Study affirms oral disease-modifying therapies are well tolerated with high medication adherence rates
ORLANDO, Fla., April 15, 2021 /PRNewswire/ -- A recent study of patients receiving oral FDA-approved therapies used to treat relapsing forms of multiple sclerosis (MS) revealed high tolerance, low rates of adverse drug events, and similar medication adherence rates across all study medications. The retrospective study was conducted by AllianceRx Walgreens Prime, a leading specialty and home delivery pharmacy, in conjunction with Duquesne University School of Pharmacy.
MS, a chronic progressive neurodegenerative disease, affects nearly one million people in the United States with over 85 percent of patients diagnosed with relapsing-remitting disease (RRMS). The primary treatment goals are to prevent disease progression defined as reducing progressive neurological impairment, disability and incidence of relapse.
Over the last few years, more oral MS disease modifying therapies (DMTs) have received FDA approval, increasing the treatment options available for these patients. However, choosing the most appropriate therapy is patient specific and there are currently no formal guidelines on switching DMTs should a patient experience an adverse drug event (ADE), according to Scott Carson, PGY-1 resident at AllianceRx Walgreens Prime and lead author/analyst of the research. This study aimed to evaluate the oral MS disease-modifying therapies FDA-approved up until 2019 that are used to treat RRMS for efficacy, outcomes, safety and utilization.
Participants in the study included RRMS patients prescribed teriflunomide, fingolimod, simponimod, dimethyl fumarate and/or diroximel fumarate who completed initial clinical assessments, and at least one MS refill clinical assessment between July 1, 2019 and Dec. 31, 2020.
During the study, researchers analyzed pharmacy claims and clinical data of 10,370 patients who met study inclusion criteria; the sample was predominantly female, between 40 and 59 years of age, and resided in the Midwest and South. A total of 257 patients (2.48%) switched from one oral DMT to another, including 46.3% switching to a different oral DMT drug class and 53.7% switching within the same oral DMT drug class.
Carson says apart from geographical location, the demographics matched up with what is currently known about MS, such as how females are much more likely to be diagnosed than males. "Our findings revealed more patients in the southern part of the U.S. compared to the north. The study found no statistically significant difference in medication adherence as measured by Proportion of Days Covered (PDC) based upon the presence or absence of a patient-reported ADE. This may be an indication oral DMTs are well tolerated from an ADE perspective," he says. "However, the analysis only accounted for presence/absence of an ADE and did not account for their type, frequency or severity."
Carson says the findings have important takeaways for patients, providers, payers and pharma. "Patients may realize these types of therapies are generally well tolerated and have good rates of medication adherence which may help delay MS disease progression," he says. "The findings demonstrate to providers the current utilization of the study medications, information related to patient-reported ADEs, and provide insight on what patients can expect from switching therapies since there are no universally accepted guidelines for this." Carson adds that identifying causes of non-adherence is also important to payers from a cost-savings standpoint and pharma from a utilization standpoint.
Rick Miller, BS Pharm, MBA, MS Pharm, CSP, vice president of clinical and professional practice at AllianceRx Walgreens Prime and an author of the study, noted the findings demonstrated patient-reported ADEs aligned with the ADEs reported in the package inserts of the study medications.
"The study demonstrated that real world ADE data aligned with clinical trial ADE data – an important finding," he says.
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