Details
The U.S. Food and Drug Administration (FDA) initiated this study in the Sentinel System to assess for immunosuppressive medications, which, as a side effect, reduce the body’s tumor surveillance and increase the risk of developing a malignancy. Over the last several years, the FDA has approved multiple immunosuppressive therapies for psoriasis and multiple sclerosis (MS). In this study, FDA explored the Sentinel System’s ability to surveil for malignancy by focusing on describing the duration of follow-up time after incident use of immunosuppressive medications used to treat psoriasis and MS, as well as the duration of therapy. This study also described the duration of follow-up for patients with prevalent Crohn’s disease, MS, psoriasis, and ulcerative colitis diagnoses.
Results indicated that for most immunosuppressive medications, greater than 60% of patients had follow-up time less than three years; less than 1% had greater than ten years of follow-up time. These results were further stratified by age groups and calendar year. Among patients with psoriasis, MS, or inflammatory bowel disease (IBD), the majority (greater than 65%) had less than three years of follow-up time.
Given that this study found a minority of patients had follow-up time of more than three years, the Sentinel System may have limited ability to detect malignancies that take several years to develop. This study helped understand the capabilities regarding conducting analyses using administrative claims for long-latency outcomes including malignancies.