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This section focuses on reporting data from published real-world data studies in which patient data was reviewed for safety, long-term efficacy, overall survival, for drugs already used in clinical practice.

Early Real-World Data Shows Increased Patient Satisfaction, Demonstrates Effectiveness for AD Therapy Landing Page

Early Real-World Data Shows Increased Patient Satisfaction, Demonstrates Effectiveness for AD Therapy

Dupilumab is approved for patients with moderate-to-severe atopic dermatitis (AD) who have not been able to adequately control their symptoms with topical therapies. As part of the RELIEVE-AD study, researchers sought to measure the effectiveness of dupilumab for AD flares, pain-related skin symptoms, disease control, and overall patient satisfaction and found positive results.

Adults who were prescribed dupilumab and enrolled in its patient support program were eligible to participate in the prospective, longitudinal patient survey that measured patient outcomes in clinical practice. The survey was conducted at baseline, prior to dupilumab initiation and at months 1, 2, 3, 6, 9, and 12. The results of this dataset reflect the interim 6-month patient-reported outcomes.

Using the same dataset, two studies were published, the first focuses on improving symptoms and disease control, and the second focused on disease burden and patient satisfaction.

The first study was led by Bruce Strober, MD, University of Connecticut Health Center, Farmington, CT, and Probity Medical Research, Waterloo, ON, Canada, and colleagues.

Among the 674 patients who initiated dupilumab treatment, “at month 6, 41.3% and 23.3% of patients reported experiencing no or one flare in the past 4 weeks, respectively, vs 3.0% and 10.7% at baseline (both P<0.001).”

Additionally the researchers reported that, “Mean symptom ratings at baseline vs month 6 were 5.9 vs 1.8, 5.2 vs 1.6, and 5.5 vs 1.7 for skin pain, burning, and sensitivity, respectively (all P<0.001).”

Disease control was measured using the 6-item AD Control Tool (ADCT) with total scores 0 to 24 with answers less than 7 implying adequate control. Per the dataset, the mean ADCT total score decreased from 15.9 at baseline to 6.4 at month 1 and 4.8 at month 6 (both P<0.001). A similar trend was observed across mean ADCT item scores, explained Dr Strober and fellow researchers.

“Overall, 73% of patients had adequate AD control at month 6 vs 5.9% of patients at baseline (P<0.001),” according the results.

In the second study examining the same data set, Alexa B Kimball, MD, Harvard Medical School, Beth Israel Deaconess Medical Center, Boston, MA, and co-researchers (including Dr Strober), asked patients, “How satisfied are you with your current treatment(s) for atopic dermatitis?” and described the use of concomitant AD therapies following dupilumab initiation.

Treatment at baseline was defined as use in the past 4 weeks of: prescription topicals (corticosteroids, calcineurin inhibitors), PDE4 inhibitor, systemic corticosteroids, systemic immunosuppressants, or phototherapy.

Researchers of the study explained that although the dataset is still maturing, after introduction of dupilumab to their AD treatment regimen patients reported:

  • A rapid and continuous improvement in treatment satisfaction, with the majority of patients becoming extremely or very satisfied after 1 month of treatment (first time point assessed); and
  • A rapid and sustained decrease in the use of concomitant AD therapies, especially systemic corticosteroids, potentially reducing treatment burden.

“Patients who reported being very/extremely satisfied with their current AD [treatment] increased from 2.9% at baseline to 57.8% at month 1 and 70.9% at month 6 (both P<0.001),” said Dr Kimball.

Additionally, “Patients using concomitant AD [treatment] from ≥3 drug categories reduced from 13.1% at baseline, to 1.7% at month 1 and 1.5% at month 6 (both P<0.001), and use from 2 categories reduced from 34.3% to 14.7% at month 1 and 12.1% at month 6 (both P<0.001).”

Data showed similar trends for treatments with individual drug categories, including systemic corticosteroids which decreased by 73.5% by month 6. The proportion of patients without any concomitant AD therapy increased from 12.8% at baseline to 39.6% at month 1 and 41.3% at month 6 (both P<0.001).

“This dataset is still maturing, and a more complete assessment of the effects of dupilumab on disease control in the real-world clinical setting will be conducted when final data become available over the full 12-month follow-up period,” concluded researchers for both studies.

—Edan Stanley

References:

  1. Strober B, Mallya UG, Yang M, et al. Dupilumab improves outcomes in patients with atopic dermatitis (AD) in clinical practice – results from the RELIEVE-AD study. Poster presented at: The 28th European Academy of Dermatology and Venereology Congress (EADV 2019); October 9-13, 2019; Madrid, Spain.
  2. Strober B, Mallya UG, Yang M, et al. Dupilumab improves outcomes in patients with atopic dermatitis (AD) in clinical practice – results from the RELIEVE-AD study. Poster presented at: AMCP Nexus 2019; October 29-November 2, 2019; National Harbor, Maryland.
  3. Kimball, AB, Mallya UG, Yang M, et al. Dupilumab improves treatment satisfaction and reduces treatment burden in adults with atopic dermatitis: results from the RELIEVE-AD study. Poster presented at: The 28th European Academy of Dermatology and Venereology Congress (EADV 2019); October 9-13, 2019; Madrid, Spain.