Why does real world evidence (RWE) matter?
Clinical trials happen in a highly controlled setting and while they are extremely useful in gathering robust information about drugs and how they work, there are many more variables that might affect how a drug works in a real-life setting outside of clinical trials e.g. different patient populations and environments. Therefore, RWE is a vital data source in understanding whether the results we see in clinical trials are translated into patients’ everyday life.
What were we investigating?
Treatment-resistant depression (TRD) has a major negative impact on patients’ quality of life, their relationships and on their work. The aim of this RWE study was to assess various demographics, disease burden, healthcare resource use and treatment outcomes with current standard of care over time among patients with TRD in Europe, as these are currently not well understood.
How did we do it?
This study was a prospective, multicenter, observational cohort study of adult patients with moderate to severe TRD, conducted in Europe.
Patients with TRD and moderate to severe depression (N=411)
Patients with TRD started a new treatment for major depressive disorder (MDD) in addition to, or to replace, their previous treatment in line with local standard of care.
New treatment, in line with local standard of care: Monotherapy or Combination therapy or Augmentation therapy
Data were collected on socio-demographics, clinical characteristics, treatments, treatment outcomes, disability, daily functioning and Health-related Quality of Life (HRQoL) at baseline, month 6 and month 12.
What did we discover?
At 6 months, nearly 75% of patients showed no response to treatment.
At 12 months, 70% of patients showed no response to treatment.
Patients who did not respond to treatment showed high measures of functional impairment and low HRQoL scores.
What does this mean for patients?
- Remission failure
Despite complex treatment regimens, most patients failed to achieve remission, and showed only small improvements in disease severity, disability and functional impairment, and quality of life.
- Personal burden
The high levels of impaired daily functioning and poor HRQoL in patients who failed to respond to
treatment at 6 and 12 months indicate a personal and societal burden.
These results highlight the need for new treatment strategies for patients with TRD.