Evaluating the Use of Prednisone to Decrease Pegylated Interferon Beta-1a Side Effects



Status:Recruiting
Conditions:Neurology, Multiple Sclerosis
Therapuetic Areas:Neurology, Other
Healthy:No
Age Range:18 - Any
Updated:2/9/2018
Start Date:September 25, 2017
End Date:July 1, 2018

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A Trial of Prednisone and Acetaminophen Versus Acetaminophen Alone in Minimizing Flu-like Symptoms From Pegylated Interferon Beta-1a

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.

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.

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
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Teaneck, New Jersey 07666
Phone: 551-208-3003
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