Mallinckrodt and the LFA Present Data from Survey of Over 1,500 Individuals with Self-Reported Lupus

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 survey  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 accessedhere. 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.