Patient Survey Studies Find Multiple Sclerosis Relapse is Underreported; Approximately Half of Patients Do Not Always Engage with Healthcare Practitioners During Relapse

STAINES-UPON-THAMES, United Kingdom, Oct. 27, 2017 /PRNewswire/ -- Mallinckrodt plc (NYSE: MNK), a leading global specialty pharmaceutical company, today announced results from two company-sponsored surveys – the Multiple Sclerosis in America 2017 Survey (Poster P805) and a national patient survey conducted by Harris Poll (Poster P1267) – that suggest patient-reported multiple sclerosis (MS) relapse rates may be higher than often thought. The surveys found that approximately one in every two patients experiencing a relapse do not always report it to their healthcare provider (HCP). The findings are being presented at MSParis2017, the 7^th Joint ECTRIMS-ACTRIMS Meeting, from October 25-28, in Paris, France.

"The surveys provide valuable patient insights that underscore the need for further education about MS relapse and its treatment," said Tunde Otulana, MD, Chief Medical Officer at Mallinckrodt. "Increased engagement and timely follow-up during and after relapse should be prioritized to enhance patient satisfaction with their treatment plan."

"Relapse Prevalence, Symptoms, and Health Care Engagement: Insights from Patients with Multiple Sclerosis from the Multiple Sclerosis in America 2017 Survey" [Poster P805] includes data of 5,311 patients with MS on the prevalence and characterization of MS relapse and HCP engagement during and after relapse. The annual survey was fielded online in the first quarter of 2017 by Health Union, LLC, a company that cultivates online communities for people with chronic health conditions, including MS. All participants were required to have been diagnosed with MS and to live in the U.S.

Key Findings

• 72.2% reported having relapsing-remitting MS; 12.1% reported having secondary-progressive MS; 9.3% reported having primary-progressive MS; and 6.5% were unsure how to characterize their MS.
• Roughly three-quarters (74.8%) of respondents with a relapsing form of MS reported current use of disease-modifying therapies (DMTs).
• 73.1% of respondents reported experiencing at least one relapse in the past two years.
• Annualized relapse rates amongst all respondents were: <1 per year (44.1%), 1-2 per year (35.5%), and >2 per year (20.2%).
• 46.9% of respondents with relapses said they always or often contact their HCP during a relapse; 45.8% said they sometimes or rarely contact their HCP during a relapse; and 7.3% said they never contact their HCP during a relapse.
• Common reasons for patients not engaging their HCP during a relapse were: relapse is not severe enough (57.9%), HCP is unhelpful or didn't tell me I should (30.9%), medications are ineffective or not well tolerated (25.6%), preference to manage alone (24.4%), financial or insurance barriers (16.1%), or had medication on-hand (10.0%).
• More frequent patient engagement of an HCP during a relapse was associated with lower relapse frequency.
• In addition, patients were more satisfied with both their provider and their overall treatment plan when HCP follow-up occurred within one month of reporting of the relapse (both p<0.001).

Poster P805 Limitations

• Surveys reflect convenience samples, and are subject to participation bias and recall bias. Respondents may be different and non-generalizable to the MS adult population.
• Relapse was recalled over a two-year period. Relapses are more likely to occur over longer timeframes, so recoded one-year rates may be elevated.
• Validated scales/measures were not used throughout the survey; measurement properties were not formally assessed prior to use, leading to a potential lack of clear interpretability. Such challenges in conducting voice of patient research are not uncommon.

"Understanding Patient Underreporting of MS Relapses: Insights from a 2017 Survey of Patients with Multiple Sclerosis" [Poster P1267] highlights results from a survey of 250 adults (at least 18 years of age) with MS who had a relapse within the past three years. The survey, conducted online by Harris Poll on behalf of Mallinckrodt between March 14, 2017 and April 4, 2017, sought to determine the percentage of MS patients who do not consistently report symptoms of relapse to their physicians, as well as their reasons for underreporting.

Key Findings

• While most patients (91%) believe it is at least as important (if not more important) to treat relapses as their MS, half (51%) said they do not always contact their physician when they suspect they are experiencing a relapse.
• A majority of those who do not always report their suspected relapses cited their reason for not doing so as believing the relapse would resolve on its own and didn't need to be treated (67%).
• Regardless of their relapse-reporting behavior, patients had a similar understanding of the common indicators of a relapse.
• Patients who always reported suspected relapses were more likely versus those who did not to:
• strongly agree that their doctor has spent time educating them about the signs and symptoms that could indicate a relapse (54% vs. 24%);
• state that it is very important to monitor for signs and symptoms of a relapse (83% vs. 51%), report symptoms regardless of severity (83% vs. 51%), and seek treatment for their relapse (80% vs. 48%); and
• be very satisfied with prior steroid therapy (39% vs. 17%) and be willing to be treated again with IV steroids (94% vs. 65%).

The posters with additional study details are available on the Mallinckrodt website.

ABOUT MULTIPLE SCLEROSIS
MS is a neurologic disorder that affects the central nervous system (i.e., the brain and spinal cord).¹ An MS relapse, or flare-up, can bring new or worsening symptoms.² Symptoms can include fatigue, balance/coordination issues, numbness or tingling, vision problems, muscle spasms, tremors and emotional changes.³

ABOUT MALLINCKRODT
Mallinckrodt is a global business that develops, manufactures, markets and distributes specialty pharmaceutical products and therapies. Areas of focus include autoimmune and rare diseases in specialty areas like neurology, rheumatology, nephrology, pulmonology and ophthalmology; immunotherapy and neonatal respiratory critical care therapies; and analgesics and hemostasis products. The company's core strengths include the acquisition and management of highly regulated raw materials and specialized chemistry, formulation and manufacturing capabilities. The company's Specialty Brands segment includes branded medicines and its Specialty Generics segment includes specialty generic drugs, active pharmaceutical ingredients and external manufacturing. To learn more about Mallinckrodt, visit www.mallinckrodt.com.

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Mallinckrodt, the "M" brand mark and the Mallinckrodt Pharmaceuticals logo are trademarks of a Mallinckrodt company. Other brands are trademarks of a Mallinckrodt company or their respective owners. ©2017 Mallinckrodt. ARDUS/01-01/1017/0088 10/17.

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¹ Multiple Sclerosis Foundation. Get Educated-Common Questions-Multiple Sclerosis. Available at: https://msfocus.org/Get-Educated/Common-Questions#What is Multiple Sclerosis. Accessed July 21, 2017.
² National Multiple Sclerosis Society. Relapsing-remitting MS (RRMS). Accessed April 19, 2016 at http://www.nationalmssociety.org/What-is-MS/Types-of-MS/Relapsing-remitting-MS.
³ Multiple Sclerosis Foundation. Symptoms of Multiple Sclerosis. Accessed October 17, 2017 at http://msfocus.org/Symptoms-of-Multiple-Sclerosis.aspx.

SOURCE Mallinckrodt plc

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