News Release

Mallinckrodt and the Lupus Foundation of America Present Data from Survey of Over 1,500 Individuals with Self-Reported Lupus at the 2018 American College of Rheumatology/Association of Rheumatology Health Professionals (ACR/ARHP) Annual Meeting

-- Study finds individuals with lupus experience a high disease flare burden and as a result engage in preventive and treatment measures --

STAINES-UPON-THAMES, United Kingdom and WASHINGTON, Oct. 23, 2018 /PRNewswire/ -- Mallinckrodt plc (NYSE: MNK), a leading global specialty pharmaceutical company, and the Lupus Foundation of America, the national force devoted to solving the mystery of lupus, are presenting findings from a survey1 of 1,503 individuals with lupus assessing their experience, identification and management of disease flares. The findings will be presented on Wednesday, Oct. 24 at the 2018 American College of Rheumatology/Association of Rheumatology Health Professionals (ACR/ARHP) Annual Meeting (Oct. 19-24) in Chicago, IL.

According to the survey, over three-quarters (78%) of respondents experienced disease flare activity in the past year, with half reporting four or more flares; 67% described those flares as moderate to severe and 54% self-treated flares with both prescription and over-the-counter medications they had available or had been prescribed for these situations. The frequency of self-reported flares was correlated with higher Lupus Impact Tracker (LIT) scores, a validated assessment of lupus impact on patient daily functioning and well-being.

In addition, individuals who reported more flares had more hospital admissions. The researchers concluded that based on these findings, flares are a challenge that individuals with lupus face on a continual basis and provide an opportunity for increased patient-provider counseling on best practices for flare prevention and management.

The study abstract can be accessed here. The poster presented at the 2018 ACR/ARHP Annual Meeting will be available on the company's website following the close of the conference Wednesday, Oct. 24.

"Patient-centered research, like this survey, helps advance our understanding of the impact of disease on patients' lives and the need for potential individualized treatment strategies for lupus," said Tunde Otulana, MD, Chief Medical Officer at Mallinckrodt. "Given that treatment for the over 1.5 million people living with lupus is directed at symptom management, reducing disease activity and preventing or reducing disease flares, it is important to understand how clinicians and patients can work together to identify and manage flares more effectively."

"Lupus Flare Activity from the Patient Perspective" (Abstract 2912)

Key findings from the survey include:

  • 78% of respondents had flare activity in the last year; of these, half reported four or more flares and 67% perceived their flares as moderate to severe.
  • 39% of respondents could not predict when a flare would occur but listed flare triggers as: emotional stress, "overdoing it", lack of rest, and sunlight exposure.
  • The most common flare symptoms included: Extreme fatigue/exhaustion (86.8%); aching/increased swelling of the joints (80.4%); muscle weakness/pain (73.6%); headaches (61.4%); dizziness or forgetfulness (60.1%); abdominal discomfort or digestive problems (57.4%); and the development of a rash (43.6%).
  • More than half of respondents (54%) managed flares at home, most commonly with both over-the-counter products and prescription medications they had available or had been prescribed for these situations. When suffering a flare, 42% engaged the healthcare system (doctor, emergency room or hospital); more than one-third (35%) delayed seeking care for three days or more for their most recent flare; and more than half (53%) waited 24 hours or longer to seek care.
  • Respondents who suffered more flares had worse (higher) LIT scores and more hospital admissions over the last 12 months. For example, those with seven or more flares in the past year had an average LIT score of 64.9 (compared to 27.2 among those with no flares); and respondents with seven or more flares had 2.96 times more hospital admissions than those with no flares.

Study limitations: 

  • Population based surveys may not capture the most severe cases.
  • Military, hospitalized, and upper and lower socio-economic status classes were under-represented.
  • Flare frequency, severity and burden were subject to recall bias.
  • Hospital admissions were self-reported and were not confirmed by medical records or claims.
  • Non-English speaking populations were not represented in the study sample.

The study's findings showed that, while disease flare burden is high and often results in healthcare utilization, common flare symptoms may not be congruent with how clinicians define flares, which can lead to communication challenges.

"This survey demonstrates the significant challenges individuals with lupus face on a day-to-day basis and underscores the importance of effective patient-provider communication and shared decision making in setting out plans to manage flares efficiently," explained Stevan W. Gibson, President and CEO of the Lupus Foundation of America. "This important research helps further our understanding of disease management best practices."

The online survey was administered between May and October 2017 to individuals with lupus who responded to outreach from the Lupus Foundation of America or the Research Now survey research service. Data was collected from 1,503 individuals who reported having a lupus diagnosis. Survey topics included sociodemographic characteristics, flare profile, LIT and hospital admissions. The survey respondents were 45 years old on average and had been diagnosed with lupus for 12 years; 89% of the survey respondents were female; 77% were Caucasian; 33% resided in an urban area; 48% resided in a suburban area; and 19% resided in a rural area. Mallinckrodt provided grant funding to the Lupus Foundation of America to support study data collection.

Lupus is an autoimmune disease in which the immune system produces antibodies to cells within the body leading to possible inflammation and tissue damage.2 Lupus is characterized by periods of illness "flares" and remissions, and the disease can affect the joints, skin, brain, lungs, kidneys, and blood vessels.2 Lupus can range from mild to life-threatening and should always be treated by a doctor.3 Symptoms may include fatigue, pain or swelling in joints, skin rashes, and fevers.2 Lupus impacts an estimated 1.5 million Americans and strikes mostly women of childbearing age.3 However, men, children and teenagers develop lupus, too.3 People of all races and ethnic groups can develop lupus although women of color are two to three times more likely to develop lupus than Caucasians.3 Treatment is directed at symptom management, reducing disease activity, and preventing or reducing disease flares.

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; analgesics and gastrointestinal products. To learn more about Mallinckrodt, visit

Mallinckrodt uses its website as a channel of distribution of important company information, such as press releases, investor presentations and other financial information. It also uses its website to expedite public access to time-critical information regarding the company in advance of or in lieu of distributing a press release or a filing with the U.S. Securities and Exchange Commission (SEC) disclosing the same information. Therefore, investors should look to the Investor Relations page of the website for important and time-critical information. Visitors to the website can also register to receive automatic e-mail and other notifications alerting them when new information is made available on the Investor Relations page of the website.

The Lupus Foundation of America is the national force devoted to solving the mystery of lupus, one of the world's cruelest, most unpredictable, and devastating diseases, while giving caring support to those who suffer from its brutal impact. Learn more about the Lupus Foundation of America and its national lupus research program at


Investor Relations
Daniel J. Speciale, CPA
Investor Relations and Strategy Officer

Rhonda Sciarra
Senior Communications Manager

Meredith Fischer
Chief Public Affairs Officer

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. © 2018 Mallinckrodt. US-1800464 10/18

1 Nelson W, Katz P, Daly RP, Topf L, Connolly-Strong E, Reed M. Lupus Flare Activity from the Patient Perspective [abstract]. Arthritis Rheumatol. 2018; 70 (suppl 10).  Accessed October 5, 2018.

2 Lupus Detailed Fact Sheet. The Centers for Disease Control and Prevention. Available at: Accessed October 5, 2018.

3 Lupus Foundation of America. Resource Center on Lupus. What is Lupus? Available at : . Accessed October 5, 2018.


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