Evaluating IL-23 Inhibitors with Long-Term Data and Real-World Evidence

In this episode, "Evaluating IL-23 Inhibitors with Long-Term Data and Real-World Evidence," the expert dermatologists explore the distinct but complementary roles of long term extension studies and real world evidence in evaluating the durability and safety of biologic therapies for plaque psoriasis.

The panel opens by examining the value and limitations of long term extension studies. While these studies are considered valuable primarily for identifying emerging safety signals and assessing whether adverse events accumulate over time, the panel expresses some skepticism about their ability to accurately reflect long term durability of response. This is because patients who remain in long term extension studies tend to be those who are already responding well, creating an inherently enriched population that does not capture patients who may have struggled to respond early on.

The discussion then shifts to real world evidence, with the panel outlining the key sources of this data including patient registries such as CorEvitas and various country specific registries, as well as claims based data. Registries are noted as semi real world in nature given their lack of strict entry criteria compared to clinical trials, while claims based data offers insight into how long patients persist on a given therapy, though often without accompanying efficacy data unless linked to electronic medical records.

The panel emphasizes that real world data is critical because clinical trials represent a best case scenario, with carefully screened patients, controlled comorbidities, and a high level of clinical support including dedicated nursing staff, medication delivery, and appointment reminders that do not reflect everyday practice. In contrast, real world patients may have uncontrolled comorbidities, complex medication regimens, and limited support, making adherence more challenging. When comparing drug classes in real world analyses, IL-23 inhibitors are noted to generally outperform IL-17 inhibitors, TNF inhibitors, and newer oral agents in keeping patients on therapy over time.

The last episode in this series, "Integrating Comparative Evidence to Optimize Psoriasis Treatment Decisions," features the panelists advancing their conversation on psoriasis and focusing on how clinicians can synthesize MAIC analyses, long term extension studies, real world data, and anecdotal clinical experience into a holistic framework for making individualized treatment decisions and optimizing long term outcomes for patients with plaque psoriasis.