedness – Genetics Home Reference
July 16, 2018 - Study shows biomarker panel boosts lung cancer risk assessment for smokers
July 16, 2018 - Researchers find link between bereavement during pregnancy, child’s mental health | News Center
July 16, 2018 - Legalizing same-sex marriage has meaningful effects on health care access for sexual-minority men
July 16, 2018 - New York to allow medical marijuana as substitute to opioids
July 16, 2018 - Reducing tapeworm infection could improve academic performance, reduce poverty | News Center
July 16, 2018 - Researchers describe key role of enzyme in regulating immune response against Chagas disease parasite
July 16, 2018 - Johnson & Johnson Announces Publication in The Lancet Highlighting Robust Immune Response to Janssen’s Mosaic-based Preventive Vaccine Regimen for HIV
July 16, 2018 - Do Racial and Gender Disparities Exist in Newer Glaucoma Treatments?
July 16, 2018 - Antibodies may predict transplant rejection risk
July 16, 2018 - New center sets out to stop disease before it starts | News Center
July 16, 2018 - FDA warns consumers about criminals sending fake warning letters
July 16, 2018 - Residential segregation linked with racial disparities in firearm homicide fatalities
July 16, 2018 - UW-Madison researchers develop new method to track Parkinson’s damage in the heart
July 16, 2018 - New approach to cultivate hypoallergenic tomato and strawberry varieties
July 16, 2018 - Smoking associated with delayed shinbone healing
July 16, 2018 - Sheila Dolezal, ‘team player extraordinaire,’ wins 2018 Amy J. Blue Award | News Center
July 16, 2018 - Advanced Prostate Cancer Variant More Common Than Thought
July 16, 2018 - New ways to conquer sleep apnea compete for place in bedroom
July 16, 2018 - Renowned microbe hunter Stanley Falkow dies at 84 | News Center
July 15, 2018 - FDA Slaps Stronger Warnings on Potent Class of Antibiotics, Fluoroquinolones
July 15, 2018 - Don’t let depression keep you from exercising
July 15, 2018 - Student research symposium showcases curiosity and scholarship | News Center
July 15, 2018 - Heavy smokers have increased risk of heart rhythm disorder, shows study
July 15, 2018 - Parents who had severe trauma, stresses in childhood more likely to have kids with behavioral health problems
July 15, 2018 - At colloquium, a range of views on value of predictive algorithms | News Center
Oral Drug Beats Interferon in First Pediatric MS Trial

Oral Drug Beats Interferon in First Pediatric MS Trial

image_pdfDownload PDFimage_print

Action Points

  • Note that this study was published as an abstract and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.

PARIS — In the first randomized controlled trial in pediatric multiple sclerosis, fingolimod (Gilenya) significantly cut relapses compared with interferon beta-1a (Avonex), researchers reported here.

In the PARADIGMS trial, children and adolescents in the fingolimod group had an 82% relative reduction in annualized relapse rate (ARR) over 2 years compared with those on interferon (0.67 versus 0.12, P<0.001), according to Tanuja Chitnis, MD, of Brigham & Women's Hospital in Boston, and colleagues.

They also had significant benefits on MRI markers of disease and in terms of disability, but there were more serious adverse events with fingolimod, Chitnis reported at the joint ECTRIMS-ACTRIMS meeting.

Pediatric patients experience more frequent relapses and are more likely to accumulate physical disability at an earlier age than patients diagnosed as adults, Chitnis said. Some 3% to 5% of all MS patients have a pediatric onset of their disease.

Yet there are no approved drugs for pediatric MS. Clinicians will sometimes use the injectable therapies or some of the safer oral drugs in older children, but there are no data from randomized controlled trials to support specific recommendations.

Chitnis’ group enrolled 215 children and adolescents, mean age 15, with relapsing-remitting MS who had a mean Expanded Disability Status Scale (EDSS) score of 1.5 into the PARADIGMS study. Patients had at least one relapse in the past year or two, relapses in the previous 2 years, or they had evidence of one or more gadolinium-enhancing lesions on MRI within 6 months prior to randomization.

Kids were randomized to weekly injections of interferon or to daily, oral fingolimod up to a dose of 0.5 mg, adjusted for body weight. The study had a flexible duration of up to 2 years, and the study then switched to an open-label design. Most fingolimod patients (93%) and 75% of interferon patients completed the core phase of the study while remaining on the study drug.

In addition to meeting the primary endpoint, fingolimod beat interferon on the key secondary endpoint of time to first confirmed relapse, which was significantly delayed with fingolimod. About 86% of those on the oral drug were free of relapse at 2 years compared with 39% of those on interferon.

On MRI measures, fingolimod patients had a 53% relative reduction in new or enlarging T2 lesions (P<0.001) and a 66% relative reduction in in gadolinium-enhancing lesions (P<0.001).

Fingolimod also did better at reducing the annual rate of brain atrophy over 2 years compared with interferon (-0.48 versus -0.80, P=0.014), and time to 3-month confirmed disability progression (CDP) was significantly delayed with fingolimod — 95% of those on the oral drug were free of 3-month CDP at the end of the study compared with 85% of those on interferon.

There were more serious adverse events in the fingolimod group at about 18% versus 9%. Leukopenia occurred in about 2% of fingolimod patients compared with none in the interferon group, and there were four seizure events with the oral drug but none with interferon. Regular adverse events, however, were more common with interferon.

Jerry Wolinsky, MD, of the University of Texas Health Science Center in Houston, which was a trial site, called the results “impressive,” and said fingolimod drugmaker Novartis will likely get a “favorable review to extend labeling to this age group by regulatory agencies, making use in children supportable by class I evidence.”

John Corboy, MD, of the University of Colorado Denver, said his center starts all their pediatric MS patients on a highly efficacious therapy, usually natalizumab (Tysabri).

“They’re in a much better position to benefit,” he said. “We want their brains to fully fill out their skulls.”

He said that across the U.S., relatively few pediatric MS patients receive treatment at all. “To me, that’s malpractice,” he stated.

The study was supported by Novartis.

Chitnis disclosed relevant relationships with Novartis, Roche, Biogen, Marck, Serono, and Verily.

1969-12-31T19:00:00-0500

last updated

Tagged with:

About author

Related Articles