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

Holy Name Medical Center, Inc.

Status and phase: Unknown; Phase 4

Conditions: Multiple Sclerosis

Treatments: Drug: Tylenol Pill; Drug: Plegridy; Drug: Prednisone

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03424733

US-PEG-16-10990

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Current Plegridy Users

Active Comparator group

Description:

Members in this group have been previously titrated and are currently taking the pegylated interferon beta-1 (Plegridy) injection once every two weeks. These patients will complete a total of six study injections of Plegridy (125 micrograms) totaling a 12 week study duration. Subjects must take two 325mg tablets of Tylenol 1 hour prior to each study injection, and one 20mg Prednisone tablet 4-5 hours prior to injections two through six only.

Treatment:

Drug: Prednisone

Drug: Plegridy

Drug: Tylenol Pill

New Plegridy Users

Experimental group

Description:

Members in this group have never taken the pegylated interferon beta-1a (Plegridy) injection, and so they must first by titrated by injecting with a 63 and 94 microgram Plegridy dose. Titrations, along with full dose injections (125 micrograms) occur every two weeks. Patients must take two 325mg tablets of Tylenol prior to each titration injection. The third study dosage involves subjects taking the full 125 microgram Plegridy dosage with two 325mg Tylenol tablets prior to injection. The final five study injections (four through eight) require patients to take two 325mg Tylenol tablets 1 hour prior to injection, and one 20mg Prednisone tablet 4-5 hours prior to injection.

Treatment:

Drug: Prednisone

Drug: Plegridy

Drug: Tylenol Pill