Multiple Sclerosis
Conditions
Keywords
demyelination, relapse rate, Pegylated interferon beta-1a, side effects, flu-like symptoms, injection site reactions, prednisone
Brief summary
Some of the most common side effects of the multiple sclerosis drug Plegridy (pegylated interferon beta-1a) include flu-like symptoms and injection site reactions. Physicians often advise patients to take Tylenol or aspirin prior to injection, but in this study the investigators evaluated whether using a low dose of oral steroid in combination with Tylenol reduced flu-like symptoms and injection site reactions.
Detailed description
Multiple Sclerosis (MS) is a chronic neurological disease characterized by demyelination of the brain and spine. Currently, there are several treatments designed to decrease the frequency of attacks and delay disease progression. One of these treatments, interferon beta, has shown the potential to decrease relapse rates by approximately 30%, but because the body quickly clears these proteins, patients require more frequent dosing. Another interferon therapy called pegylated interferon beta-1a (Plegridy) was released and it was shown to last longer in the body than interferon beta-1a. This is why Plegridy can be take by an injection into tissue under the skin once every 14 days. However, some of the most common side effects of interferon beta therapy include flu-like symptoms and injection skin reactions, which can often cause patients to want to stop treatment. Clinical practitioners often advise patients to take acetaminophen (Tylenol) or aspirin before the injection in order to prevent the onset or decrease the severity of flu-like symptoms. A previous study with patients taking interferon beta-1a showed that taking a low dose oral steroid (prednisone) in addiction to a medication like Tylenol reduced flu-like symptoms compared to just taking Tylenol by itself. Because Plegridy lasts longer in the body and has more convenient dosing for patients, researchers in this study decided to investigate whether taking prednisone in addition to acetaminophen before the injection would help decrease or prevent the occurrence of flu-like symptoms and injection site reactions in patients taking the therapy.
Interventions
DRUGPlegridy
Self injection into area of high adipose content. Injections include 63 and 94 microgram titration doses, and the full 125 microgram dose
DRUGPrednisone
Take one 20 milligram prednisone tablet four to five hours prior to injections two through six of the full 125 microgram Plegridy dose.
DRUGTylenol Pill
Take two 325 milligram Tylenol tablets 1 hour prior to each Plegridy injection, irregardless of dosage.
Sponsors
Biogen
Holy Name Medical Center, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Patients in both arms first take Tylenol and then take Tylenol in combination with Prednisone.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* diagnosed any form of MS (relapsing remitting, primary progressive, secondary progressive), any EDSS (expanded stability status scale) score
Exclusion criteria
* prior allergic reaction to interferon products, congestive heart failure, elevated liver enzymes
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Flu-like symptoms | 12 to 16 weeks | Reduced flu-like symptoms from Plegridy injections due to taking both Tylenol and Prednisone prior to treatment. Flu-like symptoms are measured every 6 hours for 48 hours after injection by patients self reporting their muscle aches, temperature, chills, and fatigue on a Holy Name administered Flu-like symptom questionnaire. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Injection site reactions | 12 to 16 weeks | Reduced injection site reactions from Plegridy injections due to taking both Tylenol and Prednisone prior to injection. Injection site reactions are reported to a clinical research assistant approximately one week after injection. If present, patients must record their injection site reactions using a Holy Name administered tape measurer in centimeters, as well as descriptive characteristics of the injection (location on body, swelling, redness, itching, and pain). The clinical research assistant records all of the data on an injection site reaction form. |
Countries
United States
Contacts
Primary ContactMary Ann Picone, MD
Outcome results
None listed