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

Background: Multiple sclerosis (MS) is a chronic neurodegenerative disease characterized by clinical and subclinical attacks caused by demyelinating lesions of the central nervous system. Currently, there are several disease modifying therapies that aim to decrease the frequency of attacks and delay the disease progression. One class of therapy, interferon beta-1a, has been approved for treating relapsing-remitting MS for over 20 years. Though interferon therapy has shown the potential to decrease relapse rates by approximately 30%, these small proteins are quickly cleared by the body, and patients require frequent dosing. In 2014, pegylated interferon beta-1a (Plegridy), in which a polyethylene glycol side-chain is attached to the interferon molecule, was released and showed both a more prolonged half-life and increased systemic exposure compared to interferon beta-1a.

Objectives: Some of the most common adverse side effects of pegylated interferon beta-1a therapy include flu-like symptoms (FLS) and injection site reactions (ISR), which can often dissuade patients and cause discontinuation of therapy. The purpose of this study is to investigate whether the prophylactic use of an analgesic alone and in combination with a low dose of corticosteroids would help prevent or relieve flu-like symptoms and injection site reactions.

Methods: This study is attempting to enroll a total of 50 subjects separated into two even groups, those currently taking pegylated interferon beta-1a and those new to the injection. Patients currently taking the treatment were advised to take two 325mg Tylenol tablets 1 hour prior to pegylated interferon beta-1a injection for their first study dosage. For the next five injections, these patients would again take the advised Tylenol dose 1 hour prior and also a small dosage of Prednisone (20mg) 4-5 hours prior to injection. Subjects new to the therapy would complete the same procedure as those who had been currently taking the injection, except their first two injections would be titrations. The first and second titrations require patients to take the two Tylenol tablets 1 hour prior to a 63 microgram and 94 microgram dosage of pegylated interferon beta-1a, respectively. Participants are required to record their flu-like symptoms on a FLS Score Questionnaire every six hours for 48 hours after injection, and also measure their injection site reaction with a ruler distributed by the Investigator. A research coordinator will contact the cubjects 5-7 days after patients’ injections to inquire details regarding the size, location, and physical description of their ISR. Statistical analyses will be conducted between the two patients groups and also within each participant.

Results: This study is ongoing and data is still being collected.

Conclusions: This study is still ongoing and so conclusions cannot yet be determined 

This study was supported through an investigator grant provided by Biogen